NonProduction Training T & E Requirements ??

L

louie

#1
#1
We are building a training room for one of our suppliers complete with mock systems with mock parts. This area is for training only. There will be no scheduled uptime, available R&M, etc.

Do we need to cover all the TE requirements on this? Or is it as simple as writing another procedure to cover such instances?

Have a line up meeting next week -- responses please !!!!!!
 
GAGEpack - Gage & Calibration Management
Elsmar Forum Sponsor
Marc

Marc

Fully vaccinated are you?
Leader
#2
#2
You determine the details of your training requirements, not the auditor. You may be asked to explain why you train to the detail level you train to and what you exclude and why, however.
 
L

louie

#3
#3
Marc
I think you misunderstood my dilemma...
We are a Tier 1 supplier, building a training room for our customer's new plant. Since there will be no "production" on this line, do I treat this as a pure prototype type build for documentation issues or do I have to complete all FMEA's CP's, etc. (My guys are trying to say they don't need to do the FMEA's, CP's etc., and I would like to see this treated like all "regular" projects) - What do I HAVE to do regarding R&M, LCC, statistical data??????
have line-up meeting 6/26

Thanks !!!

[This message has been edited by louie (edited 26 June 2000).]
 
Marc

Marc

Fully vaccinated are you?
Leader
#4
#4
Ah! I hadn't thought of a supplier of training rooms as a T&E supplier. I can't help you here - maybe Laura or one of the others has some insight.
 
L

Laura M

#5
#5
Not sure I can help. This is certainly unique.
The first question that comes to mind is what did the customer specify as requirements and how are you proving you meet them? I don't think all the T&E stuff would apply if it is not ultimately producing product.

Now that I think of it....would it be appropriate for the Training facility to actually produce some defective product to see if the process controls worked and "detections" on the FMEA were accurate?

Just thinking out loud....
 
Marc

Marc

Fully vaccinated are you?
Leader
#6
#6
Do we need to cover all the TE requirements on this? Or is it as simple as writing another procedure to cover such instances?
Click to expand...
I would think these are requirements that should have been specified during the quotation phase, no? :confused:

Maybe I'm misunderstanding the question.

[This message has been edited by Marc Smith (edited 28 June 2000).]
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
S HACCP and GMP+ B2 training questionarie Food Safety - ISO 22000, HACCP (21 CFR 120) 0
U Does Medical Device training video falls under labeling requirement ? Other US Medical Device Regulations 4
L Meeting training requirements for IATF Manufacturing and Related Processes 3
B PMA Training/Educational Opportunity US Medical Device Regulations 1
K Best Internal Auditor Training Internal Auditing 18
R How to Assess Online/eBook Training Effectiveness ? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
Q Training Matrix Software Training - Internal, External, Online and Distance Learning 2
S ISO 13485 certification training Training - Internal, External, Online and Distance Learning 1
S AS9120 - New Internal Auditor Training requirement? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 11
M English Language training on MHLW MO169? Japan Medical Device Regulations 1
M On-demand EU MDR Compliance toolkit with online training courses, templates & document management system Training - Internal, External, Online and Distance Learning 0
Sam.F Question about training Training - Internal, External, Online and Distance Learning 20
Q Onboarding and Training Checklist Training - Internal, External, Online and Distance Learning 5
G Any training material on the 1-10-100 rule? Training - Internal, External, Online and Distance Learning 4
Sam.F Anyone knows velocity 360 training Training - Internal, External, Online and Distance Learning 11
Q Safety Training Program Training - Internal, External, Online and Distance Learning 8
R ISO 17025 Lead Assessor Training ISO 17025 related Discussions 0
A New to QMS and regulatory... advice on training/certification? ISO 13485:2016 - Medical Device Quality Management Systems 1
T Counterfeit parts training AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
Anerol C FMEA workshop training South of Texas FMEA and Control Plans 0
Anerol C FMEA Training for South Texas Service Industry Specific Topics 0
N What quality training do you suggest? Manufacturing and Related Processes 14
Q Lead Auditor Training Training - Internal, External, Online and Distance Learning 31
S Training in D&D for engineers with no medical device experience Design and Development of Products and Processes 8
CPhelan Optimizing Training Review Training - Internal, External, Online and Distance Learning 4
Q Documenting Effectiveness of Training Training - Internal, External, Online and Distance Learning 14
J Old procedure review and training requirements Document Control Systems, Procedures, Forms and Templates 9
P Have you purchased training materials from the 13485store.com? Training - Internal, External, Online and Distance Learning 0
Q Training For Temps Training - Internal, External, Online and Distance Learning 1
S Training for PRRC (person responsible for regulatory compliance) EU Medical Device Regulations 3
T IAQG Approved Training Providers vs. Probitas Authentication Approved Training Providers AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
C Training for Manufacturing Nonconformances and CAPS with focus on the wording Nonconformance and Corrective Action 4
H Product Safety & Conformity Representative (PSCR) Training Company IATF 16949 - Automotive Quality Systems Standard 0
Q ISO Training Providers to fix careless workers? Training - Internal, External, Online and Distance Learning 19
Q Training Machinists on Company Processes Training - Internal, External, Online and Distance Learning 6
R Using Scrapped NC items for training Medical Device and FDA Regulations and Standards News 15
D IATF 16949 Clause 7.2.2 - On the job training IATF 16949 - Automotive Quality Systems Standard 2
D Training for ISO 17025 ISO 17025 related Discussions 2
Q Documented Evidence of Training ISO 13485: 2016 ISO 13485:2016 - Medical Device Quality Management Systems 46
Q Training vs competence ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
Crusader ASQ AS9100 Lead Auditor Training Career and Occupation Discussions 27
Anerol C On line training for REACH, RoHS, Halogen RoHS, REACH, ELV, IMDS and Restricted Substances 1
M Clinical evaluation report training EU Medical Device Regulations 3
E AS9146 FOD Training AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
Cats Clause ISO 9001:2015 7.1.5 Monitoring and measuring resources: Application to training providers ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
L How to find a good 510(k) submission training? Other US Medical Device Regulations 2
L How to find a good online CFDA submission training? China Medical Device Regulations 5
Sidney Vianna IAQG News New IAQG Resources - AS9104-3 Requirements for Aerospace Auditor Competency & Training Courses AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
S Lean Six Sigma Online Training Six Sigma 1
M RM 13006 Training Syllabus AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5

Similar threads

Top Bottom