This document discusses corrective action and preventative action (CAPA) processes for addressing nonconforming products in a quality management system. It provides an overview of CAPA responsibilities and procedures, the 8D problem solving approach, examples of immediate and long term corrective actions, and requirements for verifying the effectiveness of CAPA measures through validation, monitoring for recurrence, and ensuring information dissemination. The goal of CAPA is to eliminate the root causes of problems in order to improve products, processes and customer satisfaction.
The Checklist contains explanations and recommendations that:
- Facilitate the audit;
- May serve as a guide in the transition to the new version of ISO 9001: 2015 using 'fill the gap' methodology;
- Allow for QMS self-assessment for compliance with ISO 9001: 2015;
- Facilitate learning and understanding of the new version of ISO 9001:2015 requirements
- User-friendly format and professional layout - reviewed and approved by experienced ISO 9001 quality auditors.
- 72 pages
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.
QCC is one of the leading providers of training solutions in India for management systems, process improvement, business improvement and auditing. QCC helps companies understand, implement and manage business systems and processes through its training solutions in its endeavor to equip your staff with the confidence and expertise they need to attain their goal.Our training solutions are built on innovative experimental methodologies with global delivery capacity. Our presenters (trainers) are auditors, business improvement specialists, consultants, industry experts as well as trainers who have been exposed to a wide range of companies and industries in India and overseas. They develop and deliver courses for both public & in-house training, thus bringing along firsthand experience and knowledge to the delegates.
The Checklist contains explanations and recommendations that:
- Facilitate the audit;
- May serve as a guide in the transition to the new version of ISO 9001: 2015 using 'fill the gap' methodology;
- Allow for QMS self-assessment for compliance with ISO 9001: 2015;
- Facilitate learning and understanding of the new version of ISO 9001:2015 requirements
- User-friendly format and professional layout - reviewed and approved by experienced ISO 9001 quality auditors.
- 72 pages
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.
QCC is one of the leading providers of training solutions in India for management systems, process improvement, business improvement and auditing. QCC helps companies understand, implement and manage business systems and processes through its training solutions in its endeavor to equip your staff with the confidence and expertise they need to attain their goal.Our training solutions are built on innovative experimental methodologies with global delivery capacity. Our presenters (trainers) are auditors, business improvement specialists, consultants, industry experts as well as trainers who have been exposed to a wide range of companies and industries in India and overseas. They develop and deliver courses for both public & in-house training, thus bringing along firsthand experience and knowledge to the delegates.
EAC certification, custom union, cu tr certificate, TR CU certificate, Ukrsepro Certificate, Atex Certificate, CE Mark, technical passport, fire certificate, ISO, ISI, CE, RDSO, SSI, Trademark, Copy right, Patents, GOST-R, Information Security, Pollution Consent, Environment Audit, safety Audit, Training for Internal Auditor, ISO Consultancy, ISO Certification, ISO Training, Lead Auditor for ISO 9001 , ISO 14001, OHSAS 18001, ISO 22001, ISO 27001, NABL, ISO 17025, ISO 17020, ISO 17021, ISO 17025, ISO 13485, ISO 14064, ISO 14065, ISO 20001, BS 25999, ISO 28001, ISO 29001, ISO 31001, ISO 39001, ISO 50001, ISO 45001, TS 16949, IEC 17011, ISO 13335, ISO 9001 2015, ISO 15189, ISO 12207, ISO 26000, ISO 55000, ISO 10002, PAS 2060, Six Sigma Green Belt, Black Belt, Total Quality management, NSIC Registration,5S, Kaizen, TQM,TPM, Lean Six Sigma, Quality Circle, IT Security, Cyber Security, HSE, IMS
SIX SIGMA QUALITY INTERNATIONAL
108, Mehta Chambers, 1st Floor Station Rd, Vasai (W), Thane-401202, India
Mob: 09322728183 Ph: 0250-2341170/2341257
Fax: 0250-2341170 ext 206 info@sixsigma-tqm.com www.sixsigma-tqm.com
Quality Management System awareness for all ANUPAM RAY
I covered benefit and utilization ISO 9001:2015 standard, 8 quality principle, Root cause analysis, what is ISO, and basic auditing principle. Kindly comment and let me know how I can improve this.
