Slide 4 v6

Post-Audit Activities
“The Job’s not done until the
paperwork is done”…

9K2K-LAD-E-IG-D4 Ver 6
©Robere & Associates (Thailand) 2000 1

Day 4 – Post-Audit Activities
1. Review of previous
day
2. Recording the audit Did I Pass?
3. Grading NCR’s
4. Closing Meeting
5. Corrective Action &
follow-up


REVIEW OF DAY-THREE:
10 minutes review

It is important that we begin each day with a review of
the previous day’s activities. Each day lays the
foundation for the upcoming subject topics.

1. Review Homework
2. What are the areas that were unclear?
3. Identify topic areas that you want
reviewed from yesterday’s activities.


Stage Four: Report The Audit

• Recording the Audit
• Grading NCR’s
• Closing Meeting


RECORDING THE AUDIT


Positive Reporting

• Say what was done

• Say what was seen

• Say what was good:
• use of well designed methods
• well run production team
• advanced manufacturing techniques
• ownership of quality

Report ‘Who, What and Where’

• Report reference
• Auditee/location/dates
• Purpose/scope
• Reference documents
• Audit team

Key Items

• Non-conformities
• Summary
statement/Recommendations
• Signature of Audit Team Leader
• Signature of the Auditee
• Further action required

Other important details

• Distribution list
• Attendees at opening and closing
meetings
• Auditee representatives
• Audit program


Audit Report

• Communication tool
– It stays with the Auditee long after the
audit team have gone home
– Should be legible
– Contain information appropriate to the
audit (Relevant to the activity)


Audit Records

– Audit Plan
– Audit Schedule
– Audit Report
– Correct Action Program
– Non-Conformance Analysis
– Auditor Notes


END


Team Exercise:
D4-E01: Recording
Non-conformities


GRADING
NCR’s


Non-conformity: A Definition

“The non-fulfillment of a
requirement”

(ISO 9000 : 2000 – 3.6.2)


Non-conformity: Other Terms

• Non-conformance
• Deficiency
• Discrepancy
• Finding
• Non-Conformity
• Corrective Action Request
(CAR)
• Deviation


Categories of Nonconformities

MAJOR nonconformity:

The absence of a required procedure or total
breakdown of a procedure or process.

Significant failure to conform with
requirement

Breakdown of a key aspect of the quality
management system

A number of minor nonconformities listed
against the same requirement


Categories of Non-conformities

• MINOR non-conformity:

A single observed lapse in a procedure

isolated non-fulfillment of specified
requirement

negligible effect on quality


Observations

In some circumstances it may add value to also
include ‘Observations’ which:

“relate to existing conditions and which, in an
assessor’s judgement, warrant clarification or
investigation so as to improve the overall status
and effectiveness of the quality system”


Reasons for Nonconformities

• Process not in
conformance with quality
manual

• Written procedures not
implemented in the
process

• Process is ineffective


Always Remember

Auditing is looking for
conformance
BUT……
you should not shy away if
there is something to find!


Non-conformity Statements

• The facts:
• where
• what
• why - nature of the non-conformity
• ISO 9001 clause
• Documented Quality Management
System reference


Recording Non-conformities

• The findings:
• the facts
• acknowledged by auditee
• at the time they are found

• Non-conformity statements must
be:
• accurate
• complete
• helpful
• brief


Handling Possible MAJOR Non-
conformities

• Major non-conformities - always:

– inform the Lead Auditor at the earliest opportunity
– do not alarm the auditee or interviewee
– follow the certification body’s procedures

Remember: a MAJOR is defined as the absence of or
breakdown of a required Quality Management
System Element


Example Non-conformity Form
ROBERE QUALITY AUDIT
NONCONFORMITY REPORT

Company under Audit: XYZ plc Nonconformity Number ...................

Area under review: ISO 9001 Clause Number ...............
..............................................................................

Category MAJOR* MINOR* * delete one

Nonconformity

Auditor


Summary

• The Audit Report is the formal record of the
audit and:
• contains all information about the audit
• will be read by people not involved in the audit
• Non-conformity statements must:
• cover the facts, clearly and specifically
• be acknowledged by auditee at the time they are found
and be:
» accurate
» complete
» helpful
» brief


END


Team Exercise
D4-E02: Grading NCR’s


CLOSING
MEETING


Pre-Closing Meeting
• Review findings

• Agree non-conformities

• Write non-conformity statements

• Write summary statement

• Prepare agenda

• Team form an agreement on assessment
outcome
©Robere & Associates (Thailand) 2000 9K2K-LAD-E-IG-D4 Ver 6
30

Closing Meeting : Agenda
• Thank you
• Purpose
• Confirmation of scope
• Sample
• Findings
• Summary
• Follow-up activity
• Clarify
• Report availability
• Go


Closing Meeting Conduct

• Lead Auditor's meeting
• Keep to the agenda
• Keep it short
• Keep a record
(attendees)
• End on a positive note


Summary Statement–
Version 1
This Company has a Quality Management System which is well documented
and generally in conformance with the requirements of ISO 9001:2000.
However,the systems and procedures have not been fully
implemented in the contract, project management and product
shipment areas.

