13485cert

To cats from dogs–Thank you:-)

In ISO 13485, Quality Management Systems on February 29, 2012 at 2:57 am

I’m going on a new kind of journey, and this song just seemed to fit my mood.

Today was my last day as an external resource for BSI and tomorrow will be my last day as an independent consultant. On March 1st, I begin a new job as Sr. Regulatory Affairs Manager for Delcath Systems, Inc. in Queensbury, NY. I am grateful to everyone that I had the pleasure of meeting during the past two-and-half years as a 3rd party auditor, instructor and consultant. I have learned so much from you all. Your parting wishes were very kind and supportive. I sent out emails to as many of you as I could to notify you of this change. Instead of brief acknowledgement and “Good Luck!”, I received genuine words of thanks and compliments that made me feel very lucky that we have had such an unusual relationship for an auditor and auditee—very much like cats and dogs that learn to live together in the same house.

One of you described the typical relationship with an auditor quite well, “Having an auditor come to your place is always a somehow stressful time. You are always afraid of failing somewhere.” This same person sent me an email last night saying, “I feel like you are one of my friends.” Another auditee walked by me and another team member a few weeks ago while we were waiting for a ride. Instead of avoiding eye contact and walking right on by, he stopped and thanked us for really helping to bring attention to areas that need improvement. This same gentleman had endured a tough interview by me, where I pointed out mistakes in drawings, procedures and his own QC inspection of incoming raw materials. This person has the right attitude.

As an auditor we must come to a conclusion as to whether the evidence we collect demonstrates conformity or nonconformity. When we identify nonconformities, we must explain our conclusions. The toughest part of the job is how to “break the news.” If you do it well, the auditee will agree with you and thank you for helping to improve the quality system. If you do it poorly, the auditee will resent you and may even toss you on your ear.

In my first ever ISO certification audit, I was the auditee and the auditor that interrogated our team was horrible. Not only did the auditor “break the news” poorly, the conclusions were wrong in several instances. To make matters worse, the CEO and the regulatory consultant I had hired were so upset with our auditor that I had to play referee just to keep them from killing the auditor. We received a recommendation for ISO 13485 certification at end of that audit, but I learned a valuable lesson: “Always look at an audit as an opportunity to improve.” The worst that can happen is that the auditor will require you to implement a corrective action. The best that can happen is that you will need to perform internal audits to identify opportunities for corrective actions on your own. Who cares who finds the opportunities to improve?

Auditors and auditees may be cats and dogs, but we should learn to help each other get better without getting upset or feeling anxious.

My 3rd party auditing days may be done, but I will continue to share my thoughts through this blog and I hope you will share your feedback too.

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  1. I am sending my QA assistant to BSI training in June and was hoping you would be the instructor.

    My audit concluded today, and I felt it was a partnership on ways to improve, in part because I have a good auditor and because I attended one of your courses in the beginning of my quality career and you set me on the right path. I was looking forward to this audit when others in my organization were feeling sorry for me for having to go through it.

    Thanks for all your help!!

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