How to verify SOP training effectivness - Section 6.2.2 in ISO 13485

T

TomRadiak

#1
:bigwave:
Hi,

In section 6.2.2 in ISO13485 it is stated that training (of a SOP) has to be evaluated for effectivness.
- Does this mean that emplyees has to be tested (confirmed by a written test) for every SOP they read?

Best regards from a sunny Stockholm,
 
Elsmar Forum Sponsor
#2
6.2.2 c) requires you to "evaluate the effectiveness of the actions taken" (from 6.2.2b).

The question is: "How do you know (when you train on an SOP) that the trainee "got" the message?" A written test may be an indicator, but how many people do you know that are good with tests, but lousy with performance. Remember one of the major changes in 13485 is the change from "qualified" to "competent". A written test probably will not meet the competent requirement.

The answer lies in how you determine that the trainee is competent to perform to the SOP. Probably the best way is to monitor performance. If the supervisor is satisfied that the new performance is acceptable, then you've met 6.2.2 c).

The next logical question would be concerning records of the above. 6.2.2 e) requires you to "maintain appropriate records". We've battled this greatly in the ISO 9K threads, however, my belief is that it is up to you (your customer, or national agency) to determine what type of records are to be kept.

Hope that helps.

Oh, by the way, I just noticed... Welcome to the Cove :bigwave:
 
K

Kevin H

#3
Training effectiveness

Hi Tom,
I'm not working with 13485, but ISO 9001:2000 & TS 16949, but the requirements are the same. Several ways in the US that are used for training effectiveness include results of a test after training and a sign-off sheet maintained by a supervisor indicating that the employee was observed performing the job/task after training and that they performed it at an acceptable level. For professional employees, such as engineers, a typical way to verify competency is to verify it in an annual review.

For training by an independent organization, the certificate issued by the organization is normally recognized as verifying competency. A lot of these training organizations are now using tests at the end of their training to verify competency before they issue a certificate.

Hope this helps.
 

Wes Bucey

Quite Involved in Discussions
#4
Is it effective?

There are two factors to your question:
  1. Is the training effective? (Can the trainee perform the SOP correctly and consistently? Is the trainee "competent" in that task?)
  2. Is the fact of the determination of competency recorded?
The organization is the sole arbiter of what constitutes effectiveness of the training, whether it is a formal written test, a standard "practical" test, or a supervisor's judgment.

Once the competency is determined, the organization should record the fact. Where the data is recorded is immaterial for the purpose of the Standard. Some organizations keep files of each SOP, for example, with a list of everyone who has qualified as "competent." Others stick the competency data in an employee's personnel file.

An added feature that I consider "good practice" is periodic re-evaluation of the competency of the employee to perform the task (results of re-evaluation ALSO recorded.)

Note it is also good practice to re-evaluate the PROCESS of determining competency to determine if it continues to meet the organization's needs.
 
B

Bwana.Jo

#5
Important thing in "Training" requirement !

Hi, folks

I'd like to introduce my point on 'Training Requirement' between FDA QSR & ISO 13485.

ISO 13485, 6.2.2
a) Competence <-- Job Specification --> (goes to make) Job Description
b) Provide training needs, <-- Identity what needs to be trained
c) Evaluate*
d) Concentrating on awareness --> see FDA QSR 820.25 (1)
e) Records --> clue for evaluate above 'd)' or effectiveness of 'c)'

* Evaluate: refer to HR formulations.
Sc = Sa / Sb Skill
Kc = Ka / Kb Knowledge
Pc = Pa / Pb Performance
a= after training, b= before training, c= change

FDA QSR 820.25 describes
(a) General. => Determine what is necessity
(b) Training. => Identify what should be trained
(1) Personnel shall be made aware of device defects which may occur from ..their..job. => Defect device training (kind of foreseeable training; screening by operators)
(2) Personnel shall be made aware of defects and errors that may be encountered as..their job.. => Preventive training (aspect of "Risk" view to 'Reduce' training for engineerings)

Comment me ! :bigwave:

Alex Jo
 
Last edited by a moderator:

liuyy

Involved In Discussions
#6
short term and long term effectives

you must evaluate the short term effectives and long term eddectives of what actions you have taken.
 
R

rtstewart1

#7
Evaluating the training and/or the trainer

In addition to ensuring that the person being trained was competent, you should also verify that training and/or the trainer is doing an effective job. At the company that I previously worked for, we had a questionnaire on the back of our training record form and the person being trained was required to provide feedback on the training. The trainer was then required to review the comments and incorporate the feedback into future training sessions. We found it to be quite helpful in obtaining objective input on the effectiveness of the training that was being provided.
 
B

Bwana.Jo

#8
I love your inputs.. thanks !

Thanks for your inputs for considering effectiveness and measurable requisitions.

Our company doing now two kind of training certification.
One is simple training certification as general thing.
The other is for 'special operating trainee' like a special process operator/technician. They will be certified by "Certification Check Off (CCO)" for certain trained work instruction, FYR.

Measure is all the time headache for me cause that function should not be subjective. But our CCO is also nonobjective for qualifying operator, unfortunately.

Any helping concept for me... will be highly appreciated.

Thanks...Alex
 
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