Change Control - Minimum Requirements and Unhappy Staff

Wes Bucey

Quite Involved in Discussions
#11
Gosh, this situation occurs so frequently in organizations of ALL sizes, right on up to huge mega international organizations.

The problem O.P. faces is primarily political and only peripherally related to "quality procedures."

I don't mean to be pedantic, but let's go back to the basic purpose of "Change Control" and its relationship to Good Manufacturing Practices and Configuration Management.

It may soothe someone's ego to give titles (document owner, author, initiator, etc.) to various folks in the Change Chain , but no matter how complicated the product or process, Change is really a simple process, but sometimes it gets complicated when the communication flow between the folks in the Change Chain [my omnibus term for all the folks including designers, engineers, producers, customers, regulators, suppliers, accountants, clerks, etc. who either have a say or part in initiating, approving, or implementing Change] is choked or broken.

I've seen some slick software that can streamline the documentation through all the necessary levels, entities, and approvals from initial idea for a change to implementation, and subsequent review and evaluation of the change and keep track of versions, with permissions for each link in the change ranging from change to read only so no change goes undocumented and errors can be caught and corrected, eliminating willful or accidental sabotage.

Please read this post of mine (https://elsmar.com/Forums/601326-post4.html) to get an idea of how "complicated" a relatively simple Change can be to implement and document.


I'm not making a value judgement on your process or your company's software since I'm not employed as your consultant, but I can tell you there is no chance to get everyone on board of ANY change unless you can convincingly demonstrate to the majority the efficacy and efficiency of the process you hope to implement AND have included a process to review and evaluate the process once implemented.
 
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Marcelo

Inactive Registered Visitor
#12
I was note sure about exactly what the OP had asked, but I was talking to Don Hurd and he pointed out that, coming from a software background, he noted a possible problem was the understanding of what "before a change is implemented" means. It does not mean that you need to wait for a change "request" before doing anything (which is what software engineers usually do), it means that the reviews had to be performed before the changes are "deployed".

SO, in the original comment, for example, "The software allows any management level user to edit a document without prior request and only requires approval", you CAN begin editing the document without a prior request, but you cannot "approve" the final changed document before the evaluation is done.
 

JoshuaFroud

Involved In Discussions
#13
Thank you all for your responses. They confirmed things I already believed as well as giving some different and very useful points of view.

The situation is now resolved after a long discussion and all parties are happy. The main issue was using paper, rather than the actual process itself, which was not initially evident. With some adjustment to how the software is used and the permissions, everyone can be satisfied. There is a digital pre-change request that goes to the document owner to approve the edits, then stakeholder approval after the updates have been completed. This puts more responsibility on the document owner but removes the need for any physical forms for items related to document updates.

I see and understand that there is no requirement for pre-change authorisation, however, having worked in companies without this before I've seen people invest hours or even days of work updating documents only to have it instantly rejected as the changes did not mesh with already existing procedures that author was not aware of. Or if the procedure already existed, upon conducting a document audit at a previous employer we discovered there were 6 different "Customer Returns" procedures, that were wildly contradictory. Another example was a department bought in a large chiller/dehumidifier unit then raised the change request to turn it on which was declined due to airflow issues within the LEV in the room and the item had to be returned at cost. It is for reasons like this I believe in the benefit of an initial request step in change control.
 

Wolf.K

Quite Involved in Discussions
#14
I still wonder how to update our current change-request system. We have a single form sheet, and actually I am quite happy with the system, because after training people finally they understood that e.g. product flyers for medical devices are part of the labeling and therefore need to be documented in the technical file. Therefore, first step is asking the quality manager for a change request number, which is entered in the CR log; the QM already discusses the change with the person asking for the change. All changes are managed by the CR system: labeling changes, product changes, product developments, QMS software changes, and so on. But we are still fighting because some department "just do things, not bureaucracy" and later on we are in trouble because they just "overlooked" a regulatory requirement... The auditor of our notified body stated, that our system is fulfilling the requirements, but he also understands that people think it is bureaucratic... He suggested (he is not really allowed to counselling us), that we should somehow split the change request system into different parts, e.g. one form for simple document changes and one for software changes and one for "heavy" changes. Personally I think, that having three instead of one forms is not really risk-based, because e.g. people could use the simple form for complicated changes. Or, a simple document change might require several different SOPs to be modified.



What do you think? How do you manage your system? (we are still 100% paper based)


:) Wolf
 

JoshuaFroud

Involved In Discussions
#15
It is a very difficult situation when there is a culture that Quality is something that causes a problem and extra work rather than being there to help. It may be worth looking to address that in addition to any process changes you may make. I'm sure there are people here with much more experience than I that can off some insight into addressing that. However...

With regards to change request, our form has options in an initial "Type of Change" section, Document Changes, Technical Changes and Process/Facility Changes, depending on which is selected depends on how the rest of the form is utilised. This is covered by the procedure (with a process flow for a visual representation of the activities).

Doc changes require the least approvals, mainly Quality, Document Owner and key Stakeholders

Technical Changes bring in the technical, production and Quality
Process/Facility changes require a change plan and risk assessment before being conducted due to their potentially wider-reaching impacts.

I see nothing wrong with using different forms based on the situation, as long as there is a Quality review step at some point and Quality maintains the authority to bump up the change to a higher level of scrutiny if they believe it is required. Then you could potentially keep everyone happy?
 
D
#16
Your change request procedure should include all controlled documents (any document that will be retained for information to be used at a later date) that require a change. Re-write your change control procedure to reflect what you are currently doing. Make sure there is an electronic sign off from the person reviewing the change and an electronic sign off from the person approving the change. Any authorized person should be able to edit the document to submit for review and approval. Make sure the electronic document management system software is verified/validated to show objective evidence that the software is doing what it is intended to do. Good luck!
 
J

JulieChisholm

#17
Common mistake is issuing a document without having senior buy in. Anything adding work and complexity should be socialized with functional areas before it's issued to avoid these situations. Also, since I don't have access to the inner workings of your electronic system, there is no way to understand if the system captures what is required by ISO (hence, can't comment on the utility of the SOP/form implemented and what it fulfilled from an ISO standpoint). Lastly, if there was sufficient training, the Senior person would have had an opportunity to discuss their issue with the procedure/Form before issuance. Despite being the Management Rep it's just good practice to get buy in before implementing systems that cause an increase in paper, especially.
 
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