What MUST be signed and dated? FDA QSR requires signatures for specific sections

Hello Don and Marc,

I have been working with the production people (only 3) for the last two weeks and to be honest I almost got a heart attack. Why? Because there are too many signatures and dates on the batch record, which do not make any sense. The same operator records, signs and dates each step on the batch record
(15 steps per page).In order to reduce the number of signatures, dates and make life easier for the poor operator I would like to have the following text on the end of each page or the last page: Step 1 to 15 has been performed on the same day by: _ _ _ (sign) Date: _ _ _ and step 2,3, 10 has been verified by: _ _ _ (sign) Date: _ _ _

Any comments on how to make life easy?

[Don Winton]

Ouch! Overkill, way too much overkill, even for the FDA.

First, I have made some assumptions which may or may not be correct. If not, please advise.

The QSR only requires signatures for specific sections. From your description, this might fall under §820.70, Production and Process Control, which does not require a signature or date at all. Since §820.70 does not, what about 820.80(c)? Not there either. How about §820.80(d). There it is: §820.80(d)(3) requires a signature and date as well as 820.80(d)(4). It should be noted that §820.184, Device History Record, does not require signatures, only dates.

Seriously, under the assumption that the activity falls under the purview of 820.80(d), then

I would like to have the following text on the end of each page or the last page:…

Not a problem.

Any comments on how to make life easy?

A lot, but try this one. It would do well to remember probability laws when considering quality records and their generation. As the opportunities for noncompliance increase, the probability a noncompliance will be generated increases exponentially. If there is a 1% chance a noncompliant record will be generated and 15 records are, then the probability a noncompliant record IS generated is 14%. Paraphrasing Marc, what is in compliance and is appropriate applies here. You decide appropriate, the QSR decides compliance.

Hope this helps.

Regards,
Don

Don,

This activity falls under §820.70. It is not easy to persuade people to do things in another way if they have been doing the same activity for many years. At the same time they tell me that they are fed-up with all the paperwork. I think that is quite oddish,
Well it feels good to have an opinion that comes from an external sourse

[Don Winton]

Monica,

It is not easy to persuade people to do things in another way if they have been doing the same activity for many years.

Yea, tell me about it. Changing culture is probably one of the hardest things about this field. But, properly designed, they should adapt quickly. I have found that once a better way is demonstrated, most will accept it. Maybe, maybe not. Perhaps re-education is in order.

At the same time they tell me that they are fed-up with all the paperwork

What I have found is that some (not all) think the more detailed the records, the better the compliance mechanism. Nothing could be further from the truth. Just because the FDA is a government agency, some think EVERY organization must function the same (read complicated). I saw a so-called "cGMP compliance manual" the other day that was over 1000 pages long. What a waste. If I ever do one, it would probably be less than 250.

Well it feels good to have an opinion that comes from an external sourse

Thanks. We aim to be helpful. Anything else, feel free to ask.

Regards,
Don