What Compliance to ISO 9001, 6.2.2 Competence, Awareness and Training Means

[JaneB]

Thanks for the reply, Fallon.

Their late delivery schedule coupled with multiple concession requests indicated some process/operator issues which needed to be evaluated.

Yup, those are definite signs of some internal issues. And yes, if I were auditing an organisation with a quality manual that just was a copy of the Standard, I'd use that as a kind of checklist also.

It does sound as though they don't fully 'get' what quality is, yet. Ok, they have a 'Quality Manual' and OK, it mirrors the Standard. (So what, really). Anyone can - and often anyone does! - produce a 'Quality Manual' exactly regurgitating the Standard and saying Bloggs Co does this. Heck, you can buy 'em all over the net, alas.

It will be interesting to see what transpires. Let us hope something good does.

Otherwise, your next job may be assessing other suppliers

 

[ProDad]

I just read through the three pages of this thread and it helped to clarify my understanding of this part of the standard (AS9100c 6.2.2, in my case). But I would like to solicit some input about the record keeping part of this.

My company is making an effort to use Sharepoint (a web-based collaboration platform) to go as paperless as possible. Paper records have burned us so many times in audits. One of the worst areas is training records. They get lost, they need constant updating as procedures change or new processes are implemented, we have several scanned and retained versions of them for some of our longer-term employees. That creates redundancies. We have procedures to re-scan them periodically to make sure they are retained. There is overhead here that I think can be simplified.

The one facet of training records that makes it difficult to go electronic is the Employee initials or Trainer's initials or even a later competency check - initials there too. Are these needed? 4.2.4 says "records will be controlled" and 6.2.2 says records shall be maintained. But as mentioned above - it doesn't say "how".

Is it sufficient to have an electronic training record on an access restricted web site that simply lists the training that occurred, when it occurred, and who performed it? No actual inked in initials or stamps? Does this constitute "control"?

Is there a liability if an employee gets hurt and claims they were not trained and I can't produce a document with their initials showing they were trained and evaluated?

 

[John Broomfield]

I just read through the three pages of this thread and it helped to clarify my understanding of this part of the standard (AS9100c 6.2.2, in my case). But I would like to solicit some input about the record keeping part of this.

My company is making an effort to use Sharepoint (a web-based collaboration platform) to go as paperless as possible. Paper records have burned us so many times in audits. One of the worst areas is training records. They get lost, they need constant updating as procedures change or new processes are implemented, we have several scanned and retained versions of them for some of our longer-term employees. That creates redundancies. We have procedures to re-scan them periodically to make sure they are retained. There is overhead here that I think can be simplified.

The one facet of training records that makes it difficult to go electronic is the Employee initials or Trainer's initials or even a later competency check - initials there too. Are these needed? 4.2.4 says "records will be controlled" and 6.2.2 says records shall be maintained. But as mentioned above - it doesn't say "how".

Is it sufficient to have an electronic training record on an access restricted web site that simply lists the training that occurred, when it occurred, and who performed it? No actual inked in initials or stamps? Does this constitute "control"?

Is there a liability if an employee gets hurt and claims they were not trained and I can't produce a document with their initials showing they were trained and evaluated?

ProDad,

Control is defined as "establishing and meeting a requirement".

6.2.2 e) maintain appropriate records of education, training, skills and experience

You are not required to keep records of every little bit of training in a classroom, online or on the job.

You have to agree what records are appropriate. You and your colleagues may do this according to the importance of the processes. What counts is competence as you can see from 6.2.1. When it comes to records of competence these could range from:

A. Establishing all of the competencies required to do a job well and keeping a log of employees with these competencies (linked to records of abilities, skills and knowledge). This is probably inappropriate for all jobs but may be appropriate to the top managers, designers, the operators of special processes per 7.5.2 and auditors.

to

Z. A competent supervisor's evidence of assessment of a person's ability to understand what is required and to do the job. This degree of record keeping would be appropriate to most jobs. You may find that all work in your organization contributes in some way to quality.

It is largely up to you and your colleagues (particularly managers, process owners and the record keepers).

As you say, signatures and signed initials are difficult with electronically updated records. But the supervisor's typed initials may be traceable to the supervisor via his or her log-in to update the record. Consider making the competency log visible to fellow employees so everyone can see what competencies are required, who is in training and who is competent to train and assess others.

