Audit Finding For Not Retaining Test Results

Jimel

Registered
#1
Currently we have 2 options for customers, 1)they can pay for test results, which we provide and also we will save the results electronically....results are retrievable 2)customer doesn't want test results and therefore we also don't save the results electronically nor from a paper perspective. We do stamp the unit with the Testers unique ID.
The customer issued a finding due to the fact we don't save a test record in option 2 above and cited: On Clause 8.6, a) the evidence of conformity criteria. The organization shall retain the documented information.

I believe the customer maybe right. Is it possible that at stamp unit can pass as "documented information"?
 
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ScottK

Not out of the crisis
Staff member
Super Moderator
#3
Depends on what you're calling a "test".
If it's a simple go/no-go then I can see where one may not record the results, especially if it's high volume.
If I was asked for results traceable to each part, I would ask a customer to pay extra for that cert.

But, as we're in the world of ISO9001, it really comes down to risk...what's the risk of not recording the results for that particular test?
 

Tagin

Trusted Information Resource
#4
I believe the customer maybe right. Is it possible that at stamp unit can pass as "documented information"?
I don't think the stamp would qualify as documented information, since it is on the unit and so is not retained by your org. The question really comes down to this:
  • What does your current ISO documentation say as to how you meet 8.6a, and are you doing what your ISO documentation says?
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#6
Not keeping test data? Wait until the product is involved in a product liability case and your organization can not prove (with data), in court, that the device tested acceptably in accordance with the declared specification. An audit finding is nothing compared to significant amount of monies the organization will have to spend to defend itself and, possibly, pay in restitution.

Risk. Better think.
 

Al Rosen

Holed-up in a Hotel in South Florida
Staff member
Super Moderator
#8
This says it all
ISO9001 said:
8.6 Release of Products and Services
The organization shall implement planned arrangements, at appropriate stages, to verify that the product and service requirements have been met.
The release of products and services to the customer shall not proceed until the planned arrangements have been satisfactorily completed, unless otherwise approved by a relevant authority and, as applicable, by the customer.
The organization shall retain documented information on the release of products and services. The documented information shall include:
a. evidence of conformity with the acceptance criteria;

b. traceability to the person(s) authorizing the release
 
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