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September, 2000

This Month's Feature:

Corrective Actions

The goal of internal auditing is to ensure that quality related activities comply with planned arrangements and are effective. One of the keys to a good audit is to enable corrective actions for items discovered during the audit to be effective. But how can an internal auditor assist in making sure the corrective action is effective? Isn't the corrective action the responsibility of management?

The auditor(s) play two separate roles in corrective actions, in some cases three.

Auditor:
 As auditor, we are duty bound to make our findings clear and precise. The auditee needs to know the true nature of the finding. We dealt with this is previous issues. Findings really need to have two components to be of any benefit. First, the auditee needs to know what the requirement is. I recommend actually quoting the requirement. 4.1.2.3 Management representative: "The supplier's management with executive responsibility shall appoint a member of the supplier's own management who,…" The second component is that the auditee needs to know exactly what documentation or activity is not compliant. The document controller is identified as the Management Representative. This individual is not a member of management.

The more clearly the defined noncompliance, the greater chance of having an effective corrective action.

(Continued on next page)

Featured Book:
Title:
How to Plan an Audit : 
Author: ASQ Quality Audit Technical Committee
Publisher: American Society for Quality
Notes: This book contains everything required for a timely, accurate and meaningful quality audit.

You can order this book from internal-auditor.com at: http://www.internal-
auditor.com/books.htm

Tips/Tricks/Laughter:

Some auditing software allows the checklists and notes to be made on a PDA (such as Palm Pilot). Using an electronic format for auditing could be one method to increase audit effectiveness. Not only can you download the audit on a PC, but also electronically generate NCRs and Corrective Action Requests. Follow-up is also easier.

Another advantage is auditors seem to like the idea of using PDAs and it could become an incentive to gain more (or keep existing) auditors.

Observations from the field:

The true essence of problem solving lies in asking the tough questions. Digging deeper to understand what really did happen and why did it. Then we hit the fork in the road. Was it the result of lacking knowledge, or tools (a management controllable issue), or was it a lack of attention or application of that knowledge or tools (an operator controllable issue). Pay now (by investing the time and resources to answer the tough questions) or pay much more later (on a continuous basis by facing repeat occurrences). This same logic is being used successfully with our supplier who, if they aren't leaned on as well, also default to answering corrective action requests with "symptoms" and band aids rather than root causes and actual problem elimination. Not rocket science, just persistence, with bulldog tenacity. 

Ted Russell
Quality Engineer
Master Metal Engineering
http://www.mastermetal.net/

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September, 2000

This Month's Feature continued:

Suggestor:
 When informing the auditee of the nonconformance, it may be beneficial to offer a suggestion. This is especially helpful if the issue is a technical issue dealing with the requirement. The auditee is meeting the requirement, but it is not documented, or the auditee is not following part of a procedure that really doesn't have much bearing on the requirement are examples. You can also make suggestions that are not related to a noncompliance, but we will leave that to another session.

Verifyor:
 Once the corrective action is completed, the auditor must ensure that the corrective action is effective. This can be accomplished through a follow-up audit, or perhaps through the next round of internal audits. This might very well be the weakest link in the auditing process. Management changes a procedure due to an internal audit, shows the auditor the changed procedure, and we buy off on it. How do we know the procedural change was effective? We might observe it being followed today, but what about next week? Will employees go back to the "old" way, or did the new procedure stick?

These questions and more must be asked if we are to perform a proper verification of the corrective action. The length of time and the particular evidence we seek will be based on the magnitude and the severity of the noncompliance.

Summary:

Although internal auditors are not responsible for the corrective actions, we are responsible to ensure we do all we can to make corrective actions effective.

Good Auditing!

Internal Auditor Resources:

When you need help in your QMS, don't overlook your local MEP (or equivalent). MEP stands for Manufacturing Extension Partnership. In the US it is sponsored by NIST. You can reach them at:

http://www.mep.nist.gov/
Most other countries have a similar body. Contact them first!

This site, and others can be located on our links page at: http://www.internal-auditor.com

Questions and Answers:

Q - I should be a dentist! I thinking pulling teeth would be easier than getting managers to submit corrective actions on time. Help!

A - Internal Auditors everywhere shouting AMEN! Answering corrective actions is not the job of the auditor, but the job of management. If corrective actions are not completed in a timely fashion, pass the delays up stream. If upper management won't respond, then all we can expect to do is to write an nonconformance to either 4.1, 4.17 or 4.18, depending on your documentation. Don't lose sleep over it! If top management doesn't push it, your quality system is doomed anyway.

Element Understanding:

8.2.2 Internal Audit [ISO 9000:2000]

 Independence of auditors has been an issue with ISO 9000:1994. In January's issue we discussed the controversy. We might be jumping the gun a little bit here, but ISO 9000:2000 clears the issue. "Audits shall be conducted by personnel other than those who perform the activity being audited." There is little room for interpretation here. An auditor cannot audit their own activity. If you are a Receiving Quality Inspector, you would not be able to audit Receiving Inspection, for example. You still would want to ensure your auditors audit only those areas where thy have no bias.

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Last updated: February 25, 2003.