Although it is difficult to define quality as every organization looks at it differently but the totality of features and characteristics of a product or service that bear on its ability to satisfy stated or implied needs is most commonly considered as quality. If your organization is committed to ensure that its products and services are made as per customers’ requirements and intend to stay in the business by understanding and optimizing the whole system of value exchange; a quality management system can help you in fulfilling all these requirements.
42 pages editable MS Word document with detailed explanations, auditor tips and recommendations - our ISO 45001 Audit checklist can be utilized in a number of ways. The ISO 45001:2018 Audit checklist:
- provides a complete understanding of how to verify compliance with the requirements of all ISO 45001:2018 clauses;
- can be used as practice for internal auditors workshops.
- allows every employee to check his/her activity performance in compliance with the new requirements of ISO 45001:2018 and more.
Global Manager Group provides presentation on IMS auditor training that helps organization to learn how effective auditing of integrated management system as per ISO 9001, ISO 14001 and ISO 45001 requirements which gives you maximum benefits and increase health safety efficiency in the organization with IMS Certification.
For more information visit https://www.globalmanagergroup.com/
I made this one, and it is good to show how to address the new requirements -- Context of organization, interesting parties, SWOT, PEST Analysis, Risk evaluation. just want to share with someone who need it ...
What is requirement of Risk based Thinking in ISO 9001:2015 & ISO 14001:2015 ?
What is Risk? How to identify? How to assess and control?
How to incorporate Risk based thinking in to QMS & EMS?
EAC certification, custom union, cu tr certificate, TR CU certificate, Ukrsepro Certificate, Atex Certificate, CE Mark, technical passport, fire certificate, ISO, ISI, CE, RDSO, SSI, Trademark, Copy right, Patents, GOST-R, Information Security, Pollution Consent, Environment Audit, safety Audit, Training for Internal Auditor, ISO Consultancy, ISO Certification, ISO Training, Lead Auditor for ISO 9001 , ISO 14001, OHSAS 18001, ISO 22001, ISO 27001, NABL, ISO 17025, ISO 17020, ISO 17021, ISO 17025, ISO 13485, ISO 14064, ISO 14065, ISO 20001, BS 25999, ISO 28001, ISO 29001, ISO 31001, ISO 39001, ISO 50001, ISO 45001, TS 16949, IEC 17011, ISO 13335, ISO 9001 2015, ISO 15189, ISO 12207, ISO 26000, ISO 55000, ISO 10002, PAS 2060, Six Sigma Green Belt, Black Belt, Total Quality management, NSIC Registration,5S, Kaizen, TQM,TPM, Lean Six Sigma, Quality Circle, IT Security, Cyber Security, HSE, IMS
SIX SIGMA QUALITY INTERNATIONAL
108, Mehta Chambers, 1st Floor Station Rd, Vasai (W), Thane-401202, India
Mob: 09322728183 Ph: 0250-2341170/2341257
Fax: 0250-2341170 ext 206 info@sixsigma-tqm.com www.sixsigma-tqm.com
Quality Management System awareness for all ANUPAM RAY
I covered benefit and utilization ISO 9001:2015 standard, 8 quality principle, Root cause analysis, what is ISO, and basic auditing principle. Kindly comment and let me know how I can improve this.
Although it is difficult to define quality as every organization looks at it differently but the totality of features and characteristics of a product or service that bear on its ability to satisfy stated or implied needs is most commonly considered as quality. If your organization is committed to ensure that its products and services are made as per customers’ requirements and intend to stay in the business by understanding and optimizing the whole system of value exchange; a quality management system can help you in fulfilling all these requirements.
42 pages editable MS Word document with detailed explanations, auditor tips and recommendations - our ISO 45001 Audit checklist can be utilized in a number of ways. The ISO 45001:2018 Audit checklist:
- provides a complete understanding of how to verify compliance with the requirements of all ISO 45001:2018 clauses;
- can be used as practice for internal auditors workshops.
- allows every employee to check his/her activity performance in compliance with the new requirements of ISO 45001:2018 and more.
Global Manager Group provides presentation on IMS auditor training that helps organization to learn how effective auditing of integrated management system as per ISO 9001, ISO 14001 and ISO 45001 requirements which gives you maximum benefits and increase health safety efficiency in the organization with IMS Certification.
For more information visit https://www.globalmanagergroup.com/
I made this one, and it is good to show how to address the new requirements -- Context of organization, interesting parties, SWOT, PEST Analysis, Risk evaluation. just want to share with someone who need it ...
