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Need help with your internal auditing? Check with your registrar. Registrars often are approached by auditors who need experience auditing. Many times these individuals will offer their services at a low price, just for the audit hours. An alternate would be check with local Lead Assessor training providers. They often have graduates that also need auditing experience. In many cases both groups mentioned above will need auditing experience more than you will need the auditors, so you will have the upper hand. |
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Title: The Corrective Action Handbook Author: Denise E. Robitaille Publisher: Paton Press Notes: The Corrective Action Handbook will help you make your corrective action process more organized, more efficient, and more productive. It's a terrific guide to corrective action for anyone involved in a corrective action process. The book's basic precepts hold true for any size organization. The book includes sample forms that guide you through the corrective action process in a logical and straightforward manner (From Amazon.com)
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You can order this book from internal-auditor.com at: http://www.internal-auditor.com/books.htm |
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This Month's Feature ArticleVerifying Corrective ActionsAuditing to me is fun! It is my opportunity to to put my skills to work while making a worthwhile contribution to the organization. My goal is simple. I want to have a QMS that works, and works well. One of the methods to track the performance of the QMS is to look at the effectiveness of corrective actions. When we audit, we often find things. These things regularly require fixing. If the entire system is expected to function properly, then the fix if vital. How we, as auditors handle the fix (corrective actions) is also vital. Corrective actions are generated as result of nonconformances found during an audit. The auditor may have a couple of different roles to play in the corrective action process. Neither of the roles involve assuming the responsibility for the corrective action. Corrective actions are the responsibility of management of the area or activity being audited. The two potential roles for internal auditors are:
Assisting in the corrective action plan I often say that nonconformances must be understandable, actionable, and indisputable. The clearer the nonconformance, the less the auditee will need our assistance. If the auditee doesn't understand the requirements, however, an effective corrective action may not be possible. The auditee will then look to our expertise to guide the corrective action planning process. We, as auditors can assist in the corrective action plan in a couple of different ways. First, we can suggest methods of meeting the criteria that led to the nonconformance. This is normally accomplished by explaining why the requirement exists, and what evidence of compliance could look like. From there we offer may suggestions on actions that will achieve conformance. Secondly, we can review the corrective action plan that is submitted by management to determine if it will satisfy the nonconformance. Review the proposed action and the timeline presented to determine if the action plan is achievable. If you have any questions, or if the timeline or action plan is unrealistic, then work with the auditee to find a more realistic solution. A couple of additional things I need to point out. Should an auditee request assistance, bear in mind these things. First, the auditee not obligated to follow your recommendations. Even if you offer detailed instructions, they can still find their own solutions. The important thing is to have effective corrective actions. Secondly, The more input you have in the solution, the greater chance you will have of "owning" the corrective action. Should the corrective action be ineffective, for whatever reason, you undoubtedly be blamed. Verifying the corrective action Verifying the corrective action may take several different forms. Which method(s) used will be based on the severity of the nonconformance, your relationship with the auditee and the resources available. The selected method should be part of the corrective action plan. The auditee must know up front which method of verification will be used, and why it was selected. The timetable for the corrective action verification needs to part of the action plan as well. As with any plan, you need the flexibility to amend the plan should the circumstances warrant it. The three most common methods of follow-up activities are:
Reviewing submitted evidence In some instances, the manager of the audited area may provide you with evidence, which you can review for completeness and adequacy. If the corrective action is accomplished within the planned timeline, and the evidence indicates the corrective action works, then the corrective action can be closed. This works only for minor nonconformances, or where the performance meets requirements, but the documentation may not match the performance. This method of corrective action verification does not require much of the auditor's time. It tends to work well in smaller organizations. Scheduling a follow-up audit If the nonconformance was a major, or if the corrective action was complicated, a follow-up audit may be warranted. In this case, the auditor will schedule a audit of the corrective action a couple months after the corrective action has been implemented. The audit will typically consist of only the corrective action(s). Verification during the next internal audit One of the most simple verification follow-up activities is to add details of the nonconformance to the checklist for the next audit. In some organizations the follow-up is conducted during the very next audit, even if that particular activity was not scheduled to be audited. An alternative would be to wait until the next time that activity is audited. Be very careful here. If the nonconformance was substantial, you will not want to wait very long for verification! Some organizations prefer to leave the corrective action open until the audit is complete. Others close the corrective action when it is reported, and placed on the audit schedule. If you are using this method, you need to have some safeguards built in to prevent incomplete corrective actions from dragging on. This is normally accomplished by having the auditee submit evidence, as suggested above. Summary: The object is to have effective corrective actions. As auditors we cannot allow ourselves to fall into the trap of believing that once the nonconformance is written, our job is over. Our job is never over. Only after the auditor is satisfied that the corrective action has met the requirements and is effectively implemented, will the corrective action be closed. After closure, the auditor should update all records showing the closed corrective action, and make any necessary adjustments to the schedule. Make sure you report the corrective action effectiveness as required. As always...Good Auditing! |
