This document provides an introduction to a master class guide on achieving quality and compliance excellence in pharmaceuticals. It contains contributions from various experts in the pharmaceutical industry on topics related to quality assurance, compliance, and regulatory affairs. The editor's goal is to help pharmaceutical professionals implement robust quality systems and ensure adherence to regulations. The book is intended to provide guidance on all aspects of quality and compliance for drug products and operations.
Complaints in Quality Management SystemMayuriMore15
Complaints evaluation and handling, Investigation and Determination, CAPA and Return and Recall of products in Quality Management system in pharmaceutical or any industry.
This document covers most of the topics in the CSV like Importance of CVS, Why to perform CSV, Validation Deliverables, Part 11 and Annex 11 Diferences
What are the process of a well-defined Risk Assessment. When taken in sequence, support better Decision Making by contributing to a greater insight into risks and their impacts.
Process Validation is Key important factor for the Pharmaceutical Industry to maintain Consistent Quality in product which claimed by the manufacturer.
WHO Guidance on Model Certificate of Analysis (COA)MD. SELIM REZA
WHO guided Model Certificate of Analysis (COA) for pharmaceuticals/Chemical industries/API Manufacturers to submit dosier for export regulatory market or in-house release purposes.
Complaints in Quality Management SystemMayuriMore15
Complaints evaluation and handling, Investigation and Determination, CAPA and Return and Recall of products in Quality Management system in pharmaceutical or any industry.
This document covers most of the topics in the CSV like Importance of CVS, Why to perform CSV, Validation Deliverables, Part 11 and Annex 11 Diferences
What are the process of a well-defined Risk Assessment. When taken in sequence, support better Decision Making by contributing to a greater insight into risks and their impacts.
Process Validation is Key important factor for the Pharmaceutical Industry to maintain Consistent Quality in product which claimed by the manufacturer.
WHO Guidance on Model Certificate of Analysis (COA)MD. SELIM REZA
WHO guided Model Certificate of Analysis (COA) for pharmaceuticals/Chemical industries/API Manufacturers to submit dosier for export regulatory market or in-house release purposes.
FDA WARNING LETTER IS A OFFICIAL LETTER FROM USFDA TO A MANUFACTURING FIRM TO NOTICE THE SERIOUS VIOLATION FOUND AT THE FDA INSPECTION AT FIRM AND THE CORRECTIVE ACTION SHOULD TO TAKEN BY FIRM TO OVERCOME THE VIOLATION FOR FDA APPROVAL
Equipment used in pharmaceuticals dosage form manufacturing need to observe continuous qualification to monitor its performance and Concept of URS ,DQ, IQ,OQ,PQ,MQ...
Risk assessment for computer system validationBangaluru
A risk assessment is a process to identify potential hazards and analyze what could happen if a hazard occurs.
Computer system validation (sometimes called computer validation or CSV) is the process of documenting that a computer system meets a set of defined system requirements.
WHO has recently issued draft document titled "Guidelines on Validation". These guidelines (i.e., the main text included in this working document) cover the general principles of validation and qualification.
These guidelines focus mainly on the overall concept of validation and are not intended to be prescriptive in specific validation requirements. This document serves as general guidance only and the principles may be considered useful in its application in the manufacture and control of starting materials and finished pharmaceutical products (FPPs), as well as other areas. Validation of specific processes and systems, for example, in sterile product manufacture, requires much more consideration and a detailed approach that is beyond the scope of this document. The general text in this document may be applicable to validation and qualification of premises, equipment, utilities, systems, processes, and procedures.
The draft on the specific topics, the appendices to this main text, will follow. The following is an overview on the appendices that are intended to complement the text of this working document:
Appendix 1: Validation of heating, ventilation and air-conditioning systems - will be replaced by cross reference to WHO Guidelines on GMP for HVAC systems for considerations in qualification of HVAC systems (update - working document QAS/15.639/Rev. 1)
Appendix 2: Validation of water systems for pharmaceutical use - will be replaced by cross-reference to WHO Guidelines on water for pharmaceutical use for consideration in qualification of water purification systems
Appendix 3: Cleaning validation - consensus to retain
Appendix 4: Analytical method validation - update in process
Appendix 5: Validation of computerized systems - update in process
Appendix 6: Qualification of systems and equipment - update in process
Appendix 7: Non-sterile process validation - update already published as Annex 3, WHO Technical Report Series, No. 992, 2015
Comments on this draft document are due by July 12, 2016.