What is requirement of Risk based Thinking in ISO 9001:2015 & ISO 14001:2015 ?
What is Risk? How to identify? How to assess and control?
How to incorporate Risk based thinking in to QMS & EMS?
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.
Xybion presents the 7 Habits of Highly Effective CAPA programs. This detailed webinar provides best practices and deep-dive informaiton on how to implement a CAPA program in a regulated industry.
The RCCA PPT is an excellent training tool to implement into your functional group or business.
It basically forces you to peel the onion on a failure as far back until you’ve reached the root cause whereas in some cases it could be several.
It incorporates the 5 whys and the problem solving technique.
What is Quality Control
• Why implement Quality Control
• Quality Control Team
• Establishing a Quality Control Program
• Quality Control and Quality Assurance
• Quality Control Tools
• Measuring Success
• TQM, Six Sigma and ISO 9000
• Roadblocks and Barriers
Week 4:
Quality Management
OPERATIONS MANAGEMENT
1
Outline
Quality definition
Dimension of quality in product and services
Quality assurance
Quality leaders
Cost of quality
Total quality management and tools
Definition of Quality
Quality is a predictable degree of uniformity and dependability, at low cost and suitable to the market (Deming)
Quality is fitness for use (Juran)
Quality is the conformance to requirements (Crosby)
Quality is the (minimum) loss imparted by a product to
society from the time the product is shipped. (Taguchi)
Why Quality
4
Managing quality supports differentiation, low cost, and response strategies
Quality helps firms increase sales and reduce costs
Building a quality organization is a demanding task
4
Ethics and Quality Management
5
Operations managers must deliver healthy, safe, quality products and services
Poor quality risks injuries, lawsuits, recalls, and regulation
Organizations are judged by how they respond to problems
5
Dimensions of Quality for Manufacturing Product
Performance: Product’s primary operating characteristics
Features: Secondary characteristics that supplement the products basic functioning
Reliability: The probability of a product’s surviving over a specified period of time under stated conditions of use
Durability: The amount of use one gets from a product before it physically deteriorates or until replacement is preferable.
Serviceability: The ability to repair a product quickly and easily
Aesthetics: How a product looks, feels, tastes, or smells
Service Quality Attributes
Timeliness: Will a service be performed when promised?
Completeness: Are all items in an order included?
Courtesy: Do front-line employees greet each customer cheerfully and politely.
Consistency: Are services delivered in the same fashion for every customer and every time for the same customers.
Accessibility and convenience: Is the service easy to obtain?
Accuracy: Are the services performed right the first time?
Responsiveness: Can the service personnel response quickly and resolve unexpected problem?
Quality Control
All those operational techniques and activities that are used to fulfill requirements for quality.
The objectives are:
(i) To ensure true expression/correct translation of stated and implied needs of the customers.
(ii) To monitor the process for realization of the product at various stages of its operations and eliminating causes of unsatisfactory performance at all stages of quality loop in order to achieve economic effectiveness.
(iii) Inspection of the product/service package to determine conformance to customer needs.
Quality Assurance
All the planned and systematic activities implemented within the organization for quality management, to provide adequate confidence that a product or service will satisfy given requirements for quality (ISO - International Organization for Standardization).
Quality assurance is a preventive activity an.
Communications Mining Series - Zero to Hero - Session 1DianaGray10
This session provides introduction to UiPath Communication Mining, importance and platform overview. You will acquire a good understand of the phases in Communication Mining as we go over the platform with you. Topics covered:
• Communication Mining Overview
• Why is it important?
• How can it help today’s business and the benefits
• Phases in Communication Mining
• Demo on Platform overview
• Q/A
Encryption in Microsoft 365 - ExpertsLive Netherlands 2024Albert Hoitingh
In this session I delve into the encryption technology used in Microsoft 365 and Microsoft Purview. Including the concepts of Customer Key and Double Key Encryption.
GridMate - End to end testing is a critical piece to ensure quality and avoid...ThomasParaiso2
End to end testing is a critical piece to ensure quality and avoid regressions. In this session, we share our journey building an E2E testing pipeline for GridMate components (LWC and Aura) using Cypress, JSForce, FakerJS…
State of ICS and IoT Cyber Threat Landscape Report 2024 previewPrayukth K V
The IoT and OT threat landscape report has been prepared by the Threat Research Team at Sectrio using data from Sectrio, cyber threat intelligence farming facilities spread across over 85 cities around the world. In addition, Sectrio also runs AI-based advanced threat and payload engagement facilities that serve as sinks to attract and engage sophisticated threat actors, and newer malware including new variants and latent threats that are at an earlier stage of development.
