Auditing TS 16949 Cl. 7.6.3.1 - Internal Calibration Laboratory Requirements

S

SandyStarkie

#1
Good Afternoon
I also have a question concerning 7.3.3.1. It states "The laboratory shall specify and implement, as a minimum, technical requirements for

adequacy of the laboratory procedures

competency of the laboratory personnel

testing of the product

capability to perform these services correctly, traceable to the relevant process standard and

review of the related records

The two items I have in bold I could not find evidence of during an internal audit. I found a training record from lab tech from 2001 and it was before the word "Competent" was added to training ledgers. I found nothing describing how the lab tech is trained or deemed competent. Does this have to be in the lab scope or procedure?

What is evidence of review of related records?
 
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John Broomfield

Staff member
Super Moderator
#2
Good Afternoon
I also have a question concerning 7.3.3.1. It states "The laboratory shall specify and implement, as a minimum, technical requirements for

adequacy of the laboratory procedures

competency of the laboratory personnel

testing of the product

capability to perform these services correctly, traceable to the relevant process standard and

review of the related records

The two items I have in bold I could not find evidence of during an internal audit. I found a training record from lab tech from 2001 and it was before the word "Competent" was added to training ledgers. I found nothing describing how the lab tech is trained or deemed competent. Does this have to be in the lab scope or procedure?

What is evidence of review of related records?
Sandy,

Of course training does not always result in competence. You need to ask the auditee how they determine the competence of the lab techs and others whose work affects quality. You may find they have not determined the competencies required or have not verified that people are competent for the work they do or that it is simply a record keeping issue.

When planning the fulfillment of future requirements the organization considers the competences necessary to fulfill those requirements, it may even review its competency records! The same goes when assigning work to competent staff and when informing the team who has the expertise they seek.

John
 
S

SandyStarkie

#3
Thank you John... I agree that they have not defined the competence level. When I ask this often during internal audits the auditee often gets up-set and explains they have a training record. I explain that I understand that but these are old and do not show competence was evaluated so I need to know how do you determine they are competent. It seems I get no where in resolving this issue. I have added a competence column to the current training ledgers. This still does not assure the competence.
More specific, in the 7.6.3.1 clause is states "The laboratory shall specify and implement, as a minimum, technical requirements for
competency of the laboratory personnel
Does this mean the auditee must specify how they determine competence in a procedure or lab scope? Or is it enough for them to explain to me how they determine competence level?

Sorry I am so confused.....
 

John Broomfield

Staff member
Super Moderator
#4
Thank you John... I agree that they have not defined the competence level. When I ask this often during internal audits the auditee often gets up-set and explains they have a training record. I explain that I understand that but these are old and do not show competence was evaluated so I need to know how do you determine they are competent. It seems I get no where in resolving this issue. I have added a competence column to the current training ledgers. This still does not assure the competence.
More specific, in the 7.6.3.1 clause is states "The laboratory shall specify and implement, as a minimum, technical requirements for
competency of the laboratory personnel
Does this mean the auditee must specify how they determine competence in a procedure or lab scope? Or is it enough for them to explain to me how they determine competence level?

Sorry I am so confused.....
Sandy,

Start with the definition of competence. It comprises three parts:

  • Abilities (or innate attributes)
  • Skills
  • Knowledge
Often, job specifications* define these three in order to recruit the competent people or at least the people who have the required abilities. Trying to impart skills and knowledge in people who not have the ability is a waste of time and money.

Supervisors usually are clear on the competencies they require and would not be upset being asked to define them; then you can ask where these are documented. I would not talk in terms of "levels".

Does the person who owns the recruiting and training processes have these specifications? If not how do these processes result in the compencies required by the lab?

* example: http://www.ok.gov/opm/jfd/x-specs/x13.htm

John
 
Last edited:
S

SandyStarkie

#5
Thank you again John. This was very helpful information. I will improve our training processes based on better understanding. :)
 

antoine.dias

Quite Involved in Discussions
#6
Hi Everyone,

What is your interpretation of "Review of the related records" in 7.6.3.1 ?
What should be done to fulfil this and how can it help the lab process?
We had a discussion about it internally and want to know your opinion about it.

Thanks in advance
 

John Broomfield

Staff member
Super Moderator
#7
Hi Everyone,

What is your interpretation of "Review of the related records" in 7.6.3.1 ?
What should be done to fulfil this and how can it help the lab process?
We had a discussion about it internally and want to know your opinion about it.

Thanks in advance
Antoine,

Managers review the work and records to see how well their management system is helping people to do good work.

They do this to determine:

1. The adequacy or effectiveness of procedures,
2. The ability of staff to do their jobs well,
3. Their understanding of the essential abilities, skills and knowledge (to recruit further staff as required),
4. The proper provision of testing services including, as applicable, sampling, sample prep, set-up of equipment, conduct of the test, recording data, analyzing data and reporting results,
5. The capability of equipment to measure traceable to applicable standards,
6. Any needed preventive action,
7. Any needed corrections,
8. Any needed corrective action.

As you can see this, and listening to staff, is basic supervisory management.

John
 

MWR4QA

Starting to get Involved
#8
Trying to prove someone is competent on the front end is difficult. A person can have impressive credentials and experience and still commit errors. And therein lies how auditors determine competence.
In my experience...
If your MTE management system is in good order, if there are no product issues traceable back to MTE being incorrectly calibrated, if MTE reviewed during the audit are within the calibration dates auditors will usually not dig. In auditing, "If there's no smoke, there's no fire." is a pretty good rule of thumb.
 
J

JoShmo

#9
"Trying to prove someone is competent on the front end is difficult."

Not at all. If you go by the definition of competency it becomes a lot easier. Competency is defined as "the demonstrated abilty to apply skills and knowldege. If you know what a job requires from someone, why can't they be asked to demonstrate their knowledge and skills and have that observed? If you take a driving test your not experienced, by definition, but you have to demonstrate to a tester.
 
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