SBS - The best value in QMS software

Does training have to be written?

RoxaneB

Super Moderator
Super Moderator
#11
We document webinars as training and we have no control over those.
Control over what? The content of the webinars? If they are not yours, I suppose not...but you evaluate competency as the means to determine if training has been effective.

Many internal auditors go offsite to be trained by a third party. Organizations have no control over what their employees are learning. The effectiveness of the internal audit program (i.e., results, value-add to the organization, etc.) demonstrates if they are competent and some of this is supported by the effectiveness of the training. (NOTE - I say "some" because, let's be honest here, some people just should not be auditors. :lol: ).
 
Elsmar Forum Sponsor

Deli88

Involved In Discussions
#12
Verbal training with a record of who received the training is fine. Make sure you evaluate the effectiveness of the training.
Hi Julie,

We had a recent finding against us as we didn't have a documented means of evaluating the effectiveness of training.

Do you have some examples of how you would document this?

Thanks

Deli
 

Mike S.

Happy to be Alive
Trusted Information Resource
#13
Sometimes a test or similar evaluation of competence takes place after the training. For example, if you are training someone to weld, you might have them do some welding that is evaluated for acceptability.

Sometimes you monitor the output of the person who was trained to see if their output is as expected.
 

Randy

Super Moderator
#14
Hi Julie,

We had a recent finding against us as we didn't have a documented means of evaluating the effectiveness of training.

Do you have some examples of how you would document this?

Thanks

Deli
Evaluating the effectiveness of training? 3 questions come up right off the bat.

1 - Are the recipients able to do that for which they were trained in a manner that it works for you? Binary answer ... Yes or No

2 - Were the recipients capable to do that for which they were to be trained in a manner that would work for you? Binary answer .... Yes or No

3 - Was the training delivered something that was actually intended to be beneficial or was it just stylish?...... Multiple choice


I like #3 because I experienced literally hundreds of cases where people were attending a Lead Auditor course and starting off it was a total waste of time and money for and by them. The vast majority could have gotten by with an Internal Auditor course or even just a simple one day intro to whatever standard was involved...............BUT!................ Lead Auditor courses were and still are "STYLISH" and there's no intent to go beyond getting a fancy certificate with a handsome logo and being able to claim that they're "certified" because they passed a test.

You got evaluate training through performance that is directed towards a desired outcome and not with some silly test that someone like me could probably pass without doing a single second of the training (I have done it more than once during an audit to illustrate the bogus pass = competence concept just before delivering more the NC). I've an earned MBA (finance heavy) ........You don't want me managing your business finances, trust me, but I can pass the test. (got an exam 98)

Help any?
 

Big Jim

Super Moderator
#15
Hi Julie,

We had a recent finding against us as we didn't have a documented means of evaluating the effectiveness of training.

Do you have some examples of how you would document this?

Thanks

Deli
That is an inappropriate nonconfirmance and it should have been contested. The only documented information referred to in 7.2 is retained documented information which is defined as records is the appendix. A documented means of evaluating would be maintained documented information according to the appendix AND IS NOT REQUIRED FOR 7.2.
 
