7.2 Competence: How much documentation is needed?

In terms of 7.2, d) just wondering what an registration auditor might be looking for in terms of evidence of competence. For example, let's assume we hire to predefined criteria (experience, education, certifications, etc.) and collect records to demonstrate. In-house training is given and at the end of a specific period an overall job performance evaluation is done. The evaluation is simply signed-off on a log adjacent to the persons name and position. Is the signature adequate, or does the record require the criteria for the evaluation and the specific results documented. This could be documented evidence of work samples, witness of work, interviews, work history, etc. How much documentation is needed?

 

The corollary to Andy's statement is you also need to show NO evidence that somewhere along the line "skills and competence" caused a problem. In other words, if your customer feedback (from NCR's, CARS, or whatever) show that you have recurring issues with welds, you had better check out how you determine competence in the welding department! If you simply depend on a certificate, but the results are not satisfactory, your company has a problem determining competence and is relying on 'unreliable' and unverified data.

 

I'm not Andy, but it is often referred to as the "Hawthorne Effect" or "Observer Effect".
Werner Heisenberg just got totally left out of it this time...though his "Principle" is sorta similar...

 

Here is my take on this topic. Clause 7.2 requires:

1. PLAN - Determine competency requirements which your organization should determine far better than any external auditor.
2. DO - Determine the effectiveness of competency through demonstration or other means.
3. CHECK - If employee performance (through resulting n/c's and other evidence) fails to meet established product and competency requirements,
   
4. ACT - then remedial actions must be taken.
5. So the "documented information" required would be a) competency criteria as established by your org; b) performance data on the activity or process that the the employee is engaged in (e.g production records); c) evidence of remedial training or reassigment, etc for non-competent performance.
6. Always keep the PDCA cycle in mind in developing your QMS.

 

7.2c requires evaluation of the effectiveness of the actions taken. If we dissect "effectiveness" it has two parts: planned results that must be achieved AND planned activities that must be realized. So if we are to evaluate effectiveness, we have to be clear of the "planned results" in providing the necessary action/s or intervention/s to address competency needs. Documenting the evidence of reviewing whether the "planned results" are achieved after provision of the necessary action/intervention (i.e. planned activities) will satisfy the documented information requirement on 7.2c.

 

If an employee is not sufficiently competent as required by clause 7.2a and b, then clause 7.2.c calls for remedial actions (perhaps refresher training or reassignment) to be taken to bring that employee up to speed or find someone else who can to do QMS work effectively. Whatever remedial course of action is taken, (in this case the refresher training or assigning another competent employee), it must be evaluated for effectiveness in terms of achieving QMS performance requirements. The remedial course of action and its effectiveness must be documented.

 

Bear in mind the need for ongoing checking to confirm that eyesight etc. has not deteriorated and that measuring equipment, comparative standards continue to be accurately used

 

We have a few training requirements that I know of no other way to evaluate the effectiveness of other than waiting to see if something goes sideways. For instance we have an image and data policy that specifies how/where photos and data are stored on the network that we require employees to be trained on. I can look through folders to see if it looks like things are in order but I probably won't find a problem until someone complains or an audit uncovers missing or mislabeled files. Another is the QMS training for new hires, I don't really know if they "got it"unless something happens to uncover a weakness or lack of understanding. I see these things as hard to measure but maybe there is a simple solution I'm missing.

 

Yes, I think I may be.
Thanks

 

After giving Andy's reply more thought I realized that the image and data policy was a good example of where I have been veering off track. Anytime a policy is released or changed everyone is made AWARE by email announcement at the very least, If it is the product of a CA or IA I may follow up with special instructions. After this policy was released it was obvious that people were not following it, we revised it and made all aware again and still saw issues with compliance. That is when I decided to treat it more like training and require everyone to sign a record that they had read and understand the policy. We are not ISO certified yet and employees are at different levels as far as being "on board" and doing their part. The QMS training I referred to is, as Andy mentioned simply making new hires aware of our quality policy and their role in contributing to the QMS. It's not really a training either but sometimes people don't do things that they have been made aware of and it causes problems, I was trying to fix this by verifying that they got the message. I would like to know how others develop confidence that when people are made aware, that they actually are aware.

 

That makes a lot of sense and when thinking of it it that way, I was kind of heading down that path by trial and error. I guess a lot of it comes down to organizing so that when a requirement crosses over from awareness to required training, records of the training are retained for evidence. I have never heard the term "one point lesson", that is an interesting concept. Thank you for the input!