1. Non-conformity Reporting
Module 4

2. Common Errors Non-conformity description Non-conformity categorization
Soft grading
Letting the Client instruct the findings
Lack of reporting objective evidences
Misinterpretation of “Corrective Action”
Closure of nonconformity based on the correction only
Failure to follow-up on the effectiveness of the corrective actions

3. NCR Reporting Requirements
Reference : IAF / ISO 9001 Auditing Practices Group / Guidance on Documenting a Nonconformity, Feb 2005
There are three parts to a well-documented nonconformity:
the statement of nonconformity
a record of the requirement against which the nonconformity is detected
the audit evidence to support auditor findings

4. NCR Reporting Requirements
Reference : IAF / ISO 9001 Auditing Practices Group / Guidance on Documenting a Nonconformity, Feb 2005
If there is no audit evidence – there is no nonconformity.
If there is evidence – it must be documented as a nonconformity, instead of being softened with another classification (e.g. “observations”, “opportunities for improvement”, “recommendations”, etc.).
In the longer term, neither the organization, its customers, nor the Certification Body benefit by the use of softer classifications, as this risks the nonconformity being given a lower priority for corrective action.

5. What is a Non-Conformity ?
“Non-fulfillment of a requirement”
Objective evidence exists showing that:
a requirement has not been addressed (intent)
practice differs from the defined system (implementation)
the practice is not effective (effectiveness)
Avvikelse

6. Stor avvikelse Major Non-Conformity
A failure of the clients system to address a specified requirement of the standard
A frequent or purposeful failure to follow specified requirement written within the company system
A failure to achieve the fundamental aim of a system requirement
A failure to achieve legal or statutory requirements
Multiple minor nonconformities within the same requirement of the standard or company system
A purposeful failure of the company to correct nonconformities
Stor avvikelse

7. Opportunity for Improvement and Observation
A process/activity/document that, while currently conforming, could be improved to bring benefits to the client.
Observation
An area of concern, a process, document, or activity that is currently conforming that may if not improved, result in a nonconforming system, product or service
Observation

8. Raising NCRs

9. NCR Reporting Requirements
Reference : IAF / ISO 9001 Auditing Practices Group / Guidance on Documenting a Nonconformity, Feb 2005
The final (and most important) part of documenting a nonconformity is the writing of a statement of nonconformity. The statement of nonconformity drives the cause analysis, correction and corrective action by the organization, so it needs to be precise.
Formuleringen viktig

10. Auditor’s Responsibility
Reporting of NCR’s based on facts and objective evidences
Correct reporting : grading , description, presentation
Correct closure based on root cause analysis and effective corrective action to eliminate the root of the non-conformity
Follow-up on effectiveness of the corrective actions taken
Revisorns ansvar

11. Auditor’s Responsibility

12. Spårbart Important Tips
Uncovering a non-conformity presents a previously undiscovered opportunity for improvement
Be positive, be professional, be precise
A non-conformity must be factual, objective, and traceable
Someone else must be able to trace back and find the same evidence you found, based on what you wrote
Spårbart

13. Objective evidence Important Tips
Don’t see and present a non-conformity in a negative way
REMEMBER! You are not there to find NCR’s, you are doing a compliance audit
Present the non-conformity with clear objective evidence to avoid any conflict with the client
The client must be convinced that the related corrective action will bring a benefit to the management system
Objective evidence

14. Writing NCR’s

15. Closing NCRs

16. Don’t cure symptoms only! Hit the cause!
24/04/ :50
Closing NCR’s
Correction
Root Cause Analysis
The extent of the nonconformity has been determined (NCR has been corrected & the client has examined the system to see if there are other examples that need to be corrected).
If correction can not be immediate; a plan to correct the NCR may be appropriate (responsible & date).
Evidence that the correction was implemented or evidence that the plan is being implemented.
Correction is mandated for every Nonconformity , because correction removes the nonconforming element from the system.
The Root Cause is not simply repeating the finding, neither is the direct cause of the issue.
Well thought out analysis to determine the true root cause: e.g. someone did not follow a process would be direct cause; determining why someone did not follow a process would lead to the true root cause.
The root cause statement must focus on a single issue without any obvious "why“ questions remaining.
If a "why“ question can reasonably be asked about the root cause analysis, this indicates that the analysis did not go far enough.
Don’t cure symptoms only! Hit the cause! 16

17. Corrective Action
Reference : BMS / BV Business Model Lever 5 Production / Audit Realization Process / 7. Closure of Nonconformities
The corrective action or corrective action plan addresses the root cause(s) determined in the root cause analysis.
In order to accept the plan it shall include;
actions to address the root cause(s)
identification of responsible parties for the actions and
a schedule (dates) for implementation.
In order to accept the evidence of implementation:
Enough evidence is provided to show the plan is being implemented as outlined in the response (and on schedule).
Note; Evidence in full is not required to close the NCR; some evidence may be reviewed during future audit when verifying the corrective actions.

18. Closing NCR’s

19. NCR Closing Exercise Handout and Group Exercise

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