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Effective Management Skills for Managers

This blog reviews some practical management skills that managers should possess.

Are you frustrated?

Sometimes we hear phrases like: “Well, that’s just an ISO requirement.” This apparent 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 10, 2011. In just ten 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 from top management.

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 I 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.

As managers, we assume the impressive title, along with the awesome responsibility. Managers are responsible for leading others. Subordinates are not the “others” I am referring too. 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. 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.

Effective Management Skills

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 actions 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 your boss.

Posted in: ISO Certification

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Management Representative Requirement: ISO 9001:2008

The author reviews the Management Representative section 5.5.2 of ISO 9001:2008 requirement and provides eight (8)  proposed actions to take for companies who receive a finding against this section.

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.

Auditing

I audit companies to the ISO 13485 (medical Quality Management System (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. 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 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 appointed this responsibility to the Director of R&D. Both of these individuals had to put in the time to learn about their quality management systems, but both have embraced the challenge, and I have learned much 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 position.

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 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 great deal 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 generally is 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.

Management Representative Finding: 8 Proposed Actions to Take

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 an excellent 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 the effectiveness of the training.

8. Have the new MR discuss the 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 participates.

Posted in: ISO 9001:2008, ISO Certification

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7 Steps to Effective Auditor Training

A five-day lead auditor course is never enough. Effective auditor training must include practical feedback from an experienced auditor.

Recently, a client asked me to create a training course on how to train operators. I could have taught the operators myself, but there were so many people that needed training, that we felt it would be more cost-effective to train the trainers. Usually, I have multiple presentations archived that I can draw upon, but this time I had nothing. I had never trained engineers on how to be trainers before—at least not formally. I thought about what kinds of problems other quality managers have had in training internal auditors, and how I have helped the auditors improve. The one theme I recognized was that effective auditor training needs to include practical feedback from an experienced auditor.

How do you audit the auditing process?

Most quality managers are experienced and have little trouble planning an audit schedule. The next step is to conduct the audit. The problem is that there is very little objective oversight of the auditing process. The ISO 13485 standard for medical devices requires that “Auditors shall not audit their own work.” Therefore, most companies will opt for one of two solutions for auditing the internal audit process: 1) hire a consultant, or 2) ask the Director of Regulatory Affairs to audit the internal auditing process.

Both of the above strategies for auditing the internal audit process meet the requirements of ISO 13485, but neither approach helps to improve an internal auditor’s performance. I have interviewed hundreds of audit program managers over the years, and the most common feedback audit program managers give is “change the wording of this finding” or “you forgot to close this previous finding.” This type of feedback is related to the report writing phase of the audit process. I rarely hear program managers explain how they help auditors improve at the other parts of the process.

When auditors are first being trained, we typically provide examples of best practices for audit preparation, checklists, interviewing techniques, AND reports. After the auditors have been “shadowed” by the program manager for an arbitrary three times, the auditors are now miraculously “trained.” Let’s see if I can draw an analogy that will make my point…

That kind of sounds like watching your 16-year-old drive the family car three times and then giving them a license. I guess that’s why my new Ford Festiva was severely dented on all four sides within six months. You may think my father was a Saint, but I think he might have totaled his tenth car by age 18. At least I contained the damage to one vehicle.

7 Steps to Effective Auditor Training

The key to training auditors to audit is consistent follow-up over a long period of time (1-2 years depending upon the frequency of audits). I recommend following the same training process that accredited auditors must complete. I have adapted that process and developed seven (7) specific recommendations:

  1. Have a new auditor observe a few audits before they are allowed to participate (make sure they take notes and explain what you are doing and why, as you conduct audits they are observing)
  2. Have new auditors join as team members for 10-20 audits, before they are allowed to act as a lead auditor
  3. Have new lead auditors conduct team audits with another qualified lead auditor for 10-20 audits before you allow them to conduct an audit alone
  4. Shadow new auditors for 100% of their first audit and gradually observe less with each subsequent audit; try to plan the shadowing into your audit agenda
  5. Review the notes of new auditors periodically throughout the audit to provide suggestions for improvement and identify missing information
  6. Have new lead auditors submit a draft audit agenda to you before sending it to the supplier or department manager
  7. Have new lead auditors rehearse their first few opening and closing meetings with you in private before conducting the opening and closing meeting (make sure they have an opening/closing meeting checklist to help them)

