Clause 6.3 Planning of Changes (secrets revealed)

This is a new requirement of ISO 9001:2015, the previous (2008) version did make reference to planning for change at clause 5.4.2 however, this only related to changes to the management system. The new requirement requires that you plan for all types of change, and how the change might affect your management system.

Remember those risks and opportunities that you identified back at clause 4.1 with your PESTLE analysis? Well, the opportunities you identified might involve change, and if significant, those changes need to be planned for.

What is meant by changes?

Planning for changes; “what changes?” I hear you ask. Well thankfully, ISO 9001:2015 does not insist that you plan for all changes, only significant changes. How do you decide on what is a significant change?, that is entirely for you to decide. You might begin by asking yourself “what would happen if the change that we are about to implement goes wrong, and causes a negative impact?”. Let’s not forget, in quality management we are always trying to protect the customer from the effects of negative impact.

A worthwhile creative exercise is to gather a number of people together and ask them to project themselves into the future to a time after the change has been implemented. Now get them to imagine that all has gone wrong in as many ways as they can possibly think of. This will generate a list of all possible negative impacts of the change. You can then work through the list and reduce it down to only those items that are not too far-fetched, and could realistically happen. Examples of changes could be anything and might include changes to:

• Geographical location
• Infrastructure
• Processes and procedures
• Workforce
• Materials
• Communication
• Training
• Legislation
• Supplier evaluation
• Interested party requirements
  
  

Change requirements of ISO 9001:2015

The list is pretty much endless, but just to reiterate, it’s only what you consider to be a significant change that requires planning for. Here’s a trivia question for you; “how many instances of the word ‘changes’ are there in ISO 9001:2015?”. The answer is: 26, presuming my find function in Adobe Acrobat is working correctly! Reference of ‘planning for change’ doesn’t just appear at clause 6.3, it also appears at:

Resistance to change.

It’s wise to remember that people can be very resistant to change, and that includes me. For example, I hate it when I have to purchase a new T.V. All of a sudden, I have to learn the intricacies of a new handset. It’s the same with a new car, all of the controls feel like they are suddenly in the wrong place. I find it a nightmare when my wife changes the layout of the kitchen cupboards, which she likes to do once a year. I go to find a tin of tuna and end up clutching for a kitchen roll. The lesson here is, have early discussions about the benefits of the planned change early on in the process and get leadership commitment.

When planning for change, there are 4 areas in relation to the change that you must consider;

• Purpose and consequences of the change
• Integrity of the management system
• Resources
• Role, responsibility and authorities

The purpose and consequences of the change; have you clearly defined the purpose of the change, and if it is going to result in an improvement to a process, production methods, customer service or faster order response times etc? Most organisations will understand the requirement for the change, but too often, the potential consequences of the change are not discussed and planned for. You can use visualisation methods such as fishbone diagrams, mind mapping of the creative ‘group thinking’ exercise that I described earlier to aid in this process. By doing this, you are adopting a proactive approach, and avoiding having to react to the consequences of the change post-implementation. What you are hoping for after implementation are only positive impacts, and hopefully 0% negative impacts.

Integrity of the management system; planned changes (and unplanned) are almost guaranteed to affect the management system in some way or another. For example, if you introduce a new piece of machinery you will probably need to update it.

Risk assessments; these risk assessments would normally be a requirement of health, safety and environmental legislation. The risk assessments should be guided in their design by manufacturer instructions, industry best practices, environmental conditions, past experience and the results from your hazard identification processes.


Training; staff might require re-training prior to, and post-implementation of the change. Your management system records of ISO training will require updating to record the training that has occurred, and should include; when, where, by who and an assessment of the effectiveness of the training.

Maintenance processes; if there is a change to machinery or equipment, then the maintenance provision procedure might require updating to reflect the change. This might also include new tools, materials, risk assessments and waste disposal.

Monitoring processes; changes to equipment or procedures will often result in a requirement for monitoring to assess the effects of the change. The results of the monitoring should be captured and retained as records as best practice.

Method statements; high-risk procedures such as the cleaning of containers in explosive environments are controlled by method statements. A change of cleaning chemicals, tools or procedures will result in a change to the method statement and should be recorded and updated within the management system.

