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Date of Quality Management System - Training Records

Big Jim

Super Moderator
#11
The guidance document you linked explains it pretty well. Every organization is different and each determines how to approach this requirement as well as all the rest of the requirements of the standard.

In dealing with an auditor, you need to demonstrate you understand the requirement and can explain your approach to meeting it.

Although you need to keep records of the competencies needed and how they were achieved, that doesn't mandate records for every conceivable component. That would be an impossible fools errand.

So what is your approach and can you explain yourself?
 
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Ed Panek

QA RA Small Med Dev Company
Trusted Information Resource
#12
I have some very long-term employees (like 20+ years) and it's a challenge to provide training records for them - a number of their training folders just have the note "grandfathered in" written on the record. I'm thinking of drafting a statement for signature by upper management that these people were employees long before our current QMS was in place and their work has been validated by qualified personnel. The practice of maintaining training records was implemented officially when this QMS was adopted and training records are up to date since then.

Any thoughts?
From a risk-based perspective, I would just draft a memo talking about the periods under discussion, the devices made, and how many of those devices are still in use/warranty. If you suspect there are no more devices in use prior to your QMS I am not sure there is any reason needed as the risk Prob X Sev is ZERO.
 

tony s

Information Seeker
Trusted Information Resource
#13
Since my example here is an internal auditor. What should be the competencies of an internal auditor? He/she should be able to develop audit program and audit plans, devise checklist with the intention to determine conformity with the relevant requirements (internally and externally mandated - not just the ISO clauses) and to determine effectiveness (whether planned results are achieved and planned activities are realized), perform objective and impartial audits, raise audit findings that are valid and not whimsical or subjective, assess the evidences presented against a well established audit criteria and not his/her interpretation, can satisfactorily explain the intention of the standard, provide reports with balanced information (positive, negative, and recommendations) to the audited process owner and management, his/her audit findings lead to improvement of the processes and the system, etc.

Retained documented information relevant to the above , I believe, should be what a CB auditor should be looking into if he/she wants an internal auditor to demonstrate "evidence of competence".
 

Raffy

Quite Involved in Discussions
#14
I have some very long-term employees (like 20+ years) and it's a challenge to provide training records for them - a number of their training folders just have the note "grandfathered in" written on the record. I'm thinking of drafting a statement for signature by upper management that these people were employees long before our current QMS was in place and their work has been validated by qualified personnel. The practice of maintaining training records was implemented officially when this QMS was adopted and training records are up to date since then.

Any thoughts?
>> Even though that these employees workers have been working for many years, I think I need to re qualify again if they are still fit with the current requirement of the organization. Somehow, gaps will be identified on some areas. Just a thought.
Raffy
 

tony s

Information Seeker
Trusted Information Resource
#16
Even though that these employees workers have been working for many years, I think I need to re qualify again if they are still fit with the current requirement of the organization.
If I've been assisting organizations to establish QMS, OHSMS and EMS and get them certified to ISO 9001 since the 1994 version up to the present 2015, OHSAS 18001 since 1999 till its transition to ISO 45001:2018 and ISO 14001 since 1996 version until the latest 2015, do I need to attend an ISO 9001:2015 Awareness Training, get a certificate, so I can demonstrate to an external auditor that I'm competent and updated on ISO 9001:2015?
 

Big Jim

Super Moderator
#17
If I've been assisting organizations to establish QMS, OHSMS and EMS and get them certified to ISO 9001 since the 1994 version up to the present 2015, OHSAS 18001 since 1999 till its transition to ISO 45001:2018 and ISO 14001 since 1996 version until the latest 2015, do I need to attend an ISO 9001:2015 Awareness Training, get a certificate, so I can demonstrate to an external auditor that I'm competent and updated on ISO 9001:2015?
Excellent question. One way to provide competence records would be to show your log of how many consulting and auditing opportunities you have fulfilled. Unfortunately that would likely violate many nondisclosure agreements.

You might then state that how many such opportunities you have fulfilled and that your records could be viewed by an impartial and confidential 3rd party.

Their may be other methods.

In my personal experience providing the most recent training certificate has been satisfactory.
 

tony s

Information Seeker
Trusted Information Resource
#18
In my personal experience providing the most recent training certificate has been satisfactory.
I would agree if the training certificate was earned by completing and passing the expected outputs, examinations and evaluations which demonstrate the trainee has acquired the ability to apply knowledge and skills to achieve the intended results (definition of competence as per ISO 9000:2015).

For the OP's concern of employees of 20+ years in the company, there are more "appropriate" documented information that the OP's company should retain to demonstrate "evidence of competence" than just training records. Employee performance appraisal/evaluation records, licenses, trade tests results, results of evaluation of their outputs against acceptance criteria, results of review of achieving their set performance objectives, etc.
 

Big Jim

Super Moderator
#19
I would agree if the training certificate was earned by completing and passing the expected outputs, examinations and evaluations which demonstrate the trainee has acquired the ability to apply knowledge and skills to achieve the intended results (definition of competence as per ISO 9000:2015).

For the OP's concern of employees of 20+ years in the company, there are more "appropriate" documented information that the OP's company should retain to demonstrate "evidence of competence" than just training records. Employee performance appraisal/evaluation records, licenses, trade tests results, results of evaluation of their outputs against acceptance criteria, results of review of achieving their set performance objectives, etc.
Be aware I was only addressing the competency of internal auditors, and in particular contract internal auditors.
 

atitheya

Quite Involved in Discussions
#20
Employee performance appraisal/evaluation records, licenses, trade tests results, results of evaluation of their outputs against acceptance criteria, results of review of achieving their set performance objectives, etc.
You are right. These may be used to evaluate and demonstrate competence.
 
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