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ISO/TS 16949 Stage 2 Audit Nonconformance Against 7.6.3.1 Laboratory Scope

Dan M

Involved In Discussions
#1
In our Stage 2 audit we received the following minor nonconformance:

The process to ensure that the internal laboratory scope is defined is not fully effective.
The TS 16949-2009 specification requires that 'The laboratory shall specify and implement, as a minimum, technical requirements for ... competency of laboratory personnel... review of related records.
The Laboratory scope did not capture requirements for competency of personnel or review of related records.


Our laboratory scope document consists of a following matrix that includes:

Test Description | Instrument(s) | Test Method (i.e. ASTM#)

Can I address "competency of laboratory personnel" by linking to our HR Job Description for a Laboratory Technician? It defines the minimum education, experience, skills, and training necessary for the position.

I am at a total loss for how to address "review of related records." Can anyone provide some examples? Many thanks!
 
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qusys

Trusted Information Resource
#3
In our Stage 2 audit we received the following minor nonconformance:

The process to ensure that the internal laboratory scope is defined is not fully effective.
The TS 16949-2009 specification requires that 'The laboratory shall specify and implement, as a minimum, technical requirements for ... competency of laboratory personnel... review of related records.
The Laboratory scope did not capture requirements for competency of personnel or review of related records.


Our laboratory scope document consists of a following matrix that includes:

Test Description | Instrument(s) | Test Method (i.e. ASTM#)

Can I address "competency of laboratory personnel" by linking to our HR Job Description for a Laboratory Technician? It defines the minimum education, experience, skills, and training necessary for the position.

I am at a total loss for how to address "review of related records." Can anyone provide some examples? Many thanks!
Hi,
the requirement of ISO TS related to the " review of the records" for internal labs is related to the whole internal lab mgmt and not only for the training.
In the scope of the lab you shall specify how you are proceeding for the " related records review".
For example, you can set periodical meeting where you examine the KPI of the activity or the major issue of the activity and fixing solutions.
Besides you can examine the chance of changing procedure or the introduction of new method as well as the needs of new training for your personnel, in brief a sort of mgmt review for the lab based upon the technical requirements of the 7.6.3.1 clause.
Hope this helps:bigwave:
 
#4
In our Stage 2 audit we received the following minor nonconformance:

The process to ensure that the internal laboratory scope is defined is not fully effective.
The TS 16949-2009 specification requires that 'The laboratory shall specify and implement, as a minimum, technical requirements for ... competency of laboratory personnel... review of related records.
The Laboratory scope did not capture requirements for competency of personnel or review of related records.


Our laboratory scope document consists of a following matrix that includes:

Test Description | Instrument(s) | Test Method (i.e. ASTM#)

Can I address "competency of laboratory personnel" by linking to our HR Job Description for a Laboratory Technician? It defines the minimum education, experience, skills, and training necessary for the position.

I am at a total loss for how to address "review of related records." Can anyone provide some examples? Many thanks!
Dan - the auditor is wrong! I don't have the requirement open in front of me, but I faced a similar issue about lab scope not being complete. Nowhere in the description (definition in the standard) does it even suggest that competencies need to be defined within the scope and, quite frankly, your auditor is smoking something bad if they even imagine that's where you'd list them! And what do they mean about review of records? Which records? Where (clause) is it in ISO/TS 16949? Frankly an 'effective' scope is BS, anyways! So you know they are making it up!

I used examples of lab scopes from ISO/IEC 17025 accredited labs, found on the internet as an example. Competencies could be in your JD's.

This is another case of us not being the right place to help you address what the auditor hasn't properly communicated to you (or us, for that matter).

Please, call your CB, ask for their technical people and get them to explain what the auditor is asking for. If they refer you back to the auditor, tell them "No thanks, he left without telling us when he had an opportunity, if YOU don't know what they wrote, it's YOUR problem and I'm rejecting the NC"...:mg:
 

Dan M

Involved In Discussions
#5
Dan - the auditor is wrong! I don't have the requirement open in front of me, but I faced a similar issue about lab scope not being complete. Nowhere in the description (definition in the standard) does it even suggest that competencies need to be defined within the scope and, quite frankly, your auditor is smoking something bad if they even imagine that's where you'd list them! And what do they mean about review of records? Which records? Where (clause) is it in ISO/TS 16949? Frankly an 'effective' scope is BS, anyways! So you know they are making it up!

