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Hello All, Missing test procedure is real concern from regulatory standpoint. Would You consider it required part? If yes then why? Have You seen any test reports which includes test procedure + test setup pictures + calibration + results with acceptance criteria in? Advise me as is this a gap coming from testlab by not adding this info? I need to understand reasoning from experienced folks like You all. FYI, I have not seen any testlab providing such detailed info so far. why it is not required then? Thank You. source: https://www.linkedin.com/groups/2070960/2070960-6161519353117368323 Marked as spam
 Posted by Asked on July 20, 2016 12:00 am
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Private answer
Hello, allow me to express my opinion sometimes the test method used in lab is basing on the law or rule (ISO Standard or ASTM....) to a specific functioanlity of a production but Not for a actual use. The best way you could mail for the lab to differentiate these methods. Have a good day!!
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Private answer
Ben Vonk
Hello Jalpa. Test methods and results are described in test datasheets used by your testlab. These datasheets however are not part of the final report. Only test results are reported in the applicable tables in your report. The test datasheets itself however are only shared with the applicant.
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Private answer
Thomas Marmor
Hi,
Finally you are responsible for the documents that are part of your Quality System (QS). In my understanbding test Reports as a template are part of you QS and should be reviewed and monitored according your established procedure This means there must be someone who decides the Content of the document and someone who approves the document. If you take Report templates from external laboratory you have to bring them into your QS. By this you should also decide what to accept and what not to accept from the content. From my experience I haven't seen in the past test plans/instructions that tells you how to claibrate test Equipment. What I have seen are Pictures from specific test Setups. Sometimes this will be helpful. In the test Report or protocol you have to document everything tha is related to the executed Tests. This means you have also to list the used test equipment and ist calibration Status. Marked as spam
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Private answer
Ben Vonk
Hello Jalpa,
Test records with details about the test procedure are normally not a part of the report. The report will show a list of tests which are performed and which tests are waived. The results of the tests are copied in the applicable tables of the report. Test reports will have a statement like this: " Test results are valid only for the tested equipment. These tests are considered representative of the products covered by this Test Report. The test methods and results of the above tests have been reviewed and found to be in accordance with the requirements in the Standard(s) referenced at the beginning of this Test Report". The actual test records are only available for the applicant. I hope this helps to answer your question. Regards, Ben Vonk Marked as spam
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Private answer
If the testlab has a valid accreditation (e.g. CB scheme, ISO 17025) you should trust them to my opinion.
Accreditation standards contain very specific requirements for testlabs, including the use of test forms, calibration of tools, competences and qualification of employees. As part of the selection of the testlab you could ask them to provide their current accreditations, as it is not always easy to find out details (accreditation is not always on standard-level, but can be on technology-level (e.g. mechanical, software). Marked as spam
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Private answer
Scott Blood
You can certainly request this level of detail, but remember that your test lab needs to be accredited by a reputable compliance body to be able to test to specific standards. Make sure you verify that your test lab is accredited to test to your two standards of interest before going any further. This accreditation, performed by those knowledgable in your standards of interest much more so than you or I, examines the test labs' equipment controls, procedures, etc to make sure they meet standard. As long as the lab is accredited to test to your standard, you can rest easy knowing that the methods to "pass" your product have been scrutinized sufficiently and are valid.
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Private answer
Scott Blood
You can certainly request this level of detail, but remember that your test lab needs to be accredited by a reputable compliance body to be able to test to specific standards. Make sure you verify that your test lab is accredited to test to your two standards of interest before going any further. This accreditation, performed by those knowledgable in your standards of interest much more so than you or I, examines the test labs' equipment controls, procedures, etc to make sure they meet standard. As long as the lab is accredited to test to your standard, you can rest easy knowing that the methods to "pass" your product have been scrutinized sufficiently and are valid.
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Private answer
Sonja Holten
In the event detailed testresults should become necessary, (f.e. with an adverse event or during an audit) your supplier controlls kick in. There should be (quality) agreements in place, making it possible to retrieve all information you need within a reasonable time period (24 hr to a week) depending on need. Having an accredited lab helps. So during f.e. the supplier selection process, checking their credentials and capabilities and documenting that in a supplier assesment report, will result in a conclusion that you trust them enough, and that it becomes unnecessary for you to manage their documentation. So you can be happy with the high level report, and only retrieve what you need, when you need it from the lab.
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