Archive for the ‘Improvement’ Category

WANTED: Design Team Needs Über-Leader

In CE Mark, CE Medical, Change Control, Design & Development, Improvement, ISO 13485, ISO 14971, Medical CE, Medical Device on May 16, 2012 at 5:11 am

“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.

What’s in your crystal ball?

In Improvement on May 25, 2011 at 5:58 am

I could have used the same video I used in my last posting, but we all must change.

I spent the afternoon at Borders reviewing medical device regulations in preparation for a course I’m teaching tomorrow. Unfortunately, that wasn’t very much fun and my productive afternoon quickly degraded into surfing the shelves. The book The 2020 Workplace  caught my eye and I started skimming the beginning and end of the book (see The 80/20 Principle for more information on this technique). The book starts with a fictional story about a new college graduate preparing for their first day of work. The story grabbed my attention and brought to mind all kinds of Star Trek images. The beginning of the book lists ten global factors that are shaping the future workplace. I know this sounds like old news (i.e. – Thomas Friedman’s book The World is Flat), but this book is much easier to read and it won’t cause dislocation of a vertebrae when you carry it for an extended period. The end of the book, however, is what really convinced me that I need to read this book. The next to last chapter of the book makes 20 predictions about the future workplace. I am convinced that most if not all of these predictions will come to fruition. We’re not talking about flying cars, but these concepts are “game changing.” I suspect that some of these will happen by 2020—if not earlier. Other changes will be much slower to adopt into the mainstream of our workplace, but I think all of these will come to pass—my prediction is that by 2030, 16 out of 20 changes will come to pass. The final chapter is titled, “Get ready for the future workplace.” This chapter is just scary. The medical device industry is ultraconservative and I see the opposite culture in most companies I visit. If the authors are even remotely close on their predictions, every manager in the medtech industry should download their own copy onto their Kindle ASAP. Talented labor will be in acute shortage by 2020. Larger companies will not embrace change and will provide safe havens for aging employees. Start-ups will embrace the change first and capture the “net geners.” Just as the biotechnology industry has reshaped the pharmaceutical industry, the decade from 2020 to 2030 will be a period of rampant change and rapidly accelerating productivity for this industry that is overburdened with paperwork. Read this book, embrace the change, and survive.

PS – Along with my new iPhone I have a new app called “pic2shop.” I used this application to scan the barcodes of books at Borders Books. Every single book I was interested was selling for less than half-the-price on Amazon. If I bought the book for a Kindle, the price was less than a third. This app may single-handedly destroy book stores and drive everyone to electronic books. Change is coming fast!

How to Write Better Procedures

In Improvement, International Standard, ISO, ISO 13485, Quality, Quality Management Systems, Training on January 28, 2011 at 3:08 am

Knowing that we have the “Big Game” half-time show coming soon, I thought I would share a video of the 2007 show by Prince (Thank you for the suggestion Greg).

                During a CAPA course I taught earlier today, one of the attendees asked if I have a course on “How to Write Better Procedures.” Unfortunately, the only material I could offer was material from a course I taught on “Training the Trainer.” That training course focused on visual communication. There are several books related to Lean Manufacturing that explain in depth how to use visual communication to replace text (i.e. – “a picture says a thousand words”). During my ride home, however, I thought of a few other ideas that might help anyone that is in the process of writing or re-writing a procedure.

My first suggestion is to develop a standardized format for procedures. If you have a procedure for writing procedures, just make sure you allow the flexibility to deviate from the standardized format. The Standard does require that procedures have a “mandatory” format. Referring to the standardized formatting as “suggested formatting” will avoid unnecessary nonconformities.

My second suggestion is avoid making unnecessary references to other external standards. If you are writing a procedure on risk management—it makes sense to reference ISO 14971. It does not make sense to reference all the other risk analysis Standards unless you are specifically using them to perform risk analysis. Included in this category would be references to other regulatory requirements such as 21 CFR 820, the FDA QSR, or Part 1 of the Canadian MDR. Companies can claim compliance with other requirements in the Quality Manual instead. What should be referenced in a document is any related procedures or forms.

Another related suggestion is to avoid including the revision of a Standard. This is just another opportunity for unnecessary nonconformities. If you don’t specify the revision, then an auditor can only assume that the most current revision of the Standard is implied. If changes to a Standard are minor, no changes to a procedure may be warranted and a revision to the procedure can be avoided—assuming that the revision of the Standard is not specified. Some argue that you should include the revision and update the reference to document that the procedure was reviewed to see if changes were warranted. This is unnecessary. A review of procedures, where the decision is made for “no change”, can easily be documented in the Management Review under the category of “New and Revised Regulatory Requirements.”

My fourth suggestion is to indicate the process owner and training requirements associated with each procedure. By doing this, it is easier to define who is responsible for reviewing and revising procedures—as well as who is assigned CAPAs if there is finding related to the process in question. For the training requirements, the process owner should specify who needs to be trained on the process. Why? They know the procedure best. If there is a “grey area,” this should be resolved with the department manager for the job function in question. In addition, retraining requirements should be specified. By this, I mean that it is a good idea to indicate if retraining is required when a procedure has been revised. If the revision is minor, training should only be required for people that have not been trained to a previous revision.

There are a couple of great ways to identify when retraining is required for a revision and when no retraining is required, but I’ll leave those ideas for another blog…

My fifth suggestion is to adopt the Plan-Do-Check-Act (PDCA) model for the structure of procedures. For the “Plan” portion, the procedure should explain how to prepare to do something. This planning activity can apply to anything from planning to perform an audit to planning to inspect incoming raw materials. The “Do” portion is what most people refer to as the “Procedure” section. The “Check” portion of the procedure is a great place to specify the monitoring and measurement requirements for the process (see Section 8.1 of the Standard). Finally, the “Act” portion of the procedure should indicate what to do when target metrics are not met. For example, what should be done when an alert limit is reached? What should be done when an action limit is reached?

My final suggestion is to include revision history. It’s extremely helpful to know which ECO approved the document revision, why the changes were made, the nature of changes, whether there is a related corrective action, and when the change was made.

Sorry about the length of this blog…I hope this helps you Darcy.

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