Happy New Year!

The New Year is a time for reflection and typically is accompanied by change.  Change is a great topic and one that most organizations don’t always handle that well.  I have written about change management in the past (“Driving Change”).  It’s not a new concept in the management system realm, but there are changes that you need to be aware of.

In the previous versions of the standard change management was implicit, implied but not plainly expressed or defined in the standards.  Though there were many references for keeping the information up to date or maintaining information or being proactive.

In the new version of ISO 9001, there is a clause expressly requiring planning for change:

6.3 Planning of Change

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:

The purpose of the changes and their potential consequences;

The integrity of the quality management system

The availability of resources;

The allocation or reallocation of responsibilities and authorities. (ISO 9001:2015)

 

The nice thing about this clause is that it provides organizations with detailed guidance on what needs to be considered when planning for change.  The downside is that there is no requirement for maintaining documented information (i.e. records).  But as any good project manager knows, you need to document your plan.  And any good Quality Manager will know that to demonstrate that you are maintaining your quality management system, you will maintain those records.

What types of records?  Checklists (see my post), project plans, action lists, meeting minutes, document changes, budgets, etc.  The number and types of records will be dependent on the nature of the change.  Smaller changes such as equipment replacement you could have a purchase order and work order for installation.  Larger changes may involve capital budget requests, project plans, etc.

On the environmental side, planning for change is handled through the ISO 14001 revised standard in multiple sections of the standard.  The main one is:

“8.1 Operational planning and control

The organization shall control planned changes and review the consequences of unintended changes, taking action to mitigate any adverse effects, as necessary.” (ISO 14001:2015)

My next blog post will go into detail regarding all of the planning for change references in the ISO 14001:2015 standard.

The way to manage change for either or both standards are pretty much the same:

1. Identify that there is a change planned.
2. Communicate the change to all parties that may be affected.
3. Determine the effect of the change on all parts of the business, including the management system specifically (i.e. procedural changes, training needs, process changes, testing changes, approval of new suppliers). Identifying the gaps that need to be addressed.
4. Assign tasks and responsibilities for the implementation for the needs identified. Ensure clear time frames are established to ensure that the actions are proactive or, at least, timely, to the change occurring.
5. Monitor and review the implementation of the actions. Conduct inspections and audits as needed.
6. Conduct a review afterward of lessons learned throughout the process in order to improve the next time.

How do we audit change?  Well, that’s a topic for a future blog.  In the meantime, have a great 2016!