Quality Course 3, Including Iso9001


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General quality course, includes a review of all ISO9001 clauses

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  • Flipchart. Have people any experience or knowledge of ISO9000 ?
  • Cover the basics of Quality and to use the ISO standard as a tool to implement, manage, and improve the Quality Management System in your organisation. Using the standard does not mean you have to apply for the standard – it’s just a framework to help us navigate through the areas that affect Quality.
  • Organisations operating in a competitive environment must match the world or shut down. A fundamental requirement for survival is a capacity to manage change and improvement. Having ISO9001:2000 only means you have the capability of producing good quality products.
  • Tea break.
  • Done by group work mainly. I will pick some sections for you to work on – remind me to give these out by week 3. Exam will be max 3 hours and may be a little less. It will also be open book.
  • Many other websites and many other journals. Anything by Deming. 6 sigma.
  • Divide into groups and present back. Session will end at “why is Quality important?”
  • Is a Penneys or Dunnes t-shirt the same quality as one with Nike on it ? (or Tommy Hilfiger/Calvin Klein/Sergio Tacchini/Umbro…) – depends on the manufacturer, not the brand. Do you, the customer, expect different things when you buy from Penneys or CK ? Branding does not have to mean quality. (swatch, tag heuer, maclaren, casio, vs non branded). We pay extra for the branded items – is it justified ? Why do we pay more ? What is quality ? Quality – meeting customer’s needs, fitness for purpose, price, value for money, dependability, durability, reliability, ease and cost of manufacture. Quality – conformance to agreed requirements, being on target with minimum variance. Without the commitment of people, and their conviction of the benefits of Quality, nothing else will happen. This is especially true of senior management. Fitness for purpose : a car is a way of getting from A to B. So why does it need a CD player, a cup holder, 2.4L, heated seats… ? So there seems to be some reason for going beyond fitness for purpose. What might this be ? (We have moved on from selling a need, to selling benefits, to selling a dream – if you have this item you will feel beautiful, successful, confident…) Ask one group to persuade the other why they should buy a BMW. The other group tries to persuade them to buy a Skoda. Satisfying the customer : if I order a book, the shop may say they will have it in one week’s time and to call back then. Is that satisfaction ? How might we improve on this ? Would it not be better if the shop got the customer’s phone number and said they would ring the customer when they have it ? Might it be even better if they offered to send it to them for a nominal fee (cost price) ? Why do any of this ? Retention of customer. Have you any experience of where you received good or bad service ? Have you ever been in a shop or office where you felt you were an inconvenience, that you were in the way ? Coffee shops – the teapot had a cracked lid and the spout was also cracked – what impression does this give ? Did I complain – no. Why not ? Couldn’t be bothered, and this is a problem in general – we may think we’re providing a good service but maybe people can’t be bothered to complain or maybe there is too little competition. So people may just not return, and we won’t know why. Even more so when there is little or no competition. It wasn’t too long ago when certain shops closed at lunchtime, and some still do ! How is this providing customer service ? Some of the office hours for public bodies leave a lot to be desired – some close at 4pm. Even banks – it was less than 10 years ago that they closed at lunchtime and at 3pm. Why don’t these places open on Saturdays ? Or till 8pm one day a week ? Bin services at Christmas Cafes with open topped milk jugs, cream cakes on open display, especially in the summer – what impression is being given ? What is your own experience of good and bad Quality products ? Right first time. How do we know if we are satisfying the customer ? Questionnaires, surveys, reports from sales reps, increasing sales or market share in a competitive environment, returning customers, personal recommendations, a thank you card, (increasing sales or market share in a non competitive environment may not mean much, e.g. we are using more electricity now than 20 years ago but are we more satisfied with the ESB ?)
  • Do as group work first. Who is the first person that a customer or potential customer meets ? The receptionist or shop assistant, so it is critical that these people are clued in to good customer service. The first person might be a security guard and they might be asked for something – directions, where to go for a certain department, opening and closing times… A good response from the first person of contact can leave you with a good feeling. And it shows that the organisation is interested in its employees and trains them. Have you ever gone into an organisation and the guard or receptionist knew you were due ? Doesn’t it make you feel a bit more important ? The opposite is also true. If someone makes you feel you are in the way or they give the impression they don’t care, or worse, they start slagging off their organisation – what does all this say ? What impression do you get ? While the above slide may appear simple, it has big implications, especially for top management. It used to be common for top management (and everyone else) to leave Quality to the Quality department. They set up the system, they monitored it, they saw the auditors and the Quality reps from the customers, they sorted out customer complaints… - but I would contend that the Quality department has less to do with Quality than most of the other departments. Look at it this way, if everyone in an organisation was operating in a Quality conscious manner, why would we need QC inspectors, or people to handle customer complaints ? In this ideal world, the Quality department would exist as a support department, helping people stay on top of Quality, providing information and feedback, providing training, standards, criteria... Why are suppliers important for Quality ? If you get poor Quality components, how can you make good product ? Similarly, if they deliver late, how can you deliver on time ? Similarly if the packaging is damaged, or the parts are not identified correctly… Why are customers important for Quality ? They often supply the requirements, the drawings, the specifications, the packaging requirements, the delivery requirements. They also provide feedback on how good or bad your Quality is. Outside agencies – statutory and regulatory bodies, e.g. hygiene standards, product standards. Government – employment and environment legislation Society – we have expectations from a company. We don’t expect bad service or shoddy goods or packaging.
  • Flipchart. Any other reasons ? If we don’t produce Quality, we won’t keep the customer. Especially where there are alternative suppliers. And we will get a bad name. Do you know of any organisations that produced bad Quality or had a poor reputation (Datsun : name change to Nissan. ‘Made in Hong Kong’. Some people’s internet buying experiences – orders lost, not being able to get through to the help line, not having a help line.) Sometimes, even though the Quality is not as good as elsewhere, we still buy it. Why ? Price (e.g. roast beef in a supermarket versus in a butchers. Shoes in Tylers versus Clarks). So it is important to know what market you are in – do people buy on price, Quality, or perceived value for money ? What about organisations that have no competition ? Public bodies, train service, ESB, health service. Is it any coincidence that these organisations have a reputation for poorer service or for wasting their resources (leaking pipes for water companies)? It is doubly hard for these organisations to work towards high Quality service because there is less incentive to work on improving it. It is really only in the last 10 years that these organisations have tried to improve – a people’s charter, etc. Look at doctor’s and dentists – why do they not all have a TV ? I know one doctor’s that has a TV but there’s only one channel ! People like having something to take their mind off the visit. As for the dates on their magazines… TV’s are one thing that have reduced enormously in real cost, over the years. The last two items are very important when it comes to selling Quality to top management.
  • People say that Quality is expensive but how much more expensive is it to have to re-make something that’s wrong or sort through items, or send product free of charge to replace faulty items, or have a product recall, or have to travel to a customer to sort/repair/replace faulty items, or have loads of QC inspectors, or buy more components because many are lost or damaged, etc. What about the effect on an organisation’s image if it becomes widely known that they have poor Quality products or service ? These costs have been estimated to amount to between 15 % to 30 % of turnover. One of the basic principles of Quality management is that by operating in a controlled and regularly monitored environment, with people that are Quality aware and committed, a large percentage of non conformities can be eliminated (up to 50 %). How much better it is to focus on appraisal and prevention costs, than inspection, internal and external failure costs.
  • Last slide of session one. Note that this is part of the continuous assessment process. It is important to bring these answers back next week. You do not need to discuss anything that is confidential to your organisation. END OF SESSION ONE.
  • People had a long apprenticeship. Look at the surge in the last 20 years of hand made or one-off items – jumpers, shoes, cosmetics, chocolates, furniture – as people have become more affluent, they are prepared to pay premium prices for unique goods, or goods that are perceived as being unique, or ‘in fashion’. So maybe the medieval people were right all along! Manufacturers became more efficient, and so reduced costs. Becoming more efficient and reducing costs does not, by itself, improve Quality or even guarantee Quality. We can reduce costs by making products thinner (plastic bags), using cheaper ingredients, watering down the product, buying from a cheaper source, paying less to our employees, producing more for the same time period…
  • If there is no control over the process, then a product might be ok today but not ok tomorrow. QC inspectors have an unenviable task – nobody likes them, if they are doing their job properly. Everyone feels they just turn things down for no reason and that they have an easy job. They think they are only concerned with paperwork, that the forms are filled in correctly. People also resent the power they have – that they can over rule even a supervisor when it comes to whether an item is ok or nok. Would people agree with this ? A QC inspector is there to ensure that the procedures have been followed and that the sample they are checking conforms to requirements. An organisation should allow any employee to reject an item being produced if there is something wrong with it. Is it not much cheaper to reject something early on, than when it is complete ? There will always be grey areas – some faults are more serious than others, and there can be a lot of arguing over whether to let something go or not. This can result in a production supervisor or manager going to the Quality manager, to ask for their opinion. Even the date can affect whether something ships or not – if it is the end of the month, there is more pressure to let something go. While this is completely against what Quality should be about, at the end of the day, we operate in the real world, and this happens. A Quality manager may even be over ruled by the MD in these cases. Unfortunately, this is a slippery slope. Once it has happened, it can happen again and again; eventually, the Quality department will not feel any responsibility for what they are doing because their job is being undermined – any reject decision will be questioned and taken to higher authority. If this is going to happen, why are QC there ? It shows that the people in the organisation do not understand the importance of good Quality. The only real solution is for : the production department to be committed to Quality, and the MD to support the Quality department. This will signal that Quality is important and that the decision of the Quality department is to be respected. top management to be committed to Quality.
  • Is QC responsible for Quality ? If not, why not ? The people who make something or provide a service are the ones responsible for Quality. Everything else is a support. How many of your organisations still follow this philosophy of concentrating on final inspection and QC inspectors ?
  • If there are 10 steps or processes involved in making your product, it would be nice if a fault at step one was discovered before step ten. Otherwise there is a lot of wasted added value. Why are we paying all these inspectors when there is no added value to most of their work ?
  • Procedures help repeatability – e.g. if someone is out sick, the job can still be done in the same way. Preventive / predictive maintenance : doing perhaps a weekly check on the critical items – not on everything. Over time you should record what items have failed and when and why. Then by sorting this data, you can see which items need checking most frequently. This can be mush cheaper than waiting for an item to fail and have a lot of downtime. Predictive : can use vibration measurement to determine if parts are going to fail. Or developing a history of tools to see when they wear out. SPC : run a process, determine the capability of a process, set upper and lower control limits, apply the SPC rules (stop if outside the limits, stop if there is a run of 7 or more upwards or downwards, stop if there is a cluster near the top of the range…). Common causes and special causes. There will always be common causes of variation. Done in real time.
  • Also telecomms companies, medical companies. It has now spread out so that suppliers to these industries now do the same thing.
  • It is estimated that around 25 % of organisations that are currently certified, will not achieve the new standard. And that there will be a big rush to get certified during this year – most companies have not done enough about the new standard yet.
  • Do you agree with these statements ? How would you measure service Quality ? Customer feedback forms – seen in restaurants, customer surveys – seen in airports. Bin service : how many people had an overflowing bin at Christmas ? It is obvious that over Christmas, an EXTRA service is required, but what we get is a REDUCED service. In my opinion, this would not happen if there were 2 or 3 companies competing for the business.
  • QUESTION : what is a process ? What is needed to do it properly ? Too many organisations have used the standard only for registration and not for being a way to achieve customer’s requirements. The previous version of the standard (1994) did not place emphasis on continual improvement either. They locked in to a functional approach to running the organisation, but high performing organisations focus on the needs of customers, and realised that for maximum benefit, they need to focus on processes and the flow of information.
  • Last slide before tea break. Customer focus – understand current and future customer needs, striving to exceed customer expectations. 5.2, 5.6.2, 7.2.1, 7.2.3, 7.5.4 Leadership – create and maintain a culture and be involved in achieving the organisation’s objectives. Unity of purpose and direction. 5.1, 5.3, 5.4, 5.5, 5.6.1 Involvement of people – using their full ability for the organisation’s benefit.5.1(a), 5.4.1, 6.2.2, 7.2.3, 7.3.1 Process approach – efficiently achieving the desired results. 4.1(b), 7.1, 6.2.2, 7.1, 8.5.2 System approach to management – identifying, understanding, and managing inter-related processes. 4.1, 4.2.4, 5.3, 5.4.2, 7.3.1, 7.5.1 Continual improvement – a permanent objective. 4.1(f), 5.3(b), 5.6.1, 5.6.2(g), 5.6.3, 7.3.7, (any of section 8) , 8.1, 8.2.2, 8.5.1, 8.5.2, 8.5.3 Factual approach to decision making – decisions based on analysis of data. 4.1(f), 5.6.1, 5.6.2, 7.3, 7.6, 8.2.2, 8.2.4, 8.3, 8.4, 8.5.2 Mutually beneficial supplier relationships – understanding that inter-dependence adds value to both organisations. 4.2.3, 5.6.2(a), 7.2.1, 7.4.1, 7.4.3, 7.5.4, 8.2.1, 8.4(d), 8.5.2 Organisations and their suppliers are inter-dependent. Systematic approach. Need to create individual awareness of and commitment to Quality and continual improvement. Concept of internal customer. Mutually beneficial… : when introducing a new product, check the standard items available from a supplier to see if they will meet the specifications rather than ask for a special one to be developed – takes money, time, and it can be hard to maintain availability, especially for after sales back-up. Also, encourage them to make suggestions re cost savings – common wire, components, coverings, more splices, different or no packaging, better identification on the parts coming in – maybe having your part number on it for quicker sorting. Different size cartons or different multiples per carton – ones that suit you. If your supplier is willing to do these things, the benefit for them is that you are more likely to stay with them. Tea break.
  • Divide into groups. ISO 9000:2000 defines top management as the person (or group of people) who directs and controls an organisation at the highest level. Top management leadership, commitment and active involvement are essential when implementing an effective Quality management system.
  • Management control the resources – the time allocated, the number of people involved, the amount of money to be spent (equipment, training courses). Also, and just as important, if management are not with you, not only may they block certain actions that you want to implement, but there can be occasions when the only way to get a manager from another department on-side is for the MD to make him/her comply. It has been proven by many studies, that top management commitment is THE critical factor in whether any decision gets implemented. And we need more than their approval. All employees need to see that top management are actively supporting the initiative. If Quality is said to be important, how might top management show this, in real terms ? (Having and ACTING on employee suggestion schemes; wanting to review Quality issues on a regular basis; talking to the production manager about Quality regularly; making sure Quality is always in the organisation’s newsletter; ensuring that Quality information is displayed; wanting to see what action was taken on customer complaints; wanting to know what suppliers are giving problems – this can also help their bargaining position for prices). QUESTION : how can you persuade top management to e.g. go for ISO9001:2000 ? Need to do up a presentation, showing the benefits and potential cost savings
  • Where there is a process, we need to see how it is measured (KPI’s, spec., std., target) and monitored (controlled) (int. audits, mgt. rev.) All procedures need defined responsibilities and authorities, and we should look for evidence of what happens when not achieved (mgt rev., c.a., prev. action) The type of control required depends on the likelihood of occurrence and the impact of failure – also the complexity of the tasks, staff competence, staff turnover. Core processes : design, manufacturing, marketing, sales, packaging and distribution… Supporting processes : lab, purchasing, QA, accounts, human resources.
  • Divide into groups. Exercise : An electrical repair shop repairing a faulty vacuum cleaner. (A clothes/shoe shop; a table manufacturer)
  • An electrical repair shop – we tend to think of it as I leave in the faulty vacuum cleaner, and a week later, I collect it. (The reality is often, I leave in the faulty vacuum cleaner, I call back a week later an it hasn’t been touched. The repairer says they will do it tomorrow and to call back on Friday. I do this and it’s still not done. Eventually, having called in 5 times, it is ready. Then I am charged a small fortune – for fixing a wire). But for us to define the process, there are many more steps : 1 : Repairer receives faulty vacuum cleaner. 2 : Repairer must put identification on vacuum cleaner and give ticket to customer – there must be a cross reference on the 2 pieces of identification 3 : Repairer notes what is the fault, as reported by customer (this can save a lot of time later) 4 : Before the repairer tackles the fault, they must know something about vacuum cleaners, and basic electricity, etc. So they must have some training and competence. They also need tools. 5 : The repairer makes a decision as to which items they will do first (are they a friend of theirs, has the person already been waiting a month, how much can be charged for the repair…) – though I doubt if we should include this a s part of the process – or should we ? It is up to us to decide. 6 : Work starts on the vacuum cleaner. Within this step there are several steps. There will often be a sequence to what is checked, to eliminate certain possible causes. Do we need to define each step ? A lot depends on the skill of the repair person – if they have a qualification in electrical repairs, then maybe not. Eventually the cause is found. But maybe a part needs to be ordered – this again is another process. The repairer must specify the type and model number of the machine. Now we have lead time and price to consider. So a purchase order is raised and sent off. When it comes in, it should be checked that it is the correct item. The repair is carried out. 7 : The item should be checked to ensure that the fault no longer exists, so a test process is required. 8 : The item must be marked to show that it HAS been successfully repaired. 9 : Customer collects and pays for the vacuum cleaner. Why can’t repair shops let you know how much something is going to cost and when it has been repaired ? (In my opinion, lack of competition – their margins are very high on each repair).
  • This is a pictorial representation of the standard. 6.X : Plan 7.X : Do 8.X : Check 5.X : Act Note the above does not show the input of suppliers, purchasing, accounts, etc explicitly.
  • Awards for best small service, best large service, best small mfg, best large mfg. Plus an overall winner. Previous winners include Golden Pages, British Telecom, BUPA Ireland, Dairygold and GlaxoSmithKline. 2002’s re-developed Q-Mark puts a renewed emphasis on understanding the process that will enable your business to work more effectively, and so improve efficiency, profitability and focus. By systematically mapping what your organisation does you can: • Identify the priority areas for your business • Identify the key steps in each of your main activities • Identify activities that are failing to add value to your performance • Measure your firm’s most important activities (by applying key performance indicators) • Focus your efforts and resources • Compare all aspects of your performance with other businesses (through benchmarking) • Ensure your business is improving
  • Problem with Q mark is that it is only really recognised in Ireland so it is of little benefit to export organisations.
  • Is the Q mark more recognisable to Irish consumers than ISO ?
  • What is an organisation’s primary purpose ? To maximise its gains. For a non profit organisation, it is to maximise the value of the service provided, as perceived by its customers.
  • Process owner – the person responsible for the process. Process owners, and those operating it, should own the measures and the costs. Responsibility to society – health and safety of employees and of those using the product or service, protection of the environment, including using up scarce resources and pollution. Need also to prioritise what projects to tackle.
  • How do we improve Quality ? By improving the processes of the organisation – the systems, the training. The above must be a continuous process.
  • If we have a premium product, we may be able to charge a premium price – e.g. cars, Dyson vacuum cleaners and washing machines. But we must be wary of the effect of brands. Delight factors : practices, features, services, or attributes not expected or specified by the customer e.g. ordering on internet. Get an e-mail confirmation of receipt of order and e-mail when part is shipping, may get a special offer on another product, or e.g. better than promised delivery date, better material, a free upgrade. Unfortunately, delighter factors can become mere satisfiers when they are repeated, so you have to look for something new. Satisfiers : a price reduction, better responsiveness, offering a larger range or new options. The more satisfier factors, the more satisfied is the customer. Dissatisfiers : negative conditions that are not expected, e.g. bad quality or late delivery or poor service, unco-operative staff, indifference to customer complaints. If no dissatisfier factors are present, the level of customer satisfaction will not increase. You can turn around a dissatisfier if your response is very quick or replacement sent FOC. Very hard to delight a customer who is experiencing dissatisfiers from you – must clear these up first. Dissatisfiers drive up costs and result in loss of customer satisfaction and maybe loss of customers.
