Mar 30, 2008

Quality System Auditing

I got tasked with heading up a quality system audit before an ISO audit scheduled to happen later this month. We also have an upcoming State of California visit due to our facility move. This audit we're doing now is actually the first quality audit our company has done not performed by quality personnel- unless you count previous state audits. I think I need to learn how to be grumpier about non-engineering work, my "somewhere in the world there is a medical device company where engineers are doing product development work and we're competing with them" line isn't working. Anyway, we had a meeting, divvied up the areas for each person to audit and we're reporting back this coming week to write up corrective actions as part of the CAPA portion of the quality system.

As a company we're relatively new at this so I know it is going to get contentious with some blame games being played, but hopefully I can head that off by not putting up with it. We are at point A and need to get point B, we need to move forward, going back doesn't get the problems fixed. If management wants to examine the problems more deeply, that is entirely up to them (and obviously management is part of the audit), but it doesn't gain anything for us to sit there and discuss what happened in the past for each item. The problems all distill down to the same two or three issues (I thought he was doing it, no one told me to do it, etc.) anyway, all of which are fixed by doing the audit and corrective actions.

For now we're just going through each SOP on a line by line basis and making sure we're doing what we're saying. Our quality system is a patchwork of procedures that mostly came from other companies that various quality consultants worked for at one point in time. A few years ago the system was traceable to the QSR, but that hasn't been checked lately and is something someone will have to go through in the future to make sure we didn't miss anything. Every item found that we're not doing generates a corrective action, no excuses are tolerated. The corrective actions are documented and clearly designate someone in charge and a time line. This ensures that problems get taken care of, instead of "Oh we were going to do that, but never got around to it." After that a re-audit is required. The quality system isn't rocket science, but some people seem to have a very hard time with it.

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