The latest edition of the OT/ICS and IoT security Threat Landscape Report 2024 also covers:
State of global ICS asset and network exposure
Sectoral targets and attacks as well as the cost of ransom
Global APT activity, AI usage, actor and tactic profiles, and implications
Rise in volumes of AI-powered cyberattacks
Major cyber events in 2024
Malware and malicious payload trends
Cyberattack types and targets
Vulnerability exploit attempts on CVEs
Attacks on counties – USA
Expansion of bot farms – how, where, and why
In-depth analysis of the cyber threat landscape across North America, South America, Europe, APAC, and the Middle East
Why are attacks on smart factories rising?
Cyber risk predictions
Axis of attacks – Europe
Systemic attacks in the Middle East
Download the full report from here:
https://sectrio.com/resources/ot-threat-landscape-reports/sectrio-releases-ot-ics-and-iot-security-threat-landscape-report-2024/
GraphSummit Singapore | The Art of the Possible with Graph - Q2 2024Neo4j
Neha Bajwa, Vice President of Product Marketing, Neo4j
Join us as we explore breakthrough innovations enabled by interconnected data and AI. Discover firsthand how organizations use relationships in data to uncover contextual insights and solve our most pressing challenges – from optimizing supply chains, detecting fraud, and improving customer experiences to accelerating drug discoveries.
PHP Frameworks: I want to break free (IPC Berlin 2024)Ralf Eggert
In this presentation, we examine the challenges and limitations of relying too heavily on PHP frameworks in web development. We discuss the history of PHP and its frameworks to understand how this dependence has evolved. The focus will be on providing concrete tips and strategies to reduce reliance on these frameworks, based on real-world examples and practical considerations. The goal is to equip developers with the skills and knowledge to create more flexible and future-proof web applications. We'll explore the importance of maintaining autonomy in a rapidly changing tech landscape and how to make informed decisions in PHP development.
This talk is aimed at encouraging a more independent approach to using PHP frameworks, moving towards a more flexible and future-proof approach to PHP development.
DevOps and Testing slides at DASA ConnectKari Kakkonen
My and Rik Marselis slides at 30.5.2024 DASA Connect conference. We discuss about what is testing, then what is agile testing and finally what is Testing in DevOps. Finally we had lovely workshop with the participants trying to find out different ways to think about quality and testing in different parts of the DevOps infinity loop.
Alt. GDG Cloud Southlake #33: Boule & Rebala: Effective AppSec in SDLC using ...James Anderson
Effective Application Security in Software Delivery lifecycle using Deployment Firewall and DBOM
The modern software delivery process (or the CI/CD process) includes many tools, distributed teams, open-source code, and cloud platforms. Constant focus on speed to release software to market, along with the traditional slow and manual security checks has caused gaps in continuous security as an important piece in the software supply chain. Today organizations feel more susceptible to external and internal cyber threats due to the vast attack surface in their applications supply chain and the lack of end-to-end governance and risk management.
The software team must secure its software delivery process to avoid vulnerability and security breaches. This needs to be achieved with existing tool chains and without extensive rework of the delivery processes. This talk will present strategies and techniques for providing visibility into the true risk of the existing vulnerabilities, preventing the introduction of security issues in the software, resolving vulnerabilities in production environments quickly, and capturing the deployment bill of materials (DBOM).
Speakers:
Bob Boule
Robert Boule is a technology enthusiast with PASSION for technology and making things work along with a knack for helping others understand how things work. He comes with around 20 years of solution engineering experience in application security, software continuous delivery, and SaaS platforms. He is known for his dynamic presentations in CI/CD and application security integrated in software delivery lifecycle.
Gopinath Rebala
Gopinath Rebala is the CTO of OpsMx, where he has overall responsibility for the machine learning and data processing architectures for Secure Software Delivery. Gopi also has a strong connection with our customers, leading design and architecture for strategic implementations. Gopi is a frequent speaker and well-known leader in continuous delivery and integrating security into software delivery.