  • Popularised by Professor Kaoru Ishikawa.
  • Quality assurance system – e.g. ISO9002:1994 No point in making improvements if you cannot maintain them. Need reliable data on the principal elements of customer satisfaction. Need to understand the mind of the customer in terms of current and future needs – what will make their life easier, safer, richer. Implies defining a process or task, determining the value added contribution, identifying the supplier and customer of that process, what are the inputs and controls and resources required, ensuring feedback from customer to supplier. Establish check points to confirm the goal is being reached, draw up a plan for the goal’s attainment, obtain resources, implement the plan. Project management. Similar to number 4, develop and establish measures, error proofing, remove assignable and random causes of variation, ensure capability of the process, plan for continual improvement, use the 7 tools. Understand the process, eliminate errors, streamline the process, reduce variation, plan for continual improvement. Communicate the organisation’s aims to the all employees, educate front line employees in Quality management principles, train front line employees in determining customer requirements, selection of improvement projects, quality improvement tools, management of improvement projects, team-work including cross-funcational. Make sure to do after step 6. Similar to number 6.
  • No shortage of website concerning Quality.
  • Must be aware of several areas where ‘as necessary’, ‘where appropriate’, ‘where applicable’ is used. 1 – Costs are as follows : Application fee: Euro 450, Registration assessment fee : Euro 1070 -both of these are one-off fees. Annual registration fee : Euro 600, annual surveillance fees (2 of) : Euro 1430. All fees subject to VAT @21 %. So on an annual basis, it costs about Euro 2000 to maintain it. How significant is this compared to your turnover and compared to the benefit of having some customers that you might not have, if you did not have ISO ? Each organisation must make up its own mind. An organisation can approach it differently – they can adopt the standard’s systems without going for registration. 2 – It can take up to one year to set up an organisation to obtain ISO certification, if they do not have the 1994 version. For companies with the 1994 version, it can take up to 6 months. But all of this depends on the size of the organisation. It could take less time. The commitment of top management plays a significant role also. 3 – It could be considered time consuming, but it should be evaluated against other projects and investments that the organisation considers. You would not consider it unreasonable to spread the cost of a car or a piece of machinery over 3 or 5 years, yet here we are talking about one year, and it is something that should bring long term benefit to the organisation. I consider it worth it.
  • Benchmarking – maybe you process orders on line, so you could compare yourself with Amazon.
  • This is probably the key to the whole standard. If you can get your head around this, you are well on the way to understanding the standard. The customers’ needs are one of the main driving forces for a organisation. The outsourced processes must be identified in the QMS. An organisation must be managed systematically. An organisation also needs to improve its efficiency, as well as its effectiveness. Top management should promote those activities that lead to improved performance. Use self assessment and management reviews to review data and plan for improvements. Case history report : Processes needed for the Quality management system and their application throughout the organization were not identified. QUESTION : has your organisation got a QMS ? Are there flowcharts or documentation showing the sequence and interaction of each process ? Are processes monitored ? Are the results analysed ? Is the analysis acted upon and reviewed ? How are customer requirements determined ?
  • Process approach – looking at where inputs are converted into outputs and looking at the inter relation of the processes – the output from one can be the input to another. How are these controlled and reviewed for continual improvement ?
  • The organisation needs to define the documentation and records required to operate the QMS effectively, i.e. which documents need to be established, maintained, implemented. The documentation needs to satisfy any regulatory or statutory requirements, national or international standards, and the customer requirements (and other interested parties – e.g. the local council may be interested in the waste products from an organisation). It also should be appropriate to the organisation. Documentation can be in any medium suitable to the organisation. Need a balance between documentation needed and the competence of personnel. The organisation needs an overview document showing the inter-relation between its procedures and requirements. Documentation should be evaluated on the basis of : functionality, ease of use, resources needed, policies and objectives, current and future requirements, benchmarking of documentation systems, interfaces or the organisation (suppliers, customers, other interested parties). Involve the process owners in writing up documents, instructions, acceptance criteria, forms, etc. Other procedures required by ISO 9001:1994 (e.g., contract review, design control, purchasing and training) are no longer required in ISO 9001:2000. However, defined processes for these areas are still necessary and must comply with the requirements. QUESTION : does your organisation have a Quality policy, Quality objectives, Quality manual, Quality records ?
  • Divide into groups – what are the benefits of having not just documentation, but effective documentation ? Documentation should not be excessive or generate unnecessary paperwork. It should be well planned, concise, and clear. It should also be well controlled and be consistent with the type and size of organisation. Top level – Quality policy 2nd level – Quality manual (policies, organisation chart, overall flow chart, scope, standards) For the above two levels – system audit. 3rd level – Quality procedures – method, responsibilities, records, instructions, performance indicators, how we manage things, who does what, where, when. 6 obligatory. 4th level – Work instructions – SOP’s, how something is done, may not have any because of people’s qualifications and experience. 5 th level – System records and reference documents – data generated –provides objective evidence. For the 3 above levels – compliance audit. Work instructions – detailed steps of the task and how to perform it. Not mandatory unless it is management policy. Functional documents only work at SOP level – for higher level documents, we need documents based on processes. Several procedures can be incorporated into one if it suits the organisation.
  • Last slide before tea break.
  • A Quality manual sets out the organisation’s Quality policies, procedures, and practices. It is an organisation’s written record of what they say and do – quite often they are different. A Quality manual explains the organisation’s commitment to Quality, Quality objectives, policy for Quality in its processes. Case history report : No description existed of the interaction between the processes of the Quality management system. QUESTION : does your organisation have a QM ? Have you read it ? Have you access to it ?
  • Documents are usually controlled by having certain persons authorised to issue, revise, and distribute them. Need to decide how to remove obsolete documents from circulation and to do this we need to know who has them, so we need a circulation list for all controlled documents. This will be audited to ensure that people (a) have the documents they should have, and (b) have the correct revision. It can be a good idea to sign up to an automatic standards update facility – NSAI / ILI. Printed version of documents can have a header saying :”uncontrolled if printed”, or “valid only on day of printing”. Other control is to have only one or two people able to print it – and they stamp it. All soft copies must be ‘read only’ (password protected). Ask suppliers to supply the latest rev numbers for their drawings/specs annually, or have the requirement for suppliers to supply this information on the purchase orders and in the purchasing contract. Specify the frequency of sending the information. Reference documents - forms, handouts, standards, codes of practice, specifications, that need to be consulted in order to carry out an activity. QUESTION : how is document control performed in your organisation – document issue, revision, removal, retention – where, by whom and for how long ? END OF SESSION THREE.
  • Need a documented procedure for control and maintenance of all Quality records. Records provide objective evidence that the QMS is functioning and operates effectively. They should be used as a source of data to measure process and system effectiveness and help management to determine continuing system suitability. Records include completed forms, documents and files (including computer files) which contain data or information generated as a result of performing an activity. QUESTION : How are records kept, and for what period ? Who decides this period ?
  • So the first step is to know what are the customers’ requirements – how would we find this out ? (Ask for specs, drawings, do surveys, benchmark with similar organisations and visit them, ask the customer for a sample from one of their other suppliers, think things through – put yourself in the customers’ shoes. Statutory requirements – how do we find these ? Ask relevant government department, trade/business association/institution, contact the standards authority. Need to ensure that processes are developed and implemented that enable customer requirements are fulfilled and Quality objectives are achieved. Evaluate the effectiveness of the QMS, the Q policies and objectives, decide on actions for improvement, defining responsibilities and authorities, setting KPI’s. QUESTION : how are the above determined in your organisation ?
  • Measurements include KPI’s plus perhaps, benchmarking, 3 rd party evaluation, assessing customer and employee satisfaction, assessing how the organisation’s product or service performance are perceived. The outputs from all of this should feed into the management review. QUESTION : does top management get involved in these things, in your organisation ?
  • Top management need to consider breakthrough changes as well as the small step ones (to improve the organisation’s performance). Top management should ensure the optimisation of the interaction of processes, including both realisation processes and support processes. QUESTION : does management identify future as well as current customer needs ?
  • Every sub-clause in clause 5, Management responsibility, begins with the phrase, "Top management shall." Top management must provide evidence of its commitment to developing and implementing the Quality management system, as well as continually improving its effectiveness. Management must focus on meeting customer requirements and establishing the Quality policy and objectives. Responsibilities must be defined and communicated within the organization. The system must be planned, and the results reviewed at planned intervals. Review these duties with top management and explain the expected benefits for the organisation. Top managers must be willing and active participants in the transition effort. QUESTION : are process owners given responsibility and authority ? You can delegate authority but not responsibility.
  • Last slide before tea break.
  • Need to consider all interested parties : customers, end users, employees, owners/investors, suppliers, partners, society. Why is it important to determine customer requirements ? What about determining the customers’ future requirements/needs/expectations ? What about potential customers ? What are the key product/service characteristics (for customers and end users) and how do we determine that we can meet them ? (conformity, dependability, availability, delivery, post-delivery, price, life cycle costs, safety, product liability, environmental impact. Why would we want to enhance customer satisfaction ? (To gain follow-on orders). Are there any benefits to exceeding compliance ? (feel good factor for the customer, customer can see that the organisation is improving, that they have a good system, that management are committed to the future of the organisation…). What about assessing our competitors, doing a SWOT analysis, what is our competitive advantage and will this change in the future due to e.g. technology or new products ? Send out questionnaires to customers, ask sales reps for reports. May be only able to sample your customers if you have a lot of them. Also, your customer may not be the end user, so do you want to ask the end user ? An auditor will check for proactive checking of customer satisfaction. Customer complaints are only a partial solution, and are a measure of customer DIS-satisfaction. What about the impact of interested parties – owners, partners, investors, shareholders, suppliers, the public. QUESTION : is your customer the end user ? If not, how does this affect your organisation ?
  • Need also to identify and assess the competition. In relation to employees, the organisation should identify people’s needs for recognition, work satisfaction and personal development (work satisfaction – seeing a job through, getting recognition for a job well done, having some sort of control over what you do and how you do it, …). Mutually beneficial supplier relationships : identify key suppliers, and other organisations, as potential partners, work jointly to understand customers and partners needs and expectations, and set goals to secure opportunities for continuing partnerships.
  • The Quality policy should be used to lead the organisation towards improving its performance. The policy should be an equal and consistent part of the organisation’s overall policies, vision, and strategy. The Quality policy is an auditable document, so we need to be able to demonstrate the points mentioned in it (e.g. Q objectives – what are they ?) The policy should state what the organisation does. Communicate and understood by notices, newsletters, put on employee ID cards, business cards, meetings. Review at management review. Policy should have a revision number to show that it is controlled and reviewed. The policy is a leadership document, showing a commitment to Quality. The policy must refer to continual improvement and customer satisfaction. By inference, top management must provide adequate resources to achieve the goals of the Quality objectives. Use the Quality policy statement as a framework for establishing your process and product goals. Then set specific, measurable targets on the path to attaining these goals. The Quality policy shall be defined, documented, understood, implemented, maintained and responsibilities/authorities allocated and resourced. A person shall be ultimately responsible. QUESTION : what is your organisation’s Quality policy ?
  • Specific, measurable, achievable, realistic, time based. Meeting the objectives should lead to improvement – there is nothing to be gained by having targets that are the same, or lower, than your current performance. The Quality objectives must be reviewed. Product objectives will largely be determined by your product specifications. Focus your attention on the process objectives and the methods you'll use to measure process performance. These objectives must be established at the relevant functions and levels within your organisation.
  • Zero defects may be an objective, but is it realistic/achievable ? Objectives can include : customer complaint level, rework, yield, credit note quantities and value, product returns, supplier performance, warranty claims, t/o per customer. Don’t measure everything that can be measured – prioritise. In order to measure you need a realistic target. QUESTION : what are your organisation’s Quality objectives ? How are they set ? Who is involved in setting them ? END OF SESSION FOUR.
  • Need to identify and plan activities and resources needed to achieve Quality objectives.
  • What is the difference between strategy and objectives ?
  • Give examples of infrastructure – work instructions, ergonomics, heat and light. QMS planning must be reviewed periodically.
  • Last slide before tea break.
  • This can be done in the Quality manual or in job descriptions. People need to be given the responsibility AND authority to enable them to contribute to the achievement of the Quality objectives. Everyone should be aware what is their role in relation to the QMS. QUESTION : who is responsible for what, in your organisation ? Is it documented ?
  • The management representative must be given sufficient authority to carry out their role in the management, monitoring, evaluation, and improvement of the QMS. The mgt rep may also be in contact with customers and other interested parties on matters relating to the QMS.
  • E-mails, meetings, newsletters, recognition for achievements, notice boards, websites, intranets, employee surveys and suggestion schemes, briefings…
  • Planned intervals usually means once or twice per year. Obviously some areas only need an annual review – Q policy, Q objectives, maybe some training sections, purchasing… QUESTION : does your organisation carry out management reviews ?
  • Don’t combine the Quality mgt rev with env. or H & S one. Make sure to distribute charts/results well before the meeting, and state what is expected from each manager as a result.
  • The management review should go beyond mere verification of the effectiveness of the QMS, but should be a process that extends to the whole organisation, and also evaluates the efficiency of the QMS. To add value to the organisation, top management should control the performance the realisation and support processes, by reviewing them, using the Quality management principles. END OF SESSION FIVE.
  • The inputs should include elements to review both efficiency and effectiveness.
  • Other items : marketplace evaluation and strategies, status of strategic partnership activities, social, environmental, statutory and regulatory changes.
  • The management reviews should result in the identification of opportunities for improvement.
  • Marketing : may have to alter the position in the market if we want to go for a higher Q or lower Q niches. When auditing the management review, look for minutes, action plans, list of attendees and their titles (are top management at the meeting ?)
  • Resources include : people, equipment, training (to enhance competence), information, suppliers, partners, natural and financial resources, facilities, intellectual property, organisation structure, I.T., developing future managers. Resources need to be also provided at the correct time.
  • Last slide before tea break.
  • Most people in an organisation affect or can affect Quality, so this is a broad requirement. It is through people that the effectiveness and efficiency of the QMS will be improved.
  • QUESTION : has anyone had experience of not having the responsibility and authority ?
  • The training needs are determined by, among other things – the nature of the organisation’s processes, training level of people, organisation culture, new technology, new products… The objective of training is to provide people with knowledge and skills, which, together with experience, improve their competence and the performance of the organisation. Need to verify that people are competent and be able to demonstrate this. Maybe give tests – give them samples of good/bad product : get them to identify the faults and separate the good from the bad. Appraisals are part of re-evaluating training.
  • If someone does a training course, it is not really sufficient for the HR department to evaluate it to see if it is effective. It should be that person’s manager.
  • Weather and climate can affect farmers or food growers. Geological aspects affect whether to mine, or drill for oil.
  • The work environment should have a positive influence on motivation, satisfaction, and performance of people, in order to enhance the performance of the organisation. QUESTION : are there any things your organisation could do to make your work easier/better ?
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  • QUESTION : what would happen if there was a flood, or fire, or the water supply stopped for some reason ? What would happen if your computer system broke down ? Do you keep regular backups ?
  • This is the only section where a organisation can specify exclusions under the standard, but it must be able to show that the exclusions do not affect the organisation’s ability to provide product/service which meets the customers’ requirements. All exclusions must be mentioned in the Quality manual. Remember that not every product/service that the organisation provides must be covered by certification.
  • Identifying an exclusion does not absolve an organisation from responsibility to provide a product/service that meets customer and applicable regulatory requirements. Exclusions are limited to : the nature of the product/process, customer requirements, applicable regulatory requirements.
  • The organisation must satisfy itself that it has the capability to satisfy customer and other interested party requirements. Support processes (e.g. maintenance, calibration, accounts) are also critical to the success of the organisation. By identifying the inputs, the organisation can later use these to ensure that verification and validation are accomplished. The inputs can be internal or external. Remember that often, the output of one process is the input to another. Critical product features should be identified in order to develop an effective and efficient plan for controlling and monitoring the activities. Inputs can include competence of people, documentation, equipment capability and monitoring, health and safety, and work environment. Realisation processes add value, but support activities tend to add value indirectly.
  • To ensure product realisation, the organisation needs to consider support processes, desired outputs, process steps, activities, flows, control measures, training needs, equipment, methods, information, materials, and other resources.
  • Improved customer satisfaction, improved use of resources, reduction of waste are examples of measurable results achieved by greater effectiveness and efficiency of processes. QUESTION : how does your organisation know that the people have the skills to do their work ?
  • Support activities include : managing information, training of people, finance-related activities, infrastructure and service maintenance, application of safety and protective equipment, marketing.
  • Last slide before tea break.
  • QUESTION : are processes evaluated to ensure they are reliable and repeatable ? Are potential non conformities identified and prevented ?
  • QUESTION : are products/services validated to ensure they meet requirements ?
  • The organisation must satisfy itself that it can properly complete the contract and meet customer requirements. After sales support can be a big issue, particularly where tooling is involved. Who maintains it and how is it done ? Who pays for it ? For how long is it kept ? If it is cheaper to modify it for the new product, how is old product to be supplied ? What about components that become obsolete on the new product but are needed for after sales – what stock should be kept, for how long, what is the MOQ for ordering them, will the supplier guarantee to supply for the required period ? Contract requirements, competitor analysis, benchmarking, market research, processes due to statutory or regulatory requirements. QUESTION : do you have any after sales requirements where the above needs to be taken into account ?
  • How does the organisation translate the customer requirements into organisation requirements ? Need to identify and review all relevant information.
  • Acceptance of orders or of order changes, submission of tenders. In some cases, e.g. internet sales, a formal review of each order is impractical. Here, the review can cover catalogues or advertising material. Changes to orders should be in written form (e-mail is acceptable). Could state in Quality manual that all orders are automatically accepted unless the organisation goes back to the customer. END OF SESSION EIGHT.
  • QUESTION : how does your organisation do each of these ?
  • Top management should ensure that the organisation has defined, implemented, and maintained the necessary design and development processes to respond effectively and efficiently to the needs and expectations of its customers and other interested parties. The organisation should consider life cycle, health and safety, testability, usability, user-friendliness, dependability, durability, ergonomics, the environment, product disposal, and any identified risks. The organisation must ensure that the interfaces between different groups are properly managed, to ensure effective communication and clarity of responsibilities. So the organisation needs to define who is involved and who is responsible. Risk assessment should be carried out to assess the potential for, and potential effect of possible failures or faults in processes. The results should be used to define and implement preventive actions to mitigate identified risks, including risks to users. Risk assessment tools include : FMEA, fault tree analysis, relationship diagrams, simulation techniques, reliability prediction.
  • Also need to take account of inputs required for safe use of the product (operation, installation, application, storage, handling, delivery, disposal requirements…). The organisation should also take into account, the needs and expectations of the end user, as well as our customer. User input can contribute to robust design. Industry codes of practice, national or international standards.
  • Design and development output documents should be approved before being released. A prototype may need to be built. Last slide before tea break.
  • Reviews should be held by the appropriate people – top management must ensure this. The reviews are to verify that the design and development objectives are achieved. Reviews should be held at designated points during the design process, as well as at completion.
