The Ultimate Design Control SOP

Disclaimer: There is no need to create the Ultimate Design Control SOP. We need medical devices that are safer and more effective.

If Adele is worthy of six Grammy Awards, she’s probably worthy of a blog link too. Rumor has it that this is my personal favorite from Adele.

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 writing design control procedures just a few weeks ago, but my polls and LinkedIn Group discussions generated great feedback regarding 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 Standard is excluded. If this describes your company, sit back and enjoy the music.

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 to 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. In fact, I use the following diagram to describe the design process all the time: The Waterfall Diagram!

From the US FDA Website.

I first saw this in the first AAMI course I took on Design Controls. This is on the FDA website somewhere 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 Standard.

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 create design 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 I have made is that well-design forms help teams with compliance.

Therefore, if you want to rewrite your design control SOP 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 correct actions when needed

The following is a link to the guidance document on design controls from the US FDA website.

Refer to my LinkedIn polls and discussions for more ideas about design control procedures:

1. Medical Devices Group
2. Elsmar Cove Quality Forum Members Group

In addition to the comments I made in this blog, please refer back to my earlier blog on how to write a procedure.

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WANTED: Design Team Needs Über-Leader

“Mona Superwoman” by Teddy Royannez (France)

Last November Eucomed published a position paper titled, “A new EU regulatory framework for medical devices: Six steps guaranteeing rapid access to safe medical technology while safeguarding innovation.” While I have serious doubts that any government will ever be able to “guarantee” anything other than its own continued existence, I have an idea of how industry can help.

The position paper identified six steps. Each of these steps has a comparable action that could be taken in every medical device company. My list of six steps is:

Only the best leaders

1. Only one approach to design controls
2. Stronger internal procedures
3. Cross-pollination by independent reviewers
4. Clear communication of project status to management
5. Better project management skills

The most critical element to success is developing stronger design team leaders. Design teams are cross-functional teams that must comply with complex international regulations, while simultaneously the team must be creative and develop new products. This type of team is the most challenging type to manage. In order to be successful, design team leaders must be “Über-Leaders.”

The most critical skills are not technical skills, but team leadership skills. The role of a design team leader is to make sure that everyone is contributing without tromping on smaller personalities in the group. Unfortunately, there are more men in this role than women.

Why is this unfortunate? Because men suck at listening (takes one to know one).

We need a leader that will be strong but we also need someone that is in touch with the feelings of others and will use that skill to bring out the best of everyone on the team. This superwoman also needs to earn the respect of the male egos around the table. She needs to be an expert in ISO 14971, ISO 13485, Design Controls, Project Management, and managing meetings. Our beautiful heroine must also be a teacher, because some of our team members will not know everything—even if they pretend to.

The Über-Leader will always remind the team that Safety & Efficacy are paramount. As team leaders we must take the “high road” and do what’s right—even when it delays a project or fails to meet our boss’ unrealistic timetable. Superwoman must demand proof in the form of verification and validation data. It is never acceptable to go with an opinion.

She will remind us that compromise is the enemy, and we must be more creative to solve problems without taking shortcuts that jeopardize safety and efficacy. She will work harder on the project than anyone else on the team. She will keep us on schedule. She will whisper to get our attention, but she won’t be afraid to yell and kick our ass.

As Jim Croce says, “You don’t tug on Superman’s cape.” Superwoman is the only exception to this rule.

How do you control design changes?

Of JB’s recommended artists, the Josh Abbott Band was probably my favorite. I especially liked this one. I hope every man is lucky enough to know a girl like Texas. I’m lucky enough to have married a girl that grew up in Texas. They are something special.

We have been discussing the best ways to control design changes at work, and I thought it might present an opportunity to have more of an interactive discussion with my readers.

During my rounds as a 3^rd party auditor, I have seen quite a few design control procedures. The most complex consisted of 19 procedures (NOT recommended, but there were no nonconformities). The most simple consisted of one 4-page procedure, which I wrote, but I would never recommend being this brief. I have created a couple of polls in my LinkedIn profile for you to respond to if you would like to share your own company’s “design control stats”:

http://linkd.in/IJtoBL

The problem I see is that most projects are not new product designs. Sometimes the projects are not even major design changes. I think most changes involve supplier changes, component specification improvements, and design for manufacturability. These changes require review and approval of changes. These changes must also be recorded and retained as a Quality Record.

My own personal preference is to always open a design project—no matter how small the change is. In order to make the process flexible, I also prefer to define how many design reviews each project will have in the design plan rather than mandating that design reviews be held in a stage-gate fashion for 100% of projects.

Most companies will have a table of requirements with columns added to indicate if the requirements are mandatory for the project or optional. For example, “risk management plan needs to be updated? Yes/No.” I like this approach, because the table of requirements makes the decision making systematic.

Sometimes a change is only to a work instruction for a step in the manufacturing process. In these cases, some companies will use a document change order process to supplement the engineering change order process.

My feeling is that more complex products (i.e. – Class IIb & Class III in EU and Class III/PMA in US) will require more stringent design controls for the change. What does your company do to control design changes?