What is the Minimum Regulatory Requirement for Record Retention of DHR by Suppliers

C

CharlieB

#1
#1
What is the minimum regulatory requirement for record retention for records generated/ maintained by Suppliers that we source some of our product’s components from?
 
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GStough

GStough

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#2
#2
Re: *** Record Retention of DHR by Suppliers ***

CharlieB said:
What is the minimum regulatory requirement for record retention for records generated/ maintained by Suppliers that we source some of our product’s components from?
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What is the life of your product? Usually, the record retention period is tied to the life or service of the product, and then add a couple years to that.

I suppose I should ask first, what kind of product does your company make? My comment above is strictly regarding medical devices.
 
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Marc

Marc

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#3
#3
Re: What is the Minimum Regulatory Requirement for Record Retention of DHR by Supplie

Just to be clear, what is DHR?
 
GStough

GStough

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#4
#4
Re: What is the Minimum Regulatory Requirement for Record Retention of DHR by Supplie

Marc said:
Just to be clear, what is DHR?
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In the medical device world, a DHR is a Device History Record. It is usually a compilation of records of manufacture, inspection, testing, etc. and is very helpful when investigating customer complaints or other issues that need to be resolved. An FDA inspector can also ask to see a DHR as part of a facility inspection. Similarly, a third party auditor may ask to see one as part of an ISO registration or surveillance audit. Also, an internal auditor may review DHRs as part of internal audits of the manufacturing processes.
 
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Marc

Marc

Fully vaccinated are you?
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#5
#5
Re: What is the Minimum Regulatory Requirement for Record Retention of DHR by Supplie

Just making sure we're all on the same page here. You know what acronyms can do when misinterpreted.
 
C

CharlieB

#6
#6
Re: What is the Minimum Regulatory Requirement for Record Retention of DHR by Supplie

So correct, DHR is 'Device History Record' - this being all manufacturing records associated with a device amongst others.
 
C

CharlieB

#7
#7
Re: *** Record Retention of DHR by Suppliers ***

GStough said:
What is the life of your product? Usually, the record retention period is tied to the life or service of the product, and then add a couple years to that.

I suppose I should ask first, what kind of product does your company make? My comment above is strictly regarding medical devices.
Click to expand...
Our problem is that we don't have definitive lifespan of product for all existing product. We manufacture humidifiers for hospital ICU as well as CPAP application devices for home market.
 
GStough

GStough

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#8
#8
Re: What is the Minimum Regulatory Requirement for Record Retention of DHR by Supplie

CharlieB said:
So correct, DHR is 'Device History Record' - this being all manufacturing records associated with a device amongst others.
Click to expand...
Yes. Also to consider is which international, federal/national and/or regional requirements may apply. These additional regulations or standards may have more specific record retention requirements, not to mention any Customs regulations that may need to be complied with.
 
C

CharlieB

#9
#9
Re: What is the Minimum Regulatory Requirement for Record Retention of DHR by Supplie

GStough said:
Yes. Also to consider is which international, federal/national and/or regional requirements may apply. These additional regulations or standards may have more specific record retention requirements, not to mention any Customs regulations that may need to be complied with.
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Our major markets are US, Europe and Japan so the regulatory requirements of these places apply. Remember, I'm specifically after the retention period of SUPPLIER'S component manufacturing records which may be different from the retention period for the manufacturing records required by a FINISHED DEVICE MANUFACTURER.

Cheers :)
 
jkuil

jkuil

Quite Involved in Discussions
#10
#10
Re: What is the Minimum Regulatory Requirement for Record Retention of DHR by Supplie

You should define the life time of your product in order to define the retention time of your records.

If the quality of the supplied items can be assured by records obtained at incomming inspection (inspection test results, supplier CoC / CoA) and spported by supplier qualification data you are at less risk with not having supplier DMRs available. These records should therefore also be retained for the lifetime of your product.

If not, you must request your supplier to retain their DMRs according to your own retention schedule.
 
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