Defining staff competence - Small mechanical workshop

[James]

Hi folks

I manage an ISO13485 system in an NHS organisation. We custom make or modify accessories for medical devices; mainly seating systems, foot pads, guards, headrests etc for wheelchairs. We have a workshop with 14 pieces of machinery in it, as well as a wide range of hand tools. We employ 3 staff who can use all of the workshop machinery, but also other staff (around 10 qualified rehabilitation engineers) who might pop in to the workshop to use 'some' pieces of equipment for modifications they have prescribed.

As part of my system I want to establish a more compliant way of defining who can do what / how / when in relation to using certain machines, and have a system for managing workshop competence.

My background is more clinical and managerial than mechanical, so I'm struggling a little with how to approach this. The technicians are all qualified (all qualified in mechanical engineering, all over 30yrs ago), but are not registered with an accreditation body / they dont do much continuous professional development other than that mandated by the NHS. I 'think' they are knowledgeable and safe to do what they do, but how do I clearly demonstrate that? Also, I think 2 technicians are capable enough to observe the practices of rehabilitation engineer colleagues and test their competence in using particular pieces of equipment. Again, how do I pragmatically establish a mechanism for doing this appropriately?

Any thoughts appreciated!

James

 

[John Broomfield]

Qualifications may help but as we know the standard specifies competence.

So, what abilities, skills and knowledge (think ASK) are sought when recruiting and from training in a class or on the job?

How do supervisors verify they have the required competencies available to do each job well?

...who can do this verification and where is the verification recorded?

Normally, workers not yet verified as competent are more closely supervised.

Many organizations provide open access to a matrix that shows the who and what of each person’s competence status so everyone can see who can do each job well, unsupervised.

Periodic updates in prep for upcoming changes and to avoid any decay of competence also need to be considered.

 

[RoxaneB]

Qualified does not equate to competence.

Having a driver's license means one is qualified...but, while it should set them up to be a good driver, holding a license does not mean that one is necessarily a good driver.

A competent driver is determined by the number of tickets and accidents and the like, impacting their insurance rate.

So, while your staff are qualified, we're back to how to define and assess competency. It may sound simplistic, but think about their jobs and their expected results. If the expected results are around a certain % of conforming/good parts, then if a team member has that, they're golden. When rates start to slip, then you can identify a concern re: competency and take appropriate actions.

 

[Randy]

This is an OSHA and not a Medical Device question, machine competency is defined in 29CFR 1910 General Industry and that's where you need to look. In addition, seeing as your asking, what you need may be more than just machinery safety, your question seems to display a lack of basic occupational safety understanding itself. If I'm incorrect forgive my bluntness.

Here's the Machinery Safety link..... 1910 Subpart O - Machinery and Machine Guarding | Occupational Safety and Health Administration

If you're in Canada or the UK there are similar regulations.

Check out the OSHA site they have downloadable manuals and training material available

 

[James]

Thanks for the replies. Some helpful points, but I may not have explained clearly enough what I want to establish and why. I'll try and do that succinctly.

All staff recieve a broad range of occupational health, PPE, and general health and safety training. ISO13485 requires that we meet all regulatory requirements. We are doing this in terms of UK medical device regs; manufactured product is conforming.

In the UK we have 'Provision and Use of Work Equipment Regulations' (PUWER) and it is this regulation I need to improve compliance with / establish a process within our 13485 system to address. We need to demonstrate machinery competence. Staff member A has worked in the workshop for 30yrs. He qualified as an engineer 40yrs ago and has done no mechanical professional development since; neither does he want to. He has had no accidents while making things using machinery (pillar drills, bench saws, linisher, sheet metal folder, various hand tools, etc), but that doesn't tell me he can use that equipment safely or in line with current best practice; he may just have been lucky. It also doesn't tell me he could appropriately pass on his knowledge to junior colleagues, or help observe / assess their competence. The original instruction manuals for the machines are poor; the machines are old, but are inspected and maintained appropriately. A larger commercial workshop of our kind may have a training coordinator who would write up machine based competencies, and this might be a way to ensure each staff member demonstrated the competencies required for each piece of equipment.

I have my 3 staff, all of whom are nearing retirement and not interested in doing further 'train the trainer' courses to check and empart their gained knowledge in a structured way to others who use the workshop.

I wondered what options I may have to establish a machine competency framework in this scenario? What I'm thinking of is researching how each machine should be used based on current best practice; writing a brief operating procedure, maintenance schedules and competency tests for each piece of machinery, and ask my experienced staff to observe lesser skilled colleagues against these competencies. Staff then sign off their competency record when they themselves and their experienced peers agree that they can use the machine without supervision.

I'm essentially thinking that irrespective of a qualified, experienced engineer making conforming product for 30yrs without injury, this is not satisfactory in demonstrating PUWER compliance. As employers we have a duty to ensure they are using equipment competently. As things stand, they are in a better position than me to say what 'competently' looks like.

If there are established approaches employed elsewhere, I'd be grateful for any guidance.

Thanks

James

 

[John Broomfield]

James,

Suggest you PM AlanC just to make sure he has seen your PUWER enquiry:

https://elsmar.com/elsmarqualityforum/conversations/add?to=AlanC

He posted a similar inquiry here in 2015:

PUWER (Provision and Use of Work Equipment Regulations) and old machines (UK rules)

Alan was last seen here in March, 2020.

You may find this publication useful too:

https://www.hse.gov.uk/pUbns/priced/hsg93.pdf

John

 

[James]

PUWER (Provision and Use of Work Equipment Regulations) and old machines (UK rules)

Alan was last seen here in March, 2020.

John

Thanks John, I'll message AlanC. All of the equipment is safe to use, albeit some of the machines do need some e-stops fitted, which I'm progressing. What I dont have is a safe working procedure for each machine. I think I've answered my own question - I need to either commission someone to do a piece of work to write them, or write them myself. These can then be used as part of a competency checklist that we use for each machine.

 

[John Broomfield]

James,

Also note this from the HSE doc:

"API 579 Level 2 Method C – Approval based on past operation (grandfathering approach based on previous history) 35 This method is based on the assumption that past operation without problems shows that further use would not result in failure. This requires that no future foreseeable conditions exceed conditions experienced in the past."

You may find this justification useful.

John

 

[mattador78]

A lot of our training here is grandfather based on the older equipment especially manual processes, our audits have created no issues in competency of staff. As long as a person in management determines they are competent in the task unless there is a breach in HSE regs in the way they are performing it i cant see an issue. We just determine who is competent and who is capable to train through basic competency tasks and time served, a simple spreadsheet controls it for us and its controlled by myself and the production manager as to who can and cant perform tasks. Roughly every 4 months we review staff capabilities in the tasks and adjust if required or leave it alone.

 

[James]

A lot of our training here is grandfather based on the older equipment especially manual processes, our audits have created no issues in competency of staff. As long as a person in management determines they are competent in the task unless there is a breach in HSE regs in the way they are performing it i cant see an issue. We just determine who is competent and who is capable to train through basic competency tasks and time served, a simple spreadsheet controls it for us and its controlled by myself and the production manager as to who can and cant perform tasks. Roughly every 4 months we review staff capabilities in the tasks and adjust if required or leave it alone.

Thanks very much, thats helpful. Would you ask staff to 'self certify' their knowledge and understanding / that they have read the manuals and keep a signed acknowledgement in their personnel files? I might be over-thinking this. I'm also thinking from a employers liability perspective, so we have evidence of staff formally accepting that they can use equipment safely

I guess its similar to getting formal acceptance of policies being read and understood