Length of Validity - Test Results

J

jbdominguez

#1
We produce Class I Exempt medical devices. We have tests for toxicity, flammability and lead that were completed 4-6 yrs ago. Raw materials have not changed. One customer is stating that we must perform these tests annually. Is this correct?
 
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Statistical Steven

Statistician
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#2
Two part answer.

Part I. Review your validation procedure to see how often you need to revalidate. Usually once every 3 years, but you set the revalidation schedule. Unless a specification changed or a process change, usually the revalidation effort is minimal.

Part II. What is the basis for their requiring annual recertification? If it is a RoHS requirement (especially for the lead), they should have specified in the purchase order or contract. There is no requirement that this testing is done annually (well none I know of).
 
J

JaxQC

#3
Mine’s also a two part answer. Sorry it’s a little long.

1) No there is not an “annual validation” requirement.
2) In fairness to the customer though they want proof that the same conditions/results are still present as when the testing was performed. The response given was “Raw materials have not changed.” Which leaves a lot of questions open.

  • How do you know?
  • Has the supplier been audited since 4-6 years ago?
  • Could they have made a change you don’t know about?
  • Do you collect CofC’s from them or just take their word?
  • Do you track their quality?
  • Is raw material the only variable?
  • Could production or another supplier have changed an item?
  • Are the testing standards (acceptable limits and testing methods) the same as 4-6 years ago?
  • Are the testing requirements the same as before? (toxicity, flammability, lead & now removability in addition). May want to check both non-soluble (particulate) & soluble residue (oils, cleaning residue) not to mention Bioburden or TOC depending.

What the Customer was wanting to hear…
Eg…No Mr. Customer we don’t do an annual validation. We have not changed the raw material supplier in 6 years and we perform a random audit of the material just to confirm they have not made changes every 2 years to their CofC, through a 3rd party, with no discrepancies found in the last 3 audits. We track when their 3rd party accreditation is expiring and collect their re-certification. Our procedures would require us to do additional confirmation testing on each lot if they had their certification expire or a supplier non-conformance ticket was issued.

The only other variable is a machining coolant which changed 3 years ago & we re-validated at that time for toxicity which passed and a process change notification was submitted to you. This is identified in our Process Agents List and MSDS are available.

The flammability & lead standards to which the testing was performed 6 years ago is still the most current which we confirm periodically.

Since removability is a larger item presently in the medical industry and was not addressed originally, our Master Validation Plan shows that testing to cover just this aspect is scheduled for next quarter which you are welcome to review as well.

It’s made up but hopefully it makes sense. The Customer really doesn’t care if it’s 365 days but does your company have a SYSTEM in place to insure that the possible variable (pFMEA items) are addressed and covered. If not, he want annual verification to protect himself.

Hope it helps and good luck.
 
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