  • The review should also include a review of the design and development outputs, as well as the processes, in order to satisfy the needs and expectations of both customers and people within the organisation who receive the process output. An organisation might set up a pilot line or make a small batch or customer evaluation. The review should look for product/service and process improvement, usability of output, adequacy of process and review records, failure investigation activities, future design and development process needs.
  • The design and development outputs should be reviewed to ensure that the needs and expectations of customers are satisfied (as well as the employees who receive the process output. Other interested parties should also be considered.
  • Very important to do this to offer some protection in relation to product liability and litigation. Can you include the customer as part of the validation process ? Validation of a training course is usually the feedback from attendees, but this feedback should feed back into the planning process. Validation is important for the successful reception and use by customers, employees, and other interested parties.
  • Changes should be reviewed by the designer(s) and the customer before incorporation into the design. A customer may give a concession to allow a change that was not planned (maybe a component is no longer available, or packaging may have to be changed). Need to ensure that only the latest agreed designs are being worked on (document control). The changes should be benefit the organisation and satisfy the needs and expectations of all interested parties. Changes should be identified, recorded, evaluated, reviewed, and controlled. Outputs in the form of products/service should be validated after any related change, to ensure that the change has had the desired effect. Simulation techniques can also be used to plan for prevention of potential failures in processes.
  • Top management should ensure that effective and efficient purchasing processes are defined and implemented for the evaluation and control of purchased products/services, in order that the products/services satisfy the organisation’s needs and requirements, as well as those of interested parties. Suppliers should be selected and evaluated on the basis of their ability to supply product in accordance with the organisation’s requirements. What about customers that are imposed on you by the customer, or situations where there is only one supplier of that product or service ? The use of electronic linkage with suppliers should be considered in order to optimise communication of requirements. Requirements shall be clearly defined in contracting/purchasing data. The effectiveness of the subcontractor's QMS shall be assessed. Any client supplied materials/documents shall be controlled.
  • The organisation should be able to identify potential sources for purchased products and services, and be able to develop existing suppliers and partners.
  • If our only criteria for using a supplier (making them an approved supplier) is that they have ISO9001:2000, then all PO’s should state ‘…to supply product/service x in accordance with ISO9001:2000. If this is not stated, then it’s a non conformance against clause 7.4.2(c). Question : what information is on your organisation’s purchase orders ? How do you ensure that your supplier can meet your requirements ?
  • Incoming inspection is not compulsory. It is a non-value-adding activity. Why not put the onus on the supplier to provide a good Quality product or service ? An organisation may do sample checks on critical components and/or do an audit at their plant. What about where there is no alternative supplier : What about where you are only a small customer with a large supplier ? How do you resolve problems there ? (Nobel Plastiques / Renault) Other companies like ITT Cannon can be very helpful.
  • Supplier audits may be carried out to : Assess anew or potential supplier, prior to awarding a contract, through them demonstrating their capability in achieving Quality objectives Monitor the performance of an existing supplier Periodic re-assessment Identify potentially mutually beneficial improvement potential There should be a good reason for auditing a supplier, because it is expensive. We might do it if we have a problem or they are a new or critical supplier. Also, the contract should be large enough to justify the audit expense.
  • Last slide before tea break. Situation with Deutsch – only commercial grade Quality.
  • You would not expect work instructions for e.g. a surgeon, or solicitor, or senior managers.
  • e.g. sterilised products – cannot open the package to inspect them. Welding – cannot open the weld, but you may do a sample weld first and use qualified welders. Need to validate the people, materials, the process, the equipment. You may even need to have an insurance organisation present during the validation, to witness it.
  • Example : in the news in January, there was a case of where a hospital twice mixed up a new baby with their mothers, so this is a prime example of an ineffective identification and traceability system. What would you do to prevent this ? Identity tags on baby AND mother – what info to put on it ? Mother’s full name and code number. But maybe we need to go further – what if one or other tag comes off ? Have the same info on a stamp might be one solution – and stamp it on mother and baby. What about preventive action – use a cable tie to hold on the tag and laminate the tags so that they can’t tear (or use Tyvec label). Not recommended to only identify a product’s status by its location. For a service, the only identification may be a signature (e.g. repair shop). The status of work, documents, materials etc. will be identified. Methods of identifying that verification has occurred by qualified staff shall be documented.
  • Should also be able to identify the capability status of processes and equipment. How good is the product recall capability ? Has the organisation complied with all statutory or regulatory requirements ? Is the method of identification able to endure the intended use or application (e.g. high temperatures, or water ingress) ? Special identification required on hazardous materials Mitigation of identified risks. QUESTION : how do you identify non conforming product ? How is it dispositioned and by whom ? END OF SESSION TEN.
  • Customer property examples could be : ingredients, components, if you offer a repair, maintenance, or upgrade service, packaging materials (certain sizes for their premises), if you are a handler or storage operation, services provided on behalf of a customer such as transport of customer property to a 3 rd party, intellectual property and specifications, drawings, proprietary information.
  • The intended destination may not be the customer – it could be to a depot, or distributor, or transport organisation. Ensure you have a backup of software and electronic information and have a frequency defined. Need special arrangements for hazardous materials, food products and ingredients, pharmaceutical ingredients and products. There may be situations where qualified people are needed to store, install or handle products. What about irreplaceable goods ? (Paintings, antiques, certain cars) QUESTION : does your organisation have any special preservation requirements ?
  • Methods and devices for verification and validation of processes and products (including simulations and surveys). Organisations should look at fool-proofing methods (polarity facilities in housing blocks, assembly boards set for geometry checks). These checks can reduce the need for control of monitoring and measuring devices. QUESTION : how is calibration determined in your organisation ?
  • Last slide before tea break.
  • Need also to review the validity and purpose of the measurements, and the intended use of the data, to ensure there is some added value to the organisation. The data that is easy to collect may not be beneficial. So ask why are we collecting this data ? How does it help us ? What are we going to do with this information ?
  • SPC – looking at variation – special causes vs. inherent.
  • We may produce very fancy graphs and analysis but is it understood by the people using it, by people reading it on a notice board ?
  • Customer information is vital. After all, it is their opinion of you, your organisation, and your products and service that will determine whether they continue to do business with you. Collection of this information may be passive or active. Should be set up to get this information on a regular/continual basis. Price, Quality, and delivery performance are not the only criteria – how good are you at resolving problems, at pointing out potential problems, at developing your product (R & D) or service – showing benefits for the customer, at being able to answer customer queries, at keeping customers up to date on the status of their orders… QUESTION : how is customer satisfaction determined ?
  • Who communicates with the customer ? We tend to think of our sales people, but there are many more involved : receptionist, engineering staff, purchasing staff might, marketing people, MD, production manager, accounts staff, retail staff, delivery staff – all of these can be in a position to get information and feedback from a customer, and they all give an impression of your organisation to the customer. So training becomes a more relevant issue. How Wex Elcx had to respond and react to complaints – having to manufacture and send over replacement goods, having to go over to sort through the products, having to pay for someone to sort and having to show how to prevent recurrence. (Portugal, France, N. Ireland, Holland, Scotland, England). END OF SESSION ELEVEN.
  • An audit is an objective assessment of various aspects of an organisation’s QMS at one moment in time. It is a measure of the effectiveness and efficiency of the areas audited. Auditing is verifying the system is working properly with a view to improvement using competent people, planned in advance. For outstanding actions, send out e-mail. Good auditors are looking for conformance, not the opposite. System audit : used to establish a level of confidence in the capability of the organisation (auditee) to meet specified requirements. It is used to verify that the QM adequately describes the system, that procedures have been issued and are in use, that it meets, where relevant, the requirements of a Quality system standard. Is the system being used consistently to manage the business and deliver the Quality objectives, are all the interfaces connected and does information flow to those who need it, what is the level of commitment to the system, does the system provide the means for ongoing improvement, does the system documentation support the activities of the organisation’s people ? Compliance audit – done after the award of the contract. Is an in-depth examination of procedures and work instructions to verify that the requirements of the procedures and work instructions are being met, to identify opportunities for improving the activities and the Quality system documentation. From the customer’s viewpoint, the objective of a compliance audit is to establish a level of confidence in the ongoing capability of the auditee to meet specified requirements. Objective evidence – data supporting the existence or verity of something. Observation – a statement of fact made during a Quality audit and substantiated by objective evidence. Be careful where it is only you that observes something – get corroboration to be on the safe side. Collect, evaluate, record objective evidence. Proper document review is critical, including checking rev nos. of documents. Must avoid focussing on the areas I’m most familiar with, missing key processes, dwelling on ‘glamorous’ departments, etc. Case history report : Internal audits: No evidence existed that previous audit results are considered during audit planning; reporting on verification results was not included in follow-up activities. In order to carry out a "process audit" the auditor will start with the inputs, follow the process through its various stages to examine how it is controlled and verify that the output meet what is required. Such a process may be, for example, the actions required by the organisation on receipt of a customer order, and the steps taken to convert that order into something that will allow a product ordered to be manufactured. The input here would be the customer order, and the output, the organisation's internal documents, resources and materials that allow the manufacture of the product. Another example of a process could be those steps that a dry cleaner would take to procure the chemicals required by the cleaning process itself. The input would be the need to buy chemicals, the output would be the receipt of the chemicals from the supplier. Thus the auditor will need to look at the process, determine the inputs, examine how it is controlled, and look at the outputs. The way the process is controlled may require an examination of mechanisms other than documented procedures. Such control mechanisms could be by, for example, control charts, process flow diagrams or by training of operatives to ensure they are competent. Whatever the means by which the organisation decides to control the process, the auditor will seek evidence that the control mechanism is indeed effective. The ultimate test of effectiveness is an examination of whether the end result of the process is in accordance with the inputs. An example of a buying process end result could be receipt of chemicals. If the purchase order did not contain sufficient information to allow the correct product to be supplied or was deficient in some way, then the output would not be acceptable. The customer may not get the chemicals that were required. Thus the process would not be giving the output required. Some change to the process would need to occur in order that the chemicals required were received, thereby making the process output acceptable. Thus, during an audit of the process, the auditor would need to determine if the process output, i.e. the chemicals received, met the requirements of the organisation and the process for obtaining them was operating under the controlled conditions that the organisation had defined. Auditing of processes should result in a logical audit of the activities of organisations in carrying out the various functions required to supply customers with a product or service which meets their needs. This change should therefore be viewed very positively.
  • Need to be flexible to allow changes in emphasis as a result of evidence from audits. Should involve the people from the area to be audited, in preparing audit plans – after all, they know their area best. But keep your objectivity. The audit schedule should be based on the importance of the activities to be audited, and on the results of previous audits. A C.A.R. only exists at the end of an audit. Until then, it is an audit finding. Make sure CAR’s quote examples. Get the auditee to sign the CAR and agree an action date. Remember that the action may be that no action is going to be taken. Key question – will the CAR stand up to questioning by a sceptical MD ? Some companies will try and fix an audit finding before completion of the audit, but unless it is very simple, you should not withdraw the finding, because you won’t have time to verify that the corrective action is effective. Steps in doing an audit : gain an understanding of the organisation through analysis of the business processes, gain an appreciation of how processes are controlled through documentation and discussions with the auditee, sampling objective evidence of the process, sampling documented procedures. Audits carried out by independent certification bodies, they are solely to verify compliance. Auditors should not recommend any corrective/preventive action plan or tell or advise auditees what to do – what would happen if they took your advice and it didn’t work for them ? Don’t use names in the audit report, use titles only. Remember to look at the information on documents – take time to study any documents given. Don’t just focus on the fact that the documents exist. Talk 20 % of the time, observe 40 % of the time, listen 40 % of the time. If you observe an audit finding, discuss it there and then with the auditee so that it won’t be a surprise when it appears on the report. Verify subjective evidence or else don’t record it.
  • NSAI use 3 categories of non conformance – 1(major), 2 (minor), 3 (comment). But a 3 may become a 2 or 1 if no action is taken. Also, if a 3 is too expensive to implement, you can say that it was reviewed (show evidence – minutes), but the cost/benefit analysis did not show it as being worthwhile, and/or you took some alternative action to resolve the issue. 3 essential questions : are the processes defined and the procedures appropriately controlled in relation to the business risks ? Are the processes fully deployed and implemented in accordance with the applicable control – are they working their own procedures – look for evidence ? Are the processes effective in achieving the objectives – look for evidence – do they work ? 1st party audit : compliance – self assessment, to ensure that the Quality system is operating as defined and is effective in meeting the stated objectives. 2 nd part audit – system and compliance – assessment of a supplier or sub contractor. Focus on the key areas – it may not be critical to focus on their purchasing process. Amount of supplier audits depends on current performance, results of previous audits, value of contract, major changes by supplier… 3 rd party audit – system and compliance (registration). Major non conformances must be resolved in 6 weeks, minor ones in 13 weeks. If an organisation is already registered, we may not focus too much on Q policy etc. We should focus on those areas that concern and affect our organisation. 4 phases of an audit – preparation (40 %), performance (40 %), reporting (10 %), follow-up (10 %). Don’t accept as an excuse, that a procedure is new – not an excuse for it not being effectively implemented. Be very careful of the wording in the standard – ‘where appropriate’, ‘as required’, ‘where necessary’. A serious finding is where an observation indicates there is a variation between activities and agreed procedures, or a variation between product or data and documented specified requirements or other applicable documents. But all of this is subject to how critical the process is to product realisation.
  • Start with big, open questions. For example, can ask the MD – how is business going ?; how is the Q policy arrived at ?, how is customer focus determined and enhanced ? What are the top level KPI's and how are they communicated to the rest of the organisation ? Make sure, during the audit, to get people’s names, titles, the names and numbers of any documents viewed, the areas audited. Can ask each person in an area : what do you do ?, can you explain the process of… ?, how do you control this process ?, what records do you keep ?, what training have you had and are there any records of this ? What is the role of the e.g. engineering manager ? How do you fit into the organisation ? Is there a documented procedure (flowchart) ? Are there any performance measures (KPI's) ? How are these measures used to improve performance ? Is the procedure reviewed ? When and by whom ? What is the current performance ? Are there records to show implementation ? What actions are/have you taken to improve performance ? Have they been effective ? How do you know ? What sort of things can go wrong ? How are they controlled ? Any examples of problems ? Don’t get bogged down in the procedures, how they should work – look at the reality. Work instructions may not be needed for a skilled job. Are the people following an effective system, i.e. is it meting their own objectives ? If a non conformance is an isolated case, it is usually classified as minor. A major non conformance is where there is the absence of a procedure or a total breakdown of its implementation, evidenced by lack of records. Another major is a repeat of several minor faults relating to the same clause; or a number of minors in the same area of an organisation. Make sure to verify verbal information you are given, and is the information given by someone who would know about that item ? Negative verbal info though, is usually acceptable. Problems with a product does not mean it is out of spec or non conforming. Any audit review should lead to an action plan. Do training (need names to check up on), internal audit results, and performance data late in the audit. Audit the incoming store before doing vendor assessment and purchasing. Audit document control, audit scheduling, Q policy, Q obj’s early on in the audit. Take account of shift work and of different sites. For different shifts, make sure to cover the shift hand-over. On 2 nd or 3 rd shift, look for gaps in resp. and auth. And the reporting mechanism, and how they raise corrective actions. Fro different sites, see how they handle the implementation of new procedures – they may have the implementation date x days after the date of issue. Instead of auditing by clause, your organisation may decide to audit by functional area. Auditors should consider the new audit trails and expected evidence for conformity with ISO 9001:2000. For example, auditing to the requirements for Quality objectives requires consideration of clause 5.4.1, Quality objectives, as well as related clauses that refer to Quality objectives. These include 4.2.1a, 5.1c, 5.3c, 5.4.2a, 5.6.1, 6.2.2d, 7.1a and 8.5.1. Using an electronic version of the standard will help auditors identify important cross-references.
  • Auditing is more concerned with obtaining objective evidence that existing policies, procedures or requirements have been met, and evaluates only the effectiveness and efficiency of the QMS.
  • For example, with preventive maintenance, we could look at uptime or downtime. Other areas for improving process and performance measurements are : capability, reaction time, cycle time, throughput, yield, the effectiveness and efficiency of the people, utilisation of technologies, waste reduction, cost reduction.
  • Case history report : Monitoring and measurement of processes: Methods were not applied for monitoring processes within the Quality management system. QUESTION : does your organisation measure any of these ? What are the trends ? Last slide before tea break.
  • Typical records that can be used for performance improvement include : inspection and test reports, material release notes, product acceptance forms, certs of conformance. Pareto analysis is a very sensible and useful tool – build up a record of the faults, then sort them into descending order of frequency, and tackle the top ones first.
  • QUESTION : what product or service characteristics does your organisation measure ?
  • Inspection and test reports, material release notes, product acceptance forms, certificates of conformance Pre Production Approval Process (PPAP) Advanced Quality Assurance Planning (AQAP)
  • Employees, owners, investors, suppliers, the public, statutory and regulatory bodies,
  • NACCO sent in a questionnaire every month asking things like : how satisfied are you with the Quality of information on our purchase orders or schedules, how many orders did you receive this month, were you dealt with in a courteous manner, how many amendments did we send this month, how many times did we violate the agreed lead times, etc. They then collated this information and if a supplier gave a rating less than 75 %, the supplier was contacted to see what the problem was and what could be done to correct it.
  • Top management must empower people with the authority and responsibility to report non conformities at any stage of the process. Authority for response to non conformities should be defined. Non conforming product must be clearly identified, segregated, and dispositioned (i.e. controlled, and the corrective action defined) (Material review board). The disposition process should be defined (e.g. authorised and competent people, frequency of review – there should be a maximum time that material is in a non conforming status). Recording of disposition enables trend analysis – negative trends should be acted upon and also used as an input to the management review (reduction goals and resource needs) Where practical, non conformities and their disposition should be recorded, for analysis and improvement activities. Controlling non conformities applies to product realisation and support processes. Do all employees know the risks of using non conforming material ? If non conforming material is repaired, is the product identified through the rest of the process, and can the final product be identified such that it is known that it contained a repaired part ? This could be important to check if repaired parts were or were not contributing to failures in service ?
  • QUESTION : how does your organisation control non conforming product/service ?
  • Assessing against the plans and objectives, and other defined goals – to identify areas for improvement, including possible benefits to interested parties. Need valid analysis methods, appropriate statistical techniques, making decisions and taking actions based on the results of logical analyses, balanced with experience and intuition. Purpose of data analysis is to determine the root cause of a problem – either existing or potential. From this, the best corrective and preventive actions can be put in place. Need to integrate and analyse data from throughout the organisation. The resulting information should be presented in a format suitable for the different levels in an organisation (top management may only want a summary). Year on year improvements are required. An FMEA is a risk assessment and can be used for environmental or H & S issues also.
  • Last slide before tea break.
  • This should be a proactive approach, rather than waiting for a problem to arise. Is there a system in place to identify and manage improvements ? The changes may result in changes to a product or process or the QMS or the organisation – we need to be able to control these changes and evaluate the effects and potential effects. There are no specific figures given in the standard so it can be ok to have as an objective, an improvement of 2 %.
  • Don’t start a suggestion scheme unless you are prepared to follow it through. Who decides on what is a good suggestion or not ? Who is the deciding team and does everyone know who they are ?Will the decision process be made public ? What specific rewards will be given ? How will they be given – ceremony ? Is money a good reward ?
  • The above should be used as a tool for improving both the organisation’s internal effectiveness and efficiency, as well as the satisfaction of customers and other interested parties.
