Should the organization document all business processes related to ISO 9001 Clause 4.4

[toniriazor]

Hello Cove,

I used to work in a company where each manufacturing process was documented in details and now I am facing many challenges in the new organization where I work. Unfortunately many processes here are not documented and I find this as a huge NOK from the perspective of the ISO 9001. My problem is that when you don't document process you can't measure it and there is no clear idea what should be improved; the inputs and outputs are not clear; operator/Q inspector is not performing any measurements; no records of any non-conforming products; no scrap records.

My other problem is that when processes are not documented at all , it is quite difficult to perform normal process/system audit, because my team has to audit something that we actually now is NOK per standard and in particular for this thread - clause 4.4. This factor just acts as a big demotivation factor to make the audit. My team could just lists all non-conformities without making the audit and document them.

As an example the feedback from engineering team is that on cut and threading process there are no issues and engineers don't really want to bother with writing procedures and documents. The same goes on for some of the other processes.

I've always used audits(both internal/external) as a powerful instrument to drive improvements within the QMS, but at my current workplace everything seems to be wrong. I also find it as a challenge to see how far I could drive this forward and improve the organization QMS. I am trying to involve top management as much as possible and see if that will bring improvement.

Anyway , is there a golden rule that you follow when it comes to documenting processes(where to start first for example) and has any of you been in the situation I am in? As always all feedback is greatly appreciated. Thanks.

 

[Randy]

Simple answer in the form of a question................Where is the word "all" in 4.4 (4.4.1-4.4.2)?

All that's required is (4.4.2 To the extent necessary, the organization shall and necessary is your decision not some goofy auditors. The catch is the "control" you have without the documentation.

 

[Dazzur]

You don't need to document ANY processes, it's up to you and 4.4 (4.4.2 as Randy says), gives you that choice.

Personally, I hate overly documented processes (It's mostly done to appease auditors, 90% of the time) and you absolutely can monitor a process without it being documented. You monitor the outputs (the product) or other predetermined stages (the production stages) - you don't need a piece of paper telling you what's going on to be able to do this.

Your Engineers may also be right, if it's not an issue, determined to be low risk & historically no non-conformances have occurred, why bother? it's a waste of everyone's time, why go beyond what is required?

It sounds more to like your actual system is lacking and not the process itself, but you need to justify these improvements, doing a, b & c for the sake of simply having them isn't a good enough reason, what is actually going to improve?

 

[Sidney Vianna]

Personally, I hate overly documented processes (It's mostly done to appease auditors, 90% of the time)

I am also a proponent of the KISS principle approach to documentation when the risks are commensurate to such approach. But, let’s not forget the requirements for organizational knowledge management. If corporate knowledge is not captured somehow, it can’t be managed.

 

[Ed Panek]

Risk based approach. An SOP for something like "Testing electrical leakage with a risk of user harm" is going to be more required than the "Rotating break room trash emptying" schedule SOP

 

[Big Jim]

Hello Cove,

I used to work in a company where each manufacturing process was documented in details and now I am facing many challenges in the new organization where I work. Unfortunately many processes here are not documented and I find this as a huge NOK from the perspective of the ISO 9001. My problem is that when you don't document process you can't measure it and there is no clear idea what should be improved; the inputs and outputs are not clear; operator/Q inspector is not performing any measurements; no records of any non-conforming products; no scrap records.

My other problem is that when processes are not documented at all , it is quite difficult to perform normal process/system audit, because my team has to audit something that we actually now is NOK per standard and in particular for this thread - clause 4.4. This factor just acts as a big demotivation factor to make the audit. My team could just lists all non-conformities without making the audit and document them.

As an example the feedback from engineering team is that on cut and threading process there are no issues and engineers don't really want to bother with writing procedures and documents. The same goes on for some of the other processes.

I've always used audits(both internal/external) as a powerful instrument to drive improvements within the QMS, but at my current workplace everything seems to be wrong. I also find it as a challenge to see how far I could drive this forward and improve the organization QMS. I am trying to involve top management as much as possible and see if that will bring improvement.

Anyway , is there a golden rule that you follow when it comes to documenting processes(where to start first for example) and has any of you been in the situation I am in? As always all feedback is greatly appreciated. Thanks.

This was the belief in the early days of ISO 9001. When the 2000 version was released, there were only three topics that required a written procedure. This continued in the 2008 version. However, in the 2015 there are NO requirements for written procedures. In fact the word procedure is gone. 2015 even no longer required a quality manual, although most companies still have one at their choice to help provide structure to their quality management system.

