Destroyed Training Records

jpb0205 · Nov 4, 2014

First post so hello all and hope this is in the correct place :bigwave:

My current company (pharmaceuticals) closed down and then re-opened as a much smaller organisation less than a year later. At the time of the closure, there was no anticipation of the comeback and a lot of documentation was destroyed, including staff training records. Some staff previously employed came back and now do not have their training records. We inserted an explanatory statement into each training record, that they were previously trained and are qualified by previous experience and qualification which the regulatory body (GMP inspection) found acceptable but at a recent audit, this was heavily criticised and the auditor expected much more but did not make it clear what they expected to see.

Can anyone help with what they would expect to see and/or provide any guidance on how to make the best of this pretty bad situation?

Thanks very much for any assistance.

somashekar · Nov 4, 2014

jpb0205 said:
First post so hello all and hope this is in the correct place

My current company (pharmaceuticals) closed down and then re-opened as a much smaller organisation less than a year later. At the time of the closure, there was no anticipation of the comeback and a lot of documentation was destroyed, including staff training records. Some staff previously employed came back and now do not have their training records. We inserted an explanatory statement into each training record, that they were previously trained and are qualified by previous experience and qualification which the regulatory body (GMP inspection) found acceptable but at a recent audit, this was heavily criticised and the auditor expected much more but did not make it clear what they expected to see.

Can anyone help with what they would expect to see and/or provide any guidance on how to make the best of this pretty bad situation?

Thanks very much for any assistance.

Welcome here jbp ...
Sorry to note on that loss of training record.
Its good that both management and staff are aware of the history and your selection of personnel is based on education / skill / experience
Now do not relay much on those grandfather records of training. You have made a new start (restart). Just retrain and begin fresh records. You may have very little gaps for new training. I just see retraining as the most apt step you can take.

Jen Kirley · Nov 4, 2014

I agree with retraining, after all with a much smaller organization we could reasonably expect some changes in how things are done. The training need not be A to Z, it can be an update/refresher.

AndyN · Nov 4, 2014

jpb0205 said:
First post so hello all and hope this is in the correct place

My current company (pharmaceuticals) closed down and then re-opened as a much smaller organisation less than a year later. At the time of the closure, there was no anticipation of the comeback and a lot of documentation was destroyed, including staff training records. Some staff previously employed came back and now do not have their training records. We inserted an explanatory statement into each training record, that they were previously trained and are qualified by previous experience and qualification which the regulatory body (GMP inspection) found acceptable but at a recent audit, this was heavily criticised and the auditor expected much more but did not make it clear what they expected to see.

Can anyone help with what they would expect to see and/or provide any guidance on how to make the best of this pretty bad situation?

Thanks very much for any assistance.

Welcome - firstly, don't knee jerk into training. Do an evaluation of competency, first. Simply retraining is NOT an appropriate step, anyway, since they have BEEN trained. If you do a competency evaluation, it's more beneficial to both you and the person. You may uncover some area they need to have some work, especially since the place has less people and as a result there may be some "stretching" of peoples' abilities.

normzone · Nov 4, 2014

Thanks, [AndyN]. I'm realizing I'm in a similar position and have decided to implement your advice rather than burn the barn from scratch (or something like that, it's still early)

jpb0205 · Nov 5, 2014

AndyN said:
Welcome - firstly, don't knee jerk into training. Do an evaluation of competency, first. Simply retraining is NOT an appropriate step, anyway, since they have BEEN trained. If you do a competency evaluation, it's more beneficial to both you and the person. You may uncover some area they need to have some work, especially since the place has less people and as a result there may be some "stretching" of peoples' abilities.

Great advice Andy, thanks so much for your response.

Retraining wasn't appropriate for a multitude of reasons and you are completely correct regarding small companies and multitasking requirements! An assessment of competency and sign off seems an ideal solution to me, now let's hope the auditor feels the same way ........

Thanks again :applause:

pldey42 · Nov 5, 2014

jpb0205 said:
Great advice Andy, thanks so much for your response.

Retraining wasn't appropriate for a multitude of reasons and you are completely correct regarding small companies and multitasking requirements! An assessment of competency and sign off seems an ideal solution to me, now let's hope the auditor feels the same way ........

Thanks again

An assessment of competency would be entirely correct and consistent with 6.2.2. An auditor, as you know, isn't allowed to put feelings into findings and, to make this a nonconformity, would need to show evidence of incompetence. Your managers are by far the most competent people to assess competency of staff.

It might be an idea to ask why people don't keep their own records of competency especially if it involved attending training classes and passing exams. This would be in their own self interest. (Not that I do; I tend to lose them

)

Pat

normzone · Nov 5, 2014

" why people don't keep their own records of competency especially if it involved attending training classes and passing exams. This would be in their own self interest. (Not that I do; I tend to lose them ) "

On that note, having experimented with both distributed training records and centralized formats, I now lean towards distributed.

In small organizations with limited resources, centralized record keeping tends to get done once and forgotten, only being brought out and refreshed whenever found to be nonconforming.

Distributed records, where supervisors and managers keep their own, tend to be maintained current as the persons close to the process are aware of their responsibility, and when it breaks down the problem is localized and readily addressable.

John Broomfield · Nov 6, 2014

jpb0205,

Roles that are critical to quality (including leadership) should be analyzed to define the behaviors, skills and knowledge essential for competence.

Before investing in training to impart skills and/or knowledge it is advisable to ensure you are selecting people who have the requisite attributes or behaviors.

For example, ISO 19011 recommends the requisite behaviors for auditors. Selecting someone for training who does not have fortitude would a waste of time and money if the plan was to develop this person as an auditor.

Of course, the specification for HR to recruit the right people should be a good starting point.

Unfortunately, ISO 9001 clause 6.2.2 does not support clause 6.2.1 in clarifying the competence (instead of training) requirement. You have to refer to the normative reference ISO 9000 to obtain the clarification necessary to conform to clause 6.2.1.

Destroyed Training Records

jpb0205

somashekar

Jen Kirley

Quality and Auditing Expert

AndyN

Moved On

normzone

jpb0205

pldey42

normzone

John Broomfield

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