A presentation on this guidance is given below:
Presentation on New WHO Guidance on Validations
A structured approach to the investigation process should be used with the objective of determining the root cause.
The level of effort, formality, and documentation of the investigation should be commensurate with the level of risk, in line with ICH Q9.
ICH STABILITY TESTING GUIDELINES, Drug Stability, Stability studies are preformed on Drug Stability (DS)
Drug product (DP), TYPE SIZE, NUMBER OF BATCHES (ICH/WHO GUIDELINES), LONG TERM STABILITY STUDIES, ACCELERATED STABILITY STUDIES, PROTECTION AGAINST HYDROLYSIS, PROTECTION AGAINST OXIDATION, Testing scope for solid dosages, Testing scope for liquid form, Testing scope for oral liquid form
FDA WARNING LETTER IS A OFFICIAL LETTER FROM USFDA TO A MANUFACTURING FIRM TO NOTICE THE SERIOUS VIOLATION FOUND AT THE FDA INSPECTION AT FIRM AND THE CORRECTIVE ACTION SHOULD TO TAKEN BY FIRM TO OVERCOME THE VIOLATION FOR FDA APPROVAL
Equipment used in pharmaceuticals dosage form manufacturing need to observe continuous qualification to monitor its performance and Concept of URS ,DQ, IQ,OQ,PQ,MQ...
Risk assessment for computer system validationBangaluru
A risk assessment is a process to identify potential hazards and analyze what could happen if a hazard occurs.
Computer system validation (sometimes called computer validation or CSV) is the process of documenting that a computer system meets a set of defined system requirements.
WHO has recently issued draft document titled "Guidelines on Validation". These guidelines (i.e., the main text included in this working document) cover the general principles of validation and qualification.
These guidelines focus mainly on the overall concept of validation and are not intended to be prescriptive in specific validation requirements. This document serves as general guidance only and the principles may be considered useful in its application in the manufacture and control of starting materials and finished pharmaceutical products (FPPs), as well as other areas. Validation of specific processes and systems, for example, in sterile product manufacture, requires much more consideration and a detailed approach that is beyond the scope of this document. The general text in this document may be applicable to validation and qualification of premises, equipment, utilities, systems, processes, and procedures.
The draft on the specific topics, the appendices to this main text, will follow. The following is an overview on the appendices that are intended to complement the text of this working document:
Appendix 1: Validation of heating, ventilation and air-conditioning systems - will be replaced by cross reference to WHO Guidelines on GMP for HVAC systems for considerations in qualification of HVAC systems (update - working document QAS/15.639/Rev. 1)
Appendix 2: Validation of water systems for pharmaceutical use - will be replaced by cross-reference to WHO Guidelines on water for pharmaceutical use for consideration in qualification of water purification systems
Appendix 3: Cleaning validation - consensus to retain
Appendix 4: Analytical method validation - update in process
Appendix 5: Validation of computerized systems - update in process
Appendix 6: Qualification of systems and equipment - update in process
Appendix 7: Non-sterile process validation - update already published as Annex 3, WHO Technical Report Series, No. 992, 2015
Comments on this draft document are due by July 12, 2016.
A presentation on this guidance is given below:
Presentation on New WHO Guidance on Validations
A structured approach to the investigation process should be used with the objective of determining the root cause.
The level of effort, formality, and documentation of the investigation should be commensurate with the level of risk, in line with ICH Q9.
