1. Nonconformity Writing
March 6, 2008
J. Paula Garrett
AVP

2. Objectives We will cover: Key Definitions
The structured format that all nonconformities must adhere to.
When an Opportunity should be raised.
The objective of this training is to understand the new requirements under ISO
We will briefly review how to conduct any audit, then we will go over the different types of audits, highlighting on the changes in our requirements. Please note that these are our general ISO requirements. If there is a Scheme Manual that has different requirements, then the Scheme Manual takes precedence in all cases. Always know and understand the general requirements as well as your Scheme requirements.
If you know where to find your Scheme Manual, raise your hand [this is also a test to see who is listening]. Ok, Lower your hand.
[If enough people do not know where to find their scheme manual on PG, tell them that we will show them how at the end of this webinar and make a note to do that.]

3. Key Definitions Audit Criteria Audit Evidence
Set of policies, procedures, or requirements used as a reference (against which audit evidence is compared)
May include:
ISO - QMS or EMS requirements
Customer requirements
Statutory and regulatory requirements
Industry requirements
Organization’s own policies and documentation
Audit Evidence
Records, statements of fact, or other information which are relevant to the relevant audit criteria and verifiable
May be qualitative or quantitative
Reference Clause 6 of ISO 19011:2002

4. Key Definitions Not doing it Partially doing it Doing it the wrong way
Audit Findings
Results of the evaluation of the collected audit evidence against audit criteria
Can indicate conformity or n/c with audit criteria or opportunity for improvement
Nonconformity
Non-fulfillment of a specified requirement:
Not doing it
Partially doing it
Doing it the wrong way
Specified requirements:
Conditions of customer contract
Quality standard (ISO 9001:2000)
Quality management system
Statutory or regulatory requirements
You will note that it does not indicate that these are based on auditor opinion

5. Auditing Process Collecting Information to Reaching Conclusions
Sources of information
Collect by appropriate
sampling & verification
Audit evidence
Evaluate against
audit criteria
Per section 6.5.4
Audit findings
Review
Audit conclusions

6. Nonconformity Writing
When the evaluation of the audit evidence indicates that there is a situation where the requirements of the audit criteria are not being satisfied then a nonconformity is required to be written.
This reports to the organization that their system is not operating in the manner that they planned.
As all the major management systems utilize the PDCA cycle ( plan-do-check-act) the organization’s management need this information to correct their system and prevent recurrence.
Nonconformities are not a criticism of either the organization, its management or the personnel involved in the process. They are intended to assist in the PDCA cycle in the Act activity.

7. Nonconformity Writing
To ensure that we have a process that meets the requirements we need to ensure that we integrate the following into our nonconformity writing process:-
A statement of nonconformity,
The requirement, or specific reference to the requirement,
The audit evidence observed that supports statement of nonconformity

8. Nonconformity Writing
A statement of nonconformity,
This needs to indicate which of the organizations processes failed to deliver what was planned, i.e. The management system is a PDCA cycle therefore the plan was not achieved and the system failed.

9. Nonconformity Writing
The requirement, or specific reference to the requirement,
The requirement that is being offended needs to be identified. This can be from the appropriate normative document or the organizations own requirements. Not the auditors opinion.

10. Nonconformity Writing
The audit evidence observed that supports statement of nonconformity.
Identify exactly what evidence was found on the audit to support the nonconformity.

11. Nonconformity Writing
Typically nonconformities give only a brief indication of the situation, e.g.
Nonconformities (Detail)
Area
NCR Ref
Description
Clause
Calibration
FL 1
Records of calibration were not available for instrument # Shown on control plan 3456
7.6
Records
FL 2
Records where not available to indicate that all the required topics had been covered in management review.
4.2.4

12. Nonconformity Writing
Area
NCR Ref
Description
Clause
Control of monitoring and measuring devices
FL 1
MAJOR
Description of Nonconformity:-
The organization’s process for the control of monitoring and measuring devices failed to ensure that the measuring devices had been calibrated at the specified intervals.
Requirement:- The organization shall establish processes to ensure that monitoring and measurement can be carried out and are carried out in a manner that is consistent with the monitoring and measurement requirements. Where necessary to ensure valid results, measuring equipment shall be calibrated at specified intervals.
Evidence observed:- Final Inspection department - Equipment # a vernier caliper gage referenced on control plan GM 55, observed in use has not been calibrate at the specified annual frequency the instrument had not been calibrated, for over 18 months.
7.6a

13. Nonconformity Writing
Area
NCR Ref
Description
Clause
Management review: Review input
FL 2
Minor
Description of Nonconformity:-
The organization’s process for undertaking management review failed to ensure that all the requirements of the standard were covered during the planned reviews.
Requirement:-The input to management review shall include information on:-
recommendations for improvements
Evidence observed:- The documented process for undertaking management reviews does not require the review to consider recommendations on improvements. The records of the management reviews undertaken in 2005 indicates that this topic was not covered during the management reviews.
5.6.2

14. Opportunities for Improvement
Opportunities for Improvement (OFI) – is when the audit criteria has been met, however there is a possibility that if the client reviews that particular part of their system benefits might be gained.
Be careful not to sound like you are consulting
You should NEVER raise an OFI if it is a Nonconformity.

15. Tips for Nonconformity writing
Use auditee’s terminology (when applicable)
Make it complete
Make it correct
Make it concise
Make it clear

16. Questions-Comments? There will be a quiz posted on the LMS.
You must take it and score 100%.
Should you have any questions please contact either Kathryn Crouch( ) or Paula Garrett( )
Thank you for your time and attention to this presentation. There will be a quiz posted and you will have two weeks to complete it.
While you are sending in questions, I will take you to PG to show you where your scheme manuals are (suggest that you show AS, TS, MD, 27K, 14K as examples - There is no 9k scheme manual, the 18k is hard to find)
It might be best to compile the questions and send out a group after the presentation. This is up to the presenter.

17. Thank You!