  • Management should ensure that product/service or process changes are approved, prioritised, planned, provisioned, and controlled to satisfy interested party requirements, and avoid exceeding the organisation’s capability.
  • Corrective action planning should include evaluation of the significance of problems and take account of their potential impact on costs, performance, dependability, health and safety, customer satisfaction. People from appropriate disciplines should be involved in the corrective action process. The actions taken should be monitored to ensure that they are effective – that the desired goals are met. Corrective actions should be considered for inclusion in the management review. Corrective action can be determined by an individual or a team. The organisation should balance the investment of time and other resources required against the impact of the problem under consideration.
  • Useful to set up a database or Quality Improvement Process database to record actions and ideas. This can help see trends of faults or potential faults, and as a way of knowing how effective were the actions taken. For outstanding actions, send out reminders by e-mail.
  • Training may be required for carrying out the corrective action or for people to be able to investigate the problem logically (root cause analysis). Root cause analysis should be verified by testing prior to defining and initiating action.
  • Planning for loss prevention should be systematic. It should be based on data from records, criticality effects, FMEA, etc. relative to the impact and performance of the organisation and its products/service. Use risk analysis, trend analysis, SPC, FMEA, criticality analysis, etc. to identify causes.
  • Case history report : Preventive action: There was no documented procedure for preventive action requirements.
  • The organisation needs to prioritise all of this information based on its effect upon the organisation and interested parties. Results from the evaluation of the effectiveness and efficiency of loss prevention plans should be an output from the management review, and should be an input into the modification of plans and the improvement of processes.
  • If anyone wants help in their organisation, please call me.
  • Process function : coil diameter Potential failure mode : diameter too small Potential effects of failure : weak motor Potential cause / mechanism of failure : wire wound too tight Current process controls : measure with gauge Severity : 6 – seriousness of failure Occurrence : 8 - probability Detection : 3 – likelihood that fault will reach the customer RPN : 144 Recommended action : Develop tool to control tension Responsibility : Target completion date : Results of action Action taken : Tool developed, tested, and implemented Severity : 6 Occurrence : 3 Detection : 3 RPN : 54
  • Examples of a process : ordering components, clothes, stationary; designing a product; making something…
  • High performance organisations are moving away from managing people and their activities to managing processes.
  • Can delegate authority but not responsibility.
  • Quality plans are mainly used for new processes or project-based organisations. May be generated as a result of a specific customer request. Quality plans can be a good way of conveying how a particularly complex or unusual project is to be managed.
  • Documentation comprises that which is necessary to control and verify the achievement of process output in accordance with requirements.
  • Quality Course 3, Including Iso9001

    1. 1. Getting the most out of the course <ul><li>Remember this course is for YOU and its success rests largely with you </li></ul><ul><li>If something is not clear, please ask </li></ul><ul><li>Please share your experience </li></ul><ul><li>Please confine your discussion to the problem </li></ul><ul><li>Only one person to talk at a time </li></ul><ul><li>Be patient with others – some people will have more experience than others </li></ul><ul><li>Please attend on time </li></ul><ul><li>Any item discussed in the sessions is to be treated as confidential. </li></ul>
    2. 2. Responsibility <ul><li>One point to remember – this course can only provide an overview of Quality and how it might apply to your organisation. It is not stating that you must or should apply all the items mentioned in it. That decision is up to each organisation – only you can decide which parts should apply. </li></ul>
    3. 3. Quality Training Course <ul><li>What do you hope to get from this course (why are you here) ? </li></ul><ul><li>What is your experience (if any) in Quality ? </li></ul><ul><li>Are there any areas in Quality on which you think you would like to know more ? </li></ul><ul><li>If a question on Quality occurs to you during the course, please let me know. </li></ul>
    4. 4. Product and Service Quality <ul><li>Please note that examples have been used that make reference to areas that apply to both manufacturing and non manufacturing organisations, but there will be certain areas that will apply more to manufacturing </li></ul><ul><li>Also remember that even a manufacturing organisation also provides services – invoicing of suppliers, payment to customers, engineering support staff, Quality contacts with the customer, sales staff, etc. </li></ul>
    5. 5. Course Objectives <ul><li>To ensure that : </li></ul><ul><ul><li>Participants understand the reason and importance for good Quality </li></ul></ul><ul><ul><li>Participants appreciate the benefits of adopting a Quality system </li></ul></ul><ul><ul><li>Participants are introduced to the tools and techniques used to analyse Quality data and information </li></ul></ul><ul><ul><li>Participants can prepare implementation strategies for developing a Quality and Procedure manual for their organisation </li></ul></ul><ul><li>To encourage all participants to suggest and implement Quality improvements in their organisation. </li></ul>
    6. 6. Syllabus of Course (1/4) <ul><li>Basics of Quality </li></ul><ul><li>Quality Systems </li></ul><ul><ul><li>ISO9001:2000 – this will be the framework for the course </li></ul></ul><ul><ul><li>Q Mark </li></ul></ul><ul><ul><li>TQM </li></ul></ul><ul><ul><li>Environment standard ISO14001:1996... </li></ul></ul>
    7. 7. Syllabus of Course (2/4) <ul><li>Quality Procedures </li></ul><ul><ul><li>Performance indicators </li></ul></ul><ul><ul><li>Benchmarking </li></ul></ul><ul><ul><li>Maintenance </li></ul></ul><ul><ul><li>Product recall </li></ul></ul><ul><ul><li>Supplier assessment… </li></ul></ul>
    8. 8. Syllabus of Course (3/4) <ul><li>Management Aspects </li></ul><ul><ul><li>Quality teams </li></ul></ul><ul><ul><li>Quality circles </li></ul></ul><ul><ul><li>Complaints handling </li></ul></ul><ul><ul><li>Quality costs… </li></ul></ul>
    9. 9. Syllabus of Course (4/4) <ul><li>Problem Solving Techniques - Application to Quality Improvement </li></ul><ul><ul><li>Flowcharts, histograms, sampling schemes, average and range charts, Pareto analysis etc. </li></ul></ul><ul><li>Computer Software </li></ul><ul><li>We will also use ISO9004:2000 – Quality Management Systems – guidelines for performance improvements. </li></ul>
    10. 10. Assessment <ul><li>Continuous assessment - based on practical working examples throughout the course (30 %) </li></ul><ul><li>Project work – developing/upgrading a portion of a Quality manual for your organisation (20 %) </li></ul><ul><li>Written exam – based on general Quality knowledge and application (case study) (50 %) </li></ul>
    11. 11. Reading (1/2) <ul><li>Essential </li></ul><ul><ul><li>“ Quality management (principles and techniques)” by G. Vorley </li></ul></ul><ul><ul><li>“ Essentials of total quality management” by R. Williams </li></ul></ul><ul><ul><li>ISO9001:2000 – Quality Management Systems - requirements </li></ul></ul><ul><li>Recommended </li></ul><ul><ul><li>“ A practical approach to quality control” by R H Caplan </li></ul></ul><ul><ul><li>“ Total quality management” by J. Oakland </li></ul></ul><ul><ul><li>“ Quality control handbook” by J M Juran </li></ul></ul><ul><li>Journals </li></ul><ul><ul><li>“ Best practice” by Excellence Ireland </li></ul></ul><ul><ul><li>“ Quality progress” by the American Society for Quality. </li></ul></ul>
    12. 12. Reading (2/2) <ul><li>Some other books : </li></ul><ul><ul><li>“ Quality is free” by Philip Crosby </li></ul></ul><ul><ul><li>“ Achieving quality standards” by Munro, Faure, and Bones </li></ul></ul><ul><ul><li>“ Right first time” by Frank Price </li></ul></ul><ul><ul><li>ISO9004:2000 – Quality Management Systems : guidelines for quality improvement </li></ul></ul><ul><ul><li>ISO9001:2000 for small businesses </li></ul></ul><ul><li>Other sources of information : </li></ul><ul><ul><li>www.asq.org www.bsi-global.com </li></ul></ul><ul><ul><li>www.efqm.org www.eoq.org </li></ul></ul><ul><ul><li>www.insidequality.com www.iso.org </li></ul></ul><ul><ul><li>www.nsai.ie www.qualitycoach.net </li></ul></ul><ul><ul><li>www.sqt.ie </li></ul></ul>
    13. 13. Basics of Quality <ul><li>What is Quality ? </li></ul><ul><li>Who is responsible for Quality ? </li></ul><ul><li>Why is Quality important ? </li></ul><ul><li>A short history of Quality </li></ul><ul><li>What is the Quality standard ISO9001 and how does it affect me in my work ? </li></ul><ul><li>How and why top management should be involved in Quality </li></ul><ul><li>Overview of a Quality Management System (QMS) </li></ul>
    14. 14. What is Quality ? <ul><li>Does ‘Quality’ concern products ? Service ? People ? </li></ul><ul><ul><li>Which of these (if any) needs to be addressed first ? </li></ul></ul><ul><li>Product Quality is usually defined as ‘fitness for purpose’ </li></ul><ul><ul><li>is this sufficient ? </li></ul></ul><ul><li>Service Quality can be defined as ‘satisfying the customer’ </li></ul><ul><ul><li>is this sufficient ? </li></ul></ul><ul><li>Quality - the degree to which a set of inherent characteristics fulfils requirements. </li></ul>
    15. 15. Who is responsible for Quality ? Quality Quality department Production department Top management Shop Floor staff QC inspectors Everyone in an organisation. Office staff Suppliers Customers Statutory and regulatory bodies Society
    16. 16. Why is Quality important ? (1/2) <ul><li>Because : </li></ul><ul><ul><li>I am told that Quality is important </li></ul></ul><ul><ul><li>My customer demands it </li></ul></ul><ul><ul><li>Everyone talks about it </li></ul></ul><ul><ul><li>It might help me attract more customers </li></ul></ul><ul><ul><li>My business will run better if I have a good Quality system in place </li></ul></ul><ul><ul><li>I will save money… </li></ul></ul>
    17. 17. Why is Quality important ? (2/2) <ul><li>Because we want to improve : </li></ul><ul><ul><li>Customer loyalty </li></ul></ul><ul><ul><li>Repeat business and referral </li></ul></ul><ul><ul><li>Market share and revenue </li></ul></ul><ul><ul><li>Flexible and fast responses to market changes </li></ul></ul><ul><ul><li>Costs and cycle times through the efficient use of resources </li></ul></ul><ul><ul><li>Alignment of processes </li></ul></ul><ul><ul><li>Understanding and motivation of employees. </li></ul></ul>
    18. 18. Follow-up work <ul><li>Ask others in your organisation, including the MD : </li></ul><ul><ul><li>What is Quality ? </li></ul></ul><ul><ul><li>Who is responsible for Quality ? </li></ul></ul><ul><ul><li>Why is Quality important ? </li></ul></ul><ul><li>Find out how your organisation measures Quality </li></ul><ul><li>Are these measures beneficial ? </li></ul><ul><li>Are there others that should be measured ? </li></ul><ul><li>What is done with the information ?. </li></ul>
    19. 19. A Short History of Quality (1/8) <ul><li>Originally, many items were hand made and we relied on the skill and expertise of the craftsman </li></ul><ul><li>With mechanisation and the industrial revolution, jobs became less skilled and people performed the same part of a job rather than making a complete item or providing a complete service </li></ul><ul><li>Because of the reduction in skill (or rather a reduction in training and restrictions on what people were allowed to do), people were less likely to ‘own’ what they made and felt less responsible for the finished item. This did not help Quality. Following on from this, it became necessary to check what people had made… </li></ul>
    20. 20. A Short History of Quality (2/8) <ul><li>This resulted in having people whose job it was to check the Quality of the products made. These were called Quality controllers and they inspected the products. So a lot of time and money was spent on inspection because no-one felt confident that there was control over the process </li></ul><ul><li>The inspection process became quite sophisticated and used various techniques such as sampling tables and acceptance levels, and this way of working was fine for many years. But of course it had several flaws… </li></ul>
    21. 21. A Short History of Quality (3/8) <ul><li>Some of the flaws were : </li></ul><ul><ul><li>It further alienated the people who made the product. They felt less and less responsible for it – after all, it was Quality Control’s job to check it, and find the faults. This eventually resulted in the situation where people felt QC were responsible for Quality </li></ul></ul><ul><ul><li>The tendency was to focus on the final product rather than the stages in between. This meant that if something was found to be wrong, it was often too late to correct it, and while the fault may not have reached the customer, rejects became an expensive item. Also… </li></ul></ul>
    22. 22. A Short History of Quality (4/8) <ul><li>The focus was on the product or service and not on the processes that were involved in making the product. So at best, even with 100 % inspection, faulty parts were produced before any action was taken </li></ul><ul><li>Wouldn’t it be nice if we could do something to : </li></ul><ul><ul><li>Find problems before they occurred ? </li></ul></ul><ul><ul><li>Measure and correct the processes so that we minimised the chances of non conforming product being made or a poor service being provided ?... </li></ul></ul>
    23. 23. A Short History of Quality (5/8) <ul><li>This brings us to where we are today. Tools were developed to prevent problems rather than detect them. Tools such as : </li></ul><ul><ul><li>Documented procedures for carrying out work </li></ul></ul><ul><ul><li>Preventive / predictive maintenance </li></ul></ul><ul><ul><li>Statistical Process Control </li></ul></ul><ul><ul><li>Customer feedback / surveys </li></ul></ul><ul><ul><li>Quality Management Systems… </li></ul></ul>
    24. 24. A Short History of Quality (6/8) <ul><li>The other thing that was happening was that the major customers (e.g. car companies, aircraft manufacturers, food companies, pharmaceutical companies…) wanted to ensure that their suppliers were producing good products for them </li></ul><ul><li>So the concept of auditing was introduced, where a representative of the customer would visit the supplier and go through their Quality system to ensure that it was up to the customer standard </li></ul><ul><li>The problem was that this was an expensive process, especially if you had hundreds of suppliers… </li></ul>
    25. 25. A Short History of Quality (7/8) <ul><li>Wouldn’t it be good if customers could agree on an independent audit that would mean a supplier met certain standards ? </li></ul><ul><li>So from these parallel issues (trying to prevent problems before they happened, and trying to minimise the costs of auditing all one’s suppliers) : </li></ul><ul><ul><li>The Quality Management System standard was born. It was only natural that ISO should be the organisation to do it. The standard is now in its 3 rd revision. Most Irish companies that are certified, are certified to the 1994 version. But this version becomes obsolete at the end of 2003, and all companies must update to the 2000 version by then… </li></ul></ul>
    26. 26. A Short History of Quality (8/8) <ul><li>Service organisations did not change as much over time, and it could be said that the Quality and level of service over the years has not improved as much as that of manufacturing organisations </li></ul><ul><li>But whereas the service provision may be similar, the expectations of the customer have changed a lot and it could be argued that the level of service has not kept pace with customer requirements and expectations </li></ul><ul><li>However, it is often the case that the end user, the public, are less strict or fussy about Quality than when you supply to another organisation – this can result in poor service to the public. Furthermore, organisations in a monopoly situation have a tendency to be less Quality conscious </li></ul><ul><li>Some areas are so critical to our health, that special regulations are involved – e.g. medical, pharmaceutical, food industry. </li></ul>
    27. 27. What is the Quality standard ISO9001:2000 and how does it affect me ? <ul><li>ISO9001:2000 is a Quality management system that uses a process approach to devise, document, implement, and review an organisation’s plans, objectives, and procedures relating to Quality. </li></ul><ul><li>It is based on 8 key principles as shown on the following page. </li></ul>
    28. 28. 8 Key Management Principles <ul><li>Customer focus </li></ul><ul><li>Leadership </li></ul><ul><li>Involvement of people : at all levels </li></ul><ul><li>Process approach </li></ul><ul><li>System approach to management : managing inter-related processes to ensure effective and efficient achievement of objectives </li></ul><ul><li>Continual improvement </li></ul><ul><li>Factual basis to decision making : data analysis </li></ul><ul><li>Mutually beneficial suppler relationships to create value. </li></ul>
    29. 29. How and why top management should be involved in Quality (1/2) <ul><li>Top management must provide evidence of its commitment to developing and implementing the organisation’s Quality management system </li></ul><ul><li>Top management must be involved in setting the Quality policy and Quality objectives </li></ul><ul><li>Top management must ensure that all relevant Quality information is communicated throughout the organisation </li></ul><ul><li>Top management must review the effectiveness of the Quality management system… </li></ul>
    30. 30. How and why top management should be involved in Quality (2/2) <ul><li>There is one key reason why top management must be involved with and committed to Quality : </li></ul><ul><ul><li>Without their agreement, it will be virtually impossible to implement any effective Quality system – why ? </li></ul></ul>
    31. 31. Process Based System (1/2) <ul><li>A process approach emphasises the importance of : </li></ul><ul><ul><li>Understanding and fulfilling customer requirements (and those of other interested parties – employees, suppliers, owners, the public) </li></ul></ul><ul><ul><li>Considering processes in terms of added value </li></ul></ul><ul><ul><li>Obtaining results of process performance and effectiveness </li></ul></ul><ul><ul><li>Continual improvement of processes based on objective measurement… </li></ul></ul>
    32. 32. Process Based System (2/2) <ul><li>Because the new standard in process based, a good approach can be to : </li></ul><ul><ul><li>Identify all the processes in an organisation </li></ul></ul><ul><ul><li>Draw up a process flow chart for each process (can help to include the standard clause number) </li></ul></ul><ul><ul><li>Show the controls involved for each of these processes (plan – do – check – act) </li></ul></ul><ul><ul><li>Don’t forget the supporting processes (maintenance, calibration, inspection…) </li></ul></ul><ul><ul><li>May have a separate page to refer to the scope of the document, who is responsible, the purpose of the document, what records are kept… </li></ul></ul><ul><ul><li>The next slide shows an overview of the standard as a system of related processes. </li></ul></ul>
    33. 33. Process of repairing a faulty vacuum cleaner Repair of item – Written instructions required ? Training and experience of repairer Defined sequence of actions Control of purchase orders Confirmation that correct component arrives When will the item be repaired ? Test item. Receipt of item Identification of item Note fault as reported Knowledge of repairer Sequence of actions New part required ? – P.O. Tools and equipment Identify item as being ok
    34. 34. Process-based QMS Continual improvement of the Quality Management System Customers (and other interested parties) Requirements Management responsibility Resource management Measurement analysis and improvement Product realisation Product / service Customers (and other interested parties) Satisfaction 5.x 6.x 7.x 8.x Output Input Value adding activities Information flow