In his public lecture, Christian Timmerer provides insights into the fascinating history of video streaming, starting from its humble beginnings before YouTube to the groundbreaking technologies that now dominate platforms like Netflix and ORF ON. Timmerer also presents provocative contributions of his own that have significantly influenced the industry. He concludes by looking at future challenges and invites the audience to join in a discussion.
Climate Impact of Software Testing at Nordic Testing DaysKari Kakkonen
My slides at Nordic Testing Days 6.6.2024
Climate impact / sustainability of software testing discussed on the talk. ICT and testing must carry their part of global responsibility to help with the climat warming. We can minimize the carbon footprint but we can also have a carbon handprint, a positive impact on the climate. Quality characteristics can be added with sustainability, and then measured continuously. Test environments can be used less, and in smaller scale and on demand. Test techniques can be used in optimizing or minimizing number of tests. Test automation can be used to speed up testing.
Observability Concepts EVERY Developer Should Know -- DeveloperWeek Europe.pdfPaige Cruz
Monitoring and observability aren’t traditionally found in software curriculums and many of us cobble this knowledge together from whatever vendor or ecosystem we were first introduced to and whatever is a part of your current company’s observability stack.
While the dev and ops silo continues to crumble….many organizations still relegate monitoring & observability as the purview of ops, infra and SRE teams. This is a mistake - achieving a highly observable system requires collaboration up and down the stack.
I, a former op, would like to extend an invitation to all application developers to join the observability party will share these foundational concepts to build on:
2. Agenda
QMS Perspectives
Solution to nonconforming products CAPA
Example 8D report-Hypothetical case
Effectiveness of CAPA
QMS and process operational flaws
Questions & Answer
3. There is an additional nonconforming product reported due
to `the cables coming off extrusion with a poor
surface finish product’ in process.
`Under Quality Control –QC’’ situation.
QMS -8.3 Requirements for the control of nonconforming products
Nonconformity is often an indication of weakness or flaw in the
management system that requires corrective and/or preventive
actions to improve the effectiveness of the management system
A QMS perspectives
4. Customer Complaint
ISO9000:2000 Customer Focus Principle…..requires that priority be given
Customer complain as appropriate.
…………..consistent with Company’s policy of ……..…
…Customer first !
The rule of thumb is to;
(1) Eliminate the immediate problems of product nonconformance,
(2) Consider whether the same or similar problems exist elsewhere
in the organization/in process,
(3) Prevent the problem from recurring.
Nonconformance is determine at `Verification Stage ‘ and needs to be
proven (….and to determine why the failure to detect or escape and be
delivered to customer ) before corrective action process is commenced.
5. QMS/CAR-Responsibilities
Corrective Action Roles
Action Responsibility
Customer/CAPA -Driver
Reviewing Variation
Quality team
Process Owner
Determining the cause Diagnostic team
Evaluating Action needed Diagnostic team
Implementing the action needed Implementation team
Reviewing corrective actions Diagnostic team
Management Responsibility
Management should appoint a Management Representative of the
Quality Management System.
Management is responsible to allocate adequate resources and provide
organizational structure and authority.
Procedures should delegate responsibility for implementation and
maintenance of the CAPA system.
6. Customer Communication
Customers are informed about the progress of the complaint resolution
through appropriate communications, such as;
a) Acknowledgement of receipt of complain
b) Initial customer response up dating effort being made
c) Interim reports with immediate containment actions and test
results
d) Complaint reports with 8D analysis results
e) Customer accepts 8D report and acknowledge for closure
CAPA is at `The heart of an effective quality management system’
Corrective actions must be verified and validated (if applicable) .
Majority of customer problems are traceable to either misunderstanding
of customer requirements and/ or insufficient attention being paid to
the resources required to meet customer requirements
The sources of causes are not limited ? - Communication; Documentation;
Personnel training and motivation; Materials; Tools and Equipment;
The operating environment
An overview of CAPA
7. Thought Process : Addressing nonconformance
Nonconforming
products
What
needs be
done ?
Problem definition
What actually
happened ?
Who Knows ??
What failed &
why ?
What Changed &
why?
Gather & analyse
detail/data
What records &
data available ?
