Current Quality Blog » Corrective Action

Speak Up About Your Nonconformance and Corrective Action Issues!

Sandra Gauvin — Mon, 01 Nov 2010 16:49:26 +0000

Quality Assurance Training/Online Workshops Coming Soon
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Photo by Rasmus Thomsen @ Freedigitalphotos.net

I’m thinking about offering Quality Assurance training in the form of online workshops. Initially, I want to focus on nonconformance and corrective action, and would like to expand the workshops to include other topics.

If I decide to move forward, I’d like to consider some of the issues that you’re currently dealing with, specific to nonconformance and corrective action.

Now’s your time to speak up and share your pain in the form of a comment or you can contact me through the contact page.

If Your Corrective Action Isn’t Effective, Then You’ve Missed the Point!

Sandra Gauvin — Wed, 22 Jul 2009 18:28:29 +0000

Have you ever noticed that some of the discussions on Quality forums resemble a tennis match? Each participant will go back and forth debating a question from a theoretical point of view as opposed to a practical approach and never really answer the question? This can go on for days, even months. I’ve often thought this is why Quality sometimes gets a bad reputation, because in a manufacturing environment you don’t have all the time in the world to debate what approach Deming vs. Crosby would have taken.

I recently came across a debate regarding which root cause analysis tool is THE best when working on Corrective Actions. From an auditors perspective, the tool is irrelevant. What is relevant is the thoroughness of your investigation and the effectiveness of your corrective action (i.e. the nonconforming event was corrected and has not reoccurred since). That’s it, plain and simple!

Managing Your Suppliers

Sandra Gauvin — Fri, 06 Mar 2009 17:28:20 +0000

Just yesterday I went grocery shopping and on my list was a particular brand of energy bar that hasn’t been available since the peanut butter recall. Even though I’d been buying the same brand for several years and considered myself a loyal customer, I found myself buying a sampling of other brands to try out ….which really made me question how loyal I really was….odds are if I’m able to find an adequate substitute , I’ll probably stop looking for my ‘original’ favorite because I’ll have a ‘new’ favorite. It makes you wonder how many other customers feel the same way, creating a loss of revenue for the manufacturer that may take years for them to recoup…or even worse, they may never rebound and go out of business.

Let’s learn from the peanut butter recall and take a look at ways to better manage our suppliers….

Identify Secondary Suppliers - Always make sure that you’ve identified and qualified secondary suppliers….especially for raw materials or services critical to your business. This way if something happens to the primary supplier, your business will be uninterrupted.
Audit Your Suppliers – Periodically you should audit your suppliers to make sure they’re compliant and are in control of their processes. If you’re constantly dealing with issues regarding a particular critical supplier (e.g. you reject their raw materials, order delivery is late), then you should do a physical audit and not just a questionnaire audit. It could be a warning sign of a much larger issue….think of the peanut butter recall.
Follow-up On Outstanding Corrective Actions – Stay on top of your supplier corrective actions to make sure the issues are addressed on-time. Otherwise, your supplier will quickly realize that corrective actions for your company aren’t a priority and they’ll spend time on other companies that demand action.
Analyze Your Supplier’s Certificate of Analysis – Analyze the data on the certificate of Analysis for all in-coming raw materials….I’ve seen suppliers send material that was outside of their own (the supplier’s) specifications.
Communicate Status- If you experience a recall or any issue for that matter, it’s very important that you continually update your customers on the status….even if you don’t have any new information….otherwise you take the risk of losing your customers forever.

Ask yourself this question….How loyal would your customers be if you had to recall a product and you couldn’t tell them how long before you could begin production?….I think we know the answer.

Take care,
Sandra

NonConformance Report: 4 Key Things To Consider

Sandra Gauvin — Fri, 16 Jan 2009 17:42:07 +0000

Write A Good Problem Statement
I’ve learned over the years that writing a good problem statement in your NonConformance Report is probably the most important part of any investigation. If the problem isn’t stated clearly, then it becomes too easy to misinterpret the problem and lead the investigation in the wrong direction. A Good problem statement should tell someone ‘who, what, where, and when’….the ‘why’ will be addressed in the actual investigation.

Start Your Investigation Immediately
Every investigation has an assigned timeframe (specified in your Standard Operating Procedure) in which it must be completed….that means approved and closed out. So the day the NonConformance Report is initiated, the clock starts ticking. If you wait until you have very little time left before you begin, then you most likely won’t complete a through investigation and may find yourself revisiting the issue. Set up a timeline that will include milestones along the way so that you are working on the investigation little-by-little….before you know it your NonConformance Report will be completed and on-time!

Consider All Possibilities When Determining Root Cause
In your NonConformance Report, you want to make sure that you consider everything that may be contributing to the problem and rule each one out until you’ve gotten to the most likely root cause(s)….yes there can be more than one root cause. Sometimes our workload gets a bit crazy and it becomes too easy to quickly jump to a premature conclusion.

Verify That Your Corrective Action Was Effective
Give yourself enough time to evaluate whether or not the the problem has truly been corrected. For example, if the problem used to occur whenever you manufactured product X, then you would want to make sure you have at least three cycles of making product X after your corrective action has been implemented. If the problem hasn’t occurred during the three cycles, then you most likely got to the root cause.

Let me know what your experience has been with NonConformance Reports and if this post has been helpful.