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Archive for the ‘Supplier Qualification’ Category

Risk Management – It’s Not My Job

In Contract Manufacturers, International Standard, ISO, ISO 14971, Medical Device, QA, QC, Quality, Quality Management Systems, Risk Analysis, Risk Management, Supplier Audit, Supplier Audits, Supplier Qualification, Supplier Quality on January 5, 2011 at 4:12 am

There’s no deeper meaning to this week’s YouTube selection. I just thought I would share one of my favorite guitar soloists with you. The recording quality is only good, but just watching Tim play reveals how freakishly good he is. I highly recommend the live CD with Dave Matthews and Tim Reynolds. If someone knows of a better quality recording that I can post in my blog, please let me know.

Have you experienced a discussion similar to this?

Auditor: “How do you manage risk throughout the production process?”

Auditee: “That is the responsibility of our customers. We will prepare a risk analysis if customers pay for it, but usually customers do the risk analysis.”

Most contract manufacturers in the medical device industry exclude design from their Quality Management Systems. Unfortunately, most of the contract manufacturers also associate risk management with only the design process. Risk Management cannot be “not applicable” in an ISO 13485 Quality Management System. The requirement of section 7.1 is: “The organization shall establish documented requirements for risk management throughout product realization. Records arising from risk management shall be maintained.” The Standard also references ISO 14971 as a source of guidance on Risk Management.

                For a contract manufacturer, compliance with ISO 14971 is not my primary concern as an auditor. My primary concern is to verify that contract manufacturers analyze risks associated with the processes that they perform and do their best to minimize those risks. What I don’t understand is why more companies don’t want to have strong risk management process. Risk management is how we prevent bad things from happening. Bad things like scrap, complaints and recalls. Should we expect our suppliers to have a strong risk management process?

                Duh.

                Contract manufacturers should be doing everything they can to get better at risk management. During pre-production planning they should be asking, “What happens if…” The contract manufacturer knows best HOW things will fail in production, while the customer knows best WHAT happens when things fail in production. In order to be safe and effective, both companies need to collaborate on risk analysis.

                The reason companies avoid doing risk analysis is because it’s time consuming and tedious.

                 Too bad, so sad.

                 Balancing my checkbook is time consuming and tedious too, but I balance my checkbook to prevent an overdraft charge. Not doing risk analysis can be much more painful. Scrapping out a part can cost tens or hundreds of dollars. Complaints can cost thousands of dollars. Recalls can cost millions of dollars.

                If I owned a contract manufacturing company, I would make sure that everyone in the company is involved in risk management, because we don’t want scrap, we can’t afford mistakes that lead to complaints, and a recall will put us out of business.

Supplier Evaluation – Take 5

In Forward to MDA, International Standard, ISO, Medical Device, Purchasing, QA, QC, Quality, Quality Management Systems, Supplier Audit, Supplier Audits, Supplier Qualification, Supplier Quality on January 3, 2011 at 9:47 pm

This blog has been moved to the following location and the name has been changed: http://bit.ly/SupplierEval-take5.

This blog website and the blogs within it are gradually being transferred over to my new website: http://www.MedicalDeviceAcademy.com. The titles may change, and there may be minor revisions to the content as the blogs are reviewed and edited. There will be a subscription list created for the new blog site. If you would like to be added to the list for the new blog site, please email me directly at: rob@13485cert.com.

Supplier Evaluation – Less is More

In Forward to MDA, International Standard, ISO, Medical Device, Purchasing, QA, QC, Quality, Quality Management Systems, Supplier Audit, Supplier Audits, Supplier Qualification, Supplier Quality on January 2, 2011 at 8:26 pm

This blog has been moved to the following location: http://bit.ly/Less-is-more.

This blog website and the blogs within it are gradually being transferred over to my new website: http://www.MedicalDeviceAcademy.com. The titles may change, and there may be minor revisions to the content as the blogs are reviewed and edited. There will be a subscription list created for the new blog site. If you would like to be added to the list for the new blog site, please email me directly at: rob@13485cert.com.

