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Creating Effective Quality Management System Training Presentations and Exams

The author reviews methods for developing a quality management system training presentation and exam to demonstrate training effectiveness for QMS procedures.

Training certificate Creating Effective Quality Management System Training Presentations and Exams

Training records are a basic expectation for any quality system (i.e., Clause 6.2.2 of ISO 13485), but demonstrating effectiveness (Sub-Clause 6.2.2c) and competency (Sub-Clause 6.2.2a) is also required (http://bit.ly/21CFR820-25 and http://bit.ly/13485Plus). Verifying training competency will be the subject of a future blog, but this blog focuses on the most common method for demonstrating training effectiveness—an exam.

Resource Needs

The challenge with creating a training exam is that it takes a serious time commitment to create a training presentation, to write an exam, to grade the exam each time an employee is trained, and issue training certificates. Each time you revise the procedure, you need to decide if retraining is required and how you will verify the effectiveness of training on the revised procedure. Finally, you need qualified trainers with appropriate documentation of their competency.

The larger your company is, the more value you will realize from creating training exams. Unfortunately, larger companies usually have more procedures too. It typically takes me 2-4 hours to develop a new training presentation for a process or procedure. I am currently developing training presentations for a small drug/device company that will have approximately 30 procedures. Therefore, it could take 60-80 hours to create training presentations for all the procedures.

Quality Management System Training Presentation Content

We have developed training courses for critical processes, such as CAPA, internal auditing, and design controls. Medical Device Academy will also be offering a free webinar in November on the topic of conducting more effective Management Review meetings. For other processes, such as calibration, we recommend the following step-by-step approach:

  1. Overview slide of requirements
  2. A slide for each sub-clause
  3. An example of how the procedure is applied
  4. An overview of the procedures’ key points

Our calibration procedure required a total of 11 slides—including a title slide and a slide for contact information. We also included a cross-reference to the applicable section of the procedure for each sub-clause of the ISO 13485 Standard (i.e., 7.6a, 7.6b, etc.). A balance used to weigh components was the training example, and there was a slide that explained essential considerations that can affect the accuracy of a balance.

During the process of creating the training presentation, we noticed that one of the sub-clauses of ISO 13485, 7.6, was not addressed by the procedure. Therefore, our systematic approach simplified the creation of a training presentation, and the strategy helped to identify a nonconformity in the procedure before it was released.

Exam Content

For training exams, we try to ensure that exam questions are objective and easy to grade. Therefore, most exams are ten questions. Questions are typically fill-in the blank type of questions or multiple-choice questions. “Trick questions” are not recommended, but we do recommend using questions that force the trainee to look-up the answers. This will force the trainee to become more familiar with the procedure.

For our calibration training exam, we could easily have one question corresponding to each slide, but not every sub-clause requirement is equally important. Therefore, we always try to include a question related to the most common things auditors and FDA inspectors will be looking for.

The calibration process includes a requirement to assess the impact on a product if a measurement device used for inspections is found to be Out-Of-Tolerance (OOT). Is there a need to retest or even recall products?

Almost every auditor I meet asks the above question during an audit, and most will even request records of calibrated devices that were found OOT.

Grading & Certificates

We typically use 70% as the criteria for passing an exam. The exams are protected forms with spaces to fill-in and checkboxes. There are also spaces for the trainee’s name, title, and date of the training. Exams are emailed to the instructor, and the instructor will unprotect the document. The correct answers are indicated by highlighting the choice in green. Incorrect answers are indicated by highlighting the choice in red. Explanations for why an answer is incorrect are added after the question and highlighted in yellow. The graded exam is then emailed back to the trainee—along with a training certificate similar to the one shown at the beginning of this blog.

Retraining

Brigid Glass wrote a blog posting recently (http://bit.ly/12PartSOPTemplate), where she recommended including a section on training and retraining requirements in each procedure. The challenge with revised procedures is that retraining is not always required. If retraining is needed, we recommend the following approach:

  1. Create a separate retraining exam
  2. Include a question(s) specific to the procedural revisions
  3. Include a question(s) specific to recent nonconformities in the process (if any)

If you are interested in learning more about procedures, records, and training as it relates to ISO 13485 Certification, Brigid Glass and I will be teaching a seminar hosted by FX Conferences on November 5. The following link includes a $50 discount code for the seminar: http://bit.ly/ISOCertStep4. This is part of a 6-part ISO Certification series that is available as recordings too.

 

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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