SBS - The Best Value in QMS software

We need to identify continuing training needs for external source training

#1
Training needs


We have crated a trainng matrix were we have identified what the training requirements are for each position. However, during one of our surveillance audits, our registrar raised a nonconformance because we needed to identify continuing training needs for externally sourced training. Can someone help me understand this statement?
 
Elsmar Forum Sponsor

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#2
identify continuing training needs for externally sourced training.
Well, the key words here are continuing and externally sourced. The question becomes Do you sub out any 'continuing training' - if not, be ready to say so.

I guess. It's pretty cryptic to me as well. Can you call and ask what they mean by it and their expectation(s)? In reading element 4.18 "Training Element" I do not see the word continuing anywhere.

At the time they wrote it up I would have asked them to state the nonconformance more clearly and I would have asked them their expectations. I would have asked them "Where in QS9000 does it state this?" They'll hem and haw and it will come down to their expectations in interpreting the element. They have certain basics in a system they expect to see (paradigm) and if it's not there they write you up. Every implementation I have done from the first meeting I say: "You better be ready to fight, to challange your registrar. Auditors are not always right."

Have I confused things or does this help at all?
 
#3
Thanks for your input Mark. I am inheriting this training needs nonconformance. If I had been the one audited, I would have certainly asked for clarification. It has been 18 months since the auditor wrote this nonconformance and will do a follow up in June. We have made several attempts to address it but I would like to know if he even remembers what he meant. I'm sure I will get my answer then.
 
J

John C

#4
MC1,
How about interpreting the word 'continuing' as 'ongoing'? That way it tells me that the auditor saw some need for external training (training resource not existing in house). Maybe some person was trained externally and it seems likely that it will be needed again. Or maybe it's just something he/she has come across before and now thinks everyone should do it. I would add a few words to your existing training document where it says how you identify training needs, eg; "....including continuing training needs for externally sourced training; In all cases, when reviewing a person's training plan or setting up a training plan for a new employee, the scope of training required must be comprehensive and shall not exclude training only available from external sources." You could add a list of external training organisations and training available or previously provided, just to ice the cake - A little bit of horse manure like this never does any harm. Also, it might be right on the button. If you haven't considered it, then maybe you need it.
rgds, John C
 
Thread starter Similar threads Forum Replies Date
X Existing Toolroom Process Validation - Need to identify clauses addressed. Manufacturing and Related Processes 7
Le Chiffre At what point do you need to identify a U.S. Agent - 510(k) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
T Do we need an SOP for ISO 9001? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
B Do CTQs need to be equipment specific? FMEA and Control Plans 8
K Contract Manufacturer Do they need a complaint procedure? Medical Device and FDA Regulations and Standards News 8
K Screen printing ink and machine selection_ Need help Manufacturing and Related Processes 6
D Do employee training records need to be centralized? IATF 16949 - Automotive Quality Systems Standard 10
H Need of EU Representative Designation for Turkey? EU Medical Device Regulations 3
H If we use agile - do we still need to document TF as a waterfall just for the notified bodies need? IEC 62304 - Medical Device Software Life Cycle Processes 2
briteme4 AS9102 First Article Inspection - do I need a second reviewer and signer? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
J Furnace repaired - Do I need a new initial TUS? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
B Does FDA Registration QSR need to cover non-medical devices for contract repackager? US Food and Drug Administration (FDA) 1
S Need ISO 15189:2012 Documentation toolkit. Document Control Systems, Procedures, Forms and Templates 0
J Need a contract monitoring Tool General Information Resources 0
P UDI-PI requirements on reusable surgical device, do we need serialisation? ISO 13485:2016 - Medical Device Quality Management Systems 3
J Need Help with FPY Data in Assembly Process Manufacturing and Related Processes 7
W 17025 and NIST handbook relationship (need advice) ISO 17025 related Discussions 8
lanley liao Does all of the suppliers need to integrated into the supplier list qualified of the company? Oil and Gas Industry Standards and Regulations 2
K Need procedure for D&D inputs? ISO 13485:2016 - Medical Device Quality Management Systems 4
S Need help on "Country of Origin" Medical Device and FDA Regulations and Standards News 0
Ed Panek Immediate need for 80601-2-56 Consulting expert. PM me for details Career and Occupation Discussions 0
Tagin You're Gonna Need a Bigger Root Cause Coffee Break and Water Cooler Discussions 12
M PSA Suppliers - CSR matrix and need the quality manual of PSA APQP and PPAP 6
M Need Help With Information Security Asset Risk Register IEC 27001 - Information Security Management Systems (ISMS) 2
K "World Class Product" based QM. I need advice. Quality Management System (QMS) Manuals 14
I Do I need to sign off my annual audit calendar? Internal Auditing 2
P Do we need to retrospectively use the "MD" symbol (indicating device is a medical device) on labels, e.g. finished devices within expiration date? EU Medical Device Regulations 2
M Do I need separation in my circuit with a medical charger? IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
V Certified Auditor - Need of additional certification specific to industry ( GMPs) ASQ vs ECA vs others Professional Certifications and Degrees 1
D Low risk IVD study in the UK, do I need MHRA approval? UK Medical Device Regulations 1
A Medical Device Contract Manufacturer - Does the CM need to register with FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
J Records Control - Does each individual record need to be numbered? Records and Data - Quality, Legal and Other Evidence 2
N Is there a need for clinical test of Class IIa products (for MDR)? EU Medical Device Regulations 2
J Do Software Subcontractors need to be ISO13485 compliant in the EU? EU Medical Device Regulations 3
K Do I need a "State of the art" plan? CE Marking (Conformité Européene) / CB Scheme 1
S Need advice for schooling Quality Manager and Management Related Issues 5
R What information do i need to get from the device manufacturer 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
S Need guidance on project ISO 13485:2016 - Medical Device Quality Management Systems 2
H Need MSA 4th ed. compliant attribute MSA template General Measurement Device and Calibration Topics 4
J Need Change Control Yes/No Decision Tree Template ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
C Does an accessory need an IFU if it use is discussed in the Parent device IFU? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
B Countries with no need for FSC (Free sales certificate) Other Medical Device Regulations World-Wide 0
R The term "Benefit Risk Ratio" in EU MDR, do I need to present benefit risk analysis as a RATIO Risk Management Principles and Generic Guidelines 4
A Brexit When does the UK responsible person need to be in place? UK Medical Device Regulations 10
R Do we need issue ECN (Engineering Change Notice) towards updated Material Specification? Design and Development of Products and Processes 2
N IPC-A-630 - Is this free or do i really need to pay for it? Manufacturing and Related Processes 4
C ISO/ IEC 17021 Resource requirement (need help) Document Control Systems, Procedures, Forms and Templates 5
P Need a programmer for QVI's VMS software for optical inspection machine Inspection, Prints (Drawings), Testing, Sampling and Related Topics 0
silentmonkey How to decide what characteristics need to be verified during incoming inspection? ISO 13485:2016 - Medical Device Quality Management Systems 5
D Change Approval Requirements - Does every change need formal customer approval? Design and Development of Products and Processes 17

Similar threads

Top Bottom