    35. 35. QMS and Business Plan (1/2) <ul><li>The new standard makes it easier to link the organisation’s Quality Management System with its overall business plan </li></ul><ul><li>The business plan should be a controlled document </li></ul><ul><li>It should be referenced in the Quality manual </li></ul><ul><li>It should be reviewed at specified frequencies </li></ul><ul><li>The business plan will cover all areas of an organisation (manufacturing, marketing, sales, purchasing, service level…), and might be set up as indicated on the next slide… </li></ul>
    36. 36. QMS and Business Plan (2/2) <ul><li>Example of section of organisation business plan </li></ul>3 2 Weekly reject reports Complete. WIP. Behind schedule 30 Apr 31 May 17 Apr M.D. Q.M. P.M. 1.1 1.2 1.3 Reduce defects by 5% over 2002 level 1 Perf. indicator Status Due date Resp. Actions Description Objective
    37. 37. Q Mark <ul><li>The Q-Mark is the National Symbol of Quality and is a framework through which an organisation can identify, design, maintain and improve its key processes so that it can create excellent output continuously, and effectively respond to changing or uncertain conditions. </li></ul><ul><li>It is an improvement framework that is also a national brand recognised by consumers </li></ul><ul><li>The major re-development of the Q-Mark in 2002 means that now, not only do Excellence Ireland look to see whether you have a system in place, we look to see that you have a system with a purpose </li></ul><ul><li>There are the national Quality awards held annually. </li></ul>
    38. 38. Q Mark – the four elements (1/4) <ul><li>Company Commitment - The Q-Mark encourages the involvement of everyone, with a particular emphasis on the commitment and involvement of management. Retention and market share gain are best optimised through a clear focus on the needs of current and potential customers. The Q-Mark enables the company and its management to provide this focus, and to ensure that the company's systems and processes continue to deliver on customer requirements. </li></ul>
    39. 39. Q Mark – the four elements (2/4) <ul><li>Motivated People - The Q-Mark places an emphasis on service quality, which is very often the key to sustainable competitive advantage. Motivated people are the catalyst for superior customer service, for driving improvements and for consistently meeting the needs of customers. The Q-Mark, through its practical and user friendly focus, helps foster the type of culture where employees are involved in designing, developing and improving the service given to customers. </li></ul>
    40. 40. Q Mark – the four elements (3/4) <ul><li>Excellent Business Systems and Processes - Organisations perform more effectively when all inter-related activities are understood and systematically managed. These inter-related activities or practices deliver the service to the customer. The Q-Mark provides the framework for these practices to be effective. Effective identification, management and improvement of the organisation's key processes is one of the pillars of the Q-Mark. </li></ul>
    41. 41. Q Mark – the four elements (4/4) <ul><li>Better Company - Organisational performance is maximised when it is based on a sound operations and processes system operating within a culture of continuous improvement. Improvements can then be planned based on factual evidence provided by the system. The Q-Mark requires factual evidence of process, product and service performance and looks for improvements to be made on account of these facts. </li></ul>
    42. 42. Q Mark – Applying for <ul><li>Become a member of Excellence Ireland </li></ul><ul><li>Satisfy Guidelines' requirements </li></ul><ul><ul><li>identifying, designing, maintaining and improving the processes that determine its success </li></ul></ul><ul><li>Complete Application document - an organisation will be asked to complete the application every 3 years </li></ul><ul><li>Pass Audit </li></ul><ul><li>Maintain the Q-Mark by continual improvement. </li></ul>
    43. 43. Q Mark Auditing <ul><li>Process Definition - How is the systematic approach to running the business defined under the various elements and sub-elements? </li></ul><ul><li>Deployment - Is the approach that has been defined being deployed or carried out in this way? The auditor expects that it will be and will award marks on that basis </li></ul><ul><li>Impact and Effectiveness - At this level the auditor will look at the impact that the definition and deployment of the process has had on the organisation by looking at the results of these efforts. The process may be defined and carried out as defined, but is the organisation being impacted positively? The Q-Mark framework expects that there will be a positive impact and will work with the company toward this end. </li></ul>
    44. 44. Q Mark and ISO <ul><li>The Q-Mark is the National Symbol of Quality and is very much associated in an Irish context whereas ISO has international recognition </li></ul><ul><li>The Q-Mark is more recognisable to Irish consumers than ISO </li></ul><ul><li>The Q-Mark is a score based framework that makes continuous improvement very tangible. Having a score based framework also allows Excellence Ireland to hold the National Quality Awards </li></ul><ul><li>The language of the Q-Mark is quite generic and would not be language traditional associated with quality. This, however, makes the engagement and involvement of all levels of staff much more achievable </li></ul><ul><li>The Q-Mark presents organisations with the opportunity to use the basic quality tools and techniques that are proven enablers of improvement. In terms of business improvement programmes this is a breakthrough. </li></ul>
    45. 45. Total Quality Management <ul><li>There is a British standard on TQM – BS 7850 (2 parts) </li></ul><ul><li>Some recognised awards are the European Foundation for Quality Management award (business excellence model) and the Malcolm Baldrige award (USA) </li></ul><ul><li>ISO9001:2000 incorporates many aspects of TQM, so these will be dealt with later. In relation to the unique aspects of TQM, we have : </li></ul>
    46. 46. Total Quality Management <ul><li>Increased focus on the concept of the internal customer and process owner </li></ul><ul><li>Increased focus on the investment in people and training, and involvement of people when planning change </li></ul><ul><li>The organisation should address its responsibility to society </li></ul><ul><li>The organisation must involve all the supporting functions also (e.g. finance, servicing) </li></ul><ul><li>Measurement and actions must support the overall business strategy and objectives, and they should stimulate improvement </li></ul><ul><li>Extensive use of Quality tools and techniques, and ensuring that people are trained in their use </li></ul><ul><li>Customer defined Quality </li></ul><ul><li>Knowledge of how your business is performing when compared to competitors </li></ul><ul><li>Improvement in every aspect of the business </li></ul><ul><li>Top management leadership and commitment. </li></ul>
    47. 47. TQM Improvement Plan <ul><li>Identify : identify an area for improvement </li></ul><ul><li>Evaluate : define the processes involved, gather data, define the objectives for improvement </li></ul><ul><li>Plan : identify the causes of the current status, devise possible solutions, select preferred option </li></ul><ul><li>Execute : implement the plan </li></ul><ul><li>Check : monitor, review, and appraise results – may need to tighten the specifications and/or amend the procedures. Training may be required to ensure that the new work practices become an integral part of the job </li></ul><ul><li>Amend : repeat the process if the planned solution is not achieving its objectives. </li></ul>
    48. 48. Improvement Actions versus Possible Effects
    49. 49. Improving the cost / gains ratio
    50. 50. 7 Tools of TQM <ul><li>Data gathering </li></ul><ul><li>Histogram </li></ul><ul><li>Pareto chart </li></ul><ul><li>Run chart / control chart </li></ul><ul><li>Cause and effect diagram </li></ul><ul><li>Scatter diagram </li></ul><ul><li>Stratification. </li></ul>
    51. 51. 8 Step Plan to TQM <ul><li>Install an effective Quality assurance system </li></ul><ul><li>Measure customer satisfaction </li></ul><ul><li>Satisfy the internal customer </li></ul><ul><li>Manage improvements </li></ul><ul><li>Implement process improvements </li></ul><ul><li>Introduce Quality management to the front line – those who are in direct contact with the customer </li></ul><ul><li>Introduce Quality management to the support services </li></ul><ul><li>Introduce the Quality management system. </li></ul>
    52. 52. Environment Standard – ISO14001:1996 <ul><li>4.2 : Environmental policy </li></ul><ul><li>4.3 : Planning </li></ul><ul><ul><li>4.3.1 Environmental aspects </li></ul></ul><ul><ul><li>4.3.2 Legal and other requirements </li></ul></ul><ul><ul><li>4.3.3 Objectives and targets </li></ul></ul><ul><ul><li>4.3.4 Environment management program… </li></ul></ul>
    53. 53. Environment Standard – ISO14001:1996 <ul><li>4.4 Implementation and Operation </li></ul><ul><ul><li>4.4.1 Structure and responsibility </li></ul></ul><ul><ul><li>4.4.2 Training, awareness, and competence </li></ul></ul><ul><ul><li>4.4.3 Communication </li></ul></ul><ul><ul><li>4.4.4 EMS documentation </li></ul></ul><ul><ul><li>4.4.5 Document control </li></ul></ul><ul><ul><li>4.4.6 Operational control </li></ul></ul><ul><ul><li>4.4.7 Emergency preparedness and response… </li></ul></ul>
    54. 54. Environment Standard – ISO14001:1996 <ul><li>4.5 Checking and Corrective Action </li></ul><ul><ul><li>4.5.1 Monitoring and measurement </li></ul></ul><ul><ul><li>4.5.2 Non conformance, corrective and preventive action </li></ul></ul><ul><ul><li>4.5.3 Records </li></ul></ul><ul><ul><li>4.5.4 EMS audit </li></ul></ul><ul><li>4.6 Management Review. </li></ul>
    55. 55. Computer software <ul><li>Kiss IT software ( www.oberoninternational.co.uk/kiss_it.htm ) – useful for SPC and design of experiments software </li></ul><ul><li>Can download blank Quality manuals : </li></ul><ul><ul><li>www.uptothepointconsulting.bigstep.com </li></ul></ul><ul><ul><li>www.manager-tool.com </li></ul></ul><ul><ul><li>www.qsinnovations.com </li></ul></ul><ul><ul><li>www.iso-audit.com </li></ul></ul><ul><ul><li>www.mcallister-consulting.com </li></ul></ul><ul><ul><li>www.iso-quality-manuals.com </li></ul></ul><ul><ul><li>www.iso-9000-quality-manual.com </li></ul></ul><ul><ul><li>www.qualitybiz.com </li></ul></ul>
    56. 56. Overview of Standard <ul><li>4 Quality Management System </li></ul><ul><ul><li>4.1 General requirements </li></ul></ul><ul><ul><li>4.2 Documentation requirements </li></ul></ul><ul><ul><ul><li>4.2.1 General </li></ul></ul></ul><ul><ul><ul><li>4.2.2 Quality manual </li></ul></ul></ul><ul><ul><ul><li>4.2.3 Control of documents </li></ul></ul></ul><ul><ul><ul><li>4.2.4 Control of records </li></ul></ul></ul><ul><li>This section deals with the setting up and administration of the Quality Management System (QMS). </li></ul>
    57. 57. Quality Procedures – KPI’s (1/5) <ul><li>Performance indicators – what do you think should be included here ? </li></ul><ul><ul><li>Reject levels (from different areas and processes) </li></ul></ul><ul><ul><li>Scrap levels (yield), scrap value </li></ul></ul><ul><ul><li>Percentage rework </li></ul></ul><ul><ul><li>Supplier rejects </li></ul></ul><ul><ul><li>Customer rejects </li></ul></ul><ul><li>But we should also measure business indicators such as profitability, liquidity ratio, level of debt, repeat customers, retyped invoices – whatever is important to your organisation. </li></ul>
    58. 58. Quality Procedures – Benchmarking (2/5) <ul><li>Benchmarking – comparing your product or service to e.g. </li></ul><ul><ul><li>the best in the industry </li></ul></ul><ul><ul><li>the best locally </li></ul></ul><ul><ul><li>the best in another industry that has similar processes </li></ul></ul><ul><ul><li>your competitor. </li></ul></ul>
    59. 59. Quality Procedures – Maintenance (3/5) <ul><li>Balance between never running out of spares and keeping inventory low </li></ul><ul><li>What level of cover is need for each machine ? </li></ul><ul><li>How critical is that machine ? </li></ul><ul><li>Do you need spares or a repair person within 12 hours ? </li></ul><ul><li>Do you need a second machine on standby ? </li></ul><ul><li>What would happen if there was a blackout and how critical would it be ? </li></ul><ul><li>Preventive or scheduled maintenance or just when a machine breaks down ? </li></ul><ul><li>What about your computers and servers ? What would happen if you could not e-mail suppliers or customers ? </li></ul>
    60. 60. Quality Procedures – Product Recall (4/5) <ul><li>Do you have such a procedure ? </li></ul><ul><li>How critical is it if there is a fault in the field ? </li></ul><ul><li>How do you go about it – what traceability do you have ? </li></ul><ul><li>Can you trace forwards and backwards from perhaps sketchy information from a customer ? What information do you need from them ? </li></ul>
    61. 61. Quality Procedures – Supplier Assessment (5/5) <ul><li>Do you need to assess suppliers ? </li></ul><ul><li>How to assess – </li></ul><ul><ul><li>Based on having ISO9001:2000 or some other standard </li></ul></ul><ul><ul><li>Reviewing their customer base and getting customer views on them </li></ul></ul><ul><ul><li>Auditing them </li></ul></ul><ul><ul><li>Verifying the product delivered </li></ul></ul><ul><ul><li>Certs of conformance </li></ul></ul><ul><ul><li>Inspection / test / capability results from suppliers </li></ul></ul><ul><ul><li>Other. </li></ul></ul>
    62. 62. Management Aspects – Quality Teams (1/4)
    63. 63. Management Aspects – Quality Circles (2/4)
    64. 64. Management Aspects – Complaints Handling (3/4)
    65. 65. Management Aspects – Quality Costs (4/4) <ul><li>Usually divided into four areas : </li></ul><ul><ul><li>Preventive costs </li></ul></ul><ul><ul><li>Inspection costs </li></ul></ul><ul><ul><li>Internal failure costs </li></ul></ul><ul><ul><li>External failure costs </li></ul></ul>
    66. 66. 4.1 General Requirements <ul><li>The organisation shall establish, document, implement, and maintain a Quality management system, and continually improve its effectiveness. To do this, it needs to : </li></ul><ul><ul><li>Identify all the processes involved, their sequence and how they interact </li></ul></ul><ul><ul><li>Determine criteria and methods </li></ul></ul><ul><ul><li>Ensure availability of resources and information </li></ul></ul><ul><ul><li>Monitor, measure, and analyse the processes </li></ul></ul><ul><ul><li>Ensure control over any processes that are outsourced and that affect product conformity </li></ul></ul><ul><ul><li>Implement actions to achieve planned results and ensure continual improvement. </li></ul></ul>
    67. 67. ISO9004 : 2000 – 4.1 <ul><li>Q.1 : How does management apply the process approach to achieve the effective and efficient control of its processes, resulting in performance improvement ? </li></ul>
    68. 68. 4.2 Documentation Requirements <ul><li>4.2.1 Documentation requirements – general </li></ul><ul><ul><li>A Quality policy </li></ul></ul><ul><ul><li>Quality objectives </li></ul></ul><ul><ul><li>Quality manual </li></ul></ul><ul><ul><li>Documented procedures – 6 mandatory </li></ul></ul><ul><ul><li>Other documentation/procedures to ensure effective planning, operation, and control of its processes </li></ul></ul><ul><ul><li>Records. </li></ul></ul>
    69. 69. 4.2 Benefits of effective documentation (1/2) <ul><li>Defines the nature and inter-relationship of business processes </li></ul><ul><li>Describes how the organisation operates </li></ul><ul><li>Assigns responsibilities for actions and decisions </li></ul><ul><li>Encourages consistency of action and uniformity of understanding throughout the organisation </li></ul><ul><li>Communicates instructions and information, as well as proposed changes </li></ul><ul><li>Enables new employees to become more productive and effective… </li></ul>
    70. 70. 4.2 Benefits of effective documentation (2/2) <ul><li>Ensures that activities can continue to function effectively even if key personnel are absent </li></ul><ul><li>Enables systematic auditing to verify effectiveness </li></ul><ul><li>Nominates the records to be kept, and reference documents, including work instructions </li></ul><ul><li>Stipulates key performance indicators </li></ul><ul><li>Demonstrates the commitment to Quality, to customers and employees. </li></ul>
    71. 71. ISO9004 : 2000 – 4.2 <ul><li>Q.2 : How are documents and records used to support effective and efficient operation of the processes of the organisation ? </li></ul>
    72. 72. 4.2.2 Quality Manual (1/5) <ul><li>4.2.2 Quality manual </li></ul><ul><ul><li>Covers the scope of the QMS, including any details on exclusions </li></ul></ul><ul><ul><li>Includes or refers to documented procedures </li></ul></ul><ul><ul><li>Shows or describes the interaction between processes – perhaps an overall flow chart... </li></ul></ul>
    73. 73. 4.2.2 A Quality Manual is : (2/5) <ul><li>A rule book by which the organisation functions </li></ul><ul><li>A source of information from which customers may derive confidence </li></ul><ul><li>A means of defining responsibilities and inter related activities of all employees </li></ul><ul><li>A medium for defining the level of Quality that an organisation wishes to consistently deliver </li></ul><ul><li>A vehicle for auditing, reviewing, and evaluating an organisation’s QMS </li></ul><ul><li>A single point of reference required to run an organisation’s Quality system… </li></ul>
    74. 74. 4.2.2 A Quality Manual Must : (3/5) <ul><li>Include a statement of the organisation’s policy towards Quality </li></ul><ul><li>Contain details of the organisation’s Quality management structure and organisation , together with job descriptions and responsibilities </li></ul><ul><li>Describe the organisation’s Quality control requirements, training programmes… </li></ul>
    75. 75. 4.2.2 A Quality Manual Should : (4/5) <ul><li>Identify lower level documents such as procedures, work instructions, standard operating procedures </li></ul><ul><li>Ideally cover each clause and requirements in the standard </li></ul><ul><li>It may also include form templates used internally and with suppliers (can hyperlink from the Manual to the template)… </li></ul>
    76. 76. 4.2.2 Typical Quality Manual Structure (5/5) <ul><li>Organisational overview : </li></ul><ul><ul><li>Quality objectives and commitment to Quality </li></ul></ul><ul><ul><li>General statement about Quality </li></ul></ul><ul><ul><li>Business principles </li></ul></ul><ul><ul><li>Organisational charts </li></ul></ul><ul><ul><li>Core business processes and supporting processes </li></ul></ul><ul><ul><li>Key Quality responsibilities </li></ul></ul><ul><ul><li>Manual administration </li></ul></ul><ul><ul><li>Scope and field of application </li></ul></ul><ul><li>Process definitions and system outline : </li></ul><ul><ul><li>How processes are controlled </li></ul></ul><ul><li>Reference matrix or list of documented procedures. </li></ul>
    77. 77. 4.2.3 Control of Documents <ul><li>This is one of the 6 documented procedures. </li></ul><ul><li>Ensure documents are approved before use </li></ul><ul><li>Review and update documents – revision status </li></ul><ul><li>Relevant versions available at point of use – could apply to our suppliers (e.g. purchase orders) </li></ul><ul><li>Ensure documents remain legible, retrievable, and identifiable </li></ul><ul><li>Prevent use of obsolete documents </li></ul><ul><li>External documents also need to be controlled – including standards, drawings, specifications, etc. </li></ul>
    78. 78. 4.2.4 Control of records <ul><li>This is one of the 6 documented procedures. </li></ul><ul><li>Records exist to prove evidence of conformity to requirements and of effective operation of the QMS. They must be : </li></ul><ul><ul><li>Legible </li></ul></ul><ul><ul><li>Readily identifiable </li></ul></ul><ul><ul><li>Retrievable </li></ul></ul><ul><ul><li>How do we store and protect records and for how long ? </li></ul></ul><ul><ul><li>How do we dispose of records and who is responsible for this ? </li></ul></ul>
    79. 79. 5 Management Responsibility <ul><li>5.1 Management commitment </li></ul><ul><li>5.2 Customer focus </li></ul><ul><li>5.3 Quality policy </li></ul><ul><li>5.4 Planning </li></ul><ul><li>5.5 Responsibility, authority, and communication </li></ul><ul><li>5.6 Management review. </li></ul>
    80. 80. 5.1 Management Commitment (1/4) <ul><li>Top management must : </li></ul><ul><ul><li>Communicate throughout the organisation the importance of meeting the customers’ as well as statutory requirements </li></ul></ul><ul><ul><li>Establish the Quality policy </li></ul></ul><ul><ul><li>Establish Quality objectives </li></ul></ul><ul><ul><li>Conduct management reviews </li></ul></ul><ul><ul><li>Ensure the availability of resources… </li></ul></ul>