Define outcome of investigation
Document actions to be taken
Communicate to team
Follow up & close the loop ensure
effectiveness
Data
Evalu
ation
Determine
Root
Cause
Determine
Failure
Mode
8. QMS prescribed – CAR
(a) Failure Investigation procedure
(b) Nonconforming material review procedure
(c ) Customer complaints procedure
(d) Specification Change procedure
(e) Maintenance Procedure
Step Action Clauses 8.5.2 Requirement
1 Collect the nonconformity data and classify
Reviewing nonconformities
2
Conduct Pareto analysis to identify the vital few and trivial
many
3 Organize a diagnostic team
Determining the cause4 postulate causes and test theories
5 Determine the root cause of noncoformity
6
Determine the effects of non conformity and the need for
action
Evaluating the action needed
7
Determine the action needed to prevent nonconformnity
recurring
8 Orgnize an implementation team
Implementing the action needed
9
Create or choose the conditions which ensure effective
implementation
10 Implement the agreed action
Need to validate
customer complaints
first before CAR !
9. 11 Record the results of Pareto Analysis
Record Results
12 Record the cause of nonconformity
13 Record the criteria for determining severity or priority
14 Record the proposed action to be taken
15 Record actual the actions taken
16 Record the results of the actions taken
17 Assessment of the actions taken
Reviewing
corrective
actions
18
Determine whether the actions taken were those required to
be taken
19
Determine whether the actions were performed in the best
possible way
20 Determine whether the nonconformity has recurred
21 If nonconformity has recurred repeat steps [1] to [20]
10. 10
Required Tools : Addressing nonconformance
The 8D –Method- The Problem Solving Approach
D0 Recognize Symptoms
D1 Establish a Team
D2 State and Describe the Problem
D3 Contain the Symptoms
D4 Find and Verify Root Cause
D5 Select and Verify Corrective Action
D6 Implement and Verify Permanent Corrective Action
D7 Prevent Recurrence and Correct System Flaws
D8 Recognize the Team
Tools:
Pareto; Control chart
Is/Is NOT ; 5 whys -repeated;
Histogram; Graphs
Causes & effect;
Brainstorming
FMEA and 8D CAPA
11. 11
Problem-
Solving
Process
Become Aware of
Problem
Establish Team
Describe Problem
Contain Systems
Select & Verify
Corrective Actions
Implement and
Validate Corrective
Actions
Prevent Recurrence
Recognize Team
Find Root Cause
Identify Potential
Causes
Select Probable
Causes
Is Probable
Cause a Root
Cause?
12. Problem solving approach
Correction
Remedial
Action
( MRB &
QIT team)
Call a team meeting………MRB review
Review collected information/Lot history etc.
Perform Reject Parts Analysis focusing on reasons such as
`Why the process failed to detect the nonconformance, ….if
NOT fixed additional nonconforming material may ship ??’
Analyze and initiate - Initial Customer Response
Determine Containment Actions
Trigger -PROCESS HOLD-Suspend production process
Trigger -Effect a ‘STOP SHIPMENT’ if necessary ?
Assign Lead -CAR owner
Ensure initial Customer Response(within 48 hours)
Customer
Complains
QA
Immediate Action
Acknowledge customer complain
Collect from the customer : RMA request form (Date,
S/N, Lot Number , defective sample(N/A) , non
conformance form etc. and Log –in these information.
Review & validate the nonconformity to ensure is
genuine (A times customer can be mistaken!)
Issues a QUALITY ALERT /Incident Awareness –by
communicating to those involved –MRB + QIT teams
Within 24 hours………time frame
…….Within 48 hours
13. Problem solving approach
Investigate
& Analyze
CAR + 8D team
Defined problem statement (update/refine if new
information is determined (Lead CAR Owner QIT)
DATA-Gathered, reviewed and/or evaluated
information
ANALYSIS-Results of the reviews/evaluations of the
information
Identification of cause(s) or contributing factors
Call CCB/MRB
Review & Accept Response
…..to be completed within 10 days
Identify Root
Cause The output of the root cause analysis should
be a clear statement of the most fundamental
cause(s) resulting in the nonconformity
Disseminate Information
Planned
actions
Specify:
What the action is ?-
Who will do it ?
When it should be done
Customer Closure: Customer to review & accept/response ( 2 weeks)
14. 8.3 QMS Requirement for re-verification of the products
Nonconforming products to be subject of re-verification after correction to demonstrate
conformity to requirements.
This involve verification against different requirements to the original requirements
Action should be taken to improve the verification by changing procedure, acceptance
criteria, equipment r refraining personal.
