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Rob Packard
Ship & Print Your FDA eCopy
April 2018
Top 3 Ways to Simplify Your QMS
2 min reading time

Did you wait until the last minute to update your quality system procedures to the new ISO 13485:2016 standard?

My team is helping 3 companies with this problem. One company is very large, with thousands of employees and multiple sites. Another company is small and was recently acquired by a larger company, but their quality system has not yet been merged. The third company has less than 10 employees. Despite the differences, all 3 companies can simplify their quality systems using 3 strategies.

Strategy 1
Consolidate your procedures. 28 procedures are required in ISO 13485:2016 and 25 procedures are required in 21 CFR 820. However, 2 companies have more than 70 procedures and the largest has more than 500. You don’t need a corrective action procedure and a preventive action procedure, when a CAPA procedure will do. You also don’t need a nonconforming materials procedure and a rework procedure. Those 2 procedures can be combined. Design controls requires 3 procedures, but you could easily consolidate that into 1 or 2.

Strategy 2
Be and editor–not a writer. Every time a company receives a nonconformity or an FDA 483, the first approach is to add a reminder to a procedure. This seldom is effective. Better training and monitoring quality objectives are more effective. Therefore, delete the ineffective reminders and cut the procedure down to the minimum requirements so every procedure is as simple as it can be. Then implement quality objectives for tasks that are sometimes neglected. Your new lean procedures will be easier to remember too.

Strategy 3
Don’t duplicate procedure content in your quality manual. Your manual explains how you meet requirements of each subsection in the standard, but if you have a procedure that meets the requirement–just reference the procedure. This strategy cuts down 28 subsections to a short sentence for each (e.g., This requirement is met by SOP 8.5.2).

Top 3 Ways to Simplify Your QMS

source: https://www.linkedin.com/groups/2070960/2070960-6395273031622672388

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Posted by Rob Packard
Asked on April 26, 2018 8:00 am
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Mark Schnapf Rob brings up 3 great ways to minimize an ever growing QMS for most companies. Having worked at various companies small and large, I have watched QMS's grow expontentially it seems at times. The QMS should not grow unless new requirements are to be addressed. Or it was initially deficient. The QMS governs the internal processes that should grow and expand with a business. But unless new QMS requirements are expected, a companies QMS should continuously improve, not necessarily expand.
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Great advice!
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I agree with strategy 2 and strategy 3 but why does it matter how many procedures you have. I think you should have as many as you need. The key to simplification is having a good structure that makes it easy to find what you need to know.
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thank you !
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Olivier Zarza Great post, Rob! I am relieved to read that I was not the one following these strategies 😄
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Agreed!
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I'm building a quality system to a medical device company, are you in favor of NC,CAPA and SCAR in the same procedure or to separate them. what are the pros and cons to merge them?
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