    81. 81. 5.1 Management Commitment (2/4) <ul><li>Top management should : </li></ul><ul><ul><li>Be actively involved in developing and maintaining an effective and efficient QMS. It should lead by example </li></ul></ul><ul><ul><li>Participate in improvement projects – new methods, products, solutions </li></ul></ul><ul><ul><li>Look for feedback on the effectiveness of the QMS </li></ul></ul><ul><ul><li>Create an environment that encourages employee involvement </li></ul></ul><ul><ul><li>Provide the structure and resources that are necessary to support the organisation’s strategic plans </li></ul></ul><ul><ul><li>Define methods for measurement of the organisation’s performance in order to determine whether planned objectives have been achieved… </li></ul></ul>
    82. 82. 5.1 Management Commitment (3/4) <ul><li>Top management should also demonstrate leadership in, and commitment to : </li></ul><ul><ul><li>Understanding current and future customer needs, expectations, and requirements </li></ul></ul><ul><ul><li>Promoting policies and objectives to increase awareness, motivation, and involvement of employees </li></ul></ul><ul><ul><li>Establishing continual improvement as an objective for all organisational processes </li></ul></ul><ul><ul><li>Planning for the future of the organisation and managing change </li></ul></ul><ul><ul><li>Developing and communicating a framework for achieving customer satisfaction, and satisfaction of other interested parties… </li></ul></ul>
    83. 83. 5.1 Management Commitment (4/4) <ul><li>Top management should consider : </li></ul><ul><ul><li>Ensuring that the sequence and interaction of processes are designed to achieve the desired results effectively and efficiently </li></ul></ul><ul><ul><li>Ensuring that process inputs, activities, and outputs are clearly defined and controlled </li></ul></ul><ul><ul><li>Monitoring inputs and outputs to verify that individual processes are linked, and operate effectively and efficiently </li></ul></ul><ul><ul><li>Identifying and managing risks </li></ul></ul><ul><ul><li>Exploiting performance improvement opportunities </li></ul></ul><ul><ul><li>Identifying process owners and giving them responsibility and authority. </li></ul></ul>
    84. 84. ISO9004 : 2000 – 5.1 <ul><li>Q. 3 : How does top management demonstrate its (visible) leadership, commitment, and involvement ? </li></ul>
    85. 85. 5.2 Customer Focus (1/2) <ul><li>Top management must ensure that customer requirements are determined and are met, with the aim of enhancing customer satisfaction (see also 7.2.1 and 8.2.1 later)… </li></ul>
    86. 86. 5.2 Customer Focus (2/2) <ul><li>In order to understand and meet the needs and expectations of interested parties, and organisation should : </li></ul><ul><ul><li>Identify all interested parties </li></ul></ul><ul><ul><li>Translate identified needs and expectations into requirements </li></ul></ul><ul><ul><li>Communicate the requirements throughout the organisation </li></ul></ul><ul><ul><li>Focus on process improvement to ensure value for all interested parties. </li></ul></ul>
    87. 87. ISO9004 : 2000 – 5.2 <ul><li>Q. 4 (a) : How does the organisation identify customers needs and expectations on a continual basis ? </li></ul><ul><li>Q. 4 (b) : How does the organisation identify people’s needs for recognition, work satisfaction, competence, and personal development ? </li></ul><ul><li>Q. 4 (c) : How does the organisation consider the potential benefits of establishing partnerships with its suppliers ? </li></ul><ul><li>Q. 4 (d) : How does the organisation identify other interested parties’ needs and expectations that can result in setting objectives ? </li></ul><ul><li>Q. 4 (e) : How does the organisation ensure that statutory and regulatory requirements have been considered ?. </li></ul>
    88. 88. 5.3 Quality policy (1/2) <ul><li>Top management needs to devise a Quality policy that : </li></ul><ul><ul><li>Is appropriate for the organisation </li></ul></ul><ul><ul><li>Includes a commitment to comply with the requirements of the QMS, and to continually improve its effectiveness </li></ul></ul><ul><ul><li>Provides a framework for establishing and reviewing the Quality objectives </li></ul></ul><ul><ul><li>Is communicated and understood throughout the organisation – how might this be done ? </li></ul></ul><ul><ul><li>Is reviewed for continuing suitability… </li></ul></ul>
    89. 89. 5.3 A Quality Policy Should Consider : (2/2) <ul><li>The level and type of future improvement needed for the organisation to be successful </li></ul><ul><li>The expected/desired degree of customer satisfaction </li></ul><ul><li>The development of people in the organisation </li></ul><ul><li>The needs and expectations of other interested parties </li></ul><ul><li>The resources needed to achieve and go beyond the ISO9001 requirements </li></ul><ul><li>The potential contributions of suppliers and partners. </li></ul>
    90. 90. ISO9004 : 2000 – 5.3 <ul><li>Q. 5 (a) : How does the Quality policy ensure that the needs and expectations of customers and other interested parties are understood ? </li></ul><ul><li>Q. 5 (b) : How does the Quality policy lead to visible and expected improvements ? </li></ul><ul><li>Q. 5 (c) : How does the Quality policy consider the organisation’s vision of the future ?. </li></ul>
    91. 91. 5.4.1 Quality Objectives (1/2) <ul><li>Top management needs to establish Quality objectives that : </li></ul><ul><ul><li>Fulfil product requirements </li></ul></ul><ul><ul><li>Are measurable and consistent with the Quality policy </li></ul></ul><ul><ul><li>Are established at relevant functions and levels within the organisation </li></ul></ul><ul><ul><li>The Quality objectives should be S.M.A.R.T. and have key performance indicators… </li></ul></ul>
    92. 92. 5.4.1 Setting the Quality Objectives (2/2) <ul><li>Should consider : </li></ul><ul><ul><li>The current/future needs of the organisation and the markets </li></ul></ul><ul><ul><li>Relevant findings from the management reviews </li></ul></ul><ul><ul><li>The current product and process performance </li></ul></ul><ul><ul><li>The levels of satisfaction of customers </li></ul></ul><ul><ul><li>Self assessment results (e.g. internal audits) </li></ul></ul><ul><ul><li>Competitor analysis, benchmarking, other opportunities for improvement </li></ul></ul><ul><ul><li>The resources needed to meet the objectives. </li></ul></ul>
    93. 93. 5.4.2 QMS planning (1/4) <ul><li>Top management must ensure that : </li></ul><ul><ul><li>The planning of the QMS is carried out in order to meet the requirements (4.1 ) as well as the objectives, and </li></ul></ul><ul><ul><li>The integrity of the QMS is maintained when changes are planned and implemented </li></ul></ul><ul><li>QMS planning is concerned with how to achieve the specified Quality objectives – the plan, do, check, act cycle… </li></ul>
    94. 94. 5.4.2 QMS planning (2/4) <ul><li>The planning should include </li></ul><ul><ul><li>The processes required in the QMS, considering permissible exclusions </li></ul></ul><ul><ul><li>The resources needed </li></ul></ul><ul><ul><li>The continual improvement of the QMS </li></ul></ul><ul><ul><li>Maintenance of the integrity of the QMS during changes to it </li></ul></ul><ul><ul><li>Who is responsible for each of the QMS planning aspects and methods of monitoring… </li></ul></ul>
    95. 95. 5.4.2 QMS planning (3/4) <ul><li>Inputs to the planning include : </li></ul><ul><ul><li>The strategies of the organisation </li></ul></ul><ul><ul><li>The defined organisational objectives </li></ul></ul><ul><ul><li>The defined needs and expectations of the customers and other interested parties </li></ul></ul><ul><ul><li>Evaluation of statutory and regulatory requirements </li></ul></ul><ul><ul><li>Evaluation of performance data of the products/service </li></ul></ul><ul><ul><li>Evaluation of performance data of processes </li></ul></ul><ul><ul><li>Lessons learned from previous experience </li></ul></ul><ul><ul><li>Indicated opportunities for improvement </li></ul></ul><ul><ul><li>Related risk assessment data… </li></ul></ul>
    96. 96. 5.4.2 QMS planning (4/4) <ul><li>Outputs to the planning include : </li></ul><ul><ul><li>Areas that define the product/service realisation and support processes </li></ul></ul><ul><ul><li>Skills and knowledge needed by the organisation </li></ul></ul><ul><ul><li>The responsibility and authority for implementing the process improvement plans </li></ul></ul><ul><ul><li>The resources needed (finance, infrastructure) </li></ul></ul><ul><ul><li>Performance indicators for evaluating the achievement of the organisation’s performance improvement </li></ul></ul><ul><ul><li>Documentation and records requirements. </li></ul></ul>
    97. 97. ISO9004 : 2000 – 5.4 <ul><li>Q. 6 (a) : How do the Quality objectives translate the Quality policy into measurable goals ? </li></ul><ul><li>Q. 6 (b) : How are the Quality objectives deployed to each management level to assure individual contribution to achievement ? </li></ul><ul><li>Q. 6 (c) : How does management ensure the availability of resources needed to meet the Quality objectives ?. </li></ul>
    98. 98. 5 Management Responsibility <ul><li>5.5 Responsibility, authority, and communication </li></ul><ul><ul><li>5.5.1 Responsibility and authority </li></ul></ul><ul><ul><li>5.5.2 Management representative </li></ul></ul><ul><ul><li>5.5.3 Internal communication. </li></ul></ul>
    99. 99. 5.5.1 Responsibility and authority <ul><li>Top management must ensure that responsibilities and authorities are defined and communicated within the organisation : </li></ul><ul><ul><li>Who is responsible for what – may include job descriptions. This helps identify not only who is responsible, but also the limit of their responsibility </li></ul></ul><ul><ul><li>Who has authority for decisions or for over-riding decisions </li></ul></ul><ul><ul><li>The above is only partially useful unless everyone is aware of who to contact. </li></ul></ul>
    100. 100. 5.5.2 Management Representative <ul><li>Top management must appoint a member of management who irrespective of other responsibilities, will have responsibility and authority for : </li></ul><ul><ul><li>Ensuring that the processes needed for the QMS are established, implemented, and maintained </li></ul></ul><ul><ul><li>Reporting to top management on the performance of the QMS and any need for improvement </li></ul></ul><ul><ul><li>Ensuring the promotion of awareness of customer requirements throughout the organisation. </li></ul></ul>
    101. 101. 5.5.3 Internal Communication <ul><li>Top management needs to ensure that appropriate communication processes are established and implemented within the organisation and that communication takes place regarding the effectiveness of the QMS, and communicating the Quality policy, Quality objectives, accomplishments, and interested party requirements. </li></ul><ul><ul><li>How might this be done ? </li></ul></ul><ul><li>Management should encourage feedback and communication from people in the organisation as a means of involving them. </li></ul>
    102. 102. ISO9004 : 2000 – 5.5 <ul><li>Q. 7 (a) : How does top management ensure that responsibilities are established and communicated to people in the organisation ? </li></ul><ul><li>Q. 7 (b) : How does communicating Quality requirements, objectives, and accomplishments contribute to improvement of the organisation’s performance ?. </li></ul>
    103. 103. 5 Management Responsibility <ul><li>5.6 Management review </li></ul><ul><ul><li>5.6.1 General </li></ul></ul><ul><ul><li>5.6.2 Review input </li></ul></ul><ul><ul><li>5.6.3 Review output. </li></ul></ul>
    104. 104. 5.6.1 Management Review - General (1/3) <ul><li>Top management must review the organisation’s QMS at planned intervals to ensure its continuing suitability, adequacy, efficiency, and effectiveness. Also, opportunities for improvement and assessing the need for changes to the QMS need to be reviewed, including the Quality policy and Quality objectives </li></ul><ul><li>Records must be maintained </li></ul><ul><li>There should be an agenda (covering all clauses in the standard plus the items on the next page), minutes, and corrective action plans… </li></ul>
    105. 105. 5.6.1 Management Review – General (2/3) <ul><li>Top management should stimulate the exchange of new ideas, should encourage open discussion, and evaluate the review inputs </li></ul><ul><li>The frequency of the review is determined by the needs of the organisation </li></ul><ul><li>Outputs from the review should provide information for planning performance improvement… </li></ul>
    106. 106. 5.6.1 Management Review – General (3/3) <ul><li>The objective of a management review is to ensure that the QMS : </li></ul><ul><ul><li>Is achieving the expected results </li></ul></ul><ul><ul><li>Meets the organisation’s requirements </li></ul></ul><ul><ul><li>Conforms to the requirements of ISO9001:2000 </li></ul></ul><ul><ul><li>Continues to satisfy the customers’ needs and expectations </li></ul></ul><ul><ul><li>Is functioning according to the established operating procedures </li></ul></ul><ul><ul><li>Is capable of identifying weaknesses and evaluating possible improvements. </li></ul></ul>
    107. 107. 5.6.2 Management Review Input (1/2) <ul><li>The management review input must include information on : </li></ul><ul><ul><li>Results of audits </li></ul></ul><ul><ul><li>Customer feedback </li></ul></ul><ul><ul><li>Process performance and product conformity </li></ul></ul><ul><ul><li>Status of corrective and preventive actions </li></ul></ul><ul><ul><li>Follow-up actions from previous management reviews </li></ul></ul><ul><ul><li>Changes that could affect the QMS (e.g. a new project or product line) </li></ul></ul><ul><ul><li>Recommendations and opportunities for improvement… </li></ul></ul>
    108. 108. 5.6.2 Management Review Input (2/2) <ul><li>Other inputs can include : </li></ul><ul><ul><li>Status and results of Quality objectives and improvement activities </li></ul></ul><ul><ul><li>Feedback from other interested parties, perhaps even including their participation </li></ul></ul><ul><ul><li>External factors such as technology changes, R & D, competitor performance, environmental changes, regulatory changes… </li></ul></ul><ul><ul><li>Results from benchmarking activities </li></ul></ul><ul><ul><li>Supplier performance </li></ul></ul><ul><ul><li>Control of product and process non conformities </li></ul></ul><ul><ul><li>Financial aspects of Quality activities (new investment, training, Quality costs, etc.). </li></ul></ul>
    109. 109. 5.6.3 Management Review output (1/2) <ul><li>The output of a management review shall include any decisions and actions relating to : </li></ul><ul><ul><li>The improvement of the effectiveness of the QMS and its processes </li></ul></ul><ul><ul><li>The improvement of product related to customer requirements </li></ul></ul><ul><ul><li>Resource needs </li></ul></ul><ul><li>The output from a review should feed into the organisation’s overall business review and strategy </li></ul><ul><li>The records should be sufficiently detailed to allow traceability and evaluation of the management review process itself, to ensure it is effective… </li></ul>
    110. 110. 5.6.3 Management Review output (2/2) <ul><li>The outputs should be communicated throughout the organisation, because there will usually be new product/service and process objectives arising from the review </li></ul><ul><li>The output may result in : </li></ul><ul><ul><li>modifications to the organisation’s structure or resource requirements </li></ul></ul><ul><ul><li>New initiatives for other departments (e.g. marketing, product development, design) </li></ul></ul><ul><ul><li>Plans to reduce identified risks </li></ul></ul><ul><ul><li>Performance objectives for products and processes </li></ul></ul><ul><ul><li>Performance improvement objectives for the organisation. </li></ul></ul>
    111. 111. ISO9004 : 2000 – 5.6 <ul><li>Q. 8 (a) : How does top management ensure valid input information is available for the management review ? </li></ul><ul><li>Q. 8 (b) : How does the management review activity evaluate information to improve the effectiveness and efficiency of the processes of the organisation ?. </li></ul>
    112. 112. Overview of Standard <ul><li>6 Resource Management </li></ul><ul><ul><li>6.1 Provision of resources </li></ul></ul><ul><ul><li>6.2 Human resources </li></ul></ul><ul><ul><li>6.3 Infrastructure </li></ul></ul><ul><ul><li>6.4 Work environment </li></ul></ul><ul><li>This section deals with resource management and allocation. </li></ul>
    113. 113. 6 Resource Management <ul><li>6.1 Provision of resources – determining and providing the resources needed </li></ul><ul><ul><li>To implement and maintain the QMS and continually improve its effectiveness </li></ul></ul><ul><ul><li>To enhance customer satisfaction by meeting customer requirements. </li></ul></ul>
    114. 114. ISO9004 : 2000 – 6.1 <ul><li>Q. 9 : How does top management plan for resources to be available in a timely manner ? </li></ul>
    115. 115. 6 Resource Management <ul><li>6.2 Human resources </li></ul><ul><ul><li>6.2.1 General </li></ul></ul><ul><ul><li>6.2.2 Competence, awareness, and training. </li></ul></ul>
    116. 116. 6.2.1 Human Resources – General (1/3) <ul><li>People performing work affecting Quality shall be competent on the basis of : </li></ul><ul><ul><li>Appropriate education </li></ul></ul><ul><ul><li>Training </li></ul></ul><ul><ul><li>Skills </li></ul></ul><ul><ul><li>Experience </li></ul></ul><ul><li>Whose work affects Quality ?... </li></ul>
    117. 117. 6.2.1 Human Resources – General (2/3) <ul><li>Top management needs to involve and support its employees for maximum result. This can be done through : </li></ul><ul><ul><li>ongoing training and support </li></ul></ul><ul><ul><li>defining people’s responsibilities and authorities (very important that both are defined. There is nothing worse than having the responsibility but not the authority) </li></ul></ul><ul><ul><li>establishing individual and team objectives </li></ul></ul><ul><ul><li>facilitate involvement in objectives, target setting, and decision making… </li></ul></ul>
    118. 118. 6.2.1 Human Resources – General (3/3) <ul><ul><li>by facilitating open, 2-way communication </li></ul></ul><ul><ul><li>by communicating suggestions and opinions </li></ul></ul><ul><ul><li>by continually reviewing the needs of the employees </li></ul></ul><ul><ul><li>by ensuring effective teamwork </li></ul></ul><ul><ul><li>by recognising and rewarding </li></ul></ul><ul><ul><li>by facilitating open, 2-way communication </li></ul></ul><ul><ul><li>by checking why people join and leave the organisation. </li></ul></ul>
    119. 119. 6.2.2 Competence, Awareness, and Training (1/4) <ul><li>The organisation shall : </li></ul><ul><ul><li>Determine the necessary competence (both current and future) for people performing work affecting product or service Quality </li></ul></ul><ul><ul><li>Provide training or take other actions to satisfy these needs </li></ul></ul><ul><ul><li>Evaluate the effectiveness of the actions taken (because training is a process) – how ? </li></ul></ul><ul><ul><li>Ensure that people are aware of the relevance and importance of their activities and how they contribute to the achievement of the Quality objectives </li></ul></ul><ul><ul><li>Maintain appropriate records of education, training, skills and experience… </li></ul></ul>
    120. 120. 6.2.2 Competence, Awareness, and Training (2/4) <ul><li>Evaluation of training needs should include : </li></ul><ul><ul><li>People’s current experience </li></ul></ul><ul><ul><li>People’s implicit and explicit knowledge </li></ul></ul><ul><ul><li>Teamwork requirements </li></ul></ul><ul><ul><li>Problem solving skills </li></ul></ul><ul><ul><li>Communications skills </li></ul></ul><ul><ul><li>Current and future needs and expectations of customers </li></ul></ul><ul><ul><li>Need for creativity and innovation </li></ul></ul><ul><ul><li>Specific skills required for the job </li></ul></ul><ul><ul><li>Current and future needs of the organisation… </li></ul></ul>
    121. 121. 6.2.2 Competence, Awareness, and Training (3/4) <ul><li>Need to consider : </li></ul><ul><ul><li>Future management and succession issues </li></ul></ul><ul><ul><li>Changes to an organisation’s processes, tools, and equipment </li></ul></ul><ul><ul><li>Any statutory or regulatory requirements and standards </li></ul></ul><ul><ul><li>Leadership and management skills </li></ul></ul><ul><ul><li>The organisation’s policies and objectives </li></ul></ul><ul><ul><li>Induction programs and periodic refresher training </li></ul></ul><ul><ul><li>The training and competence of employees should also take account of the customers’ and other interested party’s needs, requirements, and expectations… </li></ul></ul>
