SOP

The author has reviewed 100+ design control processes in his career, and this blog provides five steps to write design control procedures.

In my previous blog posting, I indicated six things that medical device companies can do to improve design controls. While the last posting focused on better design team leaders (WANTED: Design Team Needs Über-Leader), this posting focuses on writing stronger procedures. I shared some of my thoughts on how to write design control procedures just a few weeks ago, but my polls and LinkedIn Group discussions generated great feedback regarding how to write design control procedures.

No Need to Write Design Control Procedures

One of the people that responded to my poll commented that there was no option in the poll for “zero.” Design controls do not typically apply to contract manufacturers. These companies make what other companies design. Therefore, their Quality Manual will indicate that Clause 7.3 of the ISO 13485:2016 Standard is excluded. If this describes your company, sit back and enjoy the music.

1 Procedure Only

Another popular vote was “one.” If you only have one procedure for design controls, this meets the requirements. It might even be quite effective.

When I followed up with poll respondents, asking how many pages their procedures were, a few people suggested “one page.” These people are subscribing to the concept of using flow charts instead of text to define the design control process. I use the following diagram to describe the design process: The Waterfall Diagram!

I first saw this diagram in the first course I took on Design Controls. This is on the FDA website too. To make this diagram effective as a procedure, we might need to include some references, such as work instructions, forms, the US FDA guidance document for Design Controls, and Clause 7.3 of the ISO 13485:2016 Standard.

Many Design Control Procedures

The bulk of the remaining respondents indicated that their company has eight or more procedures related to design controls. If each of these procedures is short and specific to a single step in the Waterfall Diagram, this type of documentation structure works well. Unfortunately, many of these procedures are a bit longer.

If your company designs software, active implantable devices, or a variety of device types—it may be necessary to have more than one procedure just to address these more complex design challenges. If your company has eight lengthy procedures to design Class 1 devices that are all in the same device family, then the design process could lose some fat.

In a perfect world, everyone on the design team would be well-trained and experienced. Unfortunately, we all have to learn somehow. Therefore, to improve the effectiveness of the team, we write design control procedures for the team to follow. As an auditor and consultant, I have reviewed 100+ design control processes. One observation is that longer procedures are not followed consistently. Therefore, keep it short. Another observed is that well-designed forms help teams with compliance.

Therefore, if you want to re-write design control procedures, try the following steps:

1. Use a flow chart or diagram to illustrate the overall process
2. Keep work instructions and procedures short
3. Spend more time revising and updating forms, instead of procedures
4. Train the entire team on design controls and risk management
5. Monitor and measure team effectiveness and implement corrective actions when needed

The following is a link to the guidance document on design controls from the US FDA website. In addition to the comments I made in this blog, please refer back to my earlier blog on how to write a procedure. You can also purchase Medical Device Academy’s design control procedure and forms.