Workshop on ISO 9001 2008

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Workshop on ISO 9001 2008

  1. 1. CONTENTS 1 Introduction 2 What’s New in ISO 9001:2008 3 ISO 9000 Project Management 4 Eight Quality Management Principles 5 Requirements
  2. 2. 1
  3. 3. ISO 9000:87 ISO 9000:94 ISO 9001:2000 BS5750 ISO 9001:2008 1979 AQAP1 (NATO) 1970’s MIL-STD-9858 (1940’s) Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  4. 4.  International Organization for Standardization  Develops standards do not certify companies  Around 140 countries members  Around 13000 standards produced  Technical Committees are formed to produce standards  TC 176 for ISO 9000  International Organization for Standardization Email: central@iso.ch Web: http://www.iso.ch http://www.bsi.org.uk/iso-tc176-sc2. Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  5. 5. 2 WHAT’S NEW IN ISO 9001:2008 Compared to ISO 9001:1994
  6. 6.  Cancels and replaces second edition of 1994  revised title which no more uses the term QA, instead just QMS (QA + Customer Satisfaction)  Released on 15 Dec 2000  up-graded in contents, effectiveness, and logical implementation  9000- and 9004- series guidelines eliminated and 9004 to serve as a general purpose guidelines  Many guidelines available in the form of TR (Technical Reports)  compatible with ISO 14001 Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  7. 7. • Scope (modified): • to demonstrate its ability to provide consistently, product that meets customer and applicable regulatory requirements, and • to address customer satisfaction through the effective application of the system, including processes for continual improvement and the prevention of nonconformity Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  8. 8. • ISO 9001, 9002, & 9003 merged into a single 9001:2008 • ISO 8402 and ISO 9000-1 merged into a new ISO 9001:2008 • ISO 10011 will be merged with ISO 14010 into a new ISO 19001 Quality & Environmental Auditing • 3 years for co-existence Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  9. 9. 1. The Standard 2. The Structure 3. The Definitions 4. The Emphasis 5. The Requirements 6. The Flexibility 7. The Approach Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  10. 10. 1. New Standard  ISO 9002 and 9003 dropped  ISO 9001 modified 2. New Structure • 20 clauses abandoned • Now 5 sections Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  11. 11. 3. New Definitions • Supplier: Vendors, subcontractors, etc. • Organization: The company implementing QMS • Product Realization: The interconnected processes that are used to bring products into being. When you start with an idea and end up with a product, you’ve gone through the process of product realization 4. New Emphasis  Customer Focused  Continual Improvement  Integration of Processes with the QMS Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  12. 12. 5. New Requirements 1. Communication with customers 2. Identify customer needs and expectations 3. Meet customer needs and expectations 4. Measure and monitor customer needs and expectations 5. Meet legal and regulatory requirements 6. Internal Communication 7. Provide competent human resources 8. Provide necessary facilities and work environment 9. Evaluate the effectiveness of training 10. Measure and monitor realization processes 11. Evaluate the effectiveness and suitability of quality system 12. Identify QMS improvements 13 Improve QMS regularly Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  13. 13. 6. New Flexibility 1. Permissible Exclusions from Section 7 if a. it doesn’t apply b. customer’s requirements make it reasonable to exclude c. regulatory requirements make it reasonable to exclude However, no part can be excluded, if doing so will undermine the organization’s abilities or performance Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  14. 14. 7. New Approach PROCESS APPROACH TO QMS QMS can now be considered as a single large process with many sub- processes. Each of these sub-processes uses inputs and outputs. These are: 1. Resource Management 10. Internal Communication 2. Regulatory Research 11. Document Control 3. Market Research 12. Record Keeping 4. Product Design 13. Planning 5. Purchasing 14. Training 6. Service 15. Internal Audit 7. Product Protection 16. Management Review 8. Customer Needs Assessment 17. Measurement Processes 9. Customer Communication 18. Nonconformance Mgt Prepare by: Adnan Masood Manager QHSE 19. Continual Improvement. at TCG {0336-2350594}
  15. 15.  Generic QMS Model  Non prescriptive  Documentation culture  Implementation without training not possible  Control of vendors  HRD  SPC  Not free of cost Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  16. 16.  Main objective - image enhancing or market compulsion - not quality improvement  Delegated to lower level of management - lack of top management’s (CEO’s and dept’l heads involvement  Insufficient training/understanding  Ineffective project management  Eagerness to achieve certification (rather than Quality) as quickly as possible  dominated by the influence of non-believers  Insufficient writing strengths in management  Role of Consultants and Certification Agency Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  17. 17.  ISO does not certify itself  Hundreds of agencies available world wide  every company is free to choose  Selection criteria  Reputation  Accreditation (ISO Guide 62, scope of accreditation, IAF)  Quality of auditors with process know-how and experience  Cost  Availability and easy communication  Scope of Certification  Re-certification after every three years/surveillance after 6-12 months Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  18. 18. 3
