Subject Matter Expert Training for Auditors

SRQAAuditor

Starting to get Involved
#1
Hello,
I wanted to see what others are using or doing to provide training for people identified as subject matter experts (SME). We use SMEs for 3rd party audits and are wanting to provide them with some training as to what they should know, and what might be asked of them.

Any ideas or suggestions would be appreciated!
 
Elsmar Forum Sponsor
#2
Hello,
I wanted to see what others are using or doing to provide training for people identified as subject matter experts (SME). We use SMEs for 3rd party audits and are wanting to provide them with some training as to what they should know, and what might be asked of them.

Any ideas or suggestions would be appreciated!
You are a CB (3rd party)? Or what role are these auditors?
 

qualityfox

Involved In Discussions
#5
Are you wanting to train them to be SME or to be an auditor? IMHO, you become an SME over time based on job experience. If you are wanting to know what the SME needs to know about ISO to do audits, I believe you need to train them in the entire standard so they have a complete understanding of what an ISO compliant QMS should look like.
 
#7
Hello,
I wanted to see what others are using or doing to provide training for people identified as subject matter experts (SME). We use SMEs for 3rd party audits and are wanting to provide them with some training as to what they should know, and what might be asked of them.

Any ideas or suggestions would be appreciated!
I'm confused here as to what you're asking. Training for SME's? To audit? Or SME training for auditors? You can get any regular auditor training for an SME, but you can't "train" an SME...
 

Jim Wynne

Staff member
Admin
#9
Hello,
I wanted to see what others are using or doing to provide training for people identified as subject matter experts (SME). We use SMEs for 3rd party audits and are wanting to provide them with some training as to what they should know, and what might be asked of them.

Any ideas or suggestions would be appreciated!
What do you mean when you say that you "...use SMEs for 3rd party audits"?
 

SRQAAuditor

Starting to get Involved
#10
For instance, if an auditor is reviewing corrective and preventive action, we would have our CAPA Manager speak to the auditor. The CAPA Manager is our Subject Matter Expert for CAPA.

