Requirements for Documented Information

[Richdewtan]

Since 9001:2015 has come out - I have interpreted and many of my colleagues the same - that procedures/work instructions are not required. However, we in turn also say that if we the organization "Determine" (7.5.1b) based on either or both employee turn over and job complexity, it is wise to have a procedure/work instruction.

Today, I had an auditor say 8.5.1a1dictates writing a procedure/work instruction. First time in 30 years I have heard this interpretive use. I argue in lieu of 8.5.1a1 which gives three options to comply to: 1) document the characteristics of the product, 2) the services to be provided, 3) "or" the activities to be performed; I say the dwg's define the characteristics of the product to be produced and those same dwg's comply with 8.5.1a2 in which they define the results to be achieved by stating the nominals and their respective tolerances.

Further ISO put out a "Guidance on the requirements for Documented Information of ISO 9001:2015" which states in clause 4.4, "Although ISO 9001:2015 does not specifically requires any of them, examples of documents that can add value to a QMS may include: ...Procedures, Workand/or test instructions,"

My argument is NOT to not include these, it is that it is not required. So the question asked of me then is, "How do I verify compliance to established non written procedures?" Fair question. My response: "Observation. I look for consistency of approach and understanding as I sample varying operators, as well as their respective outputs and Inspection results."

What are your thoughts and experience on this? Also, He mentioned that Supplier Eval is not a required Procedure but a required record. Thoughts?

 

[Sidney Vianna]

"How do I verify compliance to established non written procedures?"

By interviewing the process owner(s) and understanding the key aspects of the activity and/or process in question, FOLLOWED by the observation of the work being performed, in order to ascertain if such key aspects are being achieved.

Observation of consistency in itself does not equate to conformance as mistakes also propagate by tribal knowledge.

 

[Richdewtan]

By interviewing the process owner(s) and understanding the key aspects of the activity and/or process in question, FOLLOWED by the observation of the work being performed, in order to ascertain if such key aspects are being achieved.

Observation of consistency in itself does not equate to conformance as mistakes also propagate by tribal knowledge.

I 100% agree. Though I did not specifically state it, I meant approach "and" understanding to be interpreted that that interview with the process owners had already occurred - I'll be clearer next time.

 

[ChrisM]

You need evidence of training and competency assessment to fully argue the case that a written procedure or instruction is not required.
If your organisation has trained someone to do a task, then observed their performance and deemed them "competent", and has periodically reviewed the competence of the operators performing the task then you are in a good position to argue that you do not need words to do with it.
Assessing competence is not just a matter of observing, it may also involve asking questions such as "I know this normally happens, but what would you do if........"

 

[Sidney Vianna]

While it is a FACT that many organizations overkill on document creation and develop an excessive, unnecessary amount of command media, shooting themselves in the foot with bloated documentation, it is also well known that some other organizations fail on the other side of the spectrum, documenting almost nothing and promoting the tribal knowledge approach to quality. This approach ignores the “ORGANIZATIONAL KNOWLEDGE” requirement of 9001. After all, command media, besides providing a basis for process definition, also serves the purpose of managing organizational knowledge.

 

[Kronos147]

So the question asked of me then is, "How do I verify compliance to established non written procedures?" Fair question. My response: "Observation. I look for consistency of approach and understanding as I sample varying operators, as well as their respective outputs and Inspection results."

Interview the process owner. Have them tell you the process. Make some notes about the steps or details. Audit the process. Does it match?

If the process owner says, "the employee reads the steps on the traveler, and then makes tick marks to indicate the perform each step" and then the employee does not do so, it can be said there is a non-conformance. The root cause for such a non-conformity may be "inconsistent training." The 5 whys may lead you to the training is inconstant as we do not train to a work instruction. Well, that leads to the need for a work instruction.

 

[ScottK]

Since 9001:2015 has come out - I have interpreted and many of my colleagues the same - that procedures/work instructions are not required. However, we in turn also say that if we the organization "Determine" (7.5.1b) based on either or both employee turn over and job complexity, it is wise to have a procedure/work instruction.

