Identification of Test Sample in Test Reports?

Jim Wynne

Staff member
Admin
#11
In many industries, the extra time and effort that would be required to lay out the rationale for the various tests and carefully explain the link between the results and the performance of the product under conditions of actual use (e.g., why it was a good thing that foam would come apart before the glue would fail) simply isn't worth it from a business perspective. The reasons why not vary with the business and the product, but if you have to do a lot of testing and invest this effort for every test, the value of the product itself, in terms of ROI on that investment in the form of profit, the cost will make the product unattractive as a business venture. On the whole, products with medical application offer a higher ROI than many other products, and therefore are more likely to be worth this investment.
I've questioned on occasion the relationship between test requirements and end-use performance, but in general there's a fairly large body of knowledge and experience that's drawn upon in selecting appropriate testing. It's not as if unique and innovative testing must be devised for each new product. I did encounter (in the same job as lab manager as in the earlier example I gave) a situation where the customer (GM) specified testing that was inappropriate, which wound up being a very costly error--both to them and the company I worked for. The product survived testing in accordance with the pass/fail criteria we were given, but the test specifications didn't reflect end-use conditions in one aspect, with the result being failure in the field on a significant scale. The operation was a success but the patient died. GM tried everything they could to blame the failure on us, without success.
 
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Watchcat

Trusted Information Resource
#12
Depending on the test I keep samples.
Someone in the RAPS forum just asked about recommendations/policy for sample retention. How do you decide which test (if by some way other than by whether regulators might question the results at a later date)?

For shelf life extension we store the actual samples
By "actual" samples, do you mean finished devices, which are typically used in shelf life testing, as opposed to components/materials that might be used in some other types of testing? If not that, then what is an "unactual" sample?

:vfunny:
For the uncool among us:
Urban Dictionary: regulate
 

Ronen E

Problem Solver
Staff member
Moderator
#13
After the initial explanation, I should not have had to explain further. The auditor was an idiot, and I for one won't ever aim that low.
Should not.
I guess it's a matter of efficiency - either aim low enough, or spend a lot of time in explaining/debating during audit.
 

Ronen E

Problem Solver
Staff member
Moderator
#14
Even if physical samples are kept (typically in a shared "depot"), it's not always enough for unambiguous identification if the report doesn't say which samples exactly went through a specific test. I once worked for a company that had a large room full of a variety of such retained samples (the typical device was about 3-4cm long), accumulated over many projects and many years. Luckily, the reports and the samples marking were prudent enough for identifying them years later, which came in handy for us on a number of occasions.
 

Ed Panek

QA RA Small Med Dev Company
Trusted Information Resource
#16
Someone in the RAPS forum just asked about recommendations/policy for sample retention. How do you decide which test (if by some way other than by whether regulators might question the results at a later date)?



By "actual" samples, do you mean finished devices, which are typically used in shelf life testing, as opposed to components/materials that might be used in some other types of testing? If not that, then what is an "unactual" sample?



:vfunny:
For the uncool among us:
Urban Dictionary: regulate

We had a medical dry film aging test using the Arrhenius equation and the test was run at ~45'C for a week. We also noted some slight darkening in the corners of the film sample as well as some off visual artifacts in the film itself (Silver behenate type film). We had never received an end-user complaint about this issue so we kept the samples. We attributed the issues to the accelerated portion of the test and the film density response was in range during use.

Sometime later a salesperson left film samples in their car during the summer and during the sales demo noted the same issues as the ones tested. We looked back at the samples from the test and they looked the same (Same issues on film). We added more strict requirements for storage on the labels.

Our decision to retain the samples was of an engineering value type choice. We pushed the temperature limits fo the film and we weren't entirely sure of what would happen.
 

Ronen E

Problem Solver
Staff member
Moderator
#17
We pushed the temperature limits fo the film and we weren't entirely sure of what would happen.
Which only goes to show that the use of Arrhenius' equation for "accelerated aging" without a thorough scientific justification might end up in GIGO.
Testing at elevated temperatures to find out the actual limits for e.g. storage is a different matter.
 

Watchcat

Trusted Information Resource
#18
Our decision to retain the samples was of an engineering value type choice. We pushed the temperature limits fo the film and we weren't entirely sure of what would happen.
Thanks for the clarification, but somehow I don't see this as forming the basis for a sample retention policy. ;)
 

Ed Panek

QA RA Small Med Dev Company
Trusted Information Resource
#19
It wasn't engineerings choice. It was sales and marketing expressing a time requirement upon us. "We have a customer who needs more shelf life." "We have some samples aged naturally in a controlled environment for 3 years." "Customer is asking for 6 years. Cant you accelerate it?" "Yes, but..."
 
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