How to write a value- adding nonconformity statement

 

Much auditee time and money is wasted chasing auditor comments and recommendations often in the guise of nonconformity statements or observations.  So, as part of our auditor improvement service we are offering this elearning course free of charge.

 Study this and you will be able to:

• Explain the value of a nonconformity statement
• Describe the parts of a nonconformity statement
• Write effective nonconformity statements
• Categorize nonconformities
• Initiate effective corrective action

 

* Well-crafted nonconformity statements help companies remove the root causes of costly problems.   Each nonconformity statement has three parts.  You can learn how to write each part so together the statement defines the problem clearly for the corrective action or problem solving team.   You can also learn how to weigh-up the magnitude of the nonconformity.

 Definitions

Nonconformity

Nonfulfillment of a requirement

Finding (used to be an Observation)

Statement of fact from an audit

Observation

Widely misused term that some auditors may use to impose their will or express their opinion about something they do not like

 

* You can find two of these definitions in ISO 19011 the international standard for auditing management systems.  A system, process or product that fails to meet a requirement has a nonconformity.  Notice how we do not refer to people having nonconformities!  * The term Observation used to mean a statement of fact from the audit.  ISO changed this term to Finding in the year 2000 because of the misuse of the term Observation.  You may have heard of an “observation” being reported instead of a nonconformity when the auditor is unsure, lazy or opinionated.

 Do you have a Nonconformity?

Discuss the situation with the manager responsible for the area:

1.Agree the requirement

2.Seek evidence of conformity

3.Make notes and evaluate evidence

4.Reach a conclusion

5.Agree the conclusion

 

* Never agree a nonconformity with an operator.  Seek a manager responsible for that part of the system.  * Agree the requirement and the evidence in support of any unusual interpretation of the requirement from the system standard.   * Ask the manager for any evidence that may contradict the nonconformity.

 * Update your notes and objectively evaluate whether the requirement has been met.  * Conclude “conformity” or “nonconformity” and discuss the basis for your conclusion with the manager.  Be prepared to consider contrary evidence from the auditee.

 Purpose of the Nonconformity Statement

• Record on which an auditor bases the audit conclusions
• Informs the auditee how the system has failed to meet a requirement
• Starting point for effective corrective action

 Three parts of a Nonconformity Statement

• Requirement
• Evidence
• Nature 

Requirements are from the audit criteria, for example:

• Clause reference of system standard
• Auditee’s management system
• Auditee manager’s statement
• Contract
• Regulation
• Specification

Evidence

 

Verifiable evidence can be :

• Name or job title of the auditee
• Statements
• Name of the process
• Document references
• Serial numbers
• Sample size
• Time and location
• Description of conditions

Do not use hearsay as evidence

 Nature

 

Opposite of the Requirement, some broad examples:

• Failure to determine the criteria for the marketing process to be effective
• Failure to monitor the design process
• Failure to analyze supplier data
• No evidence of approval authority
• No evidence of document approval
• No evidence of design validation

 Writing the Nonconformity Statement (1/2)

 

• Inform management of the problem
• Reach agreement
• Make notes
• Decide if corrective action would add value
• Prepare statements before the closing meeting
• Expect to be challenged if incorrect

 Writing the Nonconformity Statement (2/2)

 

Review all notes, including team members

State:  requirement

                evidence

                nature

Check: correct

                complete

                clear

Read statements aloud (to detect errors

 

 Management Acknowledging Receipt of the Statements

• Ask management to sign statements at the closing meeting
• Leave copies with auditee
• Enable management to take prompt corrective action

  Categorizing Nonconformities

 

Some are more serious than others, for example:

Critical:

• Chronic/repetitive problem
• System breakdown
• Adversely affecting the environment or the customer (especially the core process)

Less critical:

Isolated implementation problems

 Use the audit client’s guidelines

 

 Confidential Summary Statement

 

Reports the degree of conformity per the audit’s criteria, objectives and scope:

• Areas/processes audited (sample)
• Positive points (these are findings also)
• Major/minor nonconformities (extract the nature part of the nonconformity statements)
• Your conclusion per the audit’s objectives

Do not rewrite the nonconformities

 

 Giving Advice

 

 

Has the audit client paid for advice, also:

• Are all the facts known to the auditor?
• Undermines management’s responsibility
• Undermines auditor independence
• Weakens the system (corrective action process)
• What if the advice is wrong, who will pay?

Provide advisory service only if documented as an audit objective

 Questions?

 Email 

 info@aworldofquality.com 

or call 

800 666 9001