ISO 9001:2015 Cl. 8.1 - 'and to implement the actions determined in clause 6'

[JGARR]

First paragraph under 8.1. Will someone explain what is meant by:

'and to implement the actions determined in clause 6'

So is this saying we have to plan and control the processes used to implement the requirements of 6? As 6 is the planning section, is this planning not already implied?

Or are we talking about actions from 6, that may apply directly to our production planning for a specific product or service? Certainly this might apply for risks and opportunities identified under 6.

Thanks

 

[Big Jim]

It is a little redundant as you noticed. The main thing though is if the risk mitigation involves anything is Section 8, Operations, then Operations Planning (8.1) says that you Operations Planning needs to address the risk mitigation.

So if you identify a risk during the build of the product you need to plan on how to control the risk. A common way is to include it on the Traveler. Creating the Traveler is often one of the main elements of production planning.

 

[AndyN]

First paragraph under 8.1. Will someone explain what is meant by:

'and to implement the actions determined in clause 6'

So is this saying we have to plan and control the processes used to implement the requirements of 6? As 6 is the planning section, is this planning not already implied?

Or are we talking about actions from 6, that may apply directly to our production planning for a specific product or service? Certainly this might apply for risks and opportunities identified under 6.

Thanks

I have found that to consider it this way works:

Let's say in considering the Context of the Org, the leadership identify that it's a risk to the QMS to not have sufficient skilled people - they just aren't available (sound familiar). So, to address that risk, the organization decides to attract some high-school graduates and train them in a kind of apprenticeship program, involving a local community technical school, or trade school.

Using section 6 requirements, the idea would be to develop the QMS process(es) to address the development and implementation of the apprenticeship programme. There's a good chance that, since the org. never did this type of training before, the current QMS process(es) aren't sufficient for the task - and hence the need to plan, define what is going to be done, who is responsible and so on (listed in section 6). Nothing redundant here. The resulting process(es) are then deployed to meet section 8 requirements.

 

[Jen Kirley]

First paragraph under 8.1. Will someone explain what is meant by:

'and to implement the actions determined in clause 6'

So is this saying we have to plan and control the processes used to implement the requirements of 6? As 6 is the planning section, is this planning not already implied?

Or are we talking about actions from 6, that may apply directly to our production planning for a specific product or service? Certainly this might apply for risks and opportunities identified under 6.

Thanks

Simply put, do what you planned to do as per your risk determination. Don't just make plans.

 

[JGARR]

Thanks, got it

 

[qualprod]

Andyn

When yo say "are then deployed to meet", I think those are the plans for the mitigation of the risks?

Thanks

 

[AndyN]

Andyn

When yo say "are then deployed to meet", I think those are the plans for the mitigation of the risks?

Thanks

If the risk is a lack of skilled people (in my example) then the deployment of the apprentice training process is going to be the way to address this risk. I am careful to keep away from using (professional) risk management terminology, since I don't believe the ISO 9001 standard terminology needs elevation to such a vaunted level... But, whatever you want to call it is fine by me.

 

[Paul Simpson]

Some good points made earlier.

First paragraph under 8.1. Will someone explain what is meant by:

'and to implement the actions determined in clause 6'

So is this saying we have to plan and control the processes used to implement the requirements of 6? As 6 is the planning section, is this planning not already implied?

Or are we talking about actions from 6, that may apply directly to our production planning for a specific product or service? Certainly this might apply for risks and opportunities identified under 6.

Thanks

As has been mentioned clauses of 9001 are structured to follow a strategy development / risk management process.

• It all starts in 4.1 where you are expected to identify 'issues' (risks and opportunities) your QMS is intended to manage. Typically at the organisational level.
• In 4.4.1 f you are expected to address risks and opportunities associated with the processes you operate
• In 6.1 you plan to deal with all the risks and opportunities identified
• In 8.1 you implement operational controls at the process level (see 4.4.1 f again) to manage process risks.

Hope this helps.