An MD&DI October 1998 Column
Given their potential to reduce software failures, well-trained SQAEs are essential for devices that rely on software.
Software quality assurance engineers (SQAEs) play a key role in ensuring the safety and efficacy of device software and ultimately the devices themselves. As FDA begins to examine the software design process and quality system software more closely, the need for well-trained SQAEs becomes critical for product quality. A necessary but often overlooked aspect of producing well-trained SQAEs is the implementation of a training program to guarantee adequate and consistent development methods and design controls for product and quality system software. Training can also benefit new SQAE hires who may not have significant experience in the medical device industry or who may not understand the company's established development methods and relevant quality system requirements. This article focuses on some of the key elements necessary in implementing a successful software quality assurance training program.
CHOOSING A TRAINER AND ASSESSING TRAINING NEEDS
Most successful trainers exhibit common traits, such as mastery of and enthusiasm for their subject, patience, flexibility, and a willingness to explain their rationale for decisions. In some ways, successful trainers serve as mentors for new hires in that they help guide the direction a new hire takes in the company. The most important aspect of selecting a technical trainer is choosing someone who wants to train a new hire and whose personality is compatible with the particular trainee. Trainers may have undergone a similar training program earlier in their own careers, or they may have been certified as an SQAE trainer by their company through a train-the-trainer initiative. In some companies, the trainer may simply be the most experienced individual in the company. To be successful, a training program needs both genuinely interested trainers and support from corporate management.
Figure 1. Decision tree for assessing training needs.
To meet training goals and use time efficiently, it is important for the trainer to assess the individual's training needs. The trainer must determine whether the trainee is new to software quality assurance, new to the medical device industry, or new to a particular area of the medical device industry (e.g., pacemaker manufacturing). Regardless of the SQA-related experience level, training must be provided on the company's procedures for design controls, document controls, and other key aspects of the quality system. Figure 1 represents a decision tree for assessing the training needs of an individual.
PHASES OF THE TRAINING PROGRAM
A senior SQAE trainer should be assigned to each new SQAE trainee. This trainer should not only execute assigned portions of the formal training plan, but also support the new SQAE for at least six months. The training program should consist of an overall syllabus (i.e., body of knowledge), with a training plan created for each individual. This involves tailoring the syllabus to each trainee's needs and prioritizing the skills training based on the individual's experience and target assignments. If one-on-one training is not an option, the alternative would be to group new hires under a general training plan with one trainer for the group. This approach is less desirable because trainees do not receive as much individual attention, and the plan is not tailored to each person's specific needs. Instead of training when each individual is hired, the company waits until it has enough employees to form a training group. This could result in potential negative corporate impacts based on work performed by new hires as they wait for other employees to join the company so that a training group can be formed.
The training plan should begin within the first two weeks of the trainee's employment and span at least eight weeks. Individuals who lack software quality assurance experience and medical device industry exposure may require more than eight weeks. For those companies that can't afford to make this commitment, other options include requiring more experience of SQAE hires, using alternative training media (e.g., computer-based training, videotapes), relying on new hires to self-train in their off-hours, or outsourcing the software quality assurance tasks.
These options, however, are less desirable and pose greater risks to the company because they lead to inconsistent software development approaches. Without an adequate training program, manufactured devices may not meet specified requirements or may carry a high number of latent defects. Furthermore, compliance with established design control procedures may not be apparent or may be lacking entirely. In companies that tend to cut corners by failing to implement a training program, a development team may look for the answer to each query by approaching every member of the SQAE team independently, rephrasing the same question in the hopes of finding an easy answer.
The individualized training plan combines reading, lectures, and hands-on execution of tasks in the following phases:
- Assigned trainer gives lectures, combined with hands-on examples/exercises. New employee orientation, such as safety program training and quality manual training, also takes place.
- Assisted hands-on execution of tasks (shadowing trainer) with the goal of significant exposure to the job.
- Trainer and manager assess trainee's readiness to work alone on individual tasks and assignments.
- New SQAE works alone with question and answer follow-up sessions held with trainer. The trainer reviews each assignment before it is considered complete. The goal of this phase is to begin introducing the trainee into the company's workflow.
- Trainer and manager decide whether or not the employee will begin working independently. This phase consists of assessing the trainee's progress in the SQAE domain and determining whether or not the training plan has succeeded.
- New SQAE works alone. At this point, the intensive training is complete, and the trainee is an independent SQAE. On-going assessment of the SQAE's effectiveness becomes part of the com- pany's standard performance appraisal process.
SAMPLE TRAINING PLAN
The following sample training plan is designed for trainees who are new to the company and the medical device industry and have a minimum of two years' experience as SQAEs. These sessions complement lectures and assisted hands-on execution of tasks.
SESSION 1: SQAE Introduction
SESSION 2: SQA Interfaces
SESSION 3: Relevant Corporate Standards
SESSION 4: Design Controls
SESSION 5: Configuration Management (CM)
SESSION 6: Software-Related Standard Operating Procedures
SESSION 7: Assisted Hands-On Task Review
Time is the single most important issue facing the SQAE manager who decides to implement a training program. Since the most effective SQAE trainers are typically the senior SQAEs, the company usually desires close to 100% of their time to be spent on key development projects. For the training plan to succeed, expectations for the trainer's project support time must be scaled back until the assigned trainee has graduated.