With the process owners, review what is done now and determine its value and effectiveness. If ineffective or of poor value then establish a new requirement and test the value of each requirement so you have buy-in and the agreed upon requirements are fulfilled.

Please do not cook up the record keeping requirements for the record keepers to eat. Of course, you will not burden your organization with unnecessary record keeping under the guise of "ISO requires it"!

Best wishes,

John

 

[JaneB]

Is there a liability if an employee gets hurt and claims they were not trained and I can't produce a document with their initials showing they were trained and evaluated?

To John's excellent answer, I'd only add that the issue isn't whether or not you can produce something with their initials.

It's whether you can demonstrate appropriate records that demonstrate to a reasonable person that your employee was appropriately trained and assessed as competent for the work.

Which is basically sheer good business sense. As ISO 9001 is. (Or should be).

 

[kgott]

Hi all,
I'm looking for clarity to what compliance to 6.2.2 actually means. The standard states in 6.2.2, "The Organization shall a) determine the necessary competence for personnel performing work affecting product quality, b) provide training or take other actions to satisfy these needs, c) evaluate the effectiveness of the actions taken, ...) In performing an ISO audit to Element 6 I asked the QM how he complied with 6.2.2c. His said after initial training, which is documented on an internal training form, no other evaluations are needed. I mentioned in 4.2.4 where it states, "Records shall be established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system. Records shall remain legible, readily identifiable and retrievable." My question is should there be records in place documenting some form of evaluation that any training of operators given is a) understood by the trainees and b) being implemented properly by said trainees? Anyone run into this? Thanks for any input.

In MHO; the first part of the answer is easy, you evaluate the extent to which the competences gained are implemented or applied to the work by the receipient of the training.

The second part of the question how to make this assessment at a level that is reasonably and directly attributable to the that individual is the hard part.

Comparing the number of times they get things right vs the number of times they get things wrong may seem attractive but this is the incorrect application of the 80 - 20 rule, that is, unless you believe in behaviour based safety which says that 80% of the time when something goes wrong it's the workers fault.

 

[kgott]

Don't mind sharing my process and documentation folder for training with you. This has passed two separate AS9100 certifications at different companies and will soon go under a third at my current company. Change it to fit your needs, No pride in authorship. View attachment 15401

View attachment 15402

One project manager I worked with ran a competence diary for each person on the job and broke all jobs down into small parts. New starter went out with more experienced people whose job was to witness them doing the work.

When the PM was happy with the feedback from the buddies, only then did he declare them competent.

To deal with the problem of existing staff this is a form that found favour with the managers in that business.

 

[drgnrider]

Create such a matrix that maps skills necessary and identified against people who are available to do that in terms of Not skilled (cannot perform) , semi skilled (can perform and needs supervision / correction) , skilled (can perform independently) , Skilled and can train (can perform independently and knows how and why of the necessary skills, and so can train and supervise)

Such a matrix must be dynamic and work deployment and supervision must be based on this. This complies to requirement.

Should there be some other form(s) backing-up this matrix or is a "C" (for complete) under the heading of "AMSE certified" (welder) sufficient? My questions are: what was evaluated/tested (was a checklist used)? Who did the evaluation/test? When was the evaluation/test? If these standards are subject to change/expire when is recertification required?

IMHO I see the matrix as an 'index' but not as 'proof of competency'... or am I going too deep into the standard?

 

[somashekar]

Should there be some other form(s) backing-up this matrix or is a "C" (for complete) under the heading of "AMSE certified" (welder) sufficient? My questions are: what was evaluated/tested (was a checklist used)? Who did the evaluation/test? When was the evaluation/test? If these standards are subject to change/expire when is recertification required?

IMHO I see the matrix as an 'index' but not as 'proof of competency'... or am I going too deep into the standard?

