QMS Guidance Pt. 8 – ISO 9001 Clause 8.5
Clause 8.5 is an absolute beast of a clause covering ‘Production and Service Provision’ and is divided up into a number of sub-clauses each of which in its own right is important.
Anyone who has been following these guidance notes so far will know that this clause called ‘Control of Production and Service Provision’ could in some circumstances be mostly evidenced from activities undertaken in 8.1. The thinking from ISO is that 8.1 is a slightly higher level clause and 8.5.1 is what you do once you have an actual piece of work to do. Perhaps if you’re operating a continuous production process you can assume you’ve met the main needs of the clause at 8.1 but if on the other hand you’re running a batch style process then 8.5.1 comes into its own.
Like many other clauses 8.5.1 takes the form of a bullet list which asks you to run your production and service provision operating under controlled conditions.
The clause requires some documented information that defines a number of things such as the characteristics of the product or service to be delivered and the results to be achieved and so on. But other things included in the bullet list, like competent people, suitable infrastructure etc have largely been covered many other times before and you may choose to rely on what you’ve done beforehand as evidence of this. 8.5.1 is in effect the safety net memory jogger for when you start a piece of work or contract.
The one area where 8.5.1 differs is that it now introduces the idea of human error and mistake proofing, this is both significant and important to the success of he QMS overall and is not to be overlooked.
A slip of a clause or so you would think, 8.5.2 ‘Identification and Traceability’ is a really important clause though.
The clause requires you to be able to identify unique products and document this for traceability and to know the status when in process or finished.
So in effect then you’ll have to be able to identify any products or materials to be included in your process; the work in process (WIP), finished items and any non-conforming items (including non-conforming products and materials to be included). The clause is asking you to know the status of production with respect to monitoring and measurement requirements.
So identification is a must, but traceability on the other hand is an option depending on requirements. It should go without saying however that shipping batches of goods with the same batch number or reference is a big no-no and may cause all manner of problems if you need to make a product recall, or want to get paid and you need to refer back, in which case traceability is a must have.
Sub-Clause’s 8.5.3 & 8.5.4
I must admit I’m a bit baffled why these two sub-clauses have been split up, so I’m treating them together as one.
I’ll begin with 8.5.4 ‘Preservation’ which tells you to preserve outputs during product and service provision. This means that parts should always be identifiable, handled with care, stored so they wont be damaged or lost and so on. If you’re doing these activities then you’ll meet most of what you’ll have to do for 8.5.3 which asks that you exercise care with customers and suppliers property and includes components, tools, materials, data and intellectual property.
What the clause does require you to do is report to the customer or supplier any loss, damage or reasons why an item or part might be unsuitable and keep a documented record of the matter. This is another area where you don’t have to reinvent a wheel, if you’ve crafted your documentation well enough you’ll be able to do this through the non-conformance reporting system.
8.5.5 ‘Post-delivery activities’ refers to requirements but in fact is a bullet list of optional things to consider. The reality is that the requirements to perform post delivery activities will have been agreed at 8.1 which in turn is informed by 6.1, itself informed by 4.1, 4.2 & 4.4.
As an auditor this clause can trip you up, its well worth going back to the contract and the previous clauses to make sure you’re not imposing requirements which are not necessarily there.
A short and very straight-forward clause about ‘control of changes’. The clause is very lite on the detail but basically asks that you review any need for change so that conformity is maintained.
The lite touch approach means the review can take a very simple form or may be a show-stopper leading to process redesign, the choice is yours. All the clause requires you to do is document the results of the review, who authorised the change and what actions are found to be necessary. As a consultant my recommendation here is to use a quality plan (QP) and build an optional function into the plan for a review of change and then once you’ve done this communicate the change to all necessary. The clause doesn’t require this but its the most effective way of keeping control when change is necessary.
Final Words on 8.5
Clause 8.5 is a major clause in the standard and should not nor can be breezed through. As a consultant I cannot recommend strongly enough the use of a QP. A well crafted QP will address all of the issues that may arise during production and service provision, acting as a master plan and sign-posting the way to add-on documentation or processes should the need arise. Included in the QP should be lines of communication to follow in any given event, what additional documents might be used and where to find them and an indication of process owners or authorisations.
Take-Away # 1 – 8.5.1 introduces the idea of ‘human error’ and mistake proofing (actions to prevent human error) and is a great opportunity to introduce tools like ‘Poka Yoke’ from the Lean 6-Sigma playbook
Take-Away # 2 – 8.5.1 is the final check-off on how you’re going to meet customer needs before you actually start the work of production and service provision
Take Away # 3 – 8.5.2 where parts are properly identified you shouldn’t find yourself in the position of shipping the wrong parts
Take-Away # 4 – 8.5.2 by identifying parts and status with respect to monitoring and measurement requirements you’ll find your work environment becomes more organised reducing the potential for mistakes
Take-Away # 5 – 8.5.3 by exercising care for customer and suppliers property you wont find yourself in a position of reworking damaged parts that were previously passed-off as good
Take-Away # 6 – 8.5.3 communicating with the customer or supplier about problems encountered may result in a difficult conversation but delay in communication wont make matters any better or easier to explain latter on
Take-Away # 7 – 8.5.5 is a reminder to make sure that you’ve considered all of your previous agreements on what your obligations will be in the future after production has finished or the service given
Take-Away # 8 – 8.5.6 change is not inevitable but being prepared will put you in a good place when it does happen. Use of a QP will ease the process ensuring you have a fully documented time line with authorities and an understanding of how the change affects the whole process