GxP Lifeline Feature Article

Do's and Don'ts in Process Mapping for Life Science Companies

By John Gagliardi

Process Mapping Can Help Realize Return on Investment

The medical device and pharmaceutical industries are built upon process orientation to complete tasks in a uniform and documented fashion. Both industries also depend upon a systematic series of linked and reproducible activities completed by trained people to enable inputs to become outputs and outputs to realize a return on investment.

So, how does process mapping help these industries in turning inputs into predictable outputs that would help them comply with regulations, as well as realize commercial success?

Process maps can visually illustrate how work flows, how procedures link together, where greater process efficiency can be realized, and how process participants conduct themselves within the infrastructure of the quality management system (QMS). Visualization is something that employees embrace with far more success than the written word. Process maps not only can make procedures understandable, but it can serve as a training tool to ultimately show your employees and regulatory authorities how your company conducts work.

In addition, process maps can help realize return on investment. A business requirement for both the pharmaceutical and medical device industries is to show how process efficiencies can improve the business acumen of an overarching strategic plan. Process mapping can facilitate improvement of internal effectiveness. In most cases, mapping a company's processes will help you :

  • Combine process steps;
  • Use automation to supplant manual activities;
  • Modify task-driven steps for greater impact;
  • Decide on possibly outsourcing certain process tasks for cost savings, or
  • Decide on eliminating entire processes altogether.

 When to Process Map
Process maps should be constructed by a team of process owners, not just an individual. Aim for ?power mapping? by demonstrating how outputs and inputs link with all of the necessary related and people-driven tasks, which as a whole forms the foundation for the QMS.

Mapping is most beneficial when you have any of these needs:

  • Need to communicate ideas, information, and data (procedures that are easy to understand and follow);
  • Need to aid the problem-solving process during, for example, corrective actions or for change management;
  • Need to identify the actual ?roadways? of process steps to reveal potential problems and solutions during preventive action and to anticipate how processes should react through simulation;
  • Need to show linked processes and sequences for procedural accuracy and customer focus;
  • Need to help your team understand important characteristics of a process to draw conclusions, investigate, and formulate answers.

Do's and Don'ts
Mapping, depending upon the scope of the process being addressed, can be a long, highly energized exercise toward a rewarding endpoint. There is not a magic formula for successful mapping, but here are some ?do's and don'ts? based on my first-hand experience working with dozens of medical device and pharmaceutical teams.

  • Don't try to force mapping in all of your processes because not every process is easily conducive to mapping. Some processes are best served using other communication tools like storyboards, written work instructions, drawings and schematics, etc. Top-level documents like quality manuals and policies are commonly not processes, per se. Second level and work instruction level documents, on the other hand, commonly make great maps.
  • Don't map a process with a very large scope. Even if your team completes the map, it usually turns out to be so complicated and convoluted that the reader becomes confused and frustrated. If the scope starts to become too large, allow your team to split the process into sub-processes and deal with each one separately.
  • Do choose your team members carefully. Having too many or too few people, or choosing the wrong people can make the process arduous and inaccurate. Politics and ?turf-protection? have no place in the objective mapping process. Including only process owners and basic process participants is the most prudent way of handling linkage and accuracy issues.
  • Do mind your work hours. Meeting logistics are important, but productivity wanes after about three hours, depending upon the subject. In my experience, all-day mapping sessions don't work.

Process mapping can be a beneficial tool for procedure writing, training, efficiency and effectiveness checks, objective evidence, linkage determinations, and quality improvement. Like anything else, mapping is what you make of it. Inexperienced mapping teams sometimes produce outputs that are inaccurate and cumbersome. Time and practice are imperative when it comes to precision. The mapping facilitator's organizational skills and the team's tenacity are also key factors in a successful mapping process.

About the Author
John Gagliardi is the president of Midwest Process Innovation, LLC (MPI). He has 37 years of experience in the medical device and pharmaceutical industries, particularly in the areas of research and development, quality assurance, operations, process architecture, training, and regulatory affairs . MPI's core competencies include process architect, quality audits ( cGMP-QSR, cGMP-Pharma, GLP, ISOs 13485 & 9001:2000), training, FDA liaison and inspection strategy, supplier evaluations, team building and process ownership, marketing quality process, and compliance.

For questions or comments about this article, write to John Gagliardi.

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