    122. 122. 6.2.2 Competence, Awareness, and Training (4/4) <ul><li>Training plans should include : </li></ul><ul><ul><li>Objectives </li></ul></ul><ul><ul><li>Training methods </li></ul></ul><ul><ul><li>Resources needed </li></ul></ul><ul><ul><li>Identification of necessary internal support </li></ul></ul><ul><ul><li>Evaluation in terms of enhanced competence of people </li></ul></ul><ul><ul><li>Measurement of the effectiveness and the impact on the organisation </li></ul></ul><ul><li>The training and education should be evaluated in terms of expectations and impact on the effectiveness and efficiency of the organisation, and as a means of evaluating future training plans. </li></ul>
    123. 123. ISO9004 : 2000 – 6.2 <ul><li>Q. 10 (a) : How does management promote involvement and support of people for improvement of the effectiveness and efficiency of the organisation ? </li></ul><ul><li>Q. 10 (b) : How does management ensure that the competence of the people in the organisation is adequate for current and future needs ?. </li></ul>
    124. 124. 6.3 Infrastructure (1/2) <ul><li>The organisation shall determine, provide and maintain the infrastructure needed to achieve conformity to product requirements while considering the needs and expectations of interested parties. This includes, as applicable : </li></ul><ul><ul><li>Buildings, workspace, and associated utilities (tools, equipment…) </li></ul></ul><ul><ul><li>Process equipment (hardware and software) </li></ul></ul><ul><ul><li>Supporting services (e.g. transport, communication, maintenance) </li></ul></ul><ul><ul><li>Natural phenomena – weather can affect some outside activities… </li></ul></ul>
    125. 125. 6.3 Infrastructure (2/2) <ul><li>The process to define the necessary infrastructure for product realisation should include : </li></ul><ul><ul><li>Defining the objectives, function, performance, availability, cost, safety, security, and renewal </li></ul></ul><ul><ul><li>Development and implementation of the maintenance to ensure that the infrastructure continues to meet the organisation’s needs </li></ul></ul><ul><ul><li>Evaluation of the type and frequency of maintenance and verification required, based on criticality, safety, and usage </li></ul></ul><ul><ul><li>Evaluation of the infrastructure against the needs and expectations of interested parties </li></ul></ul><ul><ul><li>Consideration of environmental issues – conservation, pollution, waste, recycling </li></ul></ul><ul><ul><li>Natural phenomena need also to be considered and how to reduce these risks and protect the interests of interested parties. </li></ul></ul>
    126. 126. ISO9004 : 2000 – 6.3 <ul><li>Q. 11 (a) : How does management ensure that the infrastructure is appropriate for the achievement of the objectives of the organisation ? </li></ul><ul><li>Q. 11 (b) : How does management consider environmental issues associated with the infrastructure ?. </li></ul>
    127. 127. 6.4 Work Environment <ul><li>The organisation shall determine and manage the work environment needed to achieve conformity to product requirements. This can include : </li></ul><ul><ul><li>Opportunities for involvement of people </li></ul></ul><ul><ul><li>Safety rules, guidance, and use of safety equipment </li></ul></ul><ul><ul><li>Ergonomics </li></ul></ul><ul><ul><li>Social interaction </li></ul></ul><ul><ul><li>Facilities in the organisation – heat, light, humidity, airflow </li></ul></ul><ul><ul><li>Hygiene, cleanliness, noise, pollution, vibration etc. </li></ul></ul>
    128. 128. ISO9004 : 2000 – 6.4 <ul><li>Q. 12 : How does management ensure that the work environment promotes motivation, satisfaction, development, and performance of people in the organisation ? </li></ul>
    129. 129. ISO9004 : 2000 – 6.5 : Information (1/2) <ul><li>This is NOT part of ISO9001:2000 </li></ul><ul><ul><li>Management should treat data as a fundamental resource for conversion to information and the continual development of an organisation’s knowledge. The organisations should : </li></ul></ul><ul><ul><ul><li>Identify its information needs </li></ul></ul></ul><ul><ul><ul><li>Identify and access internal and external sources of information </li></ul></ul></ul><ul><ul><ul><li>Convert information to knowledge of use to the organisation </li></ul></ul></ul><ul><ul><ul><li>Use the information to set and meet its strategic objectives </li></ul></ul></ul><ul><ul><ul><li>Ensure appropriate security and confidentiality </li></ul></ul></ul><ul><ul><ul><li>Evaluate the benefits derived from information use in order to improve information management and knowledge… </li></ul></ul></ul>
    130. 130. ISO9004 : 2000 – 6.5 : Information (2/2) <ul><li>Q. 13 : How does management ensure that appropriate information is easily available for factually-based decision making ? </li></ul>
    131. 131. ISO9004 : 2000 – 6.6 : Suppliers and Partnerships (1/3) <ul><li>This is NOT part of ISO9001:2000 </li></ul><ul><ul><li>Management should establish relationships with suppliers and partners to promote and facilitate communication with the aim of mutually improving the effectiveness and efficiency of processes that create value </li></ul></ul><ul><ul><li>This can be done by (see over)… </li></ul></ul>
    132. 132. ISO9004 : 2000 – 6.6 : Suppliers and Partnerships (2/3) <ul><li>Optimising the number of suppliers and partners </li></ul><ul><li>Establishing 2-way communication at appropriate levels in both organisations to facilitate the rapid solution of problems and to avoid delays and disputes </li></ul><ul><li>Co-operating with suppliers in the validation of the capability of their processes </li></ul><ul><li>Monitoring the ability of suppliers to deliver conforming products with the aim of eliminating redundant verifications </li></ul><ul><li>Encouraging suppliers to implement continual improvement programs and to participate in joint activities </li></ul><ul><li>Involving suppliers in the organisation’s design and development activities to share knowledge and effectively and efficiently improve the realisation and delivery processes for conforming products </li></ul><ul><li>Involving suppliers in the identification of purchasing needs </li></ul><ul><li>Evaluating, recognising, and rewarding efforts and achievements by suppliers and partners… </li></ul>
    133. 133. ISO9004 : 2000 – 6.6 : Suppliers and Partnerships (3/3) <ul><li>Q. 14 (a) : How does management involve suppliers in the identification of purchasing needs and joint strategy development ? </li></ul><ul><li>Q. 14 (b) : How does management promote partnership arrangements with suppliers ?. </li></ul>
    134. 134. ISO9004 : 2000 – 6.7 : Natural Resources (1/2) <ul><li>This is NOT part of ISO9001:2000 </li></ul><ul><ul><li>Consideration should be given to the availability of natural resources that can influence the performance of the organisation </li></ul></ul><ul><ul><li>The organisation should have contingency plans to ensure the availability or replacement of these resources in order to minimise or prevent negative effects on the performance of the organisation… </li></ul></ul>
    135. 135. ISO9004 : 2000 – 6.7 : Natural Resources (2/2) <ul><li>Q. 15 : How does the organisation ensure the availability of necessary natural resources for its realisation processes ? </li></ul>
    136. 136. ISO9004 : 2000 – 6.8 : Financial Resources (1/3) <ul><li>This is NOT part of ISO9001:2000 </li></ul><ul><ul><li>Resource management should include activities for determining the needs for, and sources of financial resources </li></ul></ul><ul><ul><li>This should include activities for comparing actual usage versus planned usage, and taking any necessary action </li></ul></ul><ul><ul><li>Management should plan, make available, and control the financial resources necessary to implement and maintain an effective and efficient Quality Management System an to achieve the organisation’s objectives… </li></ul></ul>
    137. 137. ISO9004 : 2000 – 6.8 : Financial Resources (2/3) <ul><li>Improving the QMS can positively affect the financial position of an organisation by : </li></ul><ul><ul><li>Internally reducing process and product failures, or waste of materials or time </li></ul></ul><ul><ul><li>Externally reducing product failures, compensation costs (e.g. warranty), and costs of lost customers </li></ul></ul><ul><li>Reporting the above issues can help determine ineffective or inefficient activities, and initiate improvement actions </li></ul><ul><li>The financial reporting of activities related to the performance of the QMS and product conformity should be used in management reviews… </li></ul>
    138. 138. ISO9004 : 2000 – 6.8 : Financial Resources (3/3) <ul><li>Q. 16 (a) : How does management plan, provide, control, and monitor the financial resources necessary to maintain an effective and efficient Quality Management System and to ensure the achievement of the organisation’s objectives ? </li></ul><ul><li>Q. 16 (b) : How does management ensure awareness of people in the organisation about the link between product Quality and costs ?. </li></ul>
    139. 139. Overview of Standard <ul><li>7 Product realisation </li></ul><ul><ul><li>7.1 Planning of product realisation </li></ul></ul><ul><ul><li>7.2 Customer-related processes </li></ul></ul><ul><ul><li>7.3 Design and development </li></ul></ul><ul><ul><li>7.4 Purchasing </li></ul></ul><ul><ul><li>7.5 Production and service provision </li></ul></ul><ul><ul><li>7.6 Control of monitoring and measuring devices. </li></ul></ul>
    140. 140. 7 Product Realisation <ul><li>Section 7 is the only area where an organisation can have exclusions. For example, if an organisation does not design products, then certain of the following sections do not apply. The organisation must specify these exclusions in its Quality manual. </li></ul>
    141. 141. 7.1 Planning of Product Realisation <ul><li>The organisation shall plan and develop the processes needed for product realisation. This shall be consistent with the requirements of the other QMS processes. In particular, the organisation shall determine, as appropriate : </li></ul><ul><ul><li>The Quality objectives and requirements for the product </li></ul></ul><ul><ul><li>The need to establish processes, documents, and provide resources specific to the product </li></ul></ul><ul><ul><li>Required verification, validation, monitoring, inspection, and test activities specific to the product and the criteria of product acceptance </li></ul></ul><ul><ul><li>Management should plan the required outputs of processes, and should identify the necessary inputs and activities required for their achievement </li></ul></ul><ul><ul><li>Records needed to provide evidence that the realisation process and resulting processes meet requirements. </li></ul></ul>
    142. 142. ISO9004 : 2000 – 7.1 Product Realisation (1/7) <ul><li>Results from verification and validation of processes and outputs should be considered as inputs to a process to achieve continual improvement </li></ul><ul><li>The organisation needs to : </li></ul><ul><ul><li>Identify and communicate the significant features of each process </li></ul></ul><ul><ul><li>Provide training in the operation of processes </li></ul></ul><ul><ul><li>Share knowledge and experience in teams and workgroups </li></ul></ul><ul><ul><li>Measure and audit the processes </li></ul></ul><ul><ul><li>Analyse, review, and improve the processes… </li></ul></ul>
    143. 143. ISO9004 : 2000 – 7.1 Product Realisation (2/7) <ul><li>The role of people should be evaluated so that : </li></ul><ul><ul><li>The health and safety of people are ensured </li></ul></ul><ul><ul><li>The necessary skills exist </li></ul></ul><ul><ul><li>Process co-ordination is supported </li></ul></ul><ul><ul><li>Input from people in process analysis is provided </li></ul></ul><ul><ul><li>Innovation is promoted… </li></ul></ul>
    144. 144. ISO9004 : 2000 – 7.1 Product Realisation (3/7) <ul><li>An operation plan should be developed to manage the processes, including : </li></ul><ul><ul><li>Input and output requirements (e.g. specifications and resources) </li></ul></ul><ul><ul><li>Activities within the processes </li></ul></ul><ul><ul><li>Verification and validation of processes and products </li></ul></ul><ul><ul><li>Analysis of the process including dependability </li></ul></ul><ul><ul><li>Identification, assessment, and mitigation of risk </li></ul></ul><ul><ul><li>Corrective and preventive actions </li></ul></ul><ul><ul><li>Opportunities and actions for process improvement </li></ul></ul><ul><ul><li>Control of changes to processes and products… </li></ul></ul>
    145. 145. ISO9004 : 2000 – 7.1 Product Realisation (4/7) <ul><li>Inputs derived from activities not yet fully evaluated should be subject to evaluation through subsequent review, verification, and validation </li></ul><ul><li>The organisation should identify significant or critical features of products and processes in order to develop an effective and efficient plan for controlling and monitoring the activities within its processes </li></ul><ul><li>Examples of input issues include competence of people, documentation, equipment capability and monitoring, health, safety, and work environment </li></ul><ul><li>For verification purposes, the outputs should be recorded and evaluated against the input requirements and acceptance criteria </li></ul><ul><ul><li>The evaluation should identify corrective and preventive actions, potential improvements </li></ul></ul><ul><ul><li>Variation of the product can be carried out in the process in order to identify variation… </li></ul></ul>
    146. 146. ISO9004 : 2000 – 7.1 Product Realisation (5/7) <ul><li>Management should periodically review process performance to ensure it is operating according to planned arrangements </li></ul><ul><li>Examples include : </li></ul><ul><ul><li>Reliability and repeatability of the process </li></ul></ul><ul><ul><li>Identification and prevention of potential non conformities </li></ul></ul><ul><ul><li>Adequacy of design and development inputs and outputs </li></ul></ul><ul><ul><li>Consistency of inputs and outputs with planned objectives </li></ul></ul><ul><ul><li>Potential for improvement </li></ul></ul><ul><ul><li>Unresolved issues… </li></ul></ul>
    147. 147. ISO9004 : 2000 – 7.1 Product Realisation (6/7) <ul><li>Management should ensure that the validation of products demonstrates that they meet the needs and expectations of customers and other interested parties </li></ul><ul><li>Validation activities include modelling, simulation, trials, reviews involving customers and other interested parties </li></ul><ul><li>Issues to consider include : </li></ul><ul><ul><li>Quality policy and objectives </li></ul></ul><ul><ul><li>Capability or qualification of equipment </li></ul></ul><ul><ul><li>Operating conditions for the product/service </li></ul></ul><ul><ul><li>Use or application of the product </li></ul></ul><ul><ul><li>Disposal of the product </li></ul></ul><ul><ul><li>Product life cycle </li></ul></ul><ul><ul><li>Environmental impact of the product </li></ul></ul><ul><ul><li>Impact on the use of natural resources, including materials and energy… </li></ul></ul>
    148. 148. ISO9004 : 2000 – 7.1 Product Realisation (7/7) <ul><li>Process validation should be carried out at appropriate intervals to ensure timely reaction to changes impacting the process </li></ul><ul><li>Particular attention should be given to those processes : </li></ul><ul><ul><li>That have high value or are safety critical </li></ul></ul><ul><ul><li>Where product deficiency only becomes apparent in use </li></ul></ul><ul><ul><li>That cannot be repeated </li></ul></ul><ul><ul><li>Where verification of product/service is not possible. </li></ul></ul>
    149. 149. ISO9004 : 2000 – 7.1 <ul><li>Q. 17 : How does top management apply the process approach to ensure the effective and efficient operation of the realisation and support processes and the associated process network ? </li></ul>
    150. 150. 7.2 Customer-related Processes <ul><li>7.2.1 Determination of requirements related to the product/service </li></ul><ul><li>7.2.2 Review of requirements related to the product/service </li></ul><ul><li>7.2.3 Customer communication. </li></ul>
    151. 151. 7.2.1 Determination of Requirements Related to the Product <ul><li>The organisation shall determine : </li></ul><ul><ul><li>Requirements specified by the customer including delivery and any post-delivery activities </li></ul></ul><ul><ul><li>Requirements not stated by the customer but necessary for the specified or intended use, where known </li></ul></ul><ul><ul><li>Statutory or regulatory requirements related to the product </li></ul></ul><ul><ul><li>Any additional requirements. </li></ul></ul>
    152. 152. 7.2.2 Review of Requirements Related to the Product <ul><li>This must be done before the organisation commits to supplying a product or service, and it must confirm the requirements to a customer even where the customer has not given any documented requirements. It must ensure that : </li></ul><ul><ul><li>The product/service requirements are identified </li></ul></ul><ul><ul><li>Any order or contract changes are resolved. Relevant documents must be amended and relevant people must be made aware of the changed requirements </li></ul></ul><ul><ul><li>The organisation has the ability to meet the defined requirements </li></ul></ul><ul><li>Records must be kept of these reviews and of any actions taken. </li></ul>
    153. 153. 7.2.3 Customer Communication <ul><li>The organisation shall determine and implement effective arrangements for customer communication in relation to : </li></ul><ul><ul><li>Product information </li></ul></ul><ul><ul><li>Enquiries, contracts, order handling, including amendments </li></ul></ul><ul><ul><li>Customer feedback, including customer complaints. </li></ul></ul>
    154. 154. ISO9004 : 2000 – 7.2 <ul><li>Q. 18 (a) : How has management defined customer-related processes to ensure consideration of customers’ needs ? </li></ul><ul><li>Q. 18 (b) : How has management defined other interested party processes to ensure consideration of interested parties’ needs and expectations ?. </li></ul>
    155. 155. 7 Product Realisation <ul><li>7.3 Design and development </li></ul><ul><ul><li>7.3.1 Design and development planning </li></ul></ul><ul><ul><li>7.3.2 Design and development inputs </li></ul></ul><ul><ul><li>7.3.3 Design and development outputs </li></ul></ul><ul><ul><li>7.3.4 Design and development review </li></ul></ul><ul><ul><li>7.3.5 Design and development verification </li></ul></ul><ul><ul><li>7.3.6 Design and development validation </li></ul></ul><ul><ul><li>7.3.7 Control of design and development changes. </li></ul></ul>
    156. 156. 7.3.1 Design and development planning <ul><li>The organisation needs to determine : </li></ul><ul><ul><li>The design and development stages </li></ul></ul><ul><ul><li>Review, verification, and validation, appropriate to each design and development stage </li></ul></ul><ul><ul><li>The responsibilities and authorities for design and development </li></ul></ul><ul><li>The planning output needs to be updated as the design and development progresses. </li></ul>
    157. 157. 7.3.2 Design and development inputs (1/2) <ul><li>Inputs include : </li></ul><ul><ul><li>Functional and performance requirements </li></ul></ul><ul><ul><li>Customer (and other interested parties) marketplace needs and expectations </li></ul></ul><ul><ul><li>Supplier’s contributions </li></ul></ul><ul><ul><li>Applicable statutory and regulatory requirements </li></ul></ul><ul><ul><li>Where applicable , information derived from previous similar designs </li></ul></ul><ul><ul><li>Other requirements essential for design and development </li></ul></ul><ul><li>Records need to be maintained and the inputs reviewed for adequacy </li></ul><ul><li>Requirements must be complete, unambiguous, and not in conflict with each other… </li></ul>
    158. 158. 7.3.2 Design and development inputs (2/2) <ul><li>Internal inputs include : </li></ul><ul><ul><li>Policies and objectives </li></ul></ul><ul><ul><li>Technological developments </li></ul></ul><ul><ul><li>Feedback from previous experience </li></ul></ul><ul><ul><li>Data and records from existing products and processes </li></ul></ul><ul><ul><li>Outputs from other processes </li></ul></ul><ul><ul><li>Needs and expectations of people in the organisation, including those receiving the output of the process </li></ul></ul><ul><ul><li>Competence requirements for people performing design and development. </li></ul></ul>
    159. 159. 7.3.3. Design and development outputs (1/2) <ul><li>Shall be in a form that enables verification against the design and development inputs, and shall be approved prior to release. The outputs shall : </li></ul><ul><ul><li>Meet the input requirements </li></ul></ul><ul><ul><li>Provide appropriate information for purchasing, production, and service provision </li></ul></ul><ul><ul><li>Contain or reference product acceptance criteria </li></ul></ul><ul><ul><li>Specify the characteristics of the product that are essential for its safe and proper use </li></ul></ul><ul><li>Examples of these outputs are shown on the next slide : </li></ul>
