ISO 9001:2015 8.5.6
I'm looking for a few real-world examples of how companies meet this 8.5.6 requirement. What changes would this apply to? I've read that it's aimed at impromptu / unplanned process changes. But I can't think of any way it applies to my current co. And I'm not even sure if any of the examples I can remember from my previous companies are the correct application of this clause. Thanks.
5 Replies
Hi Betty,
At my last job where I worked for a company that designed and built jet engine test systems, we would have 3 design reviews with the Customer to make sure the final product was on track to meeting their needs and expectations. A preliminary, mid and final design review. We would document what was discussed and agreed upon in the reviews, who attended the review, date of review, then engineering design drawings and parts lists would be updated to reflect those changes. Of course, appropriate engineering approval was documented for making the updates to the design documents. I don't know if this is a helpful example, but it's an example.
That sounds great for 8.3.6 which is design changes.

I'm curious about 8.5.6 which is for production changes.
Good Afternoon Betty,

"The organization shall review and control changes for production or service provision, to the extent necessary to ensure continuing conformity with requirements.
Persons authorized to approve production or service provision changes shall be identified.
NOTE: Production or service provision changes can include the changes affecting processes, production equipment, tools, or software programs.
The organization shall retain documented information describing the results of the review of changes, the person(s) authorizing the change, and any necessary actions arising from the review."

The title of 8.5.6 is Control of Changes, it falls under 8.5 which is Control of Production and Service Provision. So, when I skim over the multitude of clauses and subjects within 8.5, I see the following (this is a slimmed-down list):
  1. The availability of documented information that defines...
  2. The availability of suitable monitoring and measuring resources
  3. suitable infrastructure
  4. appointing competent persons
  5. validation, periodic revalidation of ability to achieve planned results
  6. Control of Equipment
  7. Validation of control of special processes
  8. Production process validation
  9. ID & Traceability
  10. Property of external providers
  11. Preservation
  12. Post deliver activities
Since all of these items fall under 8.5, which is where control of changes 8.5.6 is, I would guess that anything my company did to change the processes needed to accomplish items 1-12 would apply. The key in this clause is to remember the, "to the extent necessary" verbiage. If the change poses little risk to the ability to meet product and customer requirements, then the company would not need to review extensively, and the opposite holds true. Also, if you aim to meet AS9100 requirements, the line in bold applies. Evidence of these changes must be approved, by a person who is authorized to make these changes. Going further, the persons' authority to make changes must also be identified. (Who, why, when was this person given the authority to make these changes etc..)
An example of a change that would most likely require extensive planning and review could be a change in facility location. I would guess there would be plenty of evidence that this change was reviewed, approved, managed, even had outsourced help. If a change seemed minor to a company, then the evidence of the change being reviewed would be less formal in nature.
An example of this could be the move from a paper traveler system to a paperless system.
An example of another change that would apply could be a change in how talent is recruited, was there a list of requirements that were standard, that is being changed to accommodate a worldwide shortage of employees?
One more that could be considered a major change and even risky, is a change in shipping providers (Logistics)

Hopefully this helps.
Betty,

The way I approach Change control - be it process of document related, I established a Change Control Form that must be filled out and submitted for approval. It consisted of Requesting the details of the proposed change, justification for the change and a series (4) of questions about alternatives considered, impact to other processes and/or documents and training needs. This way it forces the originator to not make arbitrary changes. Further I follow up the questions with approval signatures with Quality Required, and those affected by the change - Production Manager, Engineering, top management and any others as needed.

Hello Betty,
I'm one of the instructors for our ISO 9001:2015 Requirements from A to Z classes. We have an assignment at he end of the class in which six scenarios need to be analyzed using the ISO Standard. One of the scenarios involves a power supply which was substituted with a different model. The change was in the form of a handwritten amendment. The former power supply was, according to the project manager, who not available in a reasonable amount of time. The substituted power supply was of higher quality and at a lower cost. The premise of clause 8.5.6 is to correctly manage change. This pertains to documented information (DI) which is the requirements specified in the agreement. This also includes keeping track of changes to DI and retained documented information (records) of any changes made. In addition, the customer needs to be kept informed of any proposed or actual changes which brings clause 8.2.4 comes into action. This is a really good clause because it covers both the DI and customer communication aspects.