This document provides a supplier selection checklist covering key criteria for selecting suppliers of non-critical and critical raw materials. The checklist includes minimum criteria like specifications, price, and documentation as well as more advanced criteria assessing assurance of supply, quality/regulatory compliance, procurement/cost, innovation/technical capabilities, and responsiveness/communication. Selection depends on suppliers' ability to meet specifications, ensure stable supply at a competitive price, maintain high quality standards, and demonstrate technical and organizational strengths.
ISO 9001 Documentation - You want to get certified to ISO 9001, with help from our ISO 9001 Masterclass you will be able to document all of your business processes in one week or less! YES! If you have been sitting around and contemplating you need to take time to document your business processes, well we have done all of the hard work for you. We have created the templates where you can just simply enter your process steps. All of the templates are in word editable version so you can edit the process flows in any way you want.
,
quality management systems
,
what’s iso?
,
getting to know iso
,
benefits of iso registration
,
requirements
,
requirements activity
,
quality management system (qms)
,
resource management
,
product realization
,
measure
,
analyze and improve
,
documentation activity
,
internal audits
,
how to do an internal audit
,
audit activity
,
registration process
,
two ways to be iso certified
Paper Presnetation on ISO/IEC 17025:2017 organized at Labtech2017 in Bahrain. The topics discussed in that presentation like what are the major changes, what is considered in revised ISO 17025:2017, requirements of ISO 17025:2017, etc. are explained in this ppt presentation.
ISO 9001 Documentation - You want to get certified to ISO 9001, with help from our ISO 9001 Masterclass you will be able to document all of your business processes in one week or less! YES! If you have been sitting around and contemplating you need to take time to document your business processes, well we have done all of the hard work for you. We have created the templates where you can just simply enter your process steps. All of the templates are in word editable version so you can edit the process flows in any way you want.
,
quality management systems
,
what’s iso?
,
getting to know iso
,
benefits of iso registration
,
requirements
,
requirements activity
,
quality management system (qms)
,
resource management
,
product realization
,
measure
,
analyze and improve
,
documentation activity
,
internal audits
,
how to do an internal audit
,
audit activity
,
registration process
,
two ways to be iso certified
Paper Presnetation on ISO/IEC 17025:2017 organized at Labtech2017 in Bahrain. The topics discussed in that presentation like what are the major changes, what is considered in revised ISO 17025:2017, requirements of ISO 17025:2017, etc. are explained in this ppt presentation.
The new ISO 9001:2015 committee draft is published and distributed. There are changes which affect organizations who applied this standard. As it is among most famous ISO standards, follow up the changes would be critical and it is time to consider changes which might affect organizations' management systems.
ISO17025 Accreditation Procedures and Process Abdul Rahman
A brief description of how to achieve ISO 17025 international accreditation. In this document, you would find how the organizations should react to fulfil the criteria of ISO-17025 and
Presented for ASQ India on 3/22/2016 7PM - 8PM IST (6.30 AM -7.30AM PST). Govind will briefly discuss key changes, new requirements and a high level transition plan. The new standard is more aligned with business than ever. However this new standard also bring challenges for auditing. As a QMS manager, auditor or even a practitioner you will be expected to apply this management system standard at work.
This publication is about ISO 17025 Certification for Laboratory Accreditation. ISO/IEC 17025 accreditation provides the assurance that calibration and testing laboratories are delivering good services, and consistent data.
Global Manager Group has prepared presentation to provide information regarding documentation requirements for revised IATF 16949:2016 Certification. It described all primary documents like manual, procedures, plans, audit checklist, etc in details.
For further information about IATF 16949:2016 documentation requirements visit @ https://www.globalmanagergroup.com/
A vendor audit is a vehicle used by pharmaceutical companies, and other large companies as well, to inspect and evaluate a vendor’s quality management system, as well as its practices, products, and documentation.
The need to conduct vendor audits stems from a higher need for quality control in an industry that needs to be more regulated than any other industry in the world.
Reason why organizations use audits is to reduce cost and improve quality control
The objective of vendor audit is to develop an audit function comprising of qualified resources to effectively perform compliance audits to ensure that the contracts are being executed in accordance with the intent and address the net benefit to include cost recoveries, process improvement savings, fraud improvement and identification of hidden risks.
