ISO9001 and the Control of Changes
Have you ever had one of those days when you are working through something you have done many times before only for someone to say, oh hey we changed how we do that, or we don't use those parts now we changed that? Frustrating isn't it? It's also pretty wasteful as it can create a bunch of rework or worse useless products or services no one wants or will pay for. This is what the ISO9001:2015 clause 8.5.6 Control of Changes Clause is about, it's to ensure that everyone is working on the right thing and just as importantly, everyone knows when something has changed.
Changes in Production or Service Provision
- You must review the changes before you implement them. This is to ensure that the changes you are making don't alter the ability of the product or service you are providing to meet the requirements of the product or service that you or your customers have previously defined back in the design process. So for example, if you were manufacturing a wardrobe and its original requirement was to hold 10 coats and you made a change that reduced the length and now it only holds 7 that may be a problem and the review process will let this be flagged up and discussed.
- You must have some form of control of the changes in place, these controls should include things like who has the authorisation to approve the change, how will you communicate the change to ensure that everyone who needs to know does know.
Documented Information Required
This clause also requires you to hold on to the documented information i.e. records of the changes that you have made for the product or service. Typically an organisation may have a dedicated Change Form (sometimes called an Engineering Change Request or Change Notice) that will capture all of the required information you need in one place that can be communicated and referenced by the organisation or suppliers or customers as required.
The record does need to have some specific things captured:
- The results of the review of the Change – i.e. are there any impacts, for example, if you were making a product and you changed out a part, is the old part now obsolete, is there an excess stock that needs to be disposed of or is there a lead time change.
- Was the request approved or declined?
- Who authorised the change?
- What, if any, are the actions that you need to happen for this change to be fully implemented, if possible, it's a good idea to be specific about who will implement that action as well.
It's also a good idea to keep a register of the changes as a quick reference this can also serve as the source of a reference number to attach to the change to ensure that it is easily traceable within the system.
This clause, 8.5.6 of the ISO9001:2015 standard is really focused on helping you better control changes (and so variability) within your products or service provision. Keeping track of what has changed, when and why is vital to be able to track any adverse effects on the expected function of the product or service and ensure that it always meets the original requirements.
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