Process/Equipment Change Management


Thread Starter

D. Nguyen

Dear List:

I have recently been given a assignment to come up with a change management procedure (model) for equipment and process. As I am not quite sure how to tackle this project since its scope is so large. Just wonder if anybody out there have some suggestions concerning Engineering Change Management. I am trying to look at all options, so please do not leave out procedural or technical solutions. Also, any suggestions dealing with how to roll this out would be much appreciated. The plant that I am at, the culture is very much resistive to changes. There is currently a similar procedure that exists in our cGMP area, but it is not effective in handling temporary changes, emergency situations. Please help.

D. Nguyen
If you are talking about documentation control to improve a system that already exists, there are a number of document management packages that may help you. If you have the commitment of upper management, then you might have the resources to customize a document management system so that the flow of information is similar to the manual system now in place. We've had a software package for EC control since the mid-90's. Initially, it was customized to mirror our paper
system. Over the years, it has evolved to include new features and additional security and control. Mirroring the old paper system helped reduce user training and ease the transition to
the new software.

From your last statement, it seems like you need much more than simple document management. I hope to see some good responses on handling temporary changes. We have that problem here. There are often several approved methods for
deviating from standard procedures, but we only keep one method active at a time. I think our ERP system can support alternate bills and routings for temporary changes, but we've never tried to implement it.

D. Leese

Herman Chrisstoffer

For IT infrastructures there are rather comprehensive change management procedures in the ITIL method (IT infra structure library).
These methods could be a basis for your change management procedure for equipment and process.

Herman Chrisstoffer
You must develop a system that requires change to be business justified. Require a problem statement, solution, test plan/results, relevant capital and expense costs, and rollout/execution strategies. You must also recognize that change management is the responsibility of everyone involved - not just some team or one person - , and so the system should bridge the gap between the experts who use the equipment everyday and those who manage the money. Establish key-point responsibility for approval of all changes. Allow mid-level managers or others to recommend a change, but shield change requests until the proper justification has been agreed upon by several experts. Understand the rollout plans so whoever the change effects can be represented. Solutions may already exist that others are not aware of. Also, tie change management as closely to the documentation as you can. If you have a PDM, tie your change management to the data/documents managed in that PDM. Use the workflow/redline capabilities to enable seamless collaboration and data security. (Data security is important, especially when it seems you are 'fighting' to keep change from happening everywhere. If they don't have the documents to change, it makes change very difficult to live with. Consider a security system that manages non-editable view documents and also editable source documents.) Communicate to everyone the value and benefits of a change management system where everyone collaborates. (It's better to have everything running at 10% improvements than one or two areas running at 15% and everyone else running below expectations.) Change management should also manage standards. Document what the standards are and provide change management to the standards as well as the equipment. Make sure the standards you document are equipment/drawing standards at their final result - not 'the best steps we know of' to achieve the final result. If you do this, all of your effort will be in keeping them up to date. Also, when managing standards, capture the history behind a standard. So often a standard is established without writing down what was discussed and why a standard was set. Standards are always challenged - even by yourself sometimes - and it helps to know if new data is available that may justify making a change to the existing standards. Last thought: identify the key support people in your company and make sure that every one of them will not only support your system, but will champion it when the time comes, because it will.