  19. 19.  About one year project  project team is formed (dept’l heads) and a Proj. Coord.  project team is trained  dept’l procedures are mapped/documented  ISO 9001 requirements are interpreted into each dept.  Solutions (quality processes) to fulfill the requirements are identified  Solutions are run on trials  Solutions are added into prevalent dept’l procedures  Solutions are implemented  Internal Quality Auditing is started  Corrective Action Program is initiated  Selection of suitable certification agency  pre-audit/audit is carried out Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  20. 20.  Project Coordinator - Quality Management Representative (QMR)  Project members from each dept. (usually dept’l heads)  Main Responsibilities  process mapping/documenting  project realization  project monitoring  system designing  validation of procedures  project control  owning the QMS at a company-wide level Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  21. 21.  Quality of the Quality Management System is dependent on the Quality of Project Team  Training (ISO 9001, IQA, SQC, Process Mapping, etc.)  Visits to good models of certified firms  Self study, interest, and initiatives  membership to professional organizations, e.g.. ASQ, IQA, etc.  Browsing internet  participating in discussions with professionals Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  22. 22. Excellent C Good Satisfactory Acceptable B A 3 6 9 12 18 Time (months) Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  23. 23. 4
  24. 24.  Organizations depend on their customers and therefore should understand current and future customer needs, meet customer requirements and strive to exceed customer expectations Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  25. 25.  Leaders establish unity of purpose and direction of the organization. They should create and maintain the internal environment in which people can become fully involved in achieving the organization’s objectives Corporate Goals Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  26. 26.  People at all levels are the essence of an organization and their full involvement enables their abilities to be used for the organization’s benefit Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  27. 27.  A desired result is achieved more efficiently when related resources and activities are managed as a process Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  28. 28.  Identifying, understanding and managing a system of interrelated processes for a given objective improves the organization’s effectiveness and efficiency Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  29. 29.  Continual improvement should be a permanent objective of the organization Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  30. 30.  Effective decisions are based on the analysis of data and information Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  31. 31.  An organization and its suppliers are interdependent, and a mutually beneficial relationship enhances the ability of both to create value Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  32. 32. 5
  33. 33. CONTINUAL IMPROVEMENT OF THE QUALITY MANAGEMENT SYSTEM C R e Management C S a U q responsibility U t i u S i S s r Measurement, f T e Resource analysis and T a c O m management improvement e O t i M n t M o Input n E s Product Output E R realization Product R Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  34. 34. 1 Scope 1.1 General 1.2 Application 2 Normative Reference 3 Terms and Definitions Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  35. 35. 4 Quality Management System 4.1 General Requirements 4.2 Documentation Requirements 5 Management 5.1 Management Commitment Responsibility 5.2 Customer focus 5.3 Quality Policy 5.4 Planning 5.5 Responsibility, authority and communication 5.6 Management Review 6 Resource Management 6.1 Provision of resources 6.2 Human resources 6.3 Infrastructure 6.4 Work environment 7 Product Realization 7.1 Planning of product realization 7.2 Customer-related processes 7.3 Design and development 7.4 Purchasing 7.5 Production and service provision Prepare by: Adnan Masood Manager QHSE 7.6 Control of monitoring and measuring devices at TCG {0336-2350594}
  36. 36. 8 Measurement, Analysis and Improvement 8.1 General 8.2 Monitoring and measurement 8.3 Control of nonconforming product 8.4 Analysis of data 8.5 Improvement Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  37. 37. 1.1 General  Product consistently meets customer and applicable regulatory requirements  to enhance customer satisfaction, including continual improvement of the system and assurance of conformity to customer and applicable regulatory requirements Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  38. 38. 1.2 Application  Generic requirements; applicable to all organizations, regardless of type, size and product provided  exclusion can be considered if certain requirements not applicable  Exclusion allowed only from Clause 7 Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  39. 39.  ISO 9001:2008 Fundamentals and vocabulary Quality  (ISO 8402 is now obsolete) Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  40. 40.  As given in ISO 9001  Product also means services Supply Chain Supplier Organization Customer Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  41. 41. INTEGRATION? Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  42. 42. 4.1 Quality Management System Examples Quality • C/A with dept’l ISO 9001:2000 procedures Quality • Documentation with Processes company administration Management • Training with HRD System • Quality Objectives with Corporate Review Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  43. 43. 