So it is up to the organization to determine what if any documentation they want to have to aid in their structure.

It is unfortunate that you are locked in the past. One of my clients went so far as to say that the current requirements are liberating.

My experience has shown that a company that has extensive written procedures have trouble keeping them current and set audit traps for themselves when they are not exactly followed.

 

[Golfman25]

I think it depend on what the OP considers "documented." Long detailed procedures -- yeah, just sets you up for traps. General flowcharts, with the important points noted, provides a good combination of basic structure and detail where needed.

 

[toniriazor]

Simple answer in the form of a question................Where is the word "all" in 4.4 (4.4.1-4.4.2)?

All that's required is (4.4.2 To the extent necessary, the organization shall and necessary is your decision not some goofy auditors. The catch is the "control" you have without the documentation.

Once I read somewhere that if one control is not documented then there's no control. I've found that to be true as well.

You don't need to document ANY processes, it's up to you and 4.4 (4.4.2 as Randy says), gives you that choice.

Personally, I hate overly documented processes (It's mostly done to appease auditors, 90% of the time) and you absolutely can monitor a process without it being documented. You monitor the outputs (the product) or other predetermined stages (the production stages) - you don't need a piece of paper telling you what's going on to be able to do this.

Your Engineers may also be right, if it's not an issue, determined to be low risk & historically no non-conformances have occurred, why bother? it's a waste of everyone's time, why go beyond what is required?

It sounds more to like your actual system is lacking and not the process itself, but you need to justify these improvements, doing a, b & c for the sake of simply having them isn't a good enough reason, what is actually going to improve?

My personal view is that the production processes should be documented if the organisation wants to have lessons learned and keep the knowledge of its assets. When you don't document your processes, how do you have standardisation across the company? Today operator "X" works using one method, but tomorrow "X" is gone and operator "Y" comes in the company - how does he gonna work and perform his job when there's nothing to step on? This is creating a lot of problems for any business. When there's nothing to tell the workers what they should do and how the result is that they do whatever they want and like, which brings a lot of variation in the process.

About the low risk I like to say that there's no problem, until there's a problem, so it is always wise to try to be one step forward and put improvement before any big issue and try to go beyond what is required I consider it to be a good approach.

This was the belief in the early days of ISO 9001. When the 2000 version was released, there were only three topics that required a written procedure. This continued in the 2008 version. However, in the 2015 there are NO requirements for written procedures. In fact the word procedure is gone. 2015 even no longer required a quality manual, although most companies still have one at their choice to help provide structure to their quality management system.

So it is up to the organization to determine what if any documentation they want to have to aid in their structure.

It is unfortunate that you are locked in the past. One of my clients went so far as to say that the current requirements are liberating.

My experience has shown that a company that has extensive written procedures have trouble keeping them current and set audit traps for themselves when they are not exactly followed.

I would say that I've come to appreciate how fortunate a company with a good structure, organisation and QMS is. Also top driven - the most important factor. I mean when there are useful instruments and tools within the QMS and they are well understood by the organisation, you accomplish much more.

I think it depend on what the OP considers "documented." Long detailed procedures -- yeah, just sets you up for traps. General flowcharts, with the important points noted, provides a good combination of basic structure and detail where needed.

I've found that most people use the flowcharts first and then go into details in the procedure itself. And as you say it does not have to be complicated and overwhelming, just document the key steps and factors, but that's definitely better than nothing.

 

[Big Jim]

Once I read somewhere that if one control is not documented then there's no control. I've found that to be true as well.

That may be true with larger organizations, but small companies could be overwhelmed with over documentation. All of ISO 9001 needs to be considered with the scale of the organization in mind. I would go as far as to say that this mindset could be damaging in some organizations.

 

[Dazzur]

My personal view is that the production processes should be documented if the organisation wants to have lessons learned and keep the knowledge of its assets. When you don't document your processes, how do you have standardisation across the company? Today operator "X" works using one method, but tomorrow "X" is gone and operator "Y" comes in the company - how does he gonna work and perform his job when there's nothing to step on? This is creating a lot of problems for any business. When there's nothing to tell the workers what they should do and how the result is that they do whatever they want and like, which brings a lot of variation in the process.

I wouldn't expect the actual production operators to be familiar with the work flows, the Manager - sure for training purposes. The operatives won't read the workflows, they KNOW what they're doing. You've documented what they do, not what you want them to do.

What about integrating your process controls in other ways? Engineering drawings? Works orders? etc