Waste disposal processes; changes to packaging materials, and chemicals will affect your waste disposal processes. As with the other examples, the documentation of your management system will require updating in order to capture and record the changes.

This will involve creating new documentation and also updating existing documentation as appropriate. Considering all of this, one can see the requirement for a project manager to oversee the change process. There will be a lot of communication between various interested parties which will require resources, and new roles, responsibilities and authorities to be acquired and implemented.

Resources requirements for change; this is where the links between clause:7 and clause:5.1 become important. Top management must provide the resources that will be required for the planned change/s. Resource requirements might typically include, people, time, infrastructure, IT systems, documentation and training etc. A management review that includes the topic of ‘budget planning’ would be a good place to plan the required resources for future change. Be sure to complete a project assessment forecast plan so that you can be prepared to enter the management review meeting with an estimated cost of the proposed change.

Assessment Of Contractors

Your project assessment plan should clearly identify all of the resources that will be required to implement the planned change, prior to the change, and post-implementation. If some aspects of the planned change will be outsourced, don’t forget to make an assessment of the contractors:

• Availability
• Insurance
• Training
• Experience
• After service guarantee
• Maintenance/service contract

That is by no means an extensive list and I’m sure that you have lots of items that you might add to it. This also relates to the requirements of clause 8.4: Control of externally provided processes, products and services. Although it might seem like I’m going off on a tangent here, planned changes often rely on the services of external contractors, and this could introduce an element of risk into your planning. As we discussed in clause 6.1; actions to address risks and opportunities, you must plan for the risk elements of the planned change, including those associated with external providers.

Role, responsibility and authority; accountability is a good (and necessary) thing within management systems. Without it, you get the familiar situation within a management review meeting where the phrase “I thought you were doing” or “that’s not part of my job description is it?”. Does this sound familiar to you?, I hope not. A person might be designated responsible for doing a task, but have they also got the authority to do it?

Role, responsibility and authorities might need to be re-defined to account for the requirements of the planned change. This is a topic to be discussed at the management review meeting where your project impact assessment plan is on the agenda. Assigning roles, responsibilities and authorities are not always straightforward, and easy tasks. You might encounter resistance from those who might be calculating a perceived extra workload. With this in mind, try to apportion the tasks evenly, and you might also make an effort to ‘sell’ the planned change in terms of its benefits. This tactic will be particularly useful if you can explain how an individual’s workload might even be reduced as a consequence of the change.

Documentation requirements for ISO 9001:2015

Oddly, ISO 9001:2015 does not require you to maintain documents or records in relation to your change management process. “But how will we demonstrate to a 3rd party auditor evidence of our planning for change?”, I hear you ask. Well, unless your 3rd party auditor is psychic and can look back into the past, recording and maintaining documentation is a good idea. A simple form that records the following will suffice:

• Purpose of the change
• Resources required
• Role, responsibility and authorities
• Completion time
• Expected results

Communication

Communication, education and training are important parts of the change management process. For change to be effective, it’s very important to communicate with all those who will be affected by the change. The communication process should happen both prior to the change and post-implementation. You must educate all those affected by explaining the reasons (and benefits) for the change, and when the change will happen. You must plan and budget for any training requirements that are a consequence of the change. Where training is concerned, begin with training from a legal perspective first i.e. health, safety and environmental law and then work backwards from there.

ISO 14001:2015

There is no clause 6.3 contained within ISO 14001:2015 however, there are plenty of references to change in other clauses which will discuss in future chapters.

ISO 45001:2018

There is no clause 6.3 contained within ISO 45001:2018 however, there are plenty of references to change in other clauses which will discuss in future chapters.

For Auditors:

• Check for change planning by examining minutes of management review and through interview
• Check for resource provision
• Check for updates to role, responsibility and authorities
• Check for updates to the management system
• Check if negative impact fed through to the corrective action process
• Although it’s not a requirement of clause 6.3, you could ask to see documentation related to the change management process.
• Interview individuals affected by the change to establish if continual improvement is a consequence of the change.

Some further questions that I will be answering in future articles include:

References: www.iso.org

Be kind and create a link back to this article from your website please, thank you.

(c) All content is copyrighted to ISO Training, all rights reserved 2022.