ICH STABILITY TESTING GUIDELINES, Drug Stability, Stability studies are preformed on Drug Stability (DS)
Drug product (DP), TYPE SIZE, NUMBER OF BATCHES (ICH/WHO GUIDELINES), LONG TERM STABILITY STUDIES, ACCELERATED STABILITY STUDIES, PROTECTION AGAINST HYDROLYSIS, PROTECTION AGAINST OXIDATION, Testing scope for solid dosages, Testing scope for liquid form, Testing scope for oral liquid form
The Management Committees Design for Civil Formwork System Projection Research and Design, Supply Chain Management, Manufacturing, Quality Control, Safety Awareness, Human Resource Management. The Framework is pretty much useful as it is help to the company to realized the important of corporation growth is unlimited
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Quality Council of India through its NABH, NABL and other associated program divisions have stressed on the need and has helped elevate healthcare quality holistically and the digital transition of such organization is remarkable. Umbrella corporations like AHPI and CAHO have done a lot in uniting and steering things towards the greater objective for many member hospitals. Many organizations also have implemented for JCI, Malcolm Baldrige Framework (CII-Institute of Quality), Lean tools Implementation, EFQM (IMC Ramakrishna Bajaj National Quality Award), etc. which clearly states their growing thirst for continuous quality improvement. This quest for quality was furthered by newer accreditations in niche areas by organization like QAI, as well. Forums like AiMeD have taken it upon themselves to bring in convergence of the Indian Medical Device Industry and being an advocacy group for standardization and Quality Improvement amidst many other objectives which needs to resonate with healthcare organizations. The webinar will be a refresher course for healthcare professionals and give them insights into the winds of change.
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Here's the webinar – “Quality, Accreditations & Beyond – Winds of Change - Session 2” hosted by QurHealth, a division of GMI, a Chennai-based Health-tech, Research and Innovation Center for Ventech Solutions, USA. QurHealth’s Family health book suite goFHB is a clinical data digitalization & management solution for healthcare organizations providing the ability to send patient health records over myFHB application to their patients.
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Shamisha Learning Center, Ahmedabad, Gujarat, India-Specialized Training, Workshops and courses on Quality, Regulatory, R & D, Supply Chain and Manufacturing
Navjyoti Analytics & Research Laboratory - PresentationNavjyotiCommodity
Navjyoti Analytics and Research Laboratory, is an NABL accredited state-of-art food, water, pharma, oil and environment testing Laboratory at Ahmedabad. It's a modern facility set-up in 2017 with latest and best-in-class equipment’s and technology.
It's a Navjyoti Commodity Management Service Ltd's venture. ‘Navjyoti’ is an Agri supply chain service Company. We provide supply chain solutions for Agri commodities such as grains, cereals, pulses, beans, oilseeds and other commercial crops including storage, preservation, quality monitoring, testing and assaying, logistics besides others. We have a pan India presence with over 350 warehouses in operation. Amongst our operational warehouses, we are also working in company developed state of art modern & scientifically designed Agri Logistics Parks (ALP). Our ALPs are designed and developed with an aim to provide a common platform to the various stakeholders across the value chain along with all supporting infrastructures in rural India.
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Achieving Quality and Compliance Excellence in Pharmaceuticals
1.
2. Achieving Quality and
Compliance Excellence in
Pharmaceuticals
A Master Class GMP Guide
Edited by
Madhu Raju Saghee
Corporate Quality
Gland Pharma Limited
&
Director – Indian Region
Pharmaceutical and Healthcare Sciences Society (PHSS)
4. Achieving Quality and Compliance Excellence in Pharmaceuticals iii
DEDICATION
To P.V.N Raju
An eminent entrepreneur, industrialist and chairman of Gland Pharma with 50 years experience
in Pharmaceutical Industry who held various positions in various professional bodies and whose
vision, dynamism and leadership about the health care business are inspirational to younger
professionals like me.
&
To Dr. Tim Sandle
An illustrious microbiologist and the force behind my success in professional life.
21. xx Achieving Quality and Compliance Excellence in Pharmaceuticals
The editor is pleased to note that this task was achieved and he wishes to express his thanks to
each of the contributors for taking the time and trouble, and drawing upon many years of
experience, to produce unique and detailed chapters.
In putting the book together, the editor has not lost sight of the fact that book must, foremost,
be of use to the reader. Thus the book provides detail on global GMP, of the key dimensions of
quality and quality systems, of training and auditing, and applies these across different sectors,
from APIs to steriles. This has led to the creation of a truly global book which will be of use to
all working within, or who have an interest in, the world of Pharma.
Madhu Raju Saghee
Hyderabad, India
June, 2012
ACKNOWLEDGMENTS
I would like to express my deep gratitude to the authors and contributors who have
cooperated in preparation of this book amidst their busy work commitments. I am indebted
and grateful to Siegfried Schmitt, R. Raghunandanan, Antony Raj Gomes and T. Rajesh for
their insights in shaping this book into a master class guide. I would like to thank JPS Kohli for
his patience and diligence in the production of this work.
