What are Considered “Work Operations” under FDA’s CAPA Rules?

Q: 21 CFR Part 820.100(1) says we should establish and maintain CAPA procedures with requirements for “analyzing processes, work operations…”

Does “work operations” mean operations of processes? Should we determine criteria and methods to ensure that our “work operations” are effective? And should we monitor, measure, and analyze these processes, then take CAPA actions as necessary?

A: In general, work operations are all those things you monitor in a production process to ensure the product is being made correctly. They also include the controls you monitor to make sure the process stays in a controlled state.

Work operations are all those things you monitor in a production process to ensure the product is being made correctly.

More specifically, the concept of “work operations” can cover a variety of activities. It can mean monitoring the work itself to ensure there are no mix-ups of parts on the production line or between production lines.

It can mean monitoring people-dependent processes to ensure that — from person-to-person and shift-to-shift — the product is being made the same.

It can mean monitoring a validated process to ensure it remains in its validated state and is not used outside of the validated process parameters.

It can mean monitoring the work environment for cleanliness as well as ensuring equipment is properly maintained and calibrated.

These are just a few examples.

So yes, you definitely should use all these activities to feed information to your CAPA system and track and trend this data. Then you have the foundation for taking timely and effective corrective and preventive actions.

Answered by Denise Dion, Vice President of Regulatory and Quality Services for EduQuest, who served 18 years at the U.S. FDA as an expert field investigator and who was co-editor of FDA’s Investigations Operations Manual, which is updated annually as a resource for FDA’s own investigators. Denise is the lead instructor for EduQuest’s 1.5-day training class, The CAPA Compliance Clinic: FDA Rules for Effective CAPA Systems, Failure Investigations, and Complaint Management.

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