Thread starter Similar threads Forum Replies Date
I Training records and levels - When does training NOT need a record? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
L Does anybody have quiz's available? ISO 13485:2016 Training Material Training - Internal, External, Online and Distance Learning 2
S Does anyone have any pointers on TS 16949 Internal Auditor Training IATF 16949 - Automotive Quality Systems Standard 4
S Does Senior Management require Training Plans? Training - Internal, External, Online and Distance Learning 7
S Does anyone have an AS9100 System Training Datum? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
A Does any one have FDA 21 CFR Part 820 QSR training material? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 13
W Does anyone have a Training Exercise for 5 Whys Problem Solving? Problem Solving, Root Cause Fault and Failure Analysis 11
M Does anyone have information on SOPFEL Training & Maintenance Documentation? Training - Internal, External, Online and Distance Learning 3
sagai Required Documentation for 820.25(b) - What does "Training shall be documented" mean 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 15
S What does Training Mandays indicate? Training - Internal, External, Online and Distance Learning 8
A Does Training come under HR department? Training - Internal, External, Online and Distance Learning 29
I Does Anyone Have any Basic Calibration Training Materials? General Measurement Device and Calibration Topics 5
T Does anyone have an effective training management and tracking system in place? Training - Internal, External, Online and Distance Learning 1
G Does BSI do ISO 9001/TS 16949 Lead Auditor training? Training - Internal, External, Online and Distance Learning 5
J Does anyone have .ppt presentations for Respirator Training? Occupational Health & Safety Management Standards 4
D Does anyone have training material they are willing to share on Cpk, FMEA, 8D? Training - Internal, External, Online and Distance Learning 7
J Does ISO9k2k require Safety Training needed in production floor ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 20
A AS9102 Training - Does anyone have a good AS9102 training presentation AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
Q Who does what training? Training of our machine operators Training - Internal, External, Online and Distance Learning 3
K Lead Internal Auditor Training - Does the lead auditor require additional training? Internal Auditing 6
S Mistake Proofing and Root cause analysis - Does anyone have any training materials? Problem Solving, Root Cause Fault and Failure Analysis 7
I Internal Auditor Training - Does TS 16949 Require Formal Training or Certification? Internal Auditing 19
N Blueprint reading training - Does anybody have any recommendations? Training - Internal, External, Online and Distance Learning 6
D Does anyone know of a good FMEA training class for TE Supplement suppliers? Training - Internal, External, Online and Distance Learning 2
Howard Atkins Does anyone know of training courses in English for VDA? VDA Standards - Germany's Automotive Standards 2
S Does anyone know where Guide 25/Palcan Training is available? Training - Internal, External, Online and Distance Learning 1
N Does anyone use SGS for ISO 13485 / CE certification Registrars and Notified Bodies 0
G Does FDA allows remote approvals of quality documentation. Is there any specific guidance on signing any quality records remotely? Document Control Systems, Procedures, Forms and Templates 1
B Does FDA Registration QSR need to cover non-medical devices for contract repackager? US Food and Drug Administration (FDA) 1
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
0 To which part of 13485 does this refer? ISO 13485:2016 - Medical Device Quality Management Systems 3
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
lanley liao Does the customer`s trademark belong to customer-supplied property? Oil and Gas Industry Standards and Regulations 2
H How does a gas turbine work on diesel fuel? Oil and Gas Industry Standards and Regulations 12
G What does performance specification include? US Food and Drug Administration (FDA) 1
W Where does a coatings and paint company fall in IATF? IATF 16949 - Automotive Quality Systems Standard 5
A How much does a complete biocompatibility test package cost? Other ISO and International Standards and European Regulations 1
B Does anybody know how to get older versions of Minitab to work in Windows 10? Quality Tools, Improvement and Analysis 9
M Does the ISO 9001:2015 standard require a disaster recovery plan or emergency response plan ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
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
S How long does it take to register a product with MHRA? UK Medical Device Regulations 4
M Quality Manual - Where does Revision History Section go? Document Control Systems, Procedures, Forms and Templates 8
U Does *anyone* know a lab that will test to EN 455-4 Medical Gloves shelf life determination? EU Medical Device Regulations 1
A Brexit When does the UK responsible person need to be in place? UK Medical Device Regulations 10
M How does IEC-60601-1 apply to a non-medical device in the patient vicinity? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
N Does anyone have experience of GB/T 34986-2017? China Medical Device Regulations 1
Z Does anyone have experience with EN ISO 17664 ? IEC 62366 - Medical Device Usability Engineering 9
F Does anyone have an ESD quality/cooler talk to share? Training - Internal, External, Online and Distance Learning 4
A What does this line from MDCG 2020-3 (MDR art. 120 substantial change) mean to you? EU Medical Device Regulations 4

Similar threads

Top Bottom