Validation & verification
Process validation can be attained through the production of samples,
collection and evaluation of data over time to verifying customer
specification is being met
This can be accomplished by reviewing product and quality problem
trend results overtime to determine if there are any similar product
or quality problems after the implementation of the corrective or
preventive actions.
Good engineering principles should include: establishing a verification or
validation protocol; verification of product output against documented
product requirements and specifications; ensuring test instruments are
maintained and calibrated; and that test results are maintained, available
and readable
15. Effectiveness of CAPA
ISO9000:2000 8.5.2 f: Requires establishing the effectiveness of CA & PA
eliminating the causes of nonconformity
Step Action
1 Review to establish what actions were taken
2
An assessment to determine whether the actions taken
were those required to be taken
3
An evaluation of whether the actions were performed in the
best possible way
4
An investigation to determine whether the nonconformity
has recurred
Perform a subsequent follow-up and audit the process to determine that
the actions taken was effective (close the loop) and ensure a high level of
confidence that the problem will NOT re-occur as a measure of success.
CAPA are improvement opportunities to achieve both robust processes and
products. QMS prescribes measuring, monitoring to determine effectiveness
16. Ensure nonconforming product and quality problems details, CAPA
actions has been properly disseminated, to individuals directly
responsible for assuring product quality and the prevention of quality
problems including dissemination for management review.
Review the CAPA (and other procedures, if necessary) and confirm
that there is a mechanism to disseminate relevant CAPA information
to those individuals directly responsible for assuring product quality
and the prevention of quality problems- Examples…
Customer satisfaction:
Customer feedback/response
Monitoring & measurement of customer response
Determining customer satisfaction monitoring method
Communication /Information dissemination
• What specific document were instituted?
• Process Change Notice are required ?
• Process Change Notices communicated ?
• Management Review & Approval ?
• Quality Data base update ?
17. Example of 8D report for CAPA
8D Type: Customer X Internal Supplier EHS Other 8D/CAR Number 12#-1234-PD
Severity: Critical X Major Minor Repeating failure Due Date 11/21/14
D1. Identify Team Members/Roles & Responsibilities
Champion: John Cayole Leader: Peter Murray
Team members: Dept/Role Phone/e-mail
1. Alex, C. Process 1234 / ACope@Afl.com
2. Grace C Operation 1235 / GC@Afl.com
3. Jack, J Engineering 1236 / JJack@Afl.com
4. Jacob, J QA 1237 / JJcobs@Afl.com
5. Rita, M Equipment 1238 / PRita@Afl.com
6. Frank, B QIT 1239 / FGego@Afl.com
D2. Define the Problem
Problem Statement: Customer out of specification (OOS) diameter on four cable delivered last month, cables and cannot be installed.
Problem Description: Center diameter of TY X#12 Cables are specification by XXX mm
Problem description is provided -See attached completed Is/Is NOT problem solving worksheet
Establish description using 5 Why analysis
Eg: Four shipped cables indicate out of specification diameter measurements and cannot be installed.
Symptom: What is the symptom reported by the team?, Has the problem been verified ?, how big is the problem ? Pareto & trend chart reviewed?
Has the causal part been identified? Has the failure mode been identified?
eg- A finding can be : `Over size cable diameter -0.380 Maximum center checks 0.393 giving 0.13mm oversize (Example !)’
Problem found at: Xyz Ltd
Qty Tested: X(Qty checked out of product
produced)
Defective: Y( Defective Qty/product
produced
Qty Stopped: Z( held due to the problem
Part #: TY -X#12 Cables Description: TY-P#12 -Cables Process: TY-P#12 Cables processing module
Customer/Supplier Xyz Inc Contact: Mr Tom Joy RMA/NCR # 23#45-0123
18. D3. Implement & Verify Interim Containment Action(s)
(Do we need to take immediate action ?)
Yes, require to take immediate action to contain this problem. Containment plan fully deployed
Product Process –Line HOLD on TY-P#12 Cables process and Effected a `STOP’ shipment
Stop defect at each process point in the process flow back to the source
% Effective
95%
Date Implemented
10/11/14
Verification
Verified action taken are to `Line HOLD, STOP ship are effective ?