4.2.1 General  Documented statements of a quality policy and quality objectives  a quality manual  documented procedures required by ISO 9001:2008  documents needed by the organization to ensure the effective planning, operation and control of its processes, and  quality records required by this standard Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  44. 44. Documentation Requirements • Documented Procedure means – Established – Documented – Implemented – Maintained Appropriate documentation as per Nature and size of the organization Documentation can be in any form or medium Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  45. 45. 4.2.2 Quality Manual  Scope and justification for exclusion  procedures of the QMS or its reference  integration between QMS and Processes Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  46. 46. How What Applicable Dept A Relevant Clauses Procedures Records QUALITY Applicable Dept B MANUAL Clauses Procedures Relevant (SUMMARY) Records Applicable Dept C Relevant Clauses Procedures Records Applicable Dept D Relevant Clauses Procedures Records Applicable Dept E Relevant Clauses Procedures Records Supporting Documents Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594} e.g. standards, Manuals, GMP’s
  47. 47. 4.2.3 Control of documents  QMS documents shall be controlled Examples  appropriate review and approval prior to issue • Quality Manual • QMS Procedures  changes in revision are identified • Dept’l Procedures  available at locations of use • Work Instructions  legible and identifiable • Drawings/standards • Machine Manuals  external documents are included in • Reference Manuals control etc.  identification of obsolete documents Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  48. 48. 4.2.4 Control of Quality Records Examples  Legible, readily identifiable • Quality Reports and retrievable • Audit Reports • Output of Mgt Reviews  clear procedure to define • Test Reports the control, including • C/P Actions retention and disposition • Customer Surveys • Design Reviews, validations etc. • Customer complaints, etc. Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  49. 49. Documented Procedures required for:  Control of documents  Control of Quality records  Product non-conformance  Internal audits  Corrective actions  Preventive actions Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  50. 50. 5.1 Management Commitment Examples  Evidence of top management commitment for development, Visible involvement of Implementation and continual CEO and dept’l heads improvement of QMS by: in: • forming quality policy  communication with the rest of the and objectives organization on the importance of meeting customer and regulatory • measuring and reviewing requirements objectives and quality • addressing resource  establishing the quality policy requirements  establishing quality objectives • addressing quality with  holding management reviews reporting team members  ensuring availability of resources regularly Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  51. 51. 5.2 Customer Focus  Top management shall ensure Examples that customer requirements are determined and fulfilled with • Customer needs identification the aim of enhancing customer procedure? satisfaction (7.2.1 and 8.2.1) (e.g. surveys, focus groups, contracts) • Top management verification (through 1st, 2nd, 3rd party assessment etc., that such requirements are fulfilled Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  52. 52. 5.3 Quality Policy Top management shall ensure that the What broad Quality aspects quality policy: should be Covered in the Quality Policy? • is appropriate to the purpose of the organization 1. Fulfillment of Customer needs • includes a commitment to comply with 2. Fulfillment of applicable the requirements and continually national laws and regulations improve the effectiveness of the QMS 3. Minimization of waste,errors • provides a framework for establishing and nonconformance and reviewing quality objectives 4. Continual improvement • communicated and understood in the 5. Employees quality and organization organizational culture • is reviewed for continuing suitability Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  53. 53. 5.4 Planning • Quality Objectives: • What does Quality – are established at relevant functions objectives for each and levels, and are measurable and function means? consistent with the quality policy • What does Quality • QMS Planning: objectives for each – Each applicable process/dept. is level means? addressed under the PDCA model; – planning at changes is carried out Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  54. 54. 5.5 Responsibility, Authority and Communication • Responsibility and Authority: Examples – defined and communicated within • Job Descriptions the organization • QMR’s clear role • Management Representative: appoint a QMS Coordination role to a management member – ensure QMS is established, implemented and maintained – report the performance and the need for improvement – promote awareness – liaison with external parties Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  55. 55. • Internal Communication: Examples ensure effective communication • Team briefing and regarding the effectiveness of the meetings QMS • notice boards • newsletter • intranet • employees surveys • Project presentations Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  56. 56. 5.6 Management Review INPUTS QUALITY PROCESS OUTPUTS QUALITY REPORT Improvements in QMS covering Management Improvements in •Audit results Reviews •Customer feedback Products/Processes •process performance •product conformity Resource Needs •C/P Action •follow-ups •changes / follow-ups •recommendations for improvements Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  57. 57. 