Are Document Approvals Consistent Across Sites And Appropriate?
By Eric Hinrichs, senior principal quality engineer (retired), Ethicon, part of the Johnson & Johnson Medical Device Companies
In medical device development, document approvals seem to always be a roadblock when you are the most pressed for time. How much time do you have to take to explain the change to an approver? What about the frustration when an approver does not have a designated alternate? Why are there so many approvers for a simple change? Why are the approvers so different from site to site? Don’t fret — there is something you may be able to do about it.
Do Your Approval Matrices Make Sense?
One of the international companies I worked for had documents that applied to multiple locations. As a project leader I was frustrated by the approval process. My team and I spent significant time having to explain a change beyond the supporting documentation to approvers whose function had nothing to do with the change — they were not impacted nor was their area of responsibility associated with the change — but they still were required approvers. We also had to deal with approvers who were not knowledgeable on the medical device or manufacturing processes needing a change. It was frustrating for me as project leader and my team. We just had to accept these frustrations and try to minimize their impact on our schedule. Yes, the medical industry is heavily regulated, but was the company’s approval process a result of such regulations or was it a result of years of accumulated internal decisions that led to a complex and inconsistent approval process that, when viewed overall, made no sense?
When the project was completed, I resolved to look into how approvers are assigned to documents. I pooled all of the approval matrices from all of the worldwide sites for every type of document approval (product specifications, test methods, operating instructions, process specifications, material specifications, etc.). When put into a spreadsheet, the results were astonishing. I found that each site had almost entirely different approvers for like documents! How did this happen? How was it allowed to happen? I asked the different sites why they had the approvers they had. The answers I received varied. Approvers were changed to address a nonconformance or changed based upon local management and what they wanted to see or control. Other sites changed their approvers to cover a perceived gap or make their site the only document approval so they could control changes and make changes to their benefit. In one site approval matrix, eight approvers were required for a change to add the expiry date to an internal process specification. One of the required approvers was the manager of building maintenance!
This lack of approver consistency or rationale was why our project team faced approval roadblocks throughout the project despite our best efforts to minimize delays through very detailed supporting documentation that practically handheld the approver through the change rationale.
Assess And Update Approval Matrices Periodically
Approvals should reflect the impacted area(s) of responsibility and ownership. R&D typically owns a device’s design during its lifetime. R&D should also own all process specifications that pertain to the manufacturing of the device, any document containing device specifications, and device test methods. Quality should always be an approver to ensure compliance with external and internal requirements. Regulatory should be an approver for changes that impact regulatory. The same rationale applies to labeling, stability, sterilization, etc. In essence, while the document owner and quality have overall oversight of changes, other departments are added only if they are directly impacted by the change.
Manufacturing sites should not be owners of any medical device test method or device specification document; these are owned by R&D. Manufacturing sites are just that – manufacturers. A company should not treat an internal manufacturing site any differently than an external manufacturing site. Giving document ownership to a manufacturing site invites trouble, as they could potentially change a specification without R&D awareness. I have seen this happen. An internal manufacturing site had to replace a polymer mixing motor and ordered a cheaper motor (to save money) that had different running parameters that would have negatively altered the polymer characteristics. By luck or coincidence, someone in R&D found out about the motor change and stopped the site from creating a potential disaster; the correct motor was ordered. In this instance the document change had only site approvers; no one from R&D or quality (headquarters – local quality – was the quality approver) was required.
Manufacturing sites should not be required to approve changes involving medical devices and their associated manufacturing processes. Now that does not mean changes to documents are made without their awareness. It is common sense to discuss changes up front to ensure there are no manufacturing site concerns. Manufacturing sites must be aware of what they will need to do to implement a change when the change is approved.
This approach means changes impacting a manufacturing site should be reviewed beforehand, much as one would do for an external supplier. Do you require an external supplier to approve a medical device specification change or change to the manufacturing parameters for your device? Certainly not, but you engage the external supplier in the change to get their input and how it will impact their manufacturing and what they will need to implement the change. This should be the same approach with any internal manufacturing site at your company.
Global Documents, One Owner
All global documents should be owned by the appropriate department to avoid developing dissimilarities among sites. For example, a test method utilized at multiple sites should have one overall owner, and approvers at each manufacturing site should be the same. This is the best way to avoid potential testing inconsistencies. One owner and one quality group (headquarters quality team) should own the test method so any changes requested are consistently applied across all sites. How else can you control the quality of your medical device if multiple sites have differing release criteria or testing methods?
Consolidate Approval Matrices
Another way to avoid approval inconsistency is to place all approval matrices for all documents and sites into one unified approval document. This ensures approvals are consistent, applicable, and appropriate. It also aids the change owner in identifying the appropriate approvers for the requested change.
The Bottom Line
If the right approvers and document owners are defined appropriately, approval can be streamlined and efficient. Not only will this save time and avoid delays, but this approach protects against potential changes that could result in a device flaw or a compromise in performance. It ensures the right approvers with the right responsibility, experience, and product knowledge are approving to ensure the change is correct and appropriate. Another benefit is this approach avoids audit observations and helps in addressing product complaints by avoiding changes without R&D awareness. As a project leader, once the approval process was changed to be consistent across all sites and with the right approvers and applicable approvers, I slept better at night.
About The Author:
Eric Hinrichs has more than 31 years in the medical device field in research and development on new products and processes, in operations on improving processes, and in quality on leading process and product validations and performing data analysis. He developed and led the implementation of numerous process redesigns while at Ethicon to improve product support execution. He authored an ASTM standard, worked on updates to United States Pharmacopeia (USP) medical standards, and helped developed new medical standards for the European Association of the Surgical Suture Industry (EASSI) in Europe. He has also co-authored a medical standard for India that is currently under consideration for adoption. He has also authored a book on career advice titled Perceptions and Expectations.