I used examples of lab scopes from ISO/IEC 17025 accredited labs, found on the internet as an example. Competencies could be in your JD's.

This is another case of us not being the right place to help you address what the auditor hasn't properly communicated to you (or us, for that matter).

Please, call your CB, ask for their technical people and get them to explain what the auditor is asking for. If they refer you back to the auditor, tell them "No thanks, he left without telling us when he had an opportunity, if YOU don't know what they wrote, it's YOUR problem and I'm rejecting the NC"...:mg:
As you can tell I have been very busy the past several weeks and hadn't a chance to follow-up to your post. I was busy coordinating our responses to the CB's corrective action requests. Due to lack of time, we capitulated and accepted the corrective action request. I added a statement to the Laboratory Scope that points toward the JD's. For "review of related records" I added the statement "laboratory personnel participate in statistical studies to analyze variation in test results. Related record are reviewed to verified that the laboratory technician is competent in performing the test."
 

morteza

Trusted Information Resource
#6
Hi Dan
I agree with Andy. The auditor is wrong.
According to ISO/TS clause 3.1.5 the lab scope contains:
- A list of tests ….
- A list of equipment …
- A list of methods
So it is not necessary to include requirements for competency of personnel.
For your case, refer to job description document can be acceptable. But please pay attention that Job Description for a Laboratory Technician is a general competency list. Maybe you need special skills for a special test which is not stated in job description document.
I recommend you to provide an independent table stating competency needed for each test or a group of tests.
 
#7
As you can tell I have been very busy the past several weeks and hadn't a chance to follow-up to your post. I was busy coordinating our responses to the CB's corrective action requests. Due to lack of time, we capitulated and accepted the corrective action request. I added a statement to the Laboratory Scope that points toward the JD's. For "review of related records" I added the statement "laboratory personnel participate in statistical studies to analyze variation in test results. Related record are reviewed to verified that the laboratory technician is competent in performing the test."
Oh, Dan, Dan! I fear all you have done is re-inforced that this auditor is (in their mind) correct in recording such an NC! So, the next TS audit he does, he's going to go to them, write the same thing and they'll do the same...and so on.

I'd still suggest that you remove it, contact your CB operations people and tell them that, in review, you realize it isn't a requirement and, that you'd prefer not to have the auditor back.

We need, in our industry, for clients to hold the CB community to a high standard! Management will never support management systems implementation, when certification drags it through the dirt like this.
 

qusys

Trusted Information Resource
#8
Hi Dan
I agree with Andy. The auditor is wrong.
According to ISO/TS clause 3.1.5 the lab scope contains:
- A list of tests ….
- A list of equipment …
- A list of methods
So it is not necessary to include requirements for competency of personnel.
For your case, refer to job description document can be acceptable. But please pay attention that Job Description for a Laboratory Technician is a general competency list. Maybe you need special skills for a special test which is not stated in job description document.
I recommend you to provide an independent table stating competency needed for each test or a group of tests.
Hi,
I do not think that the auditor was completely wrong in the essence of the NC . He wrote citing the original poster : "The TS 16949-2009 specification requires that 'The laboratory shall specify and implement, as a minimum, technical requirements for ... competency of laboratory personnel... review of related records.
The Laboratory scope did not capture requirements for competency of personnel or review of related records"
I am assuming that he was redundant in writing " The Lab scope did not capture........" , because the lab scope does not requires this, but if he did not find how the internal lab meets " the requirement for lab personnel competence" and " lab related records review" somewhere ( in the documentation of the lab , in some database or in other evidences), he was right in raising the NC.
This is a requirement related to the 7.6.3.1 clause of ISO TS.:bigwave:
 
R

rickmcq

#9
For "review of related records" I added the statement "laboratory personnel participate in statistical studies to analyze variation in test results. Related record are reviewed to verified that the laboratory technician is competent in performing the test."
May I ask how you arrived at that response?

TS says " The lab shall specify and implement, as a minimum, technical requirements for...... review of related records".

I don't have a clue what that means.

Rick
 
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