5.6B Management Review • Management reviews at planned Intervals to ensure: – Continuing suitability – Adequacy – Effectiveness – Identifying opportunities for improvement – Assessment of needs for changes to QMS Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  58. 58.  Break the group into smaller teams  Name your company and its business  Draft a quality policy and quality objectives for approval by the Board of directors  Identify the major processes  Present in the plenary session Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  59. 59.  The organization shall determine and provide the resources needed to:  Implement and maintain QMS and continually improve its effectiveness  Enhance customer satisfaction by meeting requirement Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  60. 60. 6.2.1 General Right person for the right job qualified managers? Qualified / qualified supervisors? Appropriate means appropriate workers? 1. Education 2. Training 3. Skills 4. Experience Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  61. 61. 6.2.2 Competence, Awareness and Training • Determine necessary Examples competence of people • Performance Evaluation • provide training and other means • Training Programs to to satisfy these needs fulfil the gaps • evaluate the training/other • Training evaluation means to check effectiveness • Maintaining • Provide awareness of the Resumes relevance and importance of their activities and its linkage to Quality Objectives • record of education, training, skills, and experience Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  62. 62. • Determine and maintain Examples necessary infrastructure for the • suitable machines, QMS program, e.g. workspaces, software, hardware, information – building, workspace, utilities • Support services for – process equipment (hardware/ logistics software) – supporting services, e.g. transport, communication, Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  63. 63. • The organization shall determine Examples and manage the work environment needed to achieve • work space conformity to product • heat, humidity, light airflow, requirements • hygiene, cleanliness, noise, vibration and pollution, etc. Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  64. 64. For the new organization you have just formed:  Draw an Organization Chart  Determine the infrastructure required  Determine the requirements for the work environment  Present in the plenary session Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  65. 65. 7.1 Planning 7.2 7.6 Monitoring & Customer Measuring Related Devices Processes PRODUCT REALIZATION 7.5 7.3 Production & Design & Service Development Provision 7.4 Purchasing Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  66. 66. • Quality objectives and • Product Quality requirements for the product Plans? • establish processes, documents, • Guidance ISO 10005 and provide resources specific to • Process flowcharts the product • Applicable industry standards • required verification, validation, • Relevant Regulatory monitoring, inspection and test Requests activities specific to the product and the criteria for product acceptance • identification of relevant records to provide objective evidence the realization process and resulting product fulfill requirements Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  67. 67. 7.2 Customer-related Processes 7.2.1 Determination of requirements related to the Product • Determine: Examples – customer’s requirements (including • contracts delivery & past delivery) • customer surveys, – unstated but necessary requirements focus groups – statutory and regulatory product req’t • applicable national – any additional requirement regulations determined by the organization Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  68. 68. 7.2 Customer-related Processes 7.2.2 Review of requirements related to the Product Examples • review contract before acceptance • Contract review • review of results of • ensure product reqts are defined surveys and focus • resolve issues before acceptance groups, etc. • confirm organization capability • Amendment • maintain records • ensure amendments understood, recorded, and communicated to relevant persons Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  69. 69. 7.2 Customer-related Processes 7.2.3 Customer Communication • Make effective arrangements for Examples communicating with customers in • printing of product relation to: information on packaging – product information • internet – inquiries, contracts or order handling, including amendments, and • catalogs and service manuals, etc. – customer feedback, including customer complaints Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  70. 70. Design Review Customer Regulatory Professional Inputs Review Designing Output Reqts. Verification Validation This section includes Design as well as Development
  71. 71. 7.3 Design and Development 7.3.1 D&D Planning • Determine D&D stages • Development Review Committee? • plan the review, verification and • Design & validation for each stage Documentation • responsibilities and authorities stages • define interfaces • planning documents (output) shall be updated regularly Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  72. 72. 7.3 Design and Development 7.3.2 D&D Inputs • Determine functional and • What are some performance requirements examples of design inputs? • applicable statutory and regulatory requirements • information from previous similar designs • clarity must be established in the information Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  73. 73. 