The requirements for FDA 21 CFR Part 11 are in place for a good reason: When companies are making a part that goes inside your body, the engineering and manufacturing process must be meticulously documented, tested and controlled. People’s lives are at stake.
But these regulations do pose a real logistical challenge to medical device makers trying to adopt Industry 4.0 and move to a fully digital environment.
For example, CFR820: Subpart D 820.40 (b) dictates: Changes to documents shall be reviewed and approved by an individual(s) in the same function or organization that performed the original review and approval, unless specifically designated otherwise. Approved changes shall be communicated to the appropriate personnel in a timely manner. Each manufacturer shall maintain records of changes to documents. Change records shall include a description of the change, identification of the affected documents, the signature of the approving individual(s), the approval date, and when the change becomes effective.
In a traditional, paper-based quality system, this requirement, while cumbersome, isn’t particularly difficult. The documentation is all paper based, so changes require another paper form to be attached, with the requested changes, the justification for the change and the approval of the change with the various required signatures. This was the process at an Indiana-based manufacturer of implantable spinal rods. Any change to the process—for example, changing from one type of end mill to another—would require generating a form of why the change was needed, how the change would be verified as effective, and multiple signatures. This could potentially take days, especially when dozens of changes per week needed to be documented and signed off in this way.
Instead of focusing most of their time on process improvements and new products, manufacturing engineers became paper pushers, making sure all the required paperwork was in order. It’s easy to understand, then, why this company wanted to move from its paper-based ERP and separate, paper-based QMS system to a modern, database-driven and totally paperless manufacturing ecosystem.
The challenge became the interpretation of this sentence: Each manufacturer shall maintain records of changes to documents.
What constitutes a document? What constitutes a change? And how do you document all this when there is no paper?
In order to stay well within the bounds of the standard, a strict interpretation was taken, meaning that any change would need to have a digital process of requesting a change, documenting a justification and getting approval.
A great example would be the documented change of a cutting tool. An engineer wants a better performing tool, so that change in the process requires documenting the change, the justification and the approval.
Having an edit log of the change is included in many ERP systems. But fields for justification and an approval process is an entirely different story. ProShop addressed the issue by developing a complete audit log, as well as an approvals module that allows easy configuration of which employees need to provide approval for what types of changes.
Making sure this process was easy and lightweight was essential. Imagine the difference between processing paper documents vs. all departments involved receiving instant notification of a requested change and being able to sign off with a few clicks. What may have taken days or weeks now can be done in minutes.
The pace of innovation and process improvements can accelerate exponentially. There are specialized medical QMS software programs that already do this, but they are generally isolated silos of information, detached from the ERP and MES systems that are essential to daily operation of a manufacturer. By combining all of these essential functions, manufacturing companies can unleash their true potential.
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