About the Author

Rob Packard 150x150 7 Steps to Effective Auditor TrainingRobert Packard is a regulatory consultant with 25+ years of experience in the medical device, pharmaceutical, and biotechnology industries. He is a graduate of UConn in Chemical Engineering. Robert was a senior manager at several medical device companies—including the President/CEO of a laparoscopic imaging company. His Quality Management System expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certification. From 2009-2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Robert’s specialty is regulatory submissions for high-risk medical devices, such as implants and drug/device combination products for CE marking applications, Canadian medical device applications, and 510(k) submissions. The most favorite part of his job is training others. He can be reached via phone 802.258.1881 or email. You can also follow him on Google+LinkedIn or Twitter.

Posted in: ISO Auditing

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Elsmar Cove – Wikipedia for QA Professionals

The author discusses The Elsmar Cove Forum as a great information resource on best practices and trends for Quality Assurance professionals.

Most of the people reading my blog are probably aware of a website called Elsmar Cove, but I think most people visit this site only when they need a quick answer to a question. It’s sort of like Wikipedia for Quality Assurance. Marc Smith is the creator of Elsmar Cove, http://elsmar.com/, and the forum just had its 15th anniversary. This is a no-frills website that has fantastic content and very little advertising. People from all over the world (~18,000 active participants) are contributing daily to this forum, and many of the contributors are Quality and Regulatory experts. I like to use the site to keep up on best practices and trends in Quality. It also allows me to learn from other types of Quality Systems, such as AS9100, TS16949, and ISO14001.

Someone I used to work with had a saying he learned from his first boss: “A picture tells a thousand words, but a demonstration is better than a thousand pictures.” Therefore, I thought I would try to demonstrate the power of Elsmar Cove by researching best practices in supplier evaluation.

Step 1: The first thing you do is to visit the site.

Step 2: Type “supplier evaluation” into the Google™ custom search. This will produce hundreds of links within the Elsmar Cove Forum related to supplier evaluation.

Step 3: Skim the search results to find the entry or entries you are looking for. These search results include a supplier evaluation survey that you can download and adapt to your own company. If you need a quick solution, this is fast and free.

Another approach is to limit your search to Forum discussion threads. You can do this by going to the Forum Discussion page: http://elsmar.com/Forums/index.php.

If you click on the toolbar link for “search,” a pop-up window will appear. If you type “supplier evaluation” in this search bar, you will see 531 results presented in reverse chronological order. Below are a couple of threads that I thought were particularly good:

Benchmarking Supplier Certification Programs

http://elsmar.com/Forums/showthread.php?t=42595&highlight=supplier+evaluation

Service Supplier Rating where objective pass/fail data is not available

http://elsmar.com/Forums/showthread.php?t=44412&highlight=supplier+evaluation

Choosing Supplier Evaluation Methods – Determining what a Critical Supplier is

http://elsmar.com/Forums/showthread.php?t=10951&highlight=supplier+evaluation

Supplier Approval for Distributors of Equipment

http://elsmar.com/Forums/showthread.php?t=43508&highlight=supplier+evaluation

Second-party audits – Supplier audits or product audits?

http://elsmar.com/Forums/showthread.php?t=30966&highlight=supplier+evaluation

How you do Receiving Inspection for Chemicals?

http://elsmar.com/Forums/showthread.php?t=44951&highlight=supplier+evaluation

Supplier Evaluation Responsibility

http://elsmar.com/Forums/showthread.php?t=43756&highlight=supplier+evaluation

I hope you find Elsmar Cove to be a useful information resource.

Posted in: ISO Certification

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