7.3 Design and Development 7.3.3 D&D Outputs • D&D output shall: • Examples ° meet the input requirements • actual prototypes ° provide appropriate information for • specifications purchasing, production and service • drawings provision • tooling ° Contain or reference product • jigs/fixtures acceptance criteria ° Supply the Characteristic of the product for its safe & proper use. • Systematic reviews at suitable stages • participation by relevant depts • records of reviews Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  74. 74. 7.3 Design and Development 7.3.4 D&D Review • At suitable stages Examples • by appropriate persons • Review of outcomes of experiments, trials, • identify problems and their research, etc. remedies Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  75. 75. 7.3 Design and Development 7.3.5 D&D Verification • To ensure that design output Examples meets the design inputs • Output of design reviews • records • tests • 3rd party tests • Comparative studies Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  76. 76. 7.3 Design and Development 7.3.6 D&D Validation • Ensure resulting product Examples capability for intended use or • Simulations application • Field Trials • evidences/records • Environmental tests • 3rd party tests • Trial markets evidences Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  77. 77. 7.3 Design and Development 7.3.7 D&D Changes • Changes shall be revised, Examples verified, validated and approved • changes in all before implementation drawings /specifications, • Ensure communication and including vendors’ records of changes Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  78. 78. 7.4 Purchasing PURCHASING Verification of Purchased Product Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  79. 79. 7.4 Purchasing 7.4.1 Purchasing Process • Ensure that purchased product • Procurement of conforms to specified Material requirements • hiring of services, e.g. Maintenance, • type of control over suppliers calibration, consultants, purchased product depend upon certification agencies, their necessity etc. • Vendor Evaluation • suppliers evaluation and selection Form • criteria for selection, and • Criteria for approval evaluation • records of evaluation Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  80. 80. 7.4 Purchasing 7.4.2 Purchasing Information • Product approval requirements Examples • requirements for qualification of Purchase Orders to completely define: personnel • product specification • QMS requirements • AQL • Types of tests (where applicable) • Q.A. requirements, if any Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  81. 81. 7.4 Purchasing 7.4.3 Verification of Purchased Product • Inspection and other activities to • Verification System ensure quality purchases for the products • verification system • inspection at suppliers end should for services be specified in purchasing information Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  82. 82. 7.5 Production and Service Provision 7.5.1 Control of 7.5.4 Production & Customer Service Property Provision 7.5.3 Identification and Traceability 7.5.5 7.5.2 Preservation Validation of of Product Processes Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  83. 83. 7.5 Production and Service Provision 7.5.1 Control of Production and Service Provision • Production to be carried out under Give examples of Service controlled conditions Provision Depts in the – product specs following Service – correct methods to produce Organizations? – suitable equipment • Hotel? – provision of monitoring and measurement devices • University? – monitoring and measurement • Hospitals? programs – effective release, delivery and post- • After sales service is also delivery systems included, e.g. warrantees Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  84. 84. 7.5 Production and Service Provision 7.5.2 Validation of Processes for Production and Service Provision • In the absence of any Examples measurement program, that • Validation/qualification process needs to be validated. of doctors and nurses This should include: in hospitals, welders in metal industry, cooks – review and approval criteria in hotels, etc. – approval of eqpt and qualification of • Validation of special personnel processes, e.g. types – use of specific methods and of electrodes, procedures machines, and – records environment in a – revalidation welding process. Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  85. 85. 7.5 Production and Service Provision 7.5.3 Identification and traceability • Identify the product by suitable All incoming and final means throughout product products should be assured both identification and realization traceability, e.g.. Hardware • identify product monitoring and (product marking, lot measurement status numbers); software (computer programs/files); • if traceability is required, then services (transport, test control and record unique reports), etc. identification system Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  86. 86. 7.5 Production and Service Provision 7.5.4 Customer Property • Take care of customer property Examples • identify, verify, protect, and • Blood products, tissues, babies, safeguard customer property medications, personal • if it is lost, damaged or found valuables, mobility unsuitable, then it should be aids (walkers, chairs, crutches) in hospital reported to customer and records • Customer cars in maintained hotels and companies • Authors manuscripts in publishing, etc. Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  87. 87.  Preserve conformity of product during processing and delivery to the intended destination  Preservation includes identification, handling, packaging, storage and protection.  Applies to the constitute parts of product Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  88. 88. 