In order to reduce the cost pharmaceutical companies have increasingly become dependent on their supplier/ out sourcing partners for customer success. Though it has drastically reduced the production cost for companies, there is a heightened supplier risk and lack of visibility into supplier processes.
To gain an insight into supplier process and eliminate the risks, FDA encourages companies to conduct GMP supplier audit at the manufacturing premises of the supplier.
According to GMP code, it is sole responsibility of pharmaceutical industry to ensure that the suppliers manufacturing process, analytical tests and examinations are carried out reliably by the supplier and are in compliances with the applicable standards and regulations.
After the audit supplier must provide an appropriate corrective action plan with measures that that will be implemented by the supplier within a defined time frame to the manufacturer.
ISO 9001-2015 clause 10.2 is different from ISO 9001-2008 corrective action requirements, i tried to capture the updated requirements and with a suggested format for deal with the updated requirements.
What Documentation Required for ISO 17025:2017 Accreditation?Global Manager Group
Global Manager Group has prepared presentation to provide information about Calibration and Testing Laboratory Accreditation Standard - ISO 17025 and about Documentation Requirements. All the documents like quality manual, procedures, audit checklist, etc that required for the ISO 17025:2017 Accreditation process are described in details in this presentation.
A brief Introduction to ISO 9001 2015-Quality Management SystemSARWAR SALAM
Introduction to Quality Management System ISO 9001-2015 as outlined in EDC Romfor's IMS. Preparation, role and resposibility allocation for Audit purposes.
This presentation gives a bried overview of the various parts & purpose of the ISO 9001:2015 QMS.
It revolves around the PDCA Cycle and useful in Manufacture & construction Industry.
Practical Strategies for Taking on New Studies Post COVID-19Veeva Systems
Hear expert guidance for ensuring readiness when opening your doors and making data-driven, evidence-based decisions on which studies to accept post COVID-19.
The new ISO 9001:2015 committee draft is published and distributed. There are changes which affect organizations who applied this standard. As it is among most famous ISO standards, follow up the changes would be critical and it is time to consider changes which might affect organizations' management systems.
ISO17025 Accreditation Procedures and Process Abdul Rahman
A brief description of how to achieve ISO 17025 international accreditation. In this document, you would find how the organizations should react to fulfil the criteria of ISO-17025 and
Presented for ASQ India on 3/22/2016 7PM - 8PM IST (6.30 AM -7.30AM PST). Govind will briefly discuss key changes, new requirements and a high level transition plan. The new standard is more aligned with business than ever. However this new standard also bring challenges for auditing. As a QMS manager, auditor or even a practitioner you will be expected to apply this management system standard at work.
This publication is about ISO 17025 Certification for Laboratory Accreditation. ISO/IEC 17025 accreditation provides the assurance that calibration and testing laboratories are delivering good services, and consistent data.
Global Manager Group has prepared presentation to provide information regarding documentation requirements for revised IATF 16949:2016 Certification. It described all primary documents like manual, procedures, plans, audit checklist, etc in details.
For further information about IATF 16949:2016 documentation requirements visit @ https://www.globalmanagergroup.com/
A vendor audit is a vehicle used by pharmaceutical companies, and other large companies as well, to inspect and evaluate a vendor’s quality management system, as well as its practices, products, and documentation.
The need to conduct vendor audits stems from a higher need for quality control in an industry that needs to be more regulated than any other industry in the world.
Reason why organizations use audits is to reduce cost and improve quality control
The objective of vendor audit is to develop an audit function comprising of qualified resources to effectively perform compliance audits to ensure that the contracts are being executed in accordance with the intent and address the net benefit to include cost recoveries, process improvement savings, fraud improvement and identification of hidden risks.
In order to reduce the cost pharmaceutical companies have increasingly become dependent on their supplier/ out sourcing partners for customer success. Though it has drastically reduced the production cost for companies, there is a heightened supplier risk and lack of visibility into supplier processes.
To gain an insight into supplier process and eliminate the risks, FDA encourages companies to conduct GMP supplier audit at the manufacturing premises of the supplier.
According to GMP code, it is sole responsibility of pharmaceutical industry to ensure that the suppliers manufacturing process, analytical tests and examinations are carried out reliably by the supplier and are in compliances with the applicable standards and regulations.
After the audit supplier must provide an appropriate corrective action plan with measures that that will be implemented by the supplier within a defined time frame to the manufacturer.