Hi drgnrider.
You are asked by the standard to maintain appropriate records of education, training, skills and experience.
So such a matrix can be a record, if you can justify to yourself that it is appropriate and helps in serving your purpose. Please also see that I have mentioned that such a matrix must be dynamic. This takes care of changes / expiry and re-certification requirement.
Certainly an external certificate can be a record that further supports your matrix. About what was evaluated/tested (was a checklist used)? Who did the evaluation/test? When was the evaluation/test?.... You may have these that can support your matrix, however it is upto your QMS to decide if these you want as controlled documents / records.
The 'proof of competency' is how true your matrix is to reality. There is no one outside of your organization or an auditor who can question on this. But a lack of competency against the matrix can be assessed during an audit process, and a NC ticket can be given to you with evidence. Also note that you are doing good if you show up any of your uncontrolled records to support your skills matrix during an audit process.
Also note that dynamic record maintained (as a matrix) which as a collection over a period can be an evidence for training effectiveness.
January 2012 matrix., Mr xyzee was semi skilled and July 2012 matrix., Mr xyzee is skilled , when a review (say audit) was made in December 2012. I am good here in effectiveness evaluation, as I use the same matrix to ensure that work deployment meets matrix and my personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the product requirement.

 

[drgnrider]

Hi drgnrider.
You are asked by the standard to maintain appropriate records of education, training, skills and experience.
So such a matrix can be a record, if you can justify to yourself that it is appropriate and helps in serving your purpose. Please also see that I have mentioned that such a matrix must be dynamic. This takes care of changes / expiry and re-certification requirement.

Thank you Somashekar, your reply was enlightening to say the least

While I do understand these matrices are ?supposed? to be dynamic (when I was first give this position, I was warned that I would have to say on the managers to keep them updated).

From our Quality Manual:
?? welders qualified to ASME section IX, [our] plant incorporates GTAW (TIG), GMAW (MIG), FCAW (flux core), SMAW (stick) and Submerged Arc (SAW) welding processes in the manufacturing of its products. ?

The training matrix in question for our welder?s has four headings: Blue Print Reading, Shop Documents, Measuring Equipment, & ASME Weld Qualified. Each of the five different types of welding is individually ?certified?. Do I take the matrix on faith as to what ?ASME Weld Qualified? means or SHOULD there be some supporting document to back-up the matrix? Should I ask to see a document to differentiate which process(es) this person is ?certified? in?

Not here, but I have seen many people just put a checkmark in a box to say something was done, when it was not? someone once told me ?trust, but verify?.

 

[somashekar]

Thank you Somashekar, your reply was enlightening to say the least

While I do understand these matrices are ‘supposed’ to be dynamic (when I was first give this position, I was warned that I would have to say on the managers to keep them updated).

From our Quality Manual:
“… welders qualified to ASME section IX, [our] plant incorporates GTAW (TIG), GMAW (MIG), FCAW (flux core), SMAW (stick) and Submerged Arc (SAW) welding processes in the manufacturing of its products. “

The training matrix in question for our welder’s has four headings: Blue Print Reading, Shop Documents, Measuring Equipment, & ASME Weld Qualified. Each of the five different types of welding is individually ‘certified’. Do I take the matrix on faith as to what “ASME Weld Qualified” means or SHOULD there be some supporting document to back-up the matrix? Should I ask to see a document to differentiate which process(es) this person is “certified” in?

Not here, but I have seen many people just put a checkmark in a box to say something was done, when it was not… someone once told me “trust, but verify”.

You must have as many headings as the processes demands, and a person can be qualified to various degree in several of the processes. Each welding type (technique) is unique and a separate process for me.
So ASME weld qualified is not ok for me, as that is not a process I do.
GTAW (TIG), GMAW (MIG), FCAW (flux core), SMAW (stick) and Submerged Arc (SAW)....these will be my processes, and If I say by a check mark that Mr. xyzee is qualified, then ASME weld qualified can be my route. But that is not the only route universally. Within your system you may trust and follow ASME by a certification training. You could also have some welders trained by the ASME qualified person, and could be mapped at a different level of qualification. On request by anyone, you can demonstrate Mr xyzee's ASME certificate from his personnel record or the internal training record (say a simple attendance sheet with subject of training / duration / faculty /) of the other from his personnel record.
As an auditor or the organization, trust but varify. So without a varification, no check mark will be put in any box. The whole QMS is under your trust, care and maintenance.

So back once again ....
The 'proof of competency' is how true your matrix is to reality. There is no one outside of your organization or an auditor who can question on this. But a lack of competency against the matrix can be assessed during an audit process, and a NC ticket can be given to you with evidence.
Such an NC will not happen if matrix reflects reality...