Hands up who audits clause 6.3 of ISO 9001:2015 effectively? Up until recently I probably didn’t either as I hadn’t appreciated the impact of the clause fully until something didn’t feel right during an audit but I couldn’t find where to put it.
Planning of Changes is a larger clause than what most people think and just assume that organisations are controlling changes as they should and performing audits to check they done it right. The text refers to changes to the quality management system which is probably the first assumption mistake; they feel it applies to the system and procedures when in fact it applies to everything within the context of the audit.
Changes need to be carried out in a planned manner and refers to clause 4.4 of the standard which is the clause which highlights how the system works and interacts and how it’s monitored etc. In layman’s terms, you need to ensure that if you change something, you don’t lose control and everything still works. That is the easy part.
When you start looking at the other considerations within the clause, auditors need to think about the changes that have occurred within the organisation and seek evidence that all changes were considered and planned and not just performed. “Let’s do it and worry about it later”, we are all probably guilty of that at some point in our lives.
The first consideration “the purpose of the changes and their potential consequences” is pretty wide and all-encompassing. Why are you making a change and what can go wrong is basically what this consideration is asking. How an organisation addresses this consideration could be very quick and simple or more in depth depending on the nature of the change. For a more complex or detailed change; an organisation may wish to perform a risk assessment, or has the original risk assessment the organisation has developed been updated to accommodate this change? Did they assess something previously and rate it as a low risk but now it should be upgraded to a medium or high risk? Are they changing their strategy and market, what is the impact of this change in direction? Do they actually want to make the change after they have assessed the change and determined that it’s probably not a good idea to implement?
An example to consider could be the rebranding of a business, there will be Pros and Cons about rebranding a business depending on why the rebranding is taking place, to begin with. An organisation should weigh up the impact of the rebranding exercise and determine if it is actually worthwhile or could it damage the business long term?
The second consideration “the integrity of the quality management system” is to ensure that when an organisation is planning changes, they think about how they can maintain compliance throughout the changes. How many times have you seen an organisation upgrade software such as going over to a new ERP system and something they had in place prior to the change has suddenly disappeared? I know I have raised it a couple of times, especially in the aerospace standard where the terms and conditions for suppliers were in place, then a year later we find that a recent software change removed the automatic attaching of terms to every purchase order.
Again, this has wider implications as anything an organisation does could impact the integrity of the quality management system, this sub-clause allows you to pin any issues relating to loss of integrity from a change against this.
A good example I recently experienced was an organisation deciding to move some equipment and no consideration was given to recalibrating the equipment after they moved it or what the impact was on all parts that were shipped using that machine. In theory, all the parts they had shipped which were manufactured using that equipment now need to be recalled as they may be non-conforming.
The third consideration “the availability of resources” should be self-explanatory, does an organisation have suitable resources in place to ensure that the changes they are planning on implementing are carried out? Do they have the right people, at the right time, in the right place, using the right equipment etc?
The fourth and final consideration is “the allocation or reallocation of responsibilities and authorities”, and this is probably the area where most organisations have issues. There are personnel changes on a very regular basis and a bit like the software changes, they are not being controlled. I have run into situations where a task was being performed by someone and then they left, someone else took over or was then employed and those tasks were never handed over correctly and have since been stopped. There is nothing stating you need to document all the tasks you perform day to day but if someone is taking over a role then there would need to be a good handover of those duties. Or more to the point, consider the impact on responsibilities when there are personnel changes or structure changes.
I will be ensuring in future that changes are assessed more effectively in future by myself as I feel the clause adds value to an organisation and can hopefully help protect their business and revenues through good planning and evaluation of the changes. Let’s not forget the 6 P’s quote; Proper Planning Prevents Piss Poor Performance. Good luck and happy auditing!