24. Meaningful Performance Metrics for Compliance 461
Motivation – People like knowing their efforts are worthwhile. Metrics provide short and long
term measurement of progress. They provide an orient point as people navigate continuous
improvement. Reaching those interim milestones can be highly motivating.
Objectivity – Metrics form the basis for a fact-based organization. This objectivity promotes a
positive environment within an organization. It demonstrates their achievements and
highlights the contributions made toward long-term business objectives.
Problem Solving – Metrics enable management to uncover problems earlier. They provide
early warning indicators to avoid a crisis situation. There can be increased visibility of small
changes in performance that if unchecked grow into much bigger problems.
Visibility – A common set of metrics used throughout an organization creates transparency. It
enables senior management better insight to the inner workings of their business processes.
17.2 PRINCIPLES OF ESTABLISHING PERFORMANCE METRICS FOR COMPLIANCE
“You measure your organizational capability by asking the right questions” 3
Larry Bossidy and Ram Charan
When creating a performance measurement system, it can be helpful to begin with the end in
mind. Think about the entire process from acting on the metric backwards to the data itself.
Make sure there is an understanding of
The reason for collecting the metric. How will it be used? By whom? How will the results
be communicated the information gained from the metrics to all stakeholders?
Analysis needed to transform the data into useful information. What data transformations
are needed? Who will perform them? What tools (software) are needed? What are the
validation requirements?
The process to collect the data. How will data be collected? By whom? Where will the
records be stored (paper and electronic)?
What is the data that you need?
To fully characterize a quality system, hundreds of metrics are possible. Establishing a large
number of metrics in the hope of finding some that work wastes resources and distracts
leaders. Implementation of too many metrics may not result in a compliant quality system and
may actually impede quality progress. Metrics must be carefully chosen to ensure they align
with strategy. Many organizations have implemented strategy frameworks such as the
Balanced Scorecard described in the The Strategy Focused Organization
4
. In a high performing
organization, what gets measured gets done. Having too many or the wrong metrics does not
allow an organization to focus. An excessive number of metrics can be referred to as the trivial
many. Jack Welch, the former CEO of General Electric, referred to unfocused organizations as
“measuring everything and understanding nothing”. Instead it is important to determine the
crucial few metrics. Other considerations in selecting metrics include the difficulty to measure
or collect the data, data reliability and the cost to collect, analyze and report.
25. 462 Achieving Quality and Compliance Excellence in Pharmaceuticals
Quality
Process
Input x1
Input x2
A good metrics system is built with a combination of leading and lagging indicators. Lagging
indicators measure the outcomes of what already happened. Leading indicators provide
information that may be able to predict future outcomes. More mature organizations will
typically have a greater ratio of leading to lagging metrics. Measuring the percentage of CAPAs
closed within 60 days may predict the number that will be completed past due. Most
compliance metrics are inherently lagging indicators and are typically easier to define.
Establishing predictive leading indicators can improve a quality system. For example, a typical
CAPA organization has a fixed number of resources to investigate and implement resolutions. If
there is a spike in the number of CAPAs initiated in a particular month (say 25% percent
increase compared to the typical run rate) then it would be expected that there might be an
increase in the number of days to complete the investigation. An organization that has an
internal goal for investigation completion timeliness, they could find their metric has trended
adversely. However, if they had responded to the leading indicator (CAPA Initiations) and
rebalance investigation resources, it might have been possible to avoid a performance decline.
As metrics are developed for an organization, it is often possible to begin developing metrics
with lagging indicators and then ask what actions or conditions cause this outcome to
brainstorm leading indicators. It is necessary to understand the cause and effect relationships.
In business excellence terminology, this is notated as Y = f(x) where Y is the outcome and x1,
x2, etc are the causative agents, the inputs. This can be illustrated using a process diagram
(below). The expected quality outcomes (the Y’s) are the outputs. Leading indicators x1, x2, etc
can be inputs into the process or interim measurements of the process. By understanding the
cause and effect relationships, it is possible to focus on impacting drivers which will ultimately
change the outcomes.
