I think the change occurs for business reasons. In the current fast-moving competitive job market, it is illogical to expect stakeholders and clients to have full knowledge of what they want or need to achieve business goals. Yes, we want to avoid radical changes unrelated to the project goals, but we do not want to do this at the expense of ignoring the real opportunities that can be achieved for the company by gaining the trust and satisfaction of customers.
The most important thing is to make an accurate decision about the feasibility and how to incorporate the change. The second thing, which is just as important, is that the change be managed in a way that allows stakeholders to understand what is change, what is its importance and what is its impact on the project.
A challenge I've often faced when submitting a Change Notice at my company Getinge is that obtaining approval from all the required reviewers can take a while, since these reviewers are usually functional managers with many other responsibilities on their plate and other documents they need to review. We are able to prevent project delays by making our change request process more efficient using a few different methods:
1. Review the redlined document with the approvers either in a meeting or through email before submitting the formal electronic change notice - this way the approvers can catch any errors beforehand without needing to reject the change notice and start the electronic approval process from the beginning again.
2. Ensuring that a single person from each functional department is the designated reviewer for any document changes related to your project, and that they are given a clear timeframe that they are expected to complete their approval by.
3. Keeping a spreadsheet of all change notices currently routing for approval in your project, and having just one project team member responsible for contacting the reviewers for the items that are running late, so the reviewers aren't bombarded by repetitive follow-up emails.
Companies have different procedures in order to submit a design change request. Share your experience on the steps needed to complete a design change request at your company.
At Maquet, the engineers redline the latest version of a document as a hard copy. The co-op’s will then transfer the redlines onto an electronic copy using track changes or other software techniques. After the redline is complete a final version is created with the new revision level. Both the redline and final document are uploaded onto Getinge software called “TrackWise” under the file type of document record. The document record must be attached to a change notice document type in order to be considered as design change request. The change notice is sent to document control which approves or disproves of the changes. Once document control approves of the changes then a head from each department is obligated to sign off on the new changes. If a lead disapproves of the changes then the document returns back into the original state and the process must be completed again until everyone approves.
At Siemems, the engineers must redline the original document using "track changes".
A new revision is created with all changes applied.
A verification plan including traceability to change request, assessment of change impact to input requirements, and test cases of the changes must be reviewed and accepted
The verification plan is submitted to design history file.
A changes and verification plan are evaluated by a review board.
If they pass the review then they are signed off.
If a lead disapproves of the changes then the document returns back into the original state and the process must be completed again until everyone approves.
A change request is a formal request submitted by one of the project stakeholders to make a change to a project. Approval of a change request will result in the deviation from the original project plan that was created at the beginning of a project.
All manufacturing company - Cosmetics, Pharmaceutical, Medical Device or Food industry should have a change request form. In my opinion I feel most companies follow similar procedures and protocols when it comes to requesting a change and getting it approved. It might differ depending on the kind of change needed or requested.
That been said, I have not had the opportunity to work in Medical Device Company but working in a cosmetic company where we also deal with change control, a change request form can be requested by those working with or have worked on that project. Also, a change request form can come from the project sponsors.
When a request is generated on the system and filled out this is forwarded to the project team which will include the Project Manager, Product development team, Process engineers, Costumer Representatives, and the Quality department. This is then reviewed and if the need to make changes is tangible enough, then a number is assigned, and every department involved will after to sign off on it. The final approval will come from the Vice President, Chief Financial Officer, and the Project Manager if they unanimously agree to the change. The change request is then forwarded to the Quality Assurance and Product development to review every document that this change will affect which will include the BOM, Specifications, SOPs etc. before it is transferred to the production floor.
Working in a laboratory is no less than working in a corporate sector. There are projects which needs to be taken care of. There are experiments or the assignments which are to be designed. A design change request can be updated by a worker in the team or a fellow project manger or even the PI of a lab. In all the scenarios the change request form is filled and is a used for requesting, approving and documenting the changes which is to be done on the project.The process can be long and rigorous or it may be minute too. But the most important fact which needs to be taken into consideration is that outcome of the project should have a positive aspect and should not bring down the whole project to a stand still. It is imperative that the request form should be address as soon as possible and the documentations should be done on time to accomodate the changes.