    160. 160. 7.3.3. Design and development outputs (2/2) <ul><li>Examples : </li></ul><ul><ul><li>Data demonstrating the comparison of process inputs to process outputs </li></ul></ul><ul><ul><li>Product specifications, including acceptance criteria </li></ul></ul><ul><ul><li>Process specifications </li></ul></ul><ul><ul><li>Material specifications </li></ul></ul><ul><ul><li>Testing specifications </li></ul></ul><ul><ul><li>Training requirements </li></ul></ul><ul><ul><li>User and consumer information </li></ul></ul><ul><ul><li>Purchase requirements. </li></ul></ul>
    161. 161. 7.3.4 Design and development review (1/2) <ul><li>Reviews need to be held at suitable stages in accordance with planned arrangements in order to : </li></ul><ul><ul><li>Evaluate the ability of the design and development results to meet requirements </li></ul></ul><ul><ul><li>To identify any problems and propose necessary actions </li></ul></ul><ul><li>Participants in the reviews must include representatives of the functions concerned with the design and development stages – this should include the customer for some of the stages </li></ul><ul><li>Records must be maintained of the reviews and of any necessary actions agreed </li></ul><ul><li>The design and development reviews can include : </li></ul>
    162. 162. 7.3.4 Design and development review (2/2) <ul><li>Review contents : </li></ul><ul><ul><li>Adequacy of inputs </li></ul></ul><ul><ul><li>Progress of the planned design and development process, and discussion of delays and their causes </li></ul></ul><ul><ul><li>Meeting verification and validation goals </li></ul></ul><ul><ul><li>Evaluation of potential hazards or fault modes in product use – this could also apply to review of an operating or service manual </li></ul></ul><ul><ul><li>Life cycle data </li></ul></ul><ul><ul><li>Change control and their effect during the design and development process </li></ul></ul><ul><ul><li>Identification and correction of problems </li></ul></ul><ul><ul><li>Opportunities for improvement </li></ul></ul><ul><ul><li>(Potential) impact of the product on the environment. </li></ul></ul>
    163. 163. 7.3.5 Design and development verification <ul><li>Shall be conducted in accordance with planned arrangements to ensure that the outputs meet the input requirements </li></ul><ul><li>Records of the results of the verification and any necessary actions shall be maintained </li></ul><ul><li>Areas for evaluation include : </li></ul><ul><ul><li>Comparing input requirements with process output </li></ul></ul><ul><ul><li>May include looking at alternative designs </li></ul></ul><ul><ul><li>Evaluating against similar products </li></ul></ul><ul><ul><li>Testing, simulation, trials, as a means of verification </li></ul></ul><ul><ul><li>Evaluating against lessons learnt from previous designs and process experience. </li></ul></ul>
    164. 164. 7.3.6 Design and development validation <ul><li>Shall be conducted in accordance with planned arrangements. </li></ul><ul><li>The function of validation is to ensure that the product is capable of meeting the requirements for the specified application or intended use, where known </li></ul><ul><li>Validation shall be completed before construction, delivery, installation, application, or implementation of the product or service </li></ul><ul><li>Records shall be maintained of the results and of any necessary actions </li></ul><ul><li>This applies to services and software also </li></ul><ul><li>In some cases, validation can only be performed on the product components (e.g. a bridge). This partial validation may be necessary to provide confidence in the item’s future application. </li></ul>
    165. 165. 7.3.7 Control of design and development changes <ul><li>Design and development changes shall be identified, and records maintained of the reviews and of any necessary actions </li></ul><ul><li>Changes shall be evaluated, reviewed, verified, and validated, as appropriate , and approved before implementation. An agreed change control procedure must be in place. Authority for initiating changes should be defined </li></ul><ul><li>Changes also need to be considered in the light of their possible effect on other processes </li></ul><ul><li>Any change in the processes affecting product characteristics should be recorded and communicated in order to maintain the conformity of the product/service, and provide information for corrective action or performance improvement of the organisation </li></ul><ul><li>Part of the review shall include evaluation of the effects of the changes on component parts and on product already delivered. </li></ul>
    166. 166. ISO9004 : 2000 – 7.3 <ul><li>Q. 19 (a) : How has top management defined design and development processes to ensure they respond to the needs and expectations of the organisation’s customers and other interested parties ? </li></ul><ul><li>Q. 19 (b) : How are design and development processes managed in practice, including the definition of design and development requirements and the achievement of planned outputs ? </li></ul><ul><li>Q. 19 (c) : How are activities such as design review, verification, validation, and configuration management considered in the design and development processes ?. </li></ul>
    167. 167. 7 Product Realisation <ul><li>7.4 Purchasing </li></ul><ul><ul><li>7.4.1 Purchasing process </li></ul></ul><ul><ul><li>7.4.2 Purchasing information </li></ul></ul><ul><ul><li>7.4.3 Verification of purchased product. </li></ul></ul>
    168. 168. 7.4.1 Purchasing Process (1/3) <ul><li>Purchased product must conform to purchase requirements </li></ul><ul><li>The type and extent of control applied to a supplier and the purchased product shall be dependent upon the effect of the purchased product on subsequent product realisation or the final product </li></ul><ul><li>The organisation shall evaluate and select suppliers on their ability to supply product in accordance with the organisation’s requirements </li></ul><ul><li>Criteria for selection, evaluation, and re-evaluation shall be established </li></ul><ul><li>Records shall be maintained of the results of evaluations and any necessary actions </li></ul><ul><li>Can include calibration if it is done externally </li></ul><ul><li>If we evaluate suppliers, we need to specify the frequency and method of re-evaluation </li></ul><ul><li>Suppliers should be evaluated on the basis of criticality… </li></ul>
    169. 169. 7.4.1 Purchasing Process (2/3) <ul><li>The purchasing processes should consider : </li></ul><ul><ul><li>Timely, effective, and accurate identification of needs and purchased product/service specifications </li></ul></ul><ul><ul><li>Evaluation of the purchased item costs, taking account of item performance, price, and delivery </li></ul></ul><ul><ul><li>The organisation’s need and criteria for verifying purchased product </li></ul></ul><ul><ul><li>Unique supplier processes </li></ul></ul><ul><ul><li>Contract administration requirements </li></ul></ul><ul><ul><li>Warranty agreements for non conforming items </li></ul></ul><ul><ul><li>Logistic requirements </li></ul></ul><ul><ul><li>Product identification and traceability… </li></ul></ul>
    170. 170. 7.4.1 Purchasing Process (3/3) <ul><li>Cont’d… </li></ul><ul><ul><li>Preservation of product </li></ul></ul><ul><ul><li>Documentation, including records (test, inspection, etc.) </li></ul></ul><ul><ul><li>Control of purchased products which deviates from requirements </li></ul></ul><ul><ul><li>Product/service delivery, installation or application history </li></ul></ul><ul><ul><li>Supplier development </li></ul></ul><ul><ul><li>Identification and mitigation of risks associated with purchased items </li></ul></ul><ul><li>The organisation should work with suppliers in developing requirements for product specifications and processes, and in agreeing an optimised purchasing process. This could also result in better control and availability of inventory </li></ul><ul><li>The organisation should define the needs for records of purchased item verification, and response to non conformities. </li></ul>
    171. 171. 7.4.2 Purchasing Information <ul><li>Purchasing documents shall include, where appropriate : </li></ul><ul><ul><li>The requirements for approval of product, procedures, processes, and equipment </li></ul></ul><ul><ul><li>The requirements for qualification of personnel </li></ul></ul><ul><ul><li>Any Quality Management System requirements </li></ul></ul><ul><li>The organisation must ensure that all purchase requirements are adequate before sending them to a supplier. </li></ul>
    172. 172. 7.4.3 Verification of Purchased Product (1/5) <ul><li>The organisation shall establish and implement any inspection activities necessary to ensure the purchased product meets the specified purchase requirements… </li></ul>
    173. 173. 7.4.3 Verification of Purchased Product (2/5) <ul><li>Inputs to the supplier control process can include : </li></ul><ul><ul><li>Evaluation of supplier’s relevant experience </li></ul></ul><ul><ul><li>Performance of supplier against competitors </li></ul></ul><ul><ul><li>Review of purchased item Quality, price, delivery performance and response to problems </li></ul></ul><ul><ul><li>Supplier audits – evaluation of their potential capability to provide the required items effectively and efficiently and within schedule </li></ul></ul><ul><ul><li>Checking supplier references and any available data on customer satisfaction </li></ul></ul><ul><ul><li>Financial assessment to ensure the viability of the supplier throughout the intended period of supply (after sales period should also be taken into account)… </li></ul></ul>
    174. 174. 7.4.3 Verification of Purchased Product (3/5) <ul><li>Cont’d </li></ul><ul><ul><li>Supplier response to inquiries, quotation requests, and tendering </li></ul></ul><ul><ul><li>Supplier service, installation, and support capability, and history of performance to requirements </li></ul></ul><ul><ul><li>Supplier awareness of, and competence with relevant statutory and regulatory requirements </li></ul></ul><ul><ul><li>The supplier’s logistic capability, including locations and resources in each location </li></ul></ul><ul><ul><li>The supplier’s standing in the community and its perception in society </li></ul></ul><ul><li>Management should consider any actions needed to maintain the organisation’s performance and to satisfy interested parties in the event of supplier failure (late deliveries, bad Quality items, fire/flood/vandalism at supplier’s plant, supplier goes out of business)… </li></ul>
    175. 175. 7.4.3 Verification of Purchased Product (4/5) <ul><li>This is not part of ISO9001:2000 </li></ul><ul><li>It is important to clarify with suppliers at an early stage, the procedure for dealing with non conforming goods – will the supplier : </li></ul><ul><ul><li>replace the batch </li></ul></ul><ul><ul><li>pay for sorting </li></ul></ul><ul><ul><li>send a representative to you first </li></ul></ul><ul><ul><li>give a discount </li></ul></ul><ul><ul><li>ask for a sample to be returned, etc. But what do you do while this is happening ? </li></ul></ul><ul><ul><li>What happens with the supplier’s invoice ? Do you threaten to not pay it until action has been taken ? What happens if the supplier then threatens not to supply any more goods ? Have you an alternative supplier ? You can’t jump in with heavy tactics every time there is a problem – you need to work with your suppliers… </li></ul></ul>
    176. 176. 7.4.3 Verification of Purchased Product (5/5) <ul><li>Maybe the goods are not certified as defect-free (commercial grade Quality) </li></ul><ul><li>If the organisation or its customer intends to perform verification at the supplier’s premises, the organisation shall state the intended verification arrangements and method of product release in the purchasing information. </li></ul>
    177. 177. ISO9004 : 2000 – 7.4 <ul><li>Q. 20 (a) : How has top management defined purchasing processes that ensure purchased products/services satisfy the organisation’s needs ? </li></ul><ul><li>Q. 20 (b) : How are purchasing processes managed ? </li></ul><ul><li>Q. 20 (c) : How does the organisation ensure conformity of purchased products from specification through to acceptance ?. </li></ul>
    178. 178. 7 Product Realisation <ul><li>7.5 Production and service provision </li></ul><ul><ul><li>7.5.1 Control of production and service provision </li></ul></ul><ul><ul><li>7.5.2 Validation of processes for production and service provision </li></ul></ul><ul><ul><li>7.5.3 Identification and traceability </li></ul></ul><ul><ul><li>7.5.4 Customer property </li></ul></ul><ul><ul><li>7.5.5 Preservation of product. </li></ul></ul>
    179. 179. 7.5.1 Control of production and service provision (1/2) <ul><li>The organisation shall plan and carry out production and service provision under controlled conditions, including, as applicable : </li></ul><ul><ul><li>Availability of information that describes the characteristics of the product or service </li></ul></ul><ul><ul><li>Availability or work instructions ( where necessary ) </li></ul></ul><ul><ul><li>The use and maintenance of suitable equipment </li></ul></ul><ul><ul><li>Availability and use of suitable monitoring and measuring equipment </li></ul></ul><ul><ul><li>The implementation of monitoring and measurement </li></ul></ul><ul><ul><li>The implementation of release, delivery, and post-delivery activities… </li></ul></ul>
    180. 180. 7.5.1 Control of production and service provision (2/2) <ul><li>Top management should go beyond control of the realisation process in order to achieve both compliance with requirements and provide benefits to interested parties by : </li></ul><ul><ul><li>Reducing waste </li></ul></ul><ul><ul><li>Training people </li></ul></ul><ul><ul><li>Communicating effectively and recording information </li></ul></ul><ul><ul><li>Developing supplier capability </li></ul></ul><ul><ul><li>Improving infrastructure </li></ul></ul><ul><ul><li>Preventing problems </li></ul></ul><ul><ul><li>Improving yields </li></ul></ul><ul><ul><li>Reviewing methods of monitoring. </li></ul></ul>
    181. 181. 7.5.2 Validation of production and service provision <ul><li>Processes for production and service provision must be validated where the resulting output cannot be verified by subsequent monitoring or measurement, or where any deficiencies only become apparent after the product is in use or the service has been delivered </li></ul><ul><li>The validation shall demonstrate the ability of these processes to achieve planned results </li></ul><ul><li>Arrangements shall be established for these processes, including, as applicable : </li></ul><ul><ul><li>Defined criteria for review and approval of the processes </li></ul></ul><ul><ul><li>Approval of equipment and qualification of personnel </li></ul></ul><ul><ul><li>The use of specific methods and procedures </li></ul></ul><ul><ul><li>The requirements for records </li></ul></ul><ul><ul><li>Re-validation. </li></ul></ul>
    182. 182. 7.5.3 Identification and Traceability (1/2) <ul><li>This is not an absolute requirement of ISO9001 but usually the customer will demand some form of identification and traceability, plus the organisation will normally benefit from it </li></ul><ul><li>Suitable means shall be used throughout the processes </li></ul><ul><li>Must identify the component and product status – is it ok or not ok ? Passed inspection or awaiting inspection ? Requiring rework or scrapping ? </li></ul><ul><li>The organisation must control and record the unique identification of the product (e.g. batch number) </li></ul><ul><li>For incoming goods, it is advisable to identify the status of the parts </li></ul><ul><li>For work in progress goods, the status should be clearly marked or identified so that everyone knows what inspections or tests have been performed and their results… </li></ul>
    183. 183. 7.5.3 Identification and Traceability (2/2) <ul><li>Non conforming items should be clearly identified as such, with a labelling system that does not easily come off. Many organisations have a ‘material review board’, but it may consist of only one person </li></ul><ul><li>Usually, the decision on non conforming material is : </li></ul><ul><ul><li>Repair / rework / rectification </li></ul></ul><ul><ul><li>Sort </li></ul></ul><ul><ul><li>Scrap </li></ul></ul><ul><ul><li>Ask for customer concession </li></ul></ul><ul><ul><li>Leave as is </li></ul></ul><ul><li>The above will, of course, vary, depending on whether the non conforming items are purchased goods or processed goods. </li></ul>
    184. 184. 7.5.4 Customer Property <ul><li>If the organisation is using customers’ property provided for use or incorporation into the product, it must identify, verify, protect, and safeguard it. </li></ul><ul><li>If any customer property is lost, damaged, or found unsuitable for use or incorporation into the product, this must be reported to the customer and records maintained </li></ul><ul><li>The organisation should identify responsibilities for looking after customer property </li></ul><ul><li>Note that customer property can include intellectual property. </li></ul>
    185. 185. 7.5.5 Preservation of Product <ul><li>Product must be preserved during internal processing and delivery to the intended destination </li></ul><ul><li>Preservation includes identification, handling, packaging, storage, and protection </li></ul><ul><li>Preservation also applies to the constituent parts of a product, so suppliers may be involved </li></ul><ul><li>Management should communicate to interested parties, the resources and methods needed to preserve and protect the product throughout its life cycle. </li></ul>
    186. 186. ISO9004 : 2000 – 7.5 <ul><li>Q. 21 (a) : How does top management ensure that the input to the realisation process takes account of customers’ and other interested parties’ needs ? </li></ul><ul><li>Q. 21 (b) : How are realisation processes managed from inputs to outputs ? </li></ul><ul><li>Q. 21 (c) : How are activities such as verification and validation considered in the realisation process ?. </li></ul>
    187. 187. 7.6 Control of monitoring and measurement devices (1/2) <ul><li>This area refers to calibration and it is up to the organisation to determine the amount of calibration needed to provide evidence of conformity of product to the determined requirements </li></ul><ul><li>If we outsource calibration, it then becomes a purchasing and goods inwards situation </li></ul><ul><li>The organisation must assess and record the validity of previous measurement results when the equipment is found not to conform to requirements, and it must take appropriate action on the equipment and any product affected </li></ul><ul><li>Where computer software is used for monitoring and measurement, it shall be confirmed prior to initial use and re-confirmed as necessary </li></ul><ul><li>Records of the results of calibration and verification must be maintained… </li></ul>
    188. 188. 7.6 Control of monitoring and measurement devices (2/2) <ul><li>Where necessary to ensure valid results, measuring equipment shall : </li></ul><ul><ul><li>Be calibrated or verified at specified intervals, or prior to use, against measurement standards traceable to national or international measurement standards. Where no standard exists, the basis used for calibration shall be recorded </li></ul></ul><ul><ul><li>Be adjusted or re-adjusted as necessary </li></ul></ul><ul><ul><li>Be identified to enable the calibration status to be determined </li></ul></ul><ul><ul><li>Be safeguarded from adjustments that would invalidate the measurement result </li></ul></ul><ul><ul><li>Be protected from damage and deterioration during handling, maintenance, and storage. </li></ul></ul>
    189. 189. ISO9004 : 2000 – 7.6 <ul><li>Q. 22 : How does management control the measuring and monitoring devices to ensure that the correct data is being obtained and used ? </li></ul>
    190. 190. 8 Measurement, Analysis and Improvement <ul><li>8 Measurement, analysis, and improvement </li></ul><ul><li>8.1 General </li></ul><ul><li>8.2 Monitoring and measurement </li></ul><ul><li>8.3 Control of non-conforming product </li></ul><ul><li>8.4 Analysis of data </li></ul><ul><li>8.5 Improvement. </li></ul>
    191. 191. 8.1 General (1/4) <ul><li>The organisation shall plan and implement the monitoring, measuring, analysis, and improvement processes needed to : </li></ul><ul><ul><li>Demonstrate conformity of the product </li></ul></ul><ul><ul><li>Ensure conformity of the Quality Management System </li></ul></ul><ul><ul><li>Continually improve the effectiveness of the Quality Management System – record the actions taken and their effectiveness or otherwise, and any implementation problems, to help future improvements </li></ul></ul><ul><ul><li>Satisfy customers… </li></ul></ul>
    192. 192. 8.1 General (2/4) <ul><li>The outputs of this process must feed into the management review </li></ul><ul><li>Suitable methods should be used, including statistical techniques, and the extent of their use, where appropriate </li></ul><ul><li>Examples of measurements relate to : </li></ul><ul><ul><li>Measurement and evaluation of products and services