Today, I had an auditor say 8.5.1a1dictates writing a procedure/work instruction. First time in 30 years I have heard this interpretive use. I argue in lieu of 8.5.1a1 which gives three options to comply to: 1) document the characteristics of the product, 2) the services to be provided, 3) "or" the activities to be performed; I say the dwg's define the characteristics of the product to be produced and those same dwg's comply with 8.5.1a2 in which they define the results to be achieved by stating the nominals and their respective tolerances.

Did the auditor write a nonconformance, or just offer his thoughts on the subject? If an NC was written, we really need to see how it was phrased.
I agree that documented information does not need to be a procedure or work instruction. It can be a drawing, a form, a file in workflow system, a process diagram, etc.

He mentioned that Supplier Eval is not a required Procedure but a required record. Thoughts?

Re-reading 8.4 now... in 8.4.1 that whole section only says that the organization only needs to retain documented information on the activities and actions... 8.4.2 and 8.4.2 don't mention documented information though without it I don't see how you would communicate the requirements. But again, it may not require a procedure if the processes in place are adequate. Like if you enter everything in SAP to generate Purchase Order, you may not need a procedure or work instruction.

 

[Bev D]

The need for documentation of ‘what to do’ has been discussed here a million or more times.
But I know that this mythology is strong in the iso-verse.

Of course the drawing, flowcharts, visual workplace, error proofing, etc. are also ways of ‘documenting’ what to do.
(Training records and competence assessment are 2 different things from documented instructions and each other)

Each company in each industry has very different needs. A 10 person job shop is different from a fully automated process from a very manual large scale manufacturing line from a repair shop of complex equipment.

I’ve worked at Honda Automotive where there were NO work instructions. NO training records. Damn near perfect assembly. Operators were trained by team leaders and highly experienced line operators. You knew they were properly trained and competent when they could keep up with the line speed and the next operation didn’t find any defects. If you couldn’t do the job or made errors it was immediately obvious.

I’ve worked at highly automated complex fabrication sites (semiconductor, high speed assembly) where the operators just loaded the correct program, loaded the parts and put hem in a ‘box’ after the operation. True button pushes, not knob dialers. The knowledge of what to do resided with the engineers, scientists and programmers.

I’ve worked in machine shops where the equipment operators had to be highly trained and skilled to interpret what thad to be done to meet the drawing. From lathes to xray machines.

I’ve worked with Customer Support organizations who needed complex and specific response trees to properly answer Customer questions…
And on and on and on.

This is not a one size fits all proposition. Do what you need to do. Don’t implement something just because ‘everyone else does it this way’ or because some rando auditor says you need to do it this way. THINK.

 

[Sidney Vianna]

Each company in each industry has very different needs. A 10 person job shop is different from a fully automated process from a very manual large scale manufacturing line from a repair shop of complex equipment.

All of the post is on point, as usual. But this paragraph exemplifies well the need for context awareness when making calls such as you need to have evidence of this and that.

If Billy Bob has been drilling holes and deburring machined parts since when an ounce of gold was valued as the current price of a Big Mac, it is really really really hard to make his employer to understand the need to “assess his competence” from time to time. Context awareness assists with the determination of common sense and risk assessment. But some people just don’t get it and prefer fast and hard rules.

 

[Bev D]

Well thinking IS hard.

I would also add that this obsession with work instructions, training record and competence assessment of operators is misplaced. Most defects and failures in my 42 years of experience in very diverse industries can be traced directly to the engineers and scientists training, education and hubris in the face of the vagaries of mother nature. It is they who need the above. (Once past raw innovation and into development and mfg.)

Added in edit: in response after reading a post of @Randy in another current thread I would add that service/repair ‘technicians’ and other highly skilled jobs would require documents (simple and straightforward - no boilerplate garbage), training, competency assessment, observations, etc.