Quality System Processes without Documented Procedures

[Mark Meer]

This thread went on a bit of a tangent discussing procedureless processes. Highly recommend checking it out as BevD's description of Toyota's assembly process without procedural documentation should be fascinating to anyone - like myself - who is ensconced in the documentation-as-a-means-of-control paradigm.

I thought it might be worthwhile starting a dedicated thread for discussing procedureless (or procedure-minimizing) strategies & philosophy.

Barring explicit requirements for procedure (regulatory, customer, standards), what do people think of the idea of not documenting procedures/work-instructions, whenever possible?

Hypothetically, if a company's records/data indicate everything working effectively, and personnel, if interviewed, demonstrate knowledge/competency of their role & process, is there any value in having documented procedures?

In the aforementioned thread we were talking specifically about assembly processes (incl. training & equipment control), but could this philosophy also be applied to all processes? Would this also work for purchasing, complaint handling, design & development, etc.? Why have any procedures at all if everyone - by way of knowledge & expertise - already knows what to do?

Can anyone attest to operating quality system processes with no documented procedures? Are there any challenges/concerns?

 

[Marcelo]

The need for documentation in a process should be verified during process planning (where you define requirements for a process) as a requirement or not for the process (for example, if you use a quality plan for a process, one of the questions the plan need to answer is - do the process need a documented procedure? - see, for example, examples at the annex of ISO 10015).

There's an ISO 9001 Auditing Practices Group about "auditing systems with minimum documentation" (this was created for ISO 9001:2008, and unfortunately I cannot find the link to ir right now), that mentioned that the need for a documented procedure is related to the fulfillment of the objectives for a process, meaning, if you can consistently fulfill the objectives without a documented procedure, you do not need the documented procedure. This makes sense.

 

[Sidney Vianna]

There's an ISO 9001 Auditing Practices Group about "auditing systems with minimum documentation" (this was created for ISO 9001:2008, and unfortunately I cannot find the link to ir right now),

The APG collection of papers is available @ ISO 9001 Auditing Practices Group

 

[Marcelo]

The APG collection of papers is available @ ISO 9001 Auditing Practices Group

Yes, but they removed the 2008-related documents from the website (at least I could not find it the last time I checked, although I've got the documents somewhere at home).

 

[Marcelo]

You can find it in page 187 here: https://www.cnas.org.cn/extra/col21/1208417590.pdf.

 

[somashekar]

Any documented procedure is to aid the consistent, correct and complete performing of any procedure. It could be so good that the same can be effectively used for the training, but it will still fall short of the "How to" do detailing. The documented procedure can more clearly be documenting the "What to" do detailing, keeping sequence of steps and testing stages defined within.
It will certainly work for purchasing and other said procedures too.
Talking of purchasing for example., if the documented procedure mentions comparing quotations to narrow down, its stating WHAT to be done. I am yet to see a purchasing procedure detailing HOW to compare quotations. This comes from the knowledge and experience.
I can mention in my welding procedure the correct sequence of welding, likewise in soldering etc.. Major part of HOW is still coming from Validation and operator qualification.
Therefore, documented procedure in itself is not like all or none. I can get away from the documented procedure, if I can see the required levels of operations maturity.
Well, a complete explosion diagram of a photocopier assembly can be my documented procedure, however it will fall short without competency. When competency is established, this diagram is no more a documented procedure, but its an assembly explosion diagram.

 

[Mark Meer]

...if you can consistently fulfill the objectives without a documented procedure, you do not need the documented procedure. This makes sense.

So, you would not have concerns regarding the hypothetical case of data/records indicating all is well, but no documented procedures at all?

I do see at least a couple of benefits to documenting procedures, even in this scenario:
1. Disaster recovery & replicability - If a key operator unexpectedly disappears (e.g. suddenly quits, dies in an accident,...), then their knowledge doesn't leave with them.

2. Intermittent tasks - There are certain tasks done infrequently or at variable intervals, so that memory or expertise may be unreliable.

 

[Bev D]

So, you would not have concerns regarding the hypothetical case of data/records indicating all is well, but no documented procedures at all?

I do see at least a couple of benefits to documenting procedures, even in this scenario:
1. Disaster recovery & replicability - If a key operator unexpectedly disappears (e.g. suddenly quits, dies in an accident,...), then their knowledge doesn't leave with them.

2. Intermittent tasks - There are certain tasks done infrequently or at variable intervals, so that memory or expertise may be unreliable.

Disaster recovery doesn’t come from documented procedures or even building blueprints. It comes from people who KNOW what to do and HOW to do it. They are experience, practiced and knowledgable. How do you think they build a factory from scratch? They don’t just copy an existing facility - they start from knowledge of the product and knowledge of best practices on how to build the product. They start with a foundation of the elimination of the 7 wastes, good industrial engineering practices and competency/expertise in programming, construction line layout, process validation, etc. these things just don’t come from procedures. And in the TPS there is never just one expert - that is foolish. Traditional western manufacturing may require only 1 expert - in order to save money - but that is foolish and short sighted.

As for intermittent tasks, these are really pretty rare, but again the experts (trained, experienced, practiced adn knowledgable) are assigned to these not novices. TPS also provides for error proofing so that hte task can be. Performed only one way in the correct way. These are not written words on a page. TPS also provides for ‘peer review’ to ensure that things are done correctly. Peer review is not a signature loop it is experienced, practiced and knowledgable people who sit face to face with the originator and review their work in detail. A piece of paper can’t do that. A piece of paper can’t ensure that it is read and followed.

Mark - every objection you have can be answered by removing the very barriers you cite. Really think about documented procedures. The paper can’t execute the task. The person must execute the task. adn teh expertise required to execute the task cannot be written down or transferred from teh paper. Somasheker nailed this concept.

Documented procedures are the crutch of the lazy and the ignorant. And yes I did ‘mean’ that. At some point we have to say the obvious. It doesn't matter if you are an auditor or if you’re an engineer or a manager.

 

[AndyN]

If you go back in time, before the advent of formal, documented, supply chain quality requirements, organizations still produced quality products. It's only been the military/government contracts which had spawned the need for their suppliers to document things. We seem to have misunderstood that people did good stuff with the bureaucracies that ISO 9001 compliance caused people to create. Indeed, even the first version of ISO 9001 was fairly light on requirements for "documented procedures" and only cited the need for work instructions in one clause (4.9) 'where the absence of such would adversely affect quality". It's simply not the case that documents describing processes or methods are necessary to accomplish quality work.

 

[Eredhel]

This thread and the other one has some great stuff. There is a definite lack of followup on getting the right people into positions. Seems like anymore it's getting the right paperwork instead. Still glad I'm in a smaller business.