SOP Training/Competence in 24/7 Operation contractor company

SpinDr99

Involved In Discussions
#1
Hi All, I am in a 24/7/365 contractor company. The contract states we must be compliant (not certified) to ISO-9001:2008 (yes, I know, but that's what the contract requires). Having said that, I'm documenting our processes in SOP's and stuck on training and effectiveness of training, especially for our 2nd, 3rd and weekend personnel (many are part-time). Outside of physically being there to have them read and sign, I'm open to any suggestions to document SOP review (for training), and how to then show effectiveness of the training. Most of the SOP's are processes that are not regularly performed.

I thank you in advance for any suggestions you can offer.
 
Elsmar Forum Sponsor

AMIT BALLAL

Super Moderator
#2
Hi All, I am in a 24/7/365 contractor company. The contract states we must be compliant (not certified) to ISO-9001:2008 (yes, I know, but that's what the contract requires). Having said that, I'm documenting our processes in SOP's and stuck on training and effectiveness of training, especially for our 2nd, 3rd and weekend personnel (many are part-time). Outside of physically being there to have them read and sign, I'm open to any suggestions to document SOP review (for training), and how to then show effectiveness of the training. Most of the SOP's are processes that are not regularly performed.

I thank you in advance for any suggestions you can offer.
Prepare a questionnaire based on SOP. And tell the personnel in 2nd/3rd/weekend to give a post training test to ensure they have read the SOP and understood it.

:2cents:
 

Stijloor

Staff member
Super Moderator
#3
Prepare a questionnaire based on SOP. And tell the personnel in 2nd/3rd/weekend to give a post training test to ensure they have read the SOP and understood it.

:2cents:
Next, you want to observe your personnel and verify that they are able to perform what the SOP requires. That’s called competency!
 

SpinDr99

Involved In Discussions
#4
Thanks for your replies. The arduous part here is that our part-timers aren't all on specific schedules. Many are simply on an as-needed basis and call-ins. This part of our operation is transportation and most are retired, so they're ok with only working a few times a month (ex. to fill-in for a sick driver). So training and determining competency could go on for months and months.
 

SpinDr99

Involved In Discussions
#6
Actually it's not since our contract requires 2008 COMPLIANCE. There's no requirement to become 2015 compliant or certified.
 

RoxaneB

Change Agent and Data Storyteller
Super Moderator
#7
Prepare a questionnaire based on SOP. And tell the personnel in 2nd/3rd/weekend to give a post training test to ensure they have read the SOP and understood it.

:2cents:
I agree with the sign-off, be it a physical signature or an electronic one, but I disagree with the test as a means to demonstrate effective training and/or operator competence. Why? Because:
  • Anyone can memorize information for a short period of time
  • What if there is a literacy (be it with language, reading, and/or writing) issue?
  • Some people simply do not perform well under a testing environment

I've used this analogy before and I'll use it again. If you have a driver's license, you've passed the test - however, training effectiveness and driver competence is assessed via the number of accidents and ticket you have.

It does not matter if these individuals work weekends or evenings - if your company is going to require formal training and/or physical signatures, you go to them...they don't come to you.

The other approach to take is to "grandfather" current employees and assess their competence via metrics. If an employee has contributed to no errors or issues or events, then it may be safe to presume that they are competent. Focus your training efforts, instead, on new employees and those that have been involved in quality errors or complaints or issues.
 

AMIT BALLAL

Super Moderator
#8
I agree with the sign-off, be it a physical signature or an electronic one, but I disagree with the test as a means to demonstrate effective training and/or operator competence. Why? Because:
  • Anyone can memorize information for a short period of time
  • What if there is a literacy (be it with language, reading, and/or writing) issue?
  • Some people simply do not perform well under a testing environment

I've used this analogy before and I'll use it again. If you have a driver's license, you've passed the test - however, training effectiveness and driver competence is assessed via the number of accidents and ticket you have.

It does not matter if these individuals work weekends or evenings - if your company is going to require formal training and/or physical signatures, you go to them...they don't come to you.

The other approach to take is to "grandfather" current employees and assess their competence via metrics. If an employee has contributed to no errors or issues or events, then it may be safe to presume that they are competent. Focus your training efforts, instead, on new employees and those that have been involved in quality errors or complaints or issues.
Completely agree with you Roxane, competence has to be evaluated based on actual performance - on the job. My earlier reply was only for how to assess whether the operator has read and understood the SOP.