ISO 9001-2015 clause 10.2 is different from ISO 9001-2008 corrective action requirements, i tried to capture the updated requirements and with a suggested format for deal with the updated requirements.
What Documentation Required for ISO 17025:2017 Accreditation?Global Manager Group
Global Manager Group has prepared presentation to provide information about Calibration and Testing Laboratory Accreditation Standard - ISO 17025 and about Documentation Requirements. All the documents like quality manual, procedures, audit checklist, etc that required for the ISO 17025:2017 Accreditation process are described in details in this presentation.
A brief Introduction to ISO 9001 2015-Quality Management SystemSARWAR SALAM
Introduction to Quality Management System ISO 9001-2015 as outlined in EDC Romfor's IMS. Preparation, role and resposibility allocation for Audit purposes.
This presentation gives a bried overview of the various parts & purpose of the ISO 9001:2015 QMS.
It revolves around the PDCA Cycle and useful in Manufacture & construction Industry.
Practical Strategies for Taking on New Studies Post COVID-19Veeva Systems
Hear expert guidance for ensuring readiness when opening your doors and making data-driven, evidence-based decisions on which studies to accept post COVID-19.
The Magic of Internal Audits: Mistakes, Insights and Advice from the ExpertsSafetyChain Software
In this webinar, food safety and quality expert Jeff Strout (Merieux NutriSciences) will share hot topics, expert insights (including the “wow factor”), and critical components of robust internal auditing systems that are needed to drive continuous improvement.
Fedegari Training & Education 2017 Calendar offers
programs that have been designed specifically to share experiences and allow our customers to develop a much deeper understanding of technologies and products in sterile processing and contamination control.
Process design focuses on the Multiplication and... Text Structure Work... EC ECmpus: Home
and Work rules; training you use to make things. Technology; work design Training; technology
Technology; work rules 2 Of the four strategies to reduce costs, minimizing work rules and
increasing training to empower workers to find better ways to do things best describes which
strategy? Offshoring Automation Outsourcing Process improvement 3 Economists discuss value
in terms of . Customers talk about value in terms of Value; time and place Dimensions; utilities
Cost and quality: scorecards Utilities: value dimensions 4 An open systems view argues that you
need to recognize be quick to respond, and create more than rivals. Value; products
Opportunities; value Processes; opportunities Success: profits
Which of the following should not influence your choice of technology as you design a
production or service process? Labor cost A desire to buy shiny new hardware Production
volumes Financial resources and are the two types of decisions you need to make to achieve
world-class operations management. Design; control Quality; control Design; quality Human
resource; technology 7 Which of the following approaches can help you mitigate the challenges
of poor forecasts? Minimize inventory Use all the forecasting techniques and average them
together Obtain and use the best, most recent information available Always use simple
forecasting techniques 8 If you want to be taken seriously as a supplier, you have to offer which
two value dimensions? cost and delivery cost and quality innovation and delivery Agility and
innovation
You must meet minimum requirements across which of the five value dimensions? Cost, quality,
and innovation All of them Cost and quality Delivery, and agility 10 Sustained success requires
that you offer distinctive value, so you must differentiate yourself in one of which thare
dimensions? Cost, quality, or innovation Innovation, delivery, or cost Quality, cost, or agility
Agility, innovation, or delivery
Dell pre-orders and stocks up on raw materials and components Purchasing pre-selected pre-
packaged deli meat from a cold case A local coffee shop that prepares coffee or hot beverages
depending on customer orders A customer ordering custom-sliced meat at a deli The difference
between mass production and lean production is that: Mass and lean production utilize both
methods of production based on cost reduction Lean utilizes both "push" and "pull" production
based on customer demand Mass production uses the "push" method, and lean production uses
the "pull" method Mass production uses the "pull" method, and lean production uses the "push"
method 3 A lean system is one that strives to: Lower costs through acquisition of the cheapest
resources available. Minimize the use of resources used to achieve the organization's goals. Offer
a rigid product offering to customers so that operations can be more efficient. Maximize worker
productivity through e.
Sustainable Procurement Index for Health (SPIH) ClinicUN SPHS
Delivered by Arup at the Global Forum 2020 Sustainable Procurement Index for Health Clinic session.