Regards,
 
Thread starter Similar threads Forum Replies Date
J Subject Matter Expert/Trainer Qualification Form Training - Internal, External, Online and Distance Learning 3
S Should there be a SME (Subject Matter Expert) for each element? Training - Internal, External, Online and Distance Learning 3
B Handling 'Subject Matter Experts' (SMEs) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
P Looking for subject matter for thesis about TQM, ISO9000, TS19649 IATF 16949 - Automotive Quality Systems Standard 4
B AIAG/VDA’s FMEA Manual Is a Major Advance (my take on this subject) FMEA and Control Plans 2
C Determining if Maintenance Contractor is an External Service subject to ISO 9001 Clause 8.4 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 43
M Informational USFDA Final Rule – Human Subject Protection; Acceptance of Data From Clinical Investigations for Medical Devices Medical Device and FDA Regulations and Standards News 0
WEAVER Can automatic machine testers be subject to GR&R? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
M Treatment system data analysis - Subject to CFR part 11? Entire system? Qualification and Validation (including 21 CFR Part 11) 7
M Is an R&D company subject to FDA regulation when licensing and not manufacturing? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
V Language is not a barrier if you know the "thing/subject" and "art of communicating" Coffee Break and Water Cooler Discussions 8
J ISO 9001 and Six Sigma - What is your take on this subject? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
Q Are IVD Distributors subject to "Qualification" under our Quality System? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
I Subsidiary also subject to TS16949 certification? IATF 16949 - Automotive Quality Systems Standard 6
ScottK Are printed paper products subject to REACH and RoHS? RoHS, REACH, ELV, IMDS and Restricted Substances 2
S Is firmware or embedded software subject to the same standards as software? Qualification and Validation (including 21 CFR Part 11) 9
T Am I subject to FDA regulations in Europe? Sales/service branch of an organization US Food and Drug Administration (FDA) 3
D Presentation on Subject: Potatoes (QSR interested in the potato market) Misc. Quality Assurance and Business Systems Related Topics 17
F What is Constrains k (dimension subject to law provision) - Characteristic on print? Various Other Specifications, Standards, and related Requirements 1
Antonio Vieira Self training! External training about a subject that you already dominate Training - Internal, External, Online and Distance Learning 5
J Information on the subject of ISO / TS 16949 in the electronic form IATF 16949 - Automotive Quality Systems Standard 2
A Process Statistical Design - Is there any way to handle this subject? Design and Development of Products and Processes 1
K Customer Specific Requirements - Which ones are subject to 3rd party audit? IATF 16949 - Automotive Quality Systems Standard 4
apestate Recommended Reading List - Research and reading on the subject of quality Book, Video, Blog and Web Site Reviews and Recommendations 6
D Subject: 7.4.1 - Scope of "Product" and "Supplier" Supplier Quality Assurance and other Supplier Issues 6
R Samples for marketing purposes - Subject to Contract Review? Contract Review Process 4
optomist1 Do Morals & Character Matter? Coffee Break and Water Cooler Discussions 7
R Do Brands Matter When Purchasing Bore Gauge? General Measurement Device and Calibration Topics 2
Wes Bucey Trade Secrets - not a joking matter! World News 0
K The only 5 Interviewing Questions that matter Career and Occupation Discussions 12
J Quality Organization - Does it matter where it reports to? Other US Medical Device Regulations 13
T Quality policy? A matter of interpretation? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
eternal_atlas Does the age of the lead auditor matter in QMS audits ? General Auditing Discussions 32
J CMM SPC - Does part measurement order matter? Statistical Analysis Tools, Techniques and SPC 12
Q Reduction Of Foreign Matter (Contamination) Complaints in your Factory Manufacturing and Related Processes 6
A Required platform for scales (a weighty matter?) General Measurement Device and Calibration Topics 8
T QMS in place - How to illustrate? Small matter of bringing it into action ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
Marc Just a Matter of Communication? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
B Clinical Evaluation Expert Panels - MDR EU Medical Device Regulations 1
M Informational EU – Flyer – Call for expression of interest for expert panels on medical devices and in vitro diagnostic medical devices (2019/C 323/05) Medical Device and FDA Regulations and Standards News 0
Watchcat MDD, MDR/IVDR, Working Groups, Expert Panels, MEDDEVs and Other EU Guidances EU Medical Device Regulations 32
M Informational EU – Some documents related to Call for expression of interest for expert panels on medical devices and in vitro diagnostic medical devices Medical Device and FDA Regulations and Standards News 0
M Informational EU – Call for expression of interest for expert panels on medical devices and in vitro diagnostic medical devices Medical Device and FDA Regulations and Standards News 1
M Informational EU – Commission Implementing Decision (EU) as regards the designation of expert panels in the field of medical devices Medical Device and FDA Regulations and Standards News 0
M Informational EU – Meeting minutes – Competent Authorities on Substances of Human Origin Expert Group Medical Device and FDA Regulations and Standards News 0
M Informational European Commission expert panels on medical devices and in vitro diagnostic devices Medical Device and FDA Regulations and Standards News 0
M Informational MHRA Guidance – Recommendations from the independent Expert Advisory Group on the use of Paclitaxel Drug-Coated Balloons (DCBs) and Drug-Eluting Stent Medical Device and FDA Regulations and Standards News 0
R Pls help --- Need expert advice on Video Measurement Measurement Uncertainty (MU) 0
M Informational MDCG 2019-3 Interpretation of Article 54(2)b – Pre- market clinical evaluation consultation procedure with the involvement of expert panels Medical Device and FDA Regulations and Standards News 0
M Informational RIVM – Summary International Expert Meeting on breast implant-associated lymphoma Medical Device and FDA Regulations and Standards News 0

Similar threads

Top Bottom