Sent from my CPH1821 using Tapatalk
 
Thread starter Similar threads Forum Replies Date
J Training SOP and Forms Training - Internal, External, Online and Distance Learning 3
H Training myself on my own SOP (Standard Operating Procedure) ISO 13485:2016 - Medical Device Quality Management Systems 13
T SOP (Standard Operating Procedure) Training - When to assign? Training - Internal, External, Online and Distance Learning 15
T How to verify SOP training effectivness - Section 6.2.2 in ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 7
D Warehouse Static Security Guard SOP Supply Chain Security Management Systems 4
M How to manage Sop's & other quality documents after business transfer Document Control Systems, Procedures, Forms and Templates 3
T Do we need an SOP for ISO 9001? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
S SOP Identification of Special Characteristics IATF 16949 - Automotive Quality Systems Standard 6
Y SaMD Verification and Validation SOP and Plan IEC 62304 - Medical Device Software Life Cycle Processes 8
B SOP for CNC turret punching machine for sheet metal process Manufacturing and Related Processes 0
E Procedure ( SOP) for Device Master Record ( DMR ) and for Device History Record (DHR)? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
M WI vs SOP - Shipping/Receiving Document Control Systems, Procedures, Forms and Templates 3
C Language of SOPs and SOP IDs Document Control Systems, Procedures, Forms and Templates 7
H SOP Template for seeking regulatory clearance - MDSAP Document Control Systems, Procedures, Forms and Templates 6
K Looking for guidance to write an SOP on Statistical Methodologies? Statistical Analysis Tools, Techniques and SPC 7
S Converting SOP MDD to MDR Noob ISO 13485:2016 - Medical Device Quality Management Systems 4
K What to include in SOP Definitions section Document Control Systems, Procedures, Forms and Templates 3
D ISO 13485 - 7.3.6 Design and development verification - Do most folks create a separate SOP? ISO 13485:2016 - Medical Device Quality Management Systems 6
D Naming of SOP doc's - Specific to Calibrations ISO 13485:2016 - Medical Device Quality Management Systems 2
E SIP/SOP requirements for USB port used for charging IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
Anonymous16-2 SOP (Standard Operating Procedure) Numbering Document Control Systems, Procedures, Forms and Templates 7
C SOP Template needed for ISO 13485 6.3 Infrastructure ISO 13485:2016 - Medical Device Quality Management Systems 9
C SOP unification. Revision No, Revision history Document Control Systems, Procedures, Forms and Templates 4
D Recent changes to ISO 14971 - SOP required for managing standard revisions ISO 13485:2016 - Medical Device Quality Management Systems 1
N Agile SOP for SaMD IEC 62304 - Medical Device Software Life Cycle Processes 3
S SOP for ISO 13485:2016 Quality related Software validation ISO 13485:2016 - Medical Device Quality Management Systems 12
R Is it required to have an SOP for external audits? Medical Device and FDA Regulations and Standards News 7
J Looking for a template SOP for UDI implementation for EU Medical Devices EU Medical Device Regulations 1
B How to apply external voltage to SIP/SOP IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
D Sample Calibration SOP for ISO 13485 General Measurement Device and Calibration Topics 4
J Application of mains voltage on SIP/SOP connectors of medical device IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
Q Software SOP - Use and maintenance of an ERP system Software Quality Assurance 6
M What to do in SOP Phase of Head unit testing? IATF 16949 - Automotive Quality Systems Standard 0
H Should I mention machine/Equipment password In SOP? Qualification and Validation (including 21 CFR Part 11) 4
W SOP examples wanted - Soil, Concrete and Asphalt testing ISO 17025 related Discussions 3
F Linking an ISO 31000 Risk management SOP to ISO 17025 ISO 17025 related Discussions 2
pashah Looking for Clinical Evaluation SOP acc. MEDDEV and EU MDR Other Medical Device Related Standards 1
M SOP Sample for BC/ISO22301 (Business Continuity) wanted Business Continuity & Resiliency Planning (BCRP) 4
M Risk/Benefit vs. benefit-risk - Revising an SOP covering Risk Management with the MDR in mind EU Medical Device Regulations 10
A How to manage the QMS system and SOP during the transition from MDD to MDR EU Medical Device Regulations 9
V Protocol, report or SOP for threshold analysis? Human Factors and Ergonomics in Engineering 0
V Nature of references allowed to be cited in the SOP US Food and Drug Administration (FDA) 2
W SOP for Vigilance reporting covering multiple requirements Document Control Systems, Procedures, Forms and Templates 7
M Charging consulting fees for SOP development and guidance Document Control Systems, Procedures, Forms and Templates 14
J Just Venting - Do you refer directly to MDR or you just refer to SOP's? CE Marking (Conformité Européene) / CB Scheme 3
E CSR SHIPPING - Need suggestions for making SOP/WI for our shipping dept (automotive)... Customer and Company Specific Requirements 11
S Should there be a SOP on Cybersecurity? ISO 14971 - Medical Device Risk Management 1
T The difference between SOP and Kaizen Standardization Lean in Manufacturing and Service Industries 2
J Nonconforming product procedures SOP help :) Nonconformance and Corrective Action 2
G NIST SOP 29 - Assignment of Uncertainty - Question General Measurement Device and Calibration Topics 0

Similar threads

Top Bottom