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Posts Tagged ‘Quality Management Systems’

If I had a rocket launcher…

In Elsmar Cove, International Standard, ISO, ISO 13485, Management Representative, Management Responsibility, QA, Quality, Quality Management Systems on January 21, 2011 at 12:53 am

This week’s music video selection was recommended by my friend Greg. We were eating dinner together at 1776, and he was kind enough to share this amazing musician with me. I’m not a guitarist but he pointed out that Bruce Cockburn has a very unique style. He plays three different parts simultaneously. His thumb plays base on the top string while the other fingers play two separate melodies. WOW!

                 Are you frustrated? Do you wish for a rocket launcher? Maybe you would aim it at the C-level offices and pull the trigger.

                Sometimes we hear phrases like: “Well that’s just an ISO requirement.” This obvious lack of support by top management is what frustrates every Management Representative in the world.

                There was a question posted on the Elsmar Cove website on January 10th (see previous blog for the link). In just 10 days there have been 153 postings in response to the original question. As I read through the various postings I saw several comments about a lack of support by top management. Rocket launchers are NOT the answer, but maybe a heavy bat…

                A little over a decade ago I was still learning how to supervise people. In an effort to educate myself further, I read a book (sorry can’t be sure which book anymore). In this book, the boss gave an employee a card with a picture of a baseball bat on it. The instructions provided with this magical card were to use it only when the boss failed to pay attention and the employee had something important to tell him.

                We all wish for a magical baseball bat, but unfortunately we are M-A-N-A-G-E-R-S. Along with the awesome title comes awesome responsibility. Managers are responsible for leading others. Subordinates are not the “others” I am referring to. The “others” are peers. If you cannot persuade your peers to support you, then you will fail as a manager. The Quality Department cannot fix all the problems. In fact, my philosophy is that Quality is responsible for recommending improvements, training people, and helping to implement. We assign corrective actions, but we should be assigning them to the process owner (i.e. – Manager) that is responsible for the area where the problems were created.

                If you need help persuading the unenlightened, try picking a project that is critical to the success of the stubborn one. If you can show someone that is currently a detractor how they can apply the Quality principles to help solve their problems, then you will have a convert. Converts become strong supporters. If the stubborn one happens to be at the top, figure out what the CEO’s initiatives are. Initiatives are easy to identify; they talk about it at least twenty times a week. Try showing the CEO how their initiatives can become Quality Objectives. Show them with graphs. Show up with solutions to their problem. Use the CAPA process as a framework. Show them how the management TEAM can fix it.

                If nothing seems to be working, you can always try reviewing some FDA MedWatch reports too–just to scare the crap out of the boss.

Management Representative

In Elsmar Cove, ISO, ISO 13485, Management Representative, Management Responsibility, QA, Quality, Quality Management Systems on January 18, 2011 at 5:05 pm

The video music selection for this week was a tune I heard at a restaurant called “1776” in Crystal Lake, IL. The restaurant played Chris Isaak recordings for the entire meal. Maybe the satellite radio station was stuck on the letter “I”.

 The idea for this posting was from a thread I found on Elsmar Cove:

http://elsmar.com/Forums/showthread.php?t=45658

One person posted a question about the requirement for the Management Representative (MR) to be a member of the organization’s management (see section 5.5.2 of ISO 9001:2008). Companies that are seeking initial certification sometimes struggle with this requirement. Some struggle because they do not have anyone in-house that is sufficiently trained to be the MR. Other companies struggle, because they are very small and outsource their QA functions to a consultant. The following blog is targeted at helping these companies.

     I audit companies to the ISO 13485 (medical QMS) & 9001 (QMS) Standards. The intent of both Standards was always to have the MR be part of management, but some companies did not interpret the Standards in this way. With the 2008 revision of 9001, the possibility of misinterpreting the meaning is much less likely. The companies that receive findings during the Stage 1 or Stage 2 audit for this requirement usually fall into one of two categories. Category #1: our company is small and the only person that really knows enough about ISO requirements is not a member of management. Category #2: our company is small and we outsource QA functions.

   The good news is that any manager can be assigned the responsibility of being MR. One of my clients assigned this responsibility to the VP of Sales. Another company assigned this responsibility to the Director of R&D. Both of these individuals had to put in the time to learn about Quality Management Systems, but both have embraced the challenge and I have learned a lot from them. They have a different perspective and bring a lot of value to the MR role.

    The bad news is: whomever you assign has to learn enough to be competent in the role.

   The definition of “Management” is typically a stumbling block. Most people think of managers requiring that they have other people reporting to them. This is not an absolute. The MR should report directly to a top manager such as the President or CEO to prevent conflicts of interest. As a manager, they should not require a lot of direct supervision and the President or CEO should not be overly burdened by adding one person to their list of direct reports.

   Some auditors like to see a “deputy MR” identified. My advice is to have the CEO or President sufficiently trained that they can be the “back-up” when the MR is on vacation. Every manager should know enough about their subordinate’s job duties that they can “fill in.”

   MR’s should be involved in senior staff meetings too, but not necessarily at the same frequency as every other senior staff manager. Typically operations and sales have the most frequent meetings with the CEO–often weekly. Finance is typically monthly. HR and the MR might be bi-monthly or Quarterly. Communication of the status of Quality Objectives should be regular reports to all senior staff, but you don’t have to have a Management Review to communicate the status. If the company is small enough to have only one QA person, there probably isn’t a need for more than one or two management review meetings per year.

   If your company has a finding against clause 5.5.2, I recommend the following actions:

1. Assign a person that is already a member of your senior staff as MR

2. Document the responsibility in the person’s job description

3. Document the responsibility in the org chart

4. Assign the person’s direct supervisor (typically the CEO or President) as a “deputy MR”

5. Find a good webinar on ISO training for the new MR and their boss (ideally one with a quiz and a certificate)

6. Have the new MR develop a 45 minute presentation for the senior staff on the topic of Management Responsibilities. This training should cover all of section 5 in the Standard.

7. Give the senior staff a 15 minute multiple choice quiz to evaluate effectiveness of the training.

8. Have the new MR discuss delegation of various management review inputs (see section 5.6.2) with their boss. Quality should be a shared responsibility and Management Reviews will be more effective if everyone takes part.

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