Presenters:
Dr. Kristian Steele, Associate, Arup
Ms. Anna Tuddenham, Consultant, Arup
Mr. Terry Ellis, Senior Consultant, Arup
Mr. Callum Newman, Associate Director and Group Leader for International Development, Arup
Specific Aspects of Food Safety Auditingsafefood360
This presentation explains in more detail the practices involved in food safety auditing. What to ask and what to look for? The best practices for auditing HACCP, quality management systems and prerequisite programs are all explained in this one compact slide show.
Acorn Recovery: Restore IT infra within minutesIP ServerOne
Introducing Acorn Recovery as a Service, a simple, fast, and secure managed disaster recovery (DRaaS) by IP ServerOne. A DR solution that helps restore your IT infra within minutes.
This presentation by Morris Kleiner (University of Minnesota), was made during the discussion “Competition and Regulation in Professions and Occupations” held at the Working Party No. 2 on Competition and Regulation on 10 June 2024. More papers and presentations on the topic can be found out at oe.cd/crps.
This presentation was uploaded with the author’s consent.
0x01 - Newton's Third Law: Static vs. Dynamic AbusersOWASP Beja
f you offer a service on the web, odds are that someone will abuse it. Be it an API, a SaaS, a PaaS, or even a static website, someone somewhere will try to figure out a way to use it to their own needs. In this talk we'll compare measures that are effective against static attackers and how to battle a dynamic attacker who adapts to your counter-measures.
About the Speaker
===============
Diogo Sousa, Engineering Manager @ Canonical
An opinionated individual with an interest in cryptography and its intersection with secure software development.
Sharpen existing tools or get a new toolbox? Contemporary cluster initiatives...Orkestra
UIIN Conference, Madrid, 27-29 May 2024
James Wilson, Orkestra and Deusto Business School
Emily Wise, Lund University
Madeline Smith, The Glasgow School of Art
Have you ever wondered how search works while visiting an e-commerce site, internal website, or searching through other types of online resources? Look no further than this informative session on the ways that taxonomies help end-users navigate the internet! Hear from taxonomists and other information professionals who have first-hand experience creating and working with taxonomies that aid in navigation, search, and discovery across a range of disciplines.
Eureka, I found it! - Special Libraries Association 2021 Presentation
Appendix 2 supplier checklist
1. Appendix 2: Supplier Selection check List
Key Selection Criteria (Minimum)
Non Critical raw
materials
Critical
Materials
Specifications X X
Price X X
Manufacturing information X X
Packaging, Labelling information X X
Material Safety Data Sheets X X
Logistic information (Lead time to produce, delivery time, supply route, ...) X X
Certificates (GMO, BSE/TSE, Residual solvents, ...) X X
Analytical test method X
Key Selection Criteria (Advanced)
Non Critical raw
materials
Critical
Raw
Materials
I. Assurance of Supply
I.A. Capacity
What is the capacity of the plant ? X
Is the capacity of the company sufficient to meet the long term needs ? X X
What is the maximum volume that can be manufactured and delivered on yearly basis? X
What is the maximum batch size for the products within scope? X
What would be the typical batch size for commerical manufacture? X
Does the supplier has alternative sites to manufacture the products within scope? X X
Has the company industrial experience with the chemistry involved? X
Does the company intend to manufacture in a dedicated plant? X
Does the supplier has the capability to handle specific technology? X
How soon can a validation campaign be started? X
2. What is the expected yield and yield range for the products within scope? X
I.B. Safety/Health/Environmental risk
Does the company have the necessary manufacturing permits/licenses available ? X X
What is the validity of the permits? X X
Is there a REACH program in place? X X
What are the EHS standards employed at the site of manufacture? X X
Has the facility undergone EHS audits? X X
I.C. Financial/business stability
Is the supplier willing to share data on the financial performance? X X
Is the company in good financial health? X X
What is the evolution of the financial KPIs during the last three years? X
Is there a stable shareholder structure in place? X
What is the shareholder's long term investment strategy? X
What was the turnover for the last three years? X
What percentage does the intended spend represent versus the total turnover? X
I.D. Deliveryperformance
Does the supplier has tools in order to track and evaluate their delivery performance? X X
II. Quallity /Regulatory Compliance
II. A. cGMP Compliance & Regulatorytrack record
Were there any cGMP inspections by local authorities or other regulatory authorities? X
Were there any observations or objectionalbe observations from Health authorities? X
Is the site classified as a US FDA, EU, TGA etc. acceptable site? X
Where there ISO 9001 certifications? X
Will the product(s) within scope be manufactured in an inspected an approved facility? X
II. B. Recalls & Complaints
3. Are there adequate procedures in place for complaint handling & recalls? X X
How many recalls were there in the last three years? If not zero, indicate the reason for the recall X
