ISO 9001 Planning for Changes: Do's and Don'ts


Meeting 4

 

An ongoing series of Posts: Practical advice on Clause 6.3 of ISO 9001:2015

The purpose of Planning the Changes is to maintain the integrity of the quality management system and the organization’s ability to continue to provide conforming products and services during the change.

And you will need records or other credible evidence to demonstrate compliance here.  Here’s why.

Clause 6.3, Planning of changes, states:

"When the organization determines the need for changes to the quality management system, the changes shall be carried out in a planned manner.

The organization shall consider:

  1. the purpose of the changes and their potential consequences;
  2. the integrity of the quality management system;
  3. the availability of resources;
  4. the allocation or reallocation of responsibilities and authorities."
Notice that there's no requirement regarding documentation.  However, some requirements are virtually impossible to have evidence of without records. For example, ISO 9001:2015 doesn't require retained documentation for:

For your ISO 9001 Certification Audit you will need records of the Planning for Changes activities as objective evidence for the external auditors.

Planning for Change – What to doISO 9001:2015 & You

You will need to ensure that any proposed changes are planned, introduced and implemented in a controlled manner.

Properly planning a change can help to avoid negative consequences such as rework, or cancellation or postponement of a service; it can also result in positive consequences such as the reduction of nonconforming outputs, or reduced incidents of human error.  Here are six entries for your To Do List...

1. Consider the many sources of change

The need for a change to your quality management system can be determined in many different ways.

For example, as part of management review, from internal or external audit results, reviews of nonconformities, complaints analysis, analysis of process performance, changes in context or from the changing needs of customers and other relevant interested parties.

The need for changes can result from the transfer of production lines from one site to another, changing process methods to improve trends in non-conforming outputs, and using new information and communication technology (ICT) for a service or process.

It may also result from outsourcing important processes, persons in key roles leaving (either due to retirement or medical issues), or moving to online order handling.

2. Prioritise the Changes

Address the changes that offer the prospect of greatest improvement first.  Selecting the one that colleagues are shouting loudest about may not be the best choice.

Of course, while the customer is not always right, they are always the customer and sometimes a commercial decision may change the priorities.

3. Evaluate the Impact of the proposed Change

You should evaluate the impact of such changes on your quality management system and take the necessary actions to prevent undesired effects.

This can range from the application of project management methods to establishing performance and validation testing of new processes and systems on a pilot basis before they are implemented.

The level of planning and action required will vary depending on the potential consequence(s) of the change.

4. Plan the Change Carefully

Proper planning of a change can help to avoid negative consequences such as rework, or cancellation or postponement of a service or loss of a customer.  It can also result in positive consequences such as the reduction of nonconforming outputs, or reduced incidents of human error.

5. Use Project Planning Methods when appropriate

The level of planning and action required will vary depending on the potential consequence(s) of the change.

If moving offices or introducing new production planning software, say, the risks associated with failure are considerable. You will need to use Project Management techniques, have a Project Team, top management support, finance and other resources for this type of project.

For simple projects (e.g. changing a procedure or form), the resources to hand will usually suffice.

Whatever the change, the impact of such changes on the quality management system should be evaluated by the organization and the necessary actions to prevent undesired effects should be taken.

6. Have a Procedure

Whether you're dealing with an ISO 9001 Implementation or an ISO 9001 Transition, include a Procedure to ensure that appropriate methods are used and records generated for all QMS changes.

A Flowchart of the procedure, indicating where records need to be generated, should suffice.

ISO 9001:2015 Lead Implementer

 

Planning for Change – What Not to do

1. Don’t implement too many changes simultaneously

Don’t do more than you can manage/control.  Don’t rush to get things done quickly – slow steady progress is best. 

If you can, do the changes one at a time evaluating and confirming the effectiveness of the change before moving on to the next.  When you review progress (after, say, 12 months) you’ll be surprised how much you have achieved and maintained with this approach.

2. Don’t go ‘All In’ if you can avoid it

The organization should consider actions that could reduce the potential for negative impacts of the change, such as first conducting a trial of the change before full implementation (e.g. a pilot project one one production line before roll-out on all production lines) or determining actions to be taken when the change is not successfully implemented.

3. Don’t forget the Risk-based Approach

The application of risk-based thinking can be helpful in determining the actions necessary in planning changes to the quality management system.

The organization should consider the availability of resources and necessary allocation or reallocation of responsibilities for any change. This could be done by assigning persons to a team to manage the change, or by delaying the change until the right resources are available.

Conclusion

You will need evidence to demonstrate that changes to processes are controlled.  For this purpose, many organization use Engineering Change Requests or similar to control changes to manufacturing processes.  And, of course, changes to administrative and other processes must be handled in a similar manner.

 Whatever approach you take to implementing ISO 9001:2015, you will need records and other hard evidence that the organization’s ability to continue to provide conforming products and services was maintained during the change.

ISO 9001 Gap Analysis Tool

Written by Dr John FitzGerald

Director and founder of deGRANDSON Global. After 15 years in the manufacturing industry, John has spent the past 25 years training, consulting and auditing ISO 9001 and other management systems.

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