7.6 Control of Monitoring and Measuring Devices • Identification of correct need to monitor and measure product • correct use of monitor and measuring • Correct devices • correct point of measure • calibration, at defined intervals, with • correct selection of authentic/traceable sources measuring equipment • correct use of adjustments • correct accuracy and precision of measure • safeguarding adjustments • proper handling, maintenance & storage • C/A when devices found out of calibration • confirmation of software Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  89. 89.  Draw a process of product/service realization of your new company  Present in the plenary session Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  90. 90. 8.1 General 8.3 Control of non-conforming product Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  91. 91. 8 Measurement, Analysis and Improvement 8.1 General • Plan and implement the process • This section is about for monitoring, measurement, Quality Control (QC) analysis and input to: • Conformity to customer needs, contracts, and – Ensure conformity of the product national regulation must – ensure conformity of the QMS be ensured before – ensure effectiveness and continually product is dispatched improving the QMS • Validation of measuring procedures • Regularly up-grade accuracy and effectiveness of QMS Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  92. 92. 8 Measurement, Analysis and Improvement 8.2 Monitoring and Measurement Examples of CS: • Direct interfaces 8.2.1 Customer Satisfaction • focus groups – device a method to measure and monitor customer satisfaction from • surveys customer perception point of view • sector and industry – Method for obtaining and using the studies information shall be determined. Examples of IA: • Main objective is to check the correctness and performance of functions and processes; not documentation of processes Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  93. 93. 8.2 Monitoring and Measurement 8.2.2 Internal Audit  Regularly carryout internal audit to check conformity and effectiveness of the QMS  design an effective audit program and plan, criteria  competent auditors  audit results and records  follow-ups and timely C/A Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  94. 94. 8 Measurement, Analysis and Improvement 8.2 Monitoring and Measurement Examples 8.2.3 Processes • use of SPC, – apply suitable monitoring of especially control processes where required charts – C/A when deviation occurs • monitoring and supervision of process parameters 8.2.4 Products • daily morning reviews – measure product characteristics to of quality by workers confirm fulfillment of quality and their supervisors – at appropriate stages in accordance • Appropriate product with the quality plans quality plan – define acceptance criteria – authorize release and records Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  95. 95. 8 Measurement, Analysis and Improvement 8.3 Control of nonconforming product • Ensure nonconforming product is Identification and taking identified and controlled corrective actions on: • wrong purchases • define responsibilities and • wrong deliveries authorities in this procedure • defective products • clear action: C/A, concession, re- produced grade with customers’ consent • wrong packing and evidence • wrong storage • re-verification • wrong dispatches • if detected in use, then take • wrong invoices appropriate action of recall or • etc. compensation Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  96. 96. 8 Measurement, Analysis and Improvement 8.4 Analysis of Data • Determine, collect and analyze • Analysis is not appropriate data from compiling of data measurement sources to check • Analysis is after compiling of quality conformance and analysis for data improvement in: • Analysis is part of – customer satisfaction Quality Report – product conformance • Sources of data? – process – suppliers Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  97. 97. 8 Measurement, Analysis and Improvement 8.5 Improvement 8.5.1 Continual Improvement • Clear evidence of – identify opportunities of improvement improvement from quality policy, objectives, audit processes results, analysis of data, C/P actions, • Clear evidence of and management reviews improvements – mobilize improvement programs Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  98. 98. 8 Measurement, Analysis and Improvement 8.5 Improvement 8.5.2 Corrective Action • What is the – take timely action to eliminate the difference between cause of nonconformities. Correction, Corrective Action – Review nonconformities and Preventive – determine causes Action? – evaluate • Corrective Action – determine and implement action Form – records of results • Control of Corrective – review and confirm results Actions Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  99. 99. 8 Measurement, Analysis and Improvement 8.5 Improvement 8.5.3 Preventive Action • Outputs of – determine potential nonconformities management current mistakes and future planning reviews or corrective actions – determine their causes – device actions – implement actions – record results – review action taken Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  100. 100. – What would be some of the performance indicators of the processes/products of your new company? – How would you measure and analyze them and at what frequency? – Present in the plenary session. Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  101. 101. Systems are not what documents say what they are; they are the habits of people which they practice . Most failures are not because of documents or systems; but because of people who do not change their prevalent habits (systems). Therefore, Systems usually do not fail, people do. Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  102. 102. Adnan Masood Manager QHSE The Chishtian Goods Transport Company

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