How many quality critical complaints were there in the last three years. X
II. C. Change & Deviation management
Does the supplier has effective change controls in place? X X
Does the suppliers allows the involvement and participation of the customer? X
Is there a system in place for non-conformity evaluation X X
Are there effective procedures in place for deviation reporting? X
II. D. Materials Management
Is appropriate testing performed on the incoming raw materials including the availability of the
manufacturer's CoA? X X
Is the site of manufacture verified on receipt of the raw material? X
Is there a supplier qualification program in place? X X
Are there any materials of animal origin used? X X
Is it a requirement for the suppliers to provide completed TSE/BSE questionnaires? X X
Is it a requirement for the suppliers to provide a residual solvent questionnaire? X
II.E. Quality Systems/ Agreement/Culture
Does the supplier has quality systems in place in line with the requirements for the product(s) within
scope? X X
Is the company willing to establish a Quality Agreement in accordance with your requirements and
policies? X
Is there a quality culture in the organisation driven and supported by top management? X X
Are there regular quality management review meetings? X X
II.F. Production facilities and equipment
Are there appropriate environmental controls in place appropriate to the product type ? X
If applicable to the API, has the supplier facilities in place to carry out microbiological testing on site or
is this outscourced ? X
4. If the product is manufactured in multi-purpose equipment how is ensured for product change-overs
that the residues are below an acceptable level ? X
How are the cleaning verification controls performed on the plant ? X
Are the process support laboratories for the product located on the same site of the manufacturing
site? X
If applicable to the API, can stability studies following ICH conditions be performed on site? X
II.G. Product Quality Review
Is there a system in place to make periodic quality reviews? X
Does the company use statistical tools ? X
Is there a program for continious improvement? X
II. H. Security of the supply chain?
What measures are taken to ensure the safety of the supply chain? X
Is there a full visibility on the origin of the raw materials? X
II. I. Process Validation approach
What is your process validation approach? X
Are there adequate procedures in place for process validation? X
III. Producurement/Cost
III.A. Cost Management
Is there a willingness to provide open book costing details for the products within scope? X
Does the cost of goods calculation take into account the use of recycled solvents? X
Is there a potential for price reduction based on increased efficiencies? X
Are development costs included in the price? X
Will a CAPEX program be required for the project wihtin scope? X
Have development costs been taken into account for the price setting? If yes how much can be
attributed to the cost of goods? X
What are the total costs, timelines and resources required for pilot plant scale and developmment
work ? X
5. What are the costs for the validation campaign ? X
Are there initiatives taken to lower cost of goods and work on price improvements? X
III.B. Presence in Low Cost Countries (Emerging markets)
Has the company easy access to LCC raw material sources? X
Is there an Asean platform to manage local sourcing? X
IV. Innovation/Technical
Are there areas where the company can bring innovation? X
What is the native language spoken in the company? What is the level of understanding of English on
different levels in the organisation? X X
Are there resouces available to support continuous improvment activities? If yes, how many FTEs
versus total? X
What is the company's view on sharing detailed process information? X
What is the level of competence in lean and 6S techniques? X
Is there a structured approach to resolve business problems? X
What is the approach to process trending and evaluation? Is plant and analytical data trended in real
time or retrospectively? X
What kind of advanced analytical and process chemistry equipment is available to carry out process
investigation work? X
What are the capabilities of the development lab? What type of specialist laboratory equipment is
available and in use to support the process? X
Are there plans to invest in laboratory equipment? If yes provide more details X
Provide details of material of construction of the plant that will be used for the products within scope? X
What milling technology and capacity is available?
X
Is there cold storage capacity on site ? X
Are there project management capabilities present? X
Provide the background on the number of staff and their qualifications X
What level of parameter monitoring (eg. Temperature, pressure, weight, flow rate, etc) is there on the
processing equipment? X
6. V. Responsiveness & Communication
V. A. Responsiveness
What is the standard lead time following receipt of the purschase order? X X
What is the company's responsiveness for new inquiries? X X
What is the production flexibility? X X
What is the lead time for project assessment? X X
V. B. Communication
Are there well defined functional contacts? X X
Does the supplier communicate pro-actively? X X
Is there a willingness to share detailed information on a voluntary basis? X