In this article, I'm going to cover ISO 9001 clause 8.1 Operational Planning and control. I'm going to break this clause down and turn it into something you can all understand and implement in your own organization or industry.
This clause starts off with the statement ...
The organization shall plan, implement and control the processes (see 4.4) needed to meet the requirements for the provision of products and services and to implement the actions determined in Clause 6 by …
And I’ll get to that soon but before I continue, let’s think about this. We are at the 'operation' part of the standard, where the focus shifts from the higher-level system to the operation stage, relevant to your product or service. Prior to this, it was mostly about the system.
It is time to shift your thinking away from the system and into the actual product or service, or both, that you provide. Knowing this, it is time to plan and implement the processes to control how you deliver your product or service to your customer.
We do this by implementing the actions we came up with back in clause 6. Let’s back up to clause 6 for a refresher then. Clause 6 is where we determined actions to address identified risks and opportunities and we established quality objectives.
So, for example, if here at Auditor Training Online, way back in Clause 6 we determined that an Action to prevent the risk of nonconforming assessments being released was that we would implement an additional test and review from an external trainer and assessor, then here at clause 8 Operation is where we would implement that action. We would build this process into the Operations section by determining resources and documented information amongst other things.
Right – now let’s move on with the next sections of this clause. We have to implement the actions determined in Clause 6, by doing the following:
- Determining the requirements for the products and services
- Establishing criteria for:
- the processes;
- the acceptance of products and services
- determining the resources needed to achieve conformity to the product and service requirements;
Let me break those sections down for you. To determine the requirements for your products and services this will include how you will communicate with your customer for taking enquiries and orders. You then will need to define any applicable statutory and regulatory requirements and that you can deliver to meet these claims. You should also have a review process in place before committing to supply products and services – to make sure that you can meet your customers’ requirements.
I always think of the construction industry here, where it is common to tender for work. The Tender Review process is one that requires the business to review what work the customer wants to be completed, where, how, and by when. It is up to the construction company and its Operational processes to review the Tender requirements and determine what they can directly provide or what they may need to outsource. And of course, do they have the resources to be able to deliver all of this on time and on budget?
Then this clause goes on to say:
d) implementing control of the processes in accordance with the criteria;
e) determining, maintaining and retaining documented information to the extent necessary:
1) to have confidence that the processes have been carried out as planned;
2) to demonstrate the conformity of products and services to their requirements.
The output of this planning shall be suitable for the organization’s operations.
Documented information is an option for control of the processes at this operational level. What you might see for this documented information could be quite different depending on the industry. In construction, it is common to have a Project Management Plan or Quality Project Management Plan, or PMP for short.
In these PMP's you will find all of the information you need regarding what they are to deliver, how, who, and when. A PMP is an excellent document for an auditor to review and follow up on at an operational level. A PMP is an excellent document for a business to have to manage and control the delivery of its product.
Then if you are in a manufacturing environment this documented information might look completely different. I do some work for a business that designs and manufactures commercial-grade covers for pools and dams. Their operational documented information is a job pack. The job pack has the designs, the material, the measurements, the testing, and even how to fold the finished product. This is how they control their operational processes.
This clause has a couple of final sentences to go before we can finish up.
They are:
The organization shall control planned changes and review the consequences of unintended changes, taking action to mitigate any adverse effects, as necessary.
And then finally ….
The organization shall ensure that outsourced processes are controlled (see 8.4).
This means that things don’t always go as planned. You can have a Project Management Plan or a Job Pack whatever is relevant for the type of work you are doing. But things can change, whether they are controlled (which could be the customer has requested something different) or they could be unintended (which could be a nonconformance identified).
For controlled changes, I would simply go back to the process you defined in clause 6.3 Planning of changes – which is essentially using what you already have in place anyway. And for unintended changes, I would suggest you use the Nonconformance procedure you should have in place. You don’t need to create anything new.
And of course, when it comes to outsourced processes (suppliers and contractors) there needs to be controls around the activities that they conduct at an operational level. I will remind you that this last sentence of the clause says (see 8.4) which is exactly what I am promoting also. Clause 8.4 Control of externally provided processes, products, and services is a great detailed clause of ISO 9001.
Now that you have a better understanding of these requirements, it's time to take action and implement them in your own organization and ISO 9001 quality management systems.
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