Figure 17.1: Cause and effect relationships
In addition to looking at leading and lagging metrics, it is also important to consider whether
the metric measures time, quality or quantity/cost. Time-based metrics are used to measure
the duration of a process. Metrics such as the percentage of CAPAs completed on-time is an
Output(s): Y
30. Meaningful Performance Metrics for Compliance 467
Audit &
Inspection
Process
Quality Records (CAPA,
batch records etc.
Quality documents(Quality
manual, procedures etc)
Qualified Personnel
quality base. These can be linked to product or service performance, quality costs, quality
improvement and customer satisfaction. Quality goals should be shared and be applicable
across the organization.
While Quality metrics may be collected and reported by the quality function, ownership of the
issue belongs to operating function. It has been stated that the Pareto principle applies to
quality problems6
. By this guideline 80% of the quality problems in an organization are outside
the control of the quality function, while 20% may be internal. Examples of organization wide
problems could include supplier quality requirements, R&D product designs, and distribution
system problems. Internal quality problems may include lab test issues, auditing procedures
and sampling procedures. The Quality and Compliance metrics described below represent
some of those commonly implemented in pharmaceutical operations. There are many
variations and extensions to these metrics in the industry. The metrics described are not an
exhaustive list, but provide a starting point for each organization.
17.3.1 Audits and Inspections
A basic indicator of compliance is performance against regulatory agency inspections and
inspection authority audits. The audit process is a periodic snapshot of performance by an
independent inspector. Successful regulatory inspections are required for commercialization of
products and for manufacturing authorization. Internal audits provide on-going feedback on
the health of the quality system. They provide an important indicator, but not an assurance of
health of the quality system. Feedback from all sources of quality data and review by
management is needed to fully evaluate the system. Favorable outcomes from these
inspections and audits help confirm compliance and conformance. Unfavorable outcomes can
result in significant business interruptions including loss of license to market products or
manufacture products. They can also impact public perceptions and decrease the value of a
company’s brand and image. Performance metrics against external inspections are very
reactive metrics. These inspections are conducted infrequently and can’t be relied on as a
single indicator. Internal audits should be conducted more regularly and enable a proactive
response to avoid an external finding. Functional area self-audits offer an excellent opportunity
for most proactive measurement.
Figure 17.2: Audit and inspection process
Audit Reports and Findings
32. Meaningful Performance Metrics for Compliance 469
Non-conforming events(defects,
test failures, audit findings,
complaints confirmed as
deficiencies etc)
Potentially non-conforming events
(adverse trends etc)
adjusted to include covering “hot topics”. In addition, internal groups can prepare for external
and internal audits by preparations for the frequent inspection areas and hot topics.
17.3.2 Non-conformance and CAPA Systems
The CAPA and Complaints quality systems are two of the most important windows to
compliance and the health of the quality system. They are frequently a focus area for external
inspectors. It is crucial to develop appropriate metrics. Inspectors look at CAPA data to
understand whether CAPAs are addressed thoroughly and promptly. Investigations that are
incompletely performed or open for an extended period of time are a red flag for a possible
significant unresolved problem or an unresponsive management team.
The primary objective of the CAPA system is to take actions to avoid reoccurrence, yet many
organizations fail to measure performance of reoccurrence. Establishing a process to measure
reoccurrence can provide an outstanding method to demonstrate the health of the CAPA
process. Other proactive measures include understanding whether an investigation successfully
determines the true cause of the nonconformance and whether the planned verifications of
effectiveness were successful.
Two of the most common metrics are the number/rate of non-conformances and CAPA
timeliness. A high level of non-conformances or an increasing trend should be monitored. This
is also true for potential non-conformances and planned deviations.
Figure 17.3: Non-conformance and CAPA process
CAPA Investigations
Correction Actions Implemented
Preventive Actions Implemented
Exception Report Records
33. 470 Achieving Quality and Compliance Excellence in Pharmaceuticals
Outcomes Metrics
Statistic
Method
Other Considerations
Frequency of investigations
which reach root cause
Trend Confirm the level of reoccurrences, root
cause and effectiveness and that there
are not any adverse trends or patterns
(current value against target, trending).
Consider whether there are any
products, processes or departments
with a disproportionate number of
issues.
