Record retention ideas for a sheet metal job shop supplying to a medical device mfg.

CarolX

Super Moderator
Super Moderator
#1
We were just audited by one of our customers who is a medical device manufacturer. They have a specific record retention requirement. Basically – they require all their suppliers to keep records until notified by them that they can dispose.

I really don’t know how we are going to handle this – it is so outside the norm for us –

Has anyone else faced this issue? I am tempted to set-up a process to send all our records to the customer each time I send in parts.

We are a sheet metal job shop –

Any help would be appreciated.
 
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Jim Wynne

Staff member
Admin
#2
Re: Record retention ideas for a sheet metal job shop supplying to a medical device m

We were just audited by one of our customers who is a medical device manufacturer. They have a specific record retention requirement. Basically – they require all their suppliers to keep records until notified by them that they can dispose.

I really don’t know how we are going to handle this – it is so outside the norm for us –

Has anyone else faced this issue? I am tempted to set-up a process to send all our records to the customer each time I send in parts.

We are a sheet metal job shop –

Any help would be appreciated.
Is this a new requirement, for a new customer, or was the requirement made clear when the work was accepted? If the former is true, then it's a matter of negotiation at this point, and I would have a hard time accepting the idea of keeping records indefinitely. If it's an existing requirement that just hasn't been observed until the auditor arrived, it's probably too late for negotiating, but you still might be able to get the customer to give you a specific time period. I don't think that sending the records to the customer will be very well received in any case. If your company agreed to keeping records indefinitely, and you can't convince them otherwise, you either have to do it or get rid of the customer.
 

ScottK

Not out of the crisis
Staff member
Super Moderator
#3
Re: Record retention ideas for a sheet metal job shop supplying to a medical device m

I was going to say just abot what Jim said.
If it's a special requirement that conflicts with your record control procedure then it should have been brought up in the contract. If it was known and not brought to the attention of the right people then I smell a breakdown in communication.

What's the volume of the records like? For the paper ones can you just scan them into pdfs and stash them in a secure directory for all eternity?

This isn't the customer we have in common, is it?
 

CarolX

Super Moderator
Super Moderator
#4
Re: Record retention ideas for a sheet metal job shop supplying to a medical device m

What's the volume of the records like? For the paper ones can you just scan them into pdfs and stash them in a secure directory for all eternity?
I am thinking that is the way we will have to go with this. It is a lot - when you include all divisions.

This isn't the customer we have in common, is it?
It is the parent company - and we didn't have much choice about doing business with the parent company - if we would have refused - they would have pulled all the business.
 

lindal

Involved In Discussions
#5
Re: Record retention ideas for a sheet metal job shop supplying to a medical device m

We were just audited by one of our customers who is a medical device manufacturer. They have a specific record retention requirement. Basically – they require all their suppliers to keep records until notified by them that they can dispose.

I really don’t know how we are going to handle this – it is so outside the norm for us –

Has anyone else faced this issue? I am tempted to set-up a process to send all our records to the customer each time I send in parts.

We are a sheet metal job shop –

Any help would be appreciated.
If you can get them to negotiate, I would suggest that you offer to provide them the original records in question as they are slated for destruction by your retention policy. That is what most of our suppliers do when their retention period expires.

It takes a lot of the burden off you and provides the customer the information they apprently require.

Hope that is possible in your case.
Linda
 

ScottK

Not out of the crisis
Staff member
Super Moderator
#6
Re: Record retention ideas for a sheet metal job shop supplying to a medical device m

It is the parent company - and we didn't have much choice about doing business with the parent company - if we would have refused - they would have pulled all the business.
I'm heading over to engineering and sales now to see if we have that requirement... I've never seen it as such.
And we had a couple of guys from Madison here last week - not for an audit though... doing capability studies on a new part.
 
P

Phil Fields

#7
Re: Record retention ideas for a sheet metal job shop supplying to a medical device m

It sounds like the customer may have a misinterpretation of Control of Records ref. 21 CFR Part 820 820.180 (b).
"All records required by this part shall be retained for a period of time equivalent to the design and expected life of the device, but in no case less than two years from the date of release for the commercial distribution by the manufacturer."
I would think the Purchasing Controls at the customer site would be sufficient for their record retention. They may have an audit nonconformance which is driving the request.

Phil
 
F

fireonce

#8
Re: Record retention ideas for a sheet metal job shop supplying to a medical device m

The requirement of your customer is going a little too far.In medical device field,your customer's requirement is in more detail than GMP or ISO13485.
But you have to do this unless you can persuade them.
 

CarolX

Super Moderator
Super Moderator
#9
Re: Record retention ideas for a sheet metal job shop supplying to a medical device m

It sounds like the customer may have a misinterpretation of Control of Records ref. 21 CFR Part 820 820.180 (b).
"All records required by this part shall be retained for a period of time equivalent to the design and expected life of the device, but in no case less than two years from the date of release for the commercial distribution by the manufacturer."
I would think the Purchasing Controls at the customer site would be sufficient for their record retention. They may have an audit nonconformance which is driving the request.

Phil
Phil,

Thanks for the input - I thought this sounded a little excessive. I just recevied the formal audit report and it is listed as one of the findings.
 
P

Phil Fields

#10
Re: Record retention ideas for a sheet metal job shop supplying to a medical device m

I am glad I could help. I hope this helps in resolving the issue.

Phil
 
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