Elsmar Cove – Wikipedia for QA

In Elsmar Cove, International Standard, ISO, Medical Device, Purchasing, QA, QC, Quality, Quality Management Systems, Supplier Audit, Supplier Audits, Supplier Qualification, Supplier Quality on January 2, 2011 at 4:11 pm

While you are reading, here’s a seasonal favorite from one of my favorite singers (also from North Texas State) and a country singer that everyone will recognize.

After my last blog posting I planned to write a blog on supplier evaluation and re-evaluation. After a busy December, I finally have time to write again. Before I share my own ideas, I thought I would share a great resource with you: The Elsmar Cove Forum.

                Most of the people reading my blog are probably aware of a website called Elsmar Cove, but I think most people visit this site only when they need a quick answer to a question. It’s sort of like Wikipedia for Quality Assurance. Marc Smith is the creator of Elsmar Cove, http://elsmar.com/, and the forum just had its 15-year anniversary. This is a no frills website that has fantastic content and very little advertising. People from all over the world (~18,000 active participants) are contributing daily to this forum and many of the contributors are Quality and Regulatory experts. I like to use the site to keep up on best practices and trends in Quality. It also gives me an opportunity to learn from other types of Quality Systems such as: AS9100, TS16949, and ISO14001.

                Someone I used to work with had a saying he learned from his first boss: “A picture tells a thousand words, but a demonstration is better than a thousand pictures.” Therefore, I thought I would try to demonstrate the power of Elsmar Cove by researching best practices in supplier evaluation. Step 1: The first thing you do is visit the site. Step 2: Type “supplier evaluation” into the Google™ custom search. This will produce 100’s of links within the Elsmar Cove Forum related to supplier evaluation. Step 3: Skim the search results to find the entry or entries you are looking for. These search results include a supplier evaluation survey that you can download and adapt to your own company. If you need a quick solution, this is really fast and free.

                Another approach is to limit your search to Forum discussion threads. You can do this by going to the Forum Discussion page: http://elsmar.com/Forums/index.php. If you click on the tool bar link for “search” a pop-up window will appear. If you type “supplier evaluation” in this search bar, you will see 531 results presented in reverse chronological order. Below are a couple of threads that I thought were particularly good:

Benchmarking Supplier Certification Programs

http://elsmar.com/Forums/showthread.php?t=42595&highlight=supplier+evaluation

Service Supplier Rating where objective pass/fail data is not available

http://elsmar.com/Forums/showthread.php?t=44412&highlight=supplier+evaluation

Choosing Supplier Evaluation Methods – Determining what a Critical Supplier is

http://elsmar.com/Forums/showthread.php?t=10951&highlight=supplier+evaluation

Supplier Approval for Distributors of Equipment

http://elsmar.com/Forums/showthread.php?t=43508&highlight=supplier+evaluation

Second party audits – Supplier audits or product audits?

http://elsmar.com/Forums/showthread.php?t=30966&highlight=supplier+evaluation

How you do Receiving Inspection for Chemicals?

http://elsmar.com/Forums/showthread.php?t=44951&highlight=supplier+evaluation

Supplier Evaluation Responsibility

http://elsmar.com/Forums/showthread.php?t=43756&highlight=supplier+evaluation

                I hope you find Elsmar Cove to be a useful website, and my next blog will share a few ideas for supplier evaluation of my own.

How to Qualify a Supplier

In Consulting, Forward to MDA, International Standard, ISO, Medical Device, Purchasing, QA, QC, Quality, Quality Management Systems, Supplier Audit, Supplier Qualification, Supplier Quality on November 17, 2010 at 2:49 am

This blog has been moved to the following location, and the title has been changed: http://bit.ly/HowQualifyaSupplier.

This blog website and the blogs within it are gradually being transferred over to my new website: http://www.MedicalDeviceAcademy.com. The titles may change, and there may be minor revisions to the content as the blogs are reviewed and edited. There will be a subscription list created for the new blog site. If you would like to be added to the list for the new blog site, please email me directly at: rob@13485cert.com.

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