Hi! My lab is going to apply ISO 17025 testing lab. I'm confuse about Out-of-Specification(OOS)/testing deviation/failure SOP. :confused:
Do ISO 17025 require any of these SOP? Or is it all of these cases can be classify under NONCONFORMANCE (NC) and take an CORRECTIVE ACTION (CA) to solve it?

Thanks!

Hello Jane!

Your out of specification procedure should contain appropriate action for when your instrument exceeds the specified tolerance.

It should specify how the out of tolerance is documented, who is alerted, and how investigation (if any) is to be conducted. Hopefully you have an electronic system, where you can easily verify which instruments have been calibrated by that equipment (if any- reverse traceability).

Essentially you want an action plan when the instrument fails. Hopefully while writing your out of specification procedure you conduct adequate risk analysis, where the actions equal the level of risk.

I'm not sure if I am addressing your question. Please feel free to post and let me know if that covers your issue or not.:)

Dear Brad,

Thank you for your kindly recommendations. For equipment/instrument failure, I do have a written SOP for equipment failure as discussed by you.

My concern is the testing being carried out. Maybe I should give an example here. We got two departments (TESTING SERVICE TEAM and QA/QC TEAM) are responsible to generated a testing report. Testing results from both departments must tally/conform before a testing report can be generated. Let say, TESTING SEVICE TEAM detected the sample result as positive but QA/QC TEAM detected as negative. Should both departments solve the issue by entries of corrective action procedure? Or a SOP (OOS/testing deviation) is needed to solve the deviation between these two different results?

Thanks!:)

Dear Brad,

Thank you for your kindly recommendations. For equipment/instrument failure, I do have a written SOP for equipment failure as discussed by you.

My concern is the testing being carried out. Maybe I should give an example here. We got two departments (TESTING SERVICE TEAM and QA/QC TEAM) are responsible to generated a testing report. Testing results from both departments must tally/conform before a testing report can be generated. Let say, TESTING SEVICE TEAM detected the sample result as positive but QA/QC TEAM detected as negative. Should both departments solve the issue by entries of corrective action procedure? Or a SOP (OOS/testing deviation) is needed to solve the deviation between these two different results?

Thanks!:)

Jane, in my opinion, there is a more fundamental issue of determining why one unit is passing the test, and the other unit is rejecting. Have you conducted uncertainty analysis? Is it that the acceptance criteria may be too tight, given the uncertainty in both methods?

Let's keep it simple and say that you are performing some test, and the results must be within 6% of the target. If each test method has 3% of error, then it could be the flip of a coin whether it will pass both tests or not.

Have you addressed this, or am I still missing the issue?

Jane, there is more than one Clause that may be effective here.

In terms of documenting the steps taken to correct any issue encountered, then use the Corrective Action system that is documented under Clause 4.11

However, given what you describe this may actually be a case of non-conforming work which is described under Clause 4.9

The documentation of steps taken is the same, but Clause 4.9 has some very specific requirements, such as defining who can stop work and specifically stating who has responsibility and authority to resume work (state the authority by position, not by name of person).

You might also ask your accrediting body (AB) about their policy regarding the procedures.

Hope this helps.

Dear Brad,

Thank you for your kindly recommendations. For equipment/instrument failure, I do have a written SOP for equipment failure as discussed by you.

My concern is the testing being carried out. Maybe I should give an example here. We got two departments (TESTING SERVICE TEAM and QA/QC TEAM) are responsible to generated a testing report. Testing results from both departments must tally/conform before a testing report can be generated. Let say, TESTING SEVICE TEAM detected the sample result as positive but QA/QC TEAM detected as negative. Should both departments solve the issue by entries of corrective action procedure? Or a SOP (OOS/testing deviation) is needed to solve the deviation between these two different results?

Thanks!:)

Hi Jane,

I am not sure if this will help you - referencing a Guidance document on OOS from Food drug and Administration (FDA) that is being used for Pharmaceuticals - http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070287.pdf

Thanks for all of your comments & recommendation. This forum really great!

I think Hershal’s recommendation is works to me. I may prepare a OOS SOP to describe the procedure & scope. Any OOS/deviation should consider as NC and solve through the Corrective Action.