The audit found 33 non-conformities and particular concern is felt for:
• Lack of application of the system for review of the quality
requirements of contracts.
• Evidence of a lack of disciplined control toward customer
complaints and related follow-up actions.
• Lack of quality awareness on the part of project and senior
management personnel.


Version 1
• No significant problems were found in the activities of either the
Design or pre-sales teams.
• There is a need for more frequent review of the Quality Manual
and project management procedures.
• It will therefore be necessary for the company to undertake
corrective action on the deficiencies raised and for a further audit
to be carried out to verify that it has been taken before the
company can be awarded a certificate. Corrective action should
be effected within three months from today.


Version 2
There are important omissions in the Quality Management System operated
by the company, although what exists is mostly in line with the requirements
of ISO 9001:2000. It has also been found that the systems and procedures,
which do exist, have not been universally implemented, particularly related
To the review of contracts, project planning and customer-relations areas.
The audit found 33 deficiencies of which 4 were considered to be major.

Particular concern is felt for:
• Lack of a system for reviewing the requirements of contracts.
•The absence of planning and progress control on work not directly
related to customer contracts.
•The effect that the current lack of control of customer complaints and
follow-up actions may cause.


Version 2
No significant problems were found in the activities of either the Design or
Pre-sales teams. There is a need for more frequent review of the Quality
Manual and software development procedures.

The most important conclusion is that there is a need for more senior
management involvement in and support for implementation of the
documented system. Until this is established and the declared Quality
System is applied consistently and effectively throughout the company, it
will not be possible to grant certification.

It is recommended that the company takes appropriate corrective action
and re-applies for assessment when all of the above concerns and
deficiencies have been addressed.


Summary

• Be prepared before meeting
• Ensure there are NO surprises for the
auditee
• Stick to the prepared agenda
• Don’t be drawn into discussion
• Ensure the auditee is clear as to the next
step


END


Team Exercise:
D4-E03: Role-Play:
Closing Meeting


Stage Five:
CORRECTIVE ACTIONS &
FOLLOW UP


Corrective Actions Process
Stage 1 Initiation of Non-conformity Auditor

Stage 2 Provide Programme of CA Auditee

Stage 3 Submit CA Programme to Auditor Auditee

Stage 4 Analysis of CA Programme Auditor

Stage 5 Monitoring,Reviewing,Auditing Auditee

Stage 6 Verify and closing Auditor

ACCEPT


Stage 1–Initiation of
Non-conformity
• The Auditor raises the problem:
• the facts

• the non-conformity

• the department responsible


Stage 2–Provide Program of
Corrective Action
• The Auditee Response
– Root cause analysis
– Corrective action
– Preventive action
– Approval
– The organization's Quality
Assurance function provides advice
to the responsible manager


Stage 3 – Submit Corrective
Action Program to Auditor
• The auditee responds:
– with proposed corrective action
– and identifies root cause of non-
conformity
– and initiates action to prevent
recurrence
– with target date for completion


Stage 4 – Analysis of
Corrective Action Program

• The auditor responds:
– analysis of the Corrective Action
Program against the original NC
Statement


Stage 5 - Monitoring,
Reviewing, Auditing
• The auditee responds:
– Procedures required
– Use of status log
– Corrective action review meetings
– The auditee notifies the auditor
when the actions are complete


Stage 6 - Verify and Closing

• The auditor responds:
– Verify the implementation of some
actions prior to the report close

– If Corrective Action is satisfactory,
close out the report


Example:
Corrective Action Status Log
CAR Date Subject Initiator CAR Response Approval of Verified Closed
Nos. Issued of Report Sent To Due Date Response by (Name) (Date)
(Name & Date)


Example Corrective Action Form
Auditee Representative Auditor
Date: Report Nos.
Standard ref.: Doc. Ref.

Details of Non-conformance

Non conformance Accepted By

Immediate Action

Preventive Action

Corrective Action Verified by

Name
Date


Additional Key Point
The Auditee role:

– Look across the organization to identify
the other possible area where the same
problem may occur but was not
necessarily identified during the audit.
– May provide opportunity to prevent
problems before they arise.
– Using a structured problem solving
technique to correct the problem.


Summary: Auditor Role

• Communicating/explaining the audit
report to the auditee
• Eliciting a response from the auditee
as to corrective action
• Evaluating the auditee's response
• Agreeing the corrective action
proposed
• Verifying that corrective action has
been taken
• Closing out the follow-up

Summary: Auditee Role

• Examines the evidence
• Identifies immediate action needs and act
• Check corrective action effectiveness
• Establish root cause
• Identify action to prevent recurrence
• Implement action to prevent recurrence


END


Team Exercise:
D4-E04: Corrective Action


Day-Four Summary:
We reviewed yesterdays activities
We discussed how to record the results of the audit by
using an exercise based on previous evaluations
We continued with our discussion about the audit and
about the follow-up activities that we are to perform.
We discussed how to grade NCR: Major and Minor
We discussed how to report the non-conformances to
that our auditee can understand what type of corrective
action needs to be taken.
We discussed the format and agenda of the closing
meeting.
We reviewed examples of summary statements that
would give us an idea of how to structure our report.
We discussed Corrective Actions and what we should
expect from our auditee if corrective action was
necessary.


End of Day Four
Only one-day left..


END

Team Homework


Slide 4 v6

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