The Cove Business Standards Discussion Forums More Free Files Forum Discussion Thread Post Attachments Listing Cove Discussion Forums Main Page
UL - Underwriters Laboratories - Health Sciences
Go Back   The Elsmar Cove Quality Assurance Discussion Forums > Common Quality Assurance Processes and Tools > Auditing Quality and Environmental Management Systems > Internal Auditing
Forum Username

Elsmar Cove Forum Visitor Notice(s)

Wooden Line

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


Search the Cove
Search the Site
Monitor the Elsmar Forum
Sponsor Links



Courtesy Quick Links

Links that Cove visitors will find useful in your quest for knowledge:


ASQ - American Society for Quality

International Standards Organization - ISO Standards and Information

Howard's
International Quality Services

Marcelo Antunes'
SQR Consulting, and
Medical Devices Expert Forum

Bob Doering's
Correct SPC - Precision Machining

NIST's Engineering Statistics Handbook

IRCA - International Register of Certified Auditors

SAE - Society of Automotive Engineers

Quality Digest

IEST - Institute of Environmental Sciences and Technology


LinkedIn Groups

ISO for Small Businesses

Information Security Community

Medical Devices Group

Quality and Regulatory Network

AS91XX Series - Tips and Advice

FDA (Food and Drugs)


Related Topic Tags
audit man-days, internal audits, pharmaceuticals and pharmaceutical industry, research and development (r&d), training (general), training (on-the-job), training effectiveness
Reply
 
Thread Tools Search this Thread Rate Thread Content Display Modes
  Post Number #1  
Old 5th May 2012, 12:35 PM
v9991

 
 
Total Posts: 834
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.

Sponsored Links
  Post Number #2  
Old 7th May 2012, 06:26 AM
Stijloor's Avatar
Stijloor

 
 
Total Posts: 14,962
Re: Depth of Internal Auditing and Training aspects in Research & Development (R & D)

A Quick Bump!

Can someone help?

Thank you very much!!

Stijloor.
Sponsored Links

  Post Number #3  
Old 7th May 2012, 09:06 AM
Ninja's Avatar
Ninja

 
 
Total Posts: 520
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, 01:15 PM
Randy's Avatar
Randy

 
 
Total Posts: 8,339
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, 05:14 AM
v9991

 
 
Total Posts: 834
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.
Reply

Lower Navigation Bar
Go Back   The Elsmar Cove Quality Assurance Discussion Forums > Common Quality Assurance Processes and Tools > Auditing Quality and Environmental Management Systems > Internal Auditing

Bookmarks


Visitors Currently Viewing this Thread: 1 (0 Registered Visitors (Members) and 1 Unregistered Guest Visitors)
 
Thread Tools Search this Thread
Search this Thread:

Advanced Forum Search
Display Modes Rate Thread Content
Rate Thread Content:

Forum Posting Settings
You may not post new threads
You may not post replies
You may not post attachments
You may not edit your posts

BB code is On
Smilies are On
[IMG] code is On
HTML code is Off


Similar Discussion Threads
Discussion Thread Title Thread Starter Forum Replies Last Post or Poll Vote
R&D (Research and Development) & Workorder Formats Goldstarr Documentation Control Systems, Procedures, Forms and Templates 2 23rd January 2013 08:03 AM
Quality Management System for R&D (Research & Development) work Chennaiite ISO 9000, ISO 9001, and ISO 9004 - Questions and Discussions 7 15th June 2012 04:12 AM
Training of Internal Quality Auditors - Over all the aspects of ISO10011 Parts 1 & 2? Ghai Auditing Discussions 3 3rd April 2004 10:57 AM
Auditing Depth - IT, Finance and H&S and Environment Faz1975 ISO 9000, ISO 9001, and ISO 9004 - Questions and Discussions 6 2nd February 2004 04:46 AM
R&D (Research & Development) Department - Off-site brain trust Jgryn TS 16949 - International Automotive Quality Systems Standard 1 23rd September 2003 11:35 AM



The time now is 01:22 PM. All times are GMT -4.
Your time zone can be changed in your UserCP --> Options.


 


NOTE: This forum uses "Cookies" -- The Elsmar Cove is *Copyright Free*.