Validation
Action take is fully validated. Confirm that the action taken is fully validated
D4. Define & Verify Root Cause(s)
% Contribution
Occurrence: (occurrence is the actual concern ? what went wrong and why? )
Example:
1-Manual Lathe not capable of holding tolerances due to wear and/or poor maintenance of machine.
2-Process engineering processed job to run manually in equipment they had no information on in regards to
capability, equipment not presently capable of holding tolerance
(Has the failure mode been identified, has failure mechanism been identified, what was done to identify the root cause)
Did the investigation lead to improved problem description
(What is the difference and what changed ?
Escape:
(Why the problem escaped to the customer, explain why the problem escapes to the customer)
Tooling used, operator training , not monitoring ongoing parts, processing, tap relief, previous centre lap operation,
operator workmanship, material, lack of knowledge in regards to machine capabilities, poor machine maintenance
Verification
Occurrence: (present the result of verification root cause)
Escape: (present the result of escape root cause)
(Estimate the contribution
to each of the root cause)
Date of investigation: 8/11/2014 Name: Alex Cope
Does this problem apply to
similar and/or other products at:
Y/N Responsible Verified Y/N
N This site? ACope Y
N External site(s)?
19. D5. Identify & Verify Proposed Permanent Corrective Action(s)
% Effective
Occurrence:
Processing reviewed by Supervisor, Engineering and Quality Assurance.
Determination is made on review of all inputs, machine, inspection technique, processing , material, tooling that
moving this operation to the NC machining centre at this time from the manual lathe
Escape:
Actions that will permanently eliminate the root cause
Verification
Occurrence: Verify (on sample basis)that CAR eliminates the root cause and will not cause undesirable effects
Escape:
Verify (on sample basis)that CAR eliminates the root cause and will not cause undesirable effects
D6. Implement Permanent Corrective Action(s)
Process Change Request generated by Engineering to move operation 90 to NC machine in accordance with
established PCR procedure and related forms. Equipment needs review(process to determine present capability
and what its use will be in the future. Operators and process engineers need to be made aware of capability
information for future occurrences
Date Implemented
Occurrence:
Was CAR action plan successfully implemented? What data is being presented to substantiate successes of CAR
Does management concur that CAR action is verified
Escape:
Was CAR action plan successfully implemented? What data is being presented to substantiate successes of CAR
Validation
Occurrence:
Analyze the selected indicator(that identifies the original problem) for long term to quantitatively that the CAR does
what is intended
Escape:
Validate overtime, if there is any escapes( customer feedback) assesses removal of containment actions
X/11/14,
XX/11/14,
XX/11/14,
XX/11/14
D7. Action(s) to Prevent Re-Occurrence
Responsible Verified
Y/N
Date Implemented
Has the team identified the system, practices and procedure and
specification standard that allowed the problem to occur and escape ?
What action that permanently eliminate the root cause of the problem?
What specific document and process changes have been instituted
Where appropriate -
Update these items to
reflect changes:
Product FMEA
Process FMEA Rita Y 18/11/2014
Control Plan
X Procedure
D8. Communicate Results & Recognize Team
Congratulate team, update Quality data base & raise PCN and sign-off
(Thank the team. Make special effort to reward teams that participated and contributed on 8D report)
Update and Alert Quality Data base and notify the customer if applicable
Date Opened 10/11/14 Last Updated 11/24/14 Reported by Alex Cope
Date Closed 24/24/14
Reviewed & Approved by
YA
20. All Quality System processes that can potentially identify a deviation
or a nonconformance need to interact with the CAPA System
Every organization should map their processes and understand
the inter-relationships of those processes
5.6 QMS Management Review:
Requires top management to review the QMS to ensure its
continuing suitability, adequacy and effectiveness
Does it represent the best way of doing things ? Rather than is it fit
for purpose
QMS and process operational flaws
Recommendation
Integrated CAPA system that integrates important elements from both internal
& external data sources required for CA & PA are becoming increasingly popular
with many companies, driven mainly by efforts to reduce cost of poor quality in
the industry.
21. Summary:
Elements of a Sound CA/PA Program (checklist)
Documented procedure
Method for documenting (Form or software)
Inputs (data sources)
Method for analysing inputs
Method for prioritizing
Containment
Investigation (determine root cause)
Disseminate Information
Identify solutions (corrective or preventive)
Verification or validation Impact assessment (risk analysis), where appropriate
Corrective Action Plan
Implement and Monitor Effectiveness verification
Management Review