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Depth of Internal Auditing and Training aspects in Research & Development (R & D)

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audit man-days, internal audits, pharmaceuticals and pharmaceutical industry, research and development (r&d), training (general), training (on-the-job), training effectiveness
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  Post Number #1  
Old 5th May 2012, 01:35 PM
v9991

 
 
Total Posts: 817
Question Depth of Internal Auditing and Training aspects in Research & Development (R & D)

how different would be the training/audit-criteria for R&D activities.
internal audit:
1) basically, in other routine areas, the amount of compliance/verification is more....what would be emphasis for R&D audits.
2) would the audit frequency be little different for R&D. (since the deliverables or cycle time of development is little longer ...)
3) it would be obvious to incorporate more technical persons in the audit team.
Training
4) can we exempt the R&D personel from rigorous/routine training schedule as followed by other mfg. areas?
5) obviously the scope and depth of subjects covered for R&D would be little different than that of manufacturing folks.?
your thoughts please.

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  Post Number #2  
Old 7th May 2012, 07:26 AM
Stijloor's Avatar
Stijloor

 
 
Total Posts: 14,713
Re: Depth of Internal Auditing and Training aspects in Research & Development (R & D)

A Quick Bump!

Can someone help?

Thank you very much!!

Stijloor.
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  Post Number #3  
Old 7th May 2012, 10:06 AM
Ninja's Avatar
Ninja

 
 
Total Posts: 482
Re: Depth of Internal Auditing and Training aspects in Research & Development (R & D)

Quote:
In Reply to Parent Post by v9991 View Post

how different would be the training/audit-criteria for R&D activities.
internal audit:
1) basically, in other routine areas, the amount of compliance/verification is more....what would be emphasis for R&D audits.
2) would the audit frequency be little different for R&D. (since the deliverables or cycle time of development is little longer ...)
3) it would be obvious to incorporate more technical persons in the audit team.
Training
4) can we exempt the R&D personel from rigorous/routine training schedule as followed by other mfg. areas?
5) obviously the scope and depth of subjects covered for R&D would be little different than that of manufacturing folks.?
your thoughts please.
Howdy,

I'll chime in, but others who perform Internal R&D Audits may have more depth to offer.

internal audit:
1) basically, in other routine areas, the amount of compliance/verification is more....what would be emphasis for R&D audits.
Design Control. Is R&D done according to whatever development system you have in place?
Evidence of planning, review, outputs matching inputs, verification/validation, training.
2) would the audit frequency be little different for R&D. (since the deliverables or cycle time of development is little longer ...)
Since you are auditing the PROCESS rather than the results, the frequency does not need to be different. The process happens every day (we hope).
3) it would be obvious to incorporate more technical persons in the audit team. Specifically the person(s) responsible for the development effort moving forward, though all need to have training.
Training
4) can we exempt the R&D personel from rigorous/routine training schedule as followed by other mfg. areas? Well, maybe? Folks need to be trained to what you decide they need to be trained to. R&D folks use equipment...are they trained? They likely are developing stuff for future production...do they do it on any production equipment or manufacturing processes? Should they not know what those processes are? IMO, R&D needs MORE training, not less.
5) obviously the scope and depth of subjects covered for R&D would be little different than that of manufacturing folks.? Certainly different, but remember that R&D folks still need to be part of the system achieving the goals of the company. They get a whole lot more freedom, but it is very easy to wander off into the weeds...the design control system should simply give some boundaries (Mgmt review, input/output verification, planning) to keep the goal in sight and make sure you're moving that direction.
  Post Number #4  
Old 7th May 2012, 02:15 PM
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Randy

 
 
Total Posts: 8,273
Re: Depth of Internal Auditing and Training aspects in Research & Development (R & D)

1st and foremost, there is no real requirement for training, but there is for competence, and training may be one of the methods used to achieve it.

2nd, you can't do away with what isn't required, but then again you can't exempt yourself from clause 6.2.1 or 6.2.2...That dog won't hunt

So regardless of whether or not training is happening you still must provide evidence of:
1) required competence
2) evaluation of achievement of required competence
3) and supporting records
  Post Number #5  
Old 8th May 2012, 06:14 AM
v9991

 
 
Total Posts: 817
Exclamation Re: Depth of Internal Auditing and Training aspects in Research & Development (R & D)

Thank you Ninja & Randy,
any thoughts on internal audit please.

Quote:
In Reply to Parent Post by v9991 View Post

how different would be the training/audit-criteria for R&D activities.
internal audit:
1) basically, in other routine areas, the amount of compliance/verification is more....what would be emphasis for R&D audits.
2) would the audit frequency be little different for R&D. (since the deliverables or cycle time of development is little longer ...)
3) it would be obvious to incorporate more technical persons in the audit team.
your thoughts please.
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