Seeking Resources on Minor Quality Events/Deviations

Hello FDC Division!

I am currently working on the QMS for our small biotech company. I am looking to iron out our Quality Event Reporting procedures for our Manufacturing techs to follow. As we are in a transitional phase between a paper-based and an electronic system, our biggest issue currently are minor GDP errors; like those made in logbooks, or data entry for cleaning agents used etc.

I am looking for guidance/resources on these minor errors/events and how best to handle them in a compliant manner, without requiring my Manufacturing staff to open full blown Deviation reports with subsequent investigations. Specifically if anyone has advice on delineating them from true Deviations.

Thank you for your help! If what I'm trying to find isn't clear, I'm happy to clarify. 😊

6 Replies
Jason Zuch
1 Posts
Has your organization discussed the concept of "pre-defined" Incidents (less than Deviation investigations) to address the GDP errors? I'm located in a pharmaceutical manufacturing facility where we created a procedure which included a process diagram which outlined a process which factored in timeliness of discovery/identification of error, whether it's considered raw data, & whether it's also referenceable in any way (including video reviews). Once a documentation error was determined to meet the criteria which requires an incident investigation the output of the process yields a one page standardized form which includes the referenceable source as an attachment.

Building on what Jason said there are really three buckets when you think of deviations

  1. Predefined events, including corrective maintenance and documentation errors
  2. Minor deviations - track and trend
  3. Major deviations - investigate

Predefined events definitely require a rigorous training program to make work. And without quality on the floor will lead to some big failures.

You'll probably end up with a set of flow charts to help operators navigate these rules, such as this one for documentation errors

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No, we have not discussed this in particular, but have alluded to something similar during interdepartmental meetings. I think what you are describing is exactly what I'm looking for. If you have any resources or regulatory references about this, I would be very appreciative!

This is exactly what I was looking for, and gives me a lot to think about! Do you have any further advice on how to start establishing Predefined Incidents? Did this flowchart come from a paper I could access?

Lauren, I can't think of any specific articles, white papers that go deep on this. Its always a surface approach from what I recollect.

This flow chart is from an implementation I did. I think each site will end up with a different version, based on maturity, types of activities, etc..