INDEPENDENT PROGRESS REVIEW
To ensure that the training plan is working, periodic review of the trainee's progress is helpful. This can be provided by a senior SQAE, the SQAE manager, or a knowledgeable, unbiased third party. The goal of the progress review is to identify any weak areas and ascertain whether the trainee has successfully completed the topics assigned by the trainer. If new areas of concern are noted during the progress review, the manager and trainer should modify the training plan to address these concerns. Ideally, this review coincides with a probationary performance review, if required by the company. Also, the employee's progress, including completion of the training plan, should be documented for the personnel record.
CAREER GOALS FOR THE SQAE TEAM
A competent SQAE team serves both corporate and individual objectives. The development of safer, more-effective devices benefits the company; meanwhile individuals become more valuable to the industry, resulting in their increased recognition and compensation. The short-term goal for any new SQAE should be to establish expertise by completing the training plan.
The easiest way to demonstrate competency is to pursue professional certification. At present, one of the most widely recognized certifications for SQAEs is the American Society for Quality's certification in software quality engineering (CSQE). (For further information, contact the American Society for Quality at 800/248-1946.) The CSQE, or a similar certification program, should become a goal for each member of the SQAE team. A new SQAE's long-term goals should include achieving a level of competency that leads to a role as a process improvement advocate, a trainer for a new SQAE, or both.
HOMEWORK FOR SAMPLE TRAINING PLAN
The following homework assignments correspond to the lecture sessions described in the sample training plan (above).
SESSION 1: Read company software development and software quality policy/standards.
SESSION 2: If company is certified (or pursuing certification) to any industry standards, such as ISO 9001, and if the new employee is unfamiliar with these standards, the trainee should read them thoroughly before the next session. Otherwise, the trainee should reread the company software development and quality policies/standards and document any questions. The trainee should also read the GMPs and relevant reviewer guidance.
SESSION 3: No homework.
SESSION 4: Read company standards and high-level procedures for configuration management.
SESSION 5: Read detailed software development and quality procedures, practices, etc. Also read a sample project plan, software development plan, software quality plan, and software CM plan (preferably from one of the projects/departments to be supported by this new SQAE).
SESSION 6: Create sample audit checklists against one software development procedure and one software CM procedure.
SESSION 7: No homework.
In the past three years, two device companies have adopted a training plan similar to the one described here and achieved excellent results. Initially, the time investment seemed overwhelming; however, the performance level of trained individuals who completed their training plan has been outstanding. Furthermore, the consistency in overall SQAE methodology throughout these organizations improved significantly after implementing the training program.
Trainers and trainees who completed the training plan gained significant benefits. The trainers gained satisfaction in watching the development of their assigned trainees and developed a good working relationship with them. Trainees were quickly made to feel a part of the team and established a base on which to make future decisions concerning device software.
The successful outcome of implementing a formalized SQAE training program has more than paid for the initial investment made by the two domestic device manufacturers referred to above. The lessons learned in implementing this approach follow:
- Training progresses at a different rate for each individual. Overall experience, industry experience, formal education, device knowledge, and enthusiasm all play a role in determining the right amount of time to dedicate to any specific topic.
- Not every good SQAE is a good trainer. Serving as a trainer requires a solid command of the subject, interest in training, and infinite patience.
- The SQAE manager needs to monitor the relationship between the trainer and trainee; strong personality conflicts or insufficient interest/patience on the part of the trainer is counterproductive. The manager should be prepared to intervene and assign a new trainer if necessary.
- Upon completion of each individual's training program, the sponsoring department should consider marking the event as a cause for celebration. Acknowledging the trainer's efforts is critical in keeping trainers motivated.
MEDICAL DEVICE TECHNOLOGY TRAINING PLAN
Specific technical training on the company's medical device(s) should be conducted concurrently with the general SQA lectures.
SESSION 1: Current Device Introduction
SESSION 2: Device Retrospective Review
SESSION 3: Introduction to Device Technology
SESSION 4: Current Device Software Review (Part I)
SESSION 5: Current Device Software Review (Part II)
SESSION 6: Support Software Review
Establishing a formal SQAE training program benefits both the company and the individual. A thorough body of knowledge is established for the SQAEs, and a process for attaining that body of knowledge is defined. In addition, a training program establishes consistent SQA methods throughout the company, which reduces overall corporate risks during product development. By implementing a training program, the company increases each SQAE's value, resulting in safer, more-effective devices.
A well-structured training program can provide a solid first step toward employees attaining certification. Professional certification efficiently answers third- party auditors' questions about SQAEs adequate job knowledge and moves the auditor on to other topics. Thus, if certified professionals cannot be found during the hiring process, the company should encourage new employees and support their efforts to attain certification.
The onset of regulated design controls necessitates a strong device development methodology. Software quality assurance plays a key role for every device that relies on software control, as well as for those quality system elements that rely on software. Without a solid training program, software quality assurance engineers may not be adequately equipped to implement effective medical device software design controls.
Tammy M. Pelnik is vice president of The St. Vrain Group, Inc. (Boulder, CO), and a certified quality manager. Gayla J. Suddarth is a quality manager with Tanning Technology Corp. (Denver) and a certified software quality engineer.