Managing and controlling Nonconformance Quality Management System ISO 9001

1. Yakub Aliyu,
Ph.D(Wales) MBA(Lond.)

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

22. Questions & Answers !