© - Copyright Bureau Veritas Non-conformity Reporting Module 4.

© - Copyright Bureau Veritas

Non-conformity Reporting

Module 4

2Module 4 Non-conformity Reporting© - Copyright Bureau Veritas

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


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




► 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.


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)


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


Opportunity for Improvement and Observation

Opportunity for Improvement

► 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


Raising NCRs




► 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.


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


Auditor’s Responsibility


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


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


Writing NCR’s

Non Conformity Report (SF02)

Correction (What was done to solve the urgent problem)

Root cause analysis (What failed in the system to allow this non conformity to occur)

Corrective and Preventive action (What is done to prevent recurrence)

Verification of actions

Date of completion Organization representative


Closing NCRs


Closing NCR’s

► 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.

Correction Root Cause Analysis

Don’t cure symptoms only! Hit the cause!Don’t cure symptoms only! Hit the cause!


Corrective Action

► Reference : BMS / BV Business Model Lever 5 Production / Audit Realization Process / 7. Closure of Nonconformities

1. The corrective action or corrective action plan addresses the root cause(s) determined in the root cause analysis.

2. In order to accept the plan it shall include;

a. actions to address the root cause(s)

b. identification of responsible parties for the actions and

c. a schedule (dates) for implementation.

3. In order to accept the evidence of implementation:

a. Enough evidence is provided to show the plan is being implemented as outlined in the response (and on schedule).

b. Note; Evidence in full is not required to close the NCR; some evidence may be reviewed during future audit when verifying the corrective actions.


Closing NCR’s

Non Conformity Report (SF02)

Correction (What was done to solve the urgent problem)

Root cause analysis (What failed in the system to allow this non conformity to occur)

Corrective and Preventive action (What is done to prevent recurrence)

Verification of actions

Date of completion Organization representative


NCR Closing ExerciseHandout and Group Exercise


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