Frequency of effectiveness
checks that pass
Frequency of nonconformance
reoccurrence
Trend
Process Metrics
Investigation timeliness Trend
Evaluate the percentage of
investigations are completed in a fixed
period of time, such as 60 or 90 days
Evaluate any investigations that are
open for extended periods of time
Completion of action timeliness Trend
Evaluate the percentage of actions are
completed overdue in a fixed period of
time, such as 60 or 90 days )
Evaluate any plans that are overdue for
extended periods of time
Frequency of non-conformances
(process input)
Trend
Evaluate the location of the event,
cause, product, process step
Frequency of potential non-
conformances (process input)
Trend
Evaluate the location of the event,
cause, product, process step
Frequency of planned deviations
(process input)
Trend
Evaluate the location of the event,
cause, product, process step
Table 17.3: Non-performance and CAPA metrics
17.3.2.1 Additional Considerations
Further insight into the quality system can be gained by analyzing additional CAPA system
information. This could include categorization of the nature and details of the nonconformities.
For example, categorization by product family, part number, type of process, equipment used,
etc. In addition, insight can be gained by understanding the cause and resolution of problems.
For example, categorization by equipment failure, human error, supplier, etc. A red flag can be
when a high frequency of problems are attributed to human error and the corrective action is
to re-train because it indicates a potential failure to identify the true root cause therefore an
effective action has not been taken. It is also useful to monitor those non-conformances and
CAPA that have been determined to have a higher level based on the risk evaluation. The high
risk events should be given priority for completion (and therefore timeliness) and confirmation
34. Meaningful Performance Metrics for Compliance 471
Complaint intake from field
Adverse event intake from field
Non-conformances leading to a recall
of the adequacy of the investigation and corrective actions. The appropriateness of corrections
made to address a nonconformance can be monitored. Management needs visibility to the
frequency and level of review taken when decisions are made to disposition nonconforming
product as “accept as is” without correction. Corrective actions related to product actions, such
as recalls, and complaints should be given a heightened level of priority for completion and
elevated review/approval.
17.3.3 Complaints and Product Actions
The effectiveness of the Complaints and Product Actions systems are closely evaluated by
regulators because of their criticality to the product safety and the patient. Complaints must be
evaluated, investigated, resolved and reported, as appropriate, in an effective and timely
manner.
Complaint and Product Action process measures determine the timeliness of key process steps.
Investigators will look for complaints open for extended time periods as a flag that the
complaint was difficult to resolve and this may be an indicator of a significant issue. They may
also indicate a lack of focus or resources. Adverse events have defined reporting timeframe
expectations.
Figure 17.4: Complaint and product action
Complaint records
Adverse Event records
Recalls
Regulatory Notifications
Customer Notifications
36. Meaningful Performance Metrics for Compliance 473
Supplier
System
Supplier nonconformances
Supplier metrics for scorecard
Quality Agreements
Suppliers are both a part of a company’s quality system and act within their own quality
system. Both perspectives should be monitored with performance metrics. Internal and
external non-conformance are examples of supplier driven issues. In addition, it is important to
look at a supplier as a whole quality system. A scorecard should be developed for each supplier.
This scorecard could include metrics such as audit outcomes, lot failure rates, delivery
performance and responsiveness. Performance against such a scorecard should result in a
composite metric for each supplier. The cumulative metric for all suppliers would be the
summary of the composite metric from all supplier scorecards
The supplier process metric evaluates how well we are managing the supplier network. Today,
there are no regulatory requirements to have quality agreements or conduct on-site audits of
the entire supplier base. Typically, manufacturers take a risk based approach to establishing
these. Metrics can be established to set targets for a sub-set of suppliers. For example, a target
might be to have a quality agreement in place for all critical suppliers.
Figure 17.4: Supplier System
Outcomes Metrics Statistic Method Other Considerations
Frequency of non-conformances
due to supplier
Trend Pareto Evaluate overall and by supplier
Incoming testing failures Trend Pareto Evaluate overall and by supplier
In-process failures due to supplier Trend Pareto Evaluate overall and by supplier
Performance against scorecards Trend Pareto
Process Metrics
Frequency of Quality Agreements
established
Trend
Timeliness of internal supplier
audits against schedule
Trend
Table 17.5: Supplier system metrics
Supplier Audits
Supplier Scorecard
Performance
Recalls due to supplier