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Addressing training requirements - 21 CFR Part 820.25 (1) & (2)


Quite Involved in Discussions
Per the 21 CFR 820 regulation:

Sec. 820.25 Personnel.
(a) General. Each manufacturer shall have sufficient personnel with the necessary education, background, training, and experience to assure that all activities required by this part are correctly performed.

(b) Training. Each manufacturer shall establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities. Training shall be documented.

(1) As part of their training, personnel shall be made aware of device defects which may occur from the improper performance of their specific jobs.

(2) Personnel who perform verification and validation activities shall be made aware of defects and errors that may be encountered as part of their job functions.

Just trying to get straight in my mind what the actual requirements of (1) and (2) are.

For (1), when I first read this I was thinking of providing personnel with feedback of nonconforming product / material findings. However upon re-reading this, it seems to have more of a proactive stance such that personnel are informed that if you do or don't do this then this nonconformity will happen.

For (2), I was thinking the same way as (1) -- sharing nonconformance data with those personal performing V & V. Upon re-reading, (2) sounds like a restatement of (1), only specifically applied to those performing verification and validation activities. I'm assuming the "verification and validation activities" referenced applies to actual manufacturing and not the design verification and validation activities.

If anybody could share their views on these two requirements, what they did to address them, and/or point to any other good information on the web it would be appreciated.


John Broomfield

Staff member
Super Moderator
No need to address minor product nonconformities unless your plan requires it.

Defects are product nonconformities serious enough to adversely affect the performance of the product. By now you may have mistake-proofed your production processes so defects are a distant memory. But informing employees what could go wrong should they attempt to defeat any mistake proofing is wise.

Inspectors and testers (even as makers and assemblers) need to know what they are looking for when verifying the product on the production line and before packaging the product and any information. Then the packaging itself of course.

Inspectors and testers may make errors when verifying the product and its packaging; they need to be aware of the common errors in sampling, calibrating, verifying, recording and invoking timely corrections.

Then ask yourself why these common errors still exist.


Quite Involved in Discussions

I agree with what you wrote however this FDA clause deals with training. During a customer audit last week, a finding was issued because I don't have a training plan in place to address 1) & 2) above. I'm looking for input as to how others have addressed this in their training process.

John Predmore

Quite Involved in Discussions
I work in aerospace not medical device industry, but I can tell you how we train on defects and errors. The quality standard allows that training can take different forms ; it doesn't have to involve sitting in a classroom with powerpoint slides. These activities could be listed as part of a comprehensive training procedure.

1. We have a daily stand-up meeting where production personnel are informed right away of process changes and latest customer or inspector feedback. We keep minutes which serves as a record.

2. We post pictures or physical samples of defects on a Quality Alert form at the workstation. There is a space for affected employees to sign on form they were "notified" and allowed to ask questions to satisfy their questions. We scan and keep a PDF of the form with signatures as a record.

3. We post a Visual Standard with annotated pictures at the inspection workstation with features or dimensions commonly seen as defects.

4 When we make a Production Change there is form where Quality and Mfg Managers review and decide if training on a proposed change is required. If so, we have both a Group training form and an Individual Training form to create a record. Sometimes training is a 5 minute conversation at the work station.

5. We have a quarterly Town Meeting to review status of the QMS. We held one this week. It was another opportunity to reinforce the need for adherence to procedure, product safety, and ethical behavior.

6. If there is a problem or a recognized need, we use an 8-D form for Improvement Projects or Corrective Actions. One corrective action always considered is the need for training. The lessons learned step encourages preventative thinking and to check other areas for proactive action.
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