'Retained Quality Samples' from each manufacturing batch - Thoughts on this please

Q

Quality Priest

#1
Hello all Second Post already :bigwave:

I just wondering what your thoughts are on a little dilemma I have.

I have inherited a quality system where 'Retained Quality Samples' are taken from each manufacturing batch for each product we produce. approx 5 products per day.

Whilst I cannot find anything to support the need for this amount of Retained Samples, I understand the rational behind having these samples as 'back-up' incase of problems at a later stage.

These samples now date back 3 years and there has been no cause to re-visit them.

Should I just knock the samples on the head :bonk: and take none?
What are your thoughts

Thanks
 
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Sidney Vianna

Post Responsibly
Staff member
Admin
#2
Re: Thoughts on this one please

Since you work in a highly regulated sector - Medical Devices - make sure you don't have any regulatory and statutory nor a customer requirement mandating the maintaining of such samples. Also, keep in mind that, from a risk management perspective, such samples could be very useful in case of a legal dispute, in the future.
 
C

Craig H.

#3
Re: Thoughts on this one please

Hello all Second Post already :bigwave:

I just wondering what your thoughts are on a little dilemma I have.

I have inherited a quality system where 'Retained Quality Samples' are taken from each manufacturing batch for each product we produce. approx 5 products per day.

Whilst I cannot find anything to support the need for this amount of Retained Samples, I understand the rational behind having these samples as 'back-up' incase of problems at a later stage.

These samples now date back 3 years and there has been no cause to re-visit them.

Should I just knock the samples on the head :bonk: and take none?
What are your thoughts

Thanks
We do the same thing. They come in real handy. Some customers, it seems, when they have problems, will "spam" all of their suppliers with the blame, hoping that someone will "fess up". The retained samples help us to eliminate (or, very rarely, not) us as the cause. We can then use our tech service folks to figure out what is going on in the process, if the customer will let us.

I don't know what you do with your samples, but if someone came to me to try to take our samples, the battle I would put up would be a fierce, take no prisoners mess.

That's just my take, though.
 
J

JohnM

#4
Re: 'Retained Quality Samples' from each manufacturing batch - Thoughts on this pleas

Good points, but I would also consider the cost of the samples, the cost of storing them, and the length of storage. To be useful, they have to be kept in pristine condition.

Why 5 and what are the lot sizes?

If you can document a history of their usefulness, then keep them.
There is a cost/benefit analysis to be done and if they have never been used, then the benefit is zero.

Don't be hasty to toss them, though. Maybe consider scaling down to 1 or 2 for a while.
 

Jim Wynne

Staff member
Admin
#5
Re: 'Retained Quality Samples' from each manufacturing batch - Thoughts on this pleas

There is a cost/benefit analysis to be done and if they have never been used, then the benefit is zero.
May we assume then that you also recommend against car (and life, and home) insurance if there have never been any claims? :cool:
 
J

JohnM

#6
Re: 'Retained Quality Samples' from each manufacturing batch - Thoughts on this pleas

Jim,

Actually, yes. I do recommend taking cost versus benefit into account in all decisions.

When my son was born we did not buy life insurance for him.

When my old Mazda depreciated to a Blue Book value of $1,000 and I had a $500 deductible, I saved $500 by dropping collision.

I don't agree with running wild with unsubstantiated, costly measures.

John
 
F

fireonce

#7
Re: 'Retained Quality Samples' from each manufacturing batch - Thoughts on this pleas

I suggest you reduce the quantity of sample per batch and storing time,for example the samples over 2 years may be tossed.
 
J

jgossett

#8
Re: 'Retained Quality Samples' from each manufacturing batch - Thoughts on this pleas

Just another angle that I didn't see.

You didn't mention what you manufacture or if it has a shelf life. If it is applicable you should dispose them as they expire, thus limiting the area needed for storage. However, that leads to another record for traceability of products manufactured.

We too use our retention samples as the first step in a complaint investigation as well as part of our risk management plan.

Good luck with your decision.
 
Q

Quality Priest

#9
Re: 'Retained Quality Samples' from each manufacturing batch - Thoughts on this pleas

Thanks for the input - its nice to get a non production based opinion - 'It will be faster and cheaper !!':notme:
I appreciate the 'Insurance' Aspects
Storage and disposable after shelf life are not an issue in this case as all the components are small procedural based items.

As we have no customer or regulatory requirements for these samples I think limiting the number of samples we take to the first manufacturing batch from a new raw material batch may suffice, at least this way I do have a safety net

So thanks for you input again
:thanks:
 
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