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Question and Answers: Q – During our last surveillance audit our auditor wrote us up for not having the latest edition PPAP and FMEA manuals. I was wondering how do we know when they change these editions. Have you any prior experience with this occurrence. Is there someone that would keep us updated? A – All documents get revised from time to time. Some, such as ISO standards, get changed with a lot of noise. Others, such as the PPAP manual change quietly with no apparent notification. Unfortunately it is your responsibility to make sure you have the correct version. The best way to make sure you have the most current revision is to check them yourselves. Most documents will have a web address, or phone number so you can contact them to order updated copies. Visit their site, or call the number. There may also be some subscription services that can you updated when certain standards and supporting documents get changed. I do not know of any off hand, but will post any I find. |
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Tips/Tricks/Laughter Managers seem to be always in a crisis mode. Even the most organized manager can easily forget, or put off corrective actions. To help keep them focused and increase their response, here is a tip. First, convince executive management to include corrective action responses in their objectives. This should not be a "within three days" requirements, but geared for effective corrective actions. You can also arrange meetings (something managers despise) periodically to discuss the corrective action status [be careful here]. Other possibilities could be contests, or points for response rates. Managers can trade the points in for prizes. |
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Element Understanding: ISO-9001:2000 Clause 8.2.2 Internal Audit " Follow-up activities shall include the verification of the actions taken and the reporting of verification results (see 8.5.2)" 9K2K refers to "follow-up activities", not follow-up audits. Although follow-up audits are a good method of determining effectiveness, they are not the only way. As we mentioned in the feature article, there are several different activities that can yield the results. Also make sure the results are appropriately reported. The "(see 8.5.2)" suggests the writers expect you to follow your Corrective Action procedure in internal audit corrective actions. Most registrars will be looking for the tie-in. |
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Monthly Scenario Explained: May
2001’s question: You are auditing Corrective actions and are examining your Corrective Action Requests (CARs). Of the ten you are examining, there are two that catch your eye. Both are based on customer complaints. Both deal with late shipments. The first CAR shows a root cause as the customer is late paying the bill. The Quality Manager explains that every CAR from this customer is due to late shipments. The shipments are late because the product is in "credit hold". When the customer pays the bill, the product is then shipped. The second CAR deals with a customer that continually changes the shipping date, even when he is told it could not be shipped any sooner than originally agreed on. The root cause is listed as "customer changing ship dates without agreement". The Quality Manager states the customers don't like the completed CARs, but they accept them. The
answer: Credit holds are a political nightmare. An organization cannot win when they refuse to ship until the bill is paid. They also cannot win if they ship and never get paid. Customers who change ship dates without agreement cause the same type of political problems. From an auditing standpoint, I would expect to see some dialog with the customer in an effort to resolve the problems. Just completing the CARs is not enough. If the Quality Manager can show some evidence where the organization is actually trying to resolve the differences with the customers, then I would be inclined to call this conforming. Without evidence, a nonconformance would be generated. |
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The Back Page:
I do love my job! But sometimes I get too full of myself, and invariably, someone comes along and gladly knocks me into place. It may be a student, it may be Ruth Ellen, it may be a client. As auditors, we need to continually take stock of ourselves and ensure we aren't becoming too self-important. We have important tasks and often we are the QMS "experts". When we try to be too "expert", we open ourselves up for a dish of humble pie. My grandfather used to say; "The only reason cut you down is to bring you down to their level." I've found out that sometimes we need someone to cut us down to bring us down to the level we should be! How we respond to these events are important. It is also important for us to respond appropriately when others get knocked down. Having a number of nonconformances in an internal audit can be a humbling experience. There are times when we think to ourselves that the manager had it coming. Even if that were true, we should not gloat, or rub it in. Our response needs to be one of consolation, and support. Take the necessary steps to ensure the manager's corrective actions are exemplary. This will give the manager evidence that you are not out the get them, and your only goal is to have an effective system. It could very well turn the audit into a win-win situation. Dave ...Good auditing!
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Because this site uses information from many different sources, it must be pointed out that any advice, tips, information, etc., provided should be regarded as opinion and not fact! What works well for one company may be a disaster for another. Also, what one registrar, or auditor may allow, another may not. As always, reflect on what you read, see if it fits into your own quality system, and if it conflicts with your auditor...you've got to make a decision |
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