For Medical Devices

Improving Your Quality Management System: A Step-By-Step Approach

By John Gagliardi

An Effective QMS Boosts Competitive Advantage

Medical device firms must contend not only with stiff competition in the marketplace, but also with strict FDA regulations and ISO standards. Most medical device companies recognize the importance of an effective and efficient quality management system (QMS) to help gain competitive advantage and ensure regulatory compliance. If your firm is one of those companies, here are some tips for you.

Initial Assessment
Let's take the example of Medical Device Company X, which hired a third-party ISO/cGMP-QSR architect to assess the firm's QMS and determine where existing processes could be improved to satisfy customer product and service requirements, improve the overall compliance position, and save time and money.

This company continued to be ISO 13485:2003 certified as well as compliant with the applicable current Good Manufacturing Practice (cGMP) regulations. Passing an ISO audit was not the issue. Having an impact on the bottom line and realizing product and process improvement were the overarching purposes for this initiative. The assessment pointed out areas that could be improved in the near term and other areas that would require a longer effort. Top-level management and the third party determined that this undertaking would be a 12- to 14-month process, and involve all personnel to one degree or another. This process was not going to be just relegated to the Quality Department.

The Process
After the assessment, the contracted quality management system architect reported the results indicating where improvements could be realized and how. A newly formed Quality System Review Board (QSRB) would implement meaningful change in the shortest span of time. Process owners were chosen for each representative ISO and cGMP-QSR (Quality System Regulation) section to identify their individual strategies in terms of linkages (to other processes within the QMS) and where, procedurally, the strengths and weaknesses of these bonds were commonly evident or not.

The process owners initially met as an entire QSRB to understand the group's dynamics. The quality system architect then met with process owners to clarify the purpose of this initiative, where their particular process ?fit into? the quality management system, how the process linkages worked, and what outputs are commonly captured because of this interaction.

Training and Understanding
All process owners and selected other individuals were trained to understand the architecture of ISO 13485:2003 and the cGMP-QSRs. The following steps are reflective of each evaluative step that Medical Device Company X undertook:

  • All owners developed quality plans from the resultant gaps to compile and listed items to be addressed;
  • They tracked ongoing progress;
  • They documented improvements; and
  • They turned opportunities for greater efficiency and effectiveness into action plans for success.

Metrics and Measurement
After quality (action) plans have been fully compared to other common process opportunities, linked using the ?mapping tool,? documented, and approved, all process owners then had a firm foundation for completing the next steps in an organized fashion.

Process owners then proceeded with measuring process improvement in light of business strategy, compliance indicators, and quality initiatives. All processes had a set of metrics that were directly and consistently connected with the company's business strategy and, of course, compliance requirements.

The ideal situation is to measure your processes' direct impact on yearly strategic indicators and, better yet, the ?bottom line.? This aim cannot always occur in every case, but it's a goal to strongly consider when building an effective and efficient quality management system.

Process Rebuilding
The QSRB will continue to face challenges in its initiatives for greater efficiency and process improvements. Process owners will continue to:

  • Process map (create a workflow diagram for clearer understanding of a process) to realize areas of opportunity and areas of inefficiency.
  • Develop metrics for measuring successes (or not).
  • Revise procedures as necessary to render them viable and to promote effectiveness. Reduce the number of procedures as applicable and appropriate.
  • Continue to train and promote process improvement at all levels of the company.
  • Challenge other processes that are linked to become less resource dependent and more oriented toward a validated sequence of events and predicted outputs.
  • Continue to facilitate process ownership and assimilate company goals and objectives into their own objectives to enable the overall business strategy to be a success.

The Journey Continues
This process has varying degrees of success depending upon commitment. The success of this type of endeavor starts and continues with management's commitment to establish policies designed to connect the company's overall business strategy and the goals and objectives of individuals. Management must have the commitment to realize improvement through quantitative process measurements and corrective actions, to develop plans that follow through with successful implementation as a goal, and to convert conversation into dynamic actions with real deliverables and accountability. At the end of this journey, Medical Device Company X can realize success with documented measurements showing process effectiveness and improved efficiencies.

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.

Learn more about Midwest Process Innovation:

Read other articles for medical device companies:

Case Study:


White Paper:

Reducing the Documentation Burden in FDA Design Control

Click here to view all available resources.

If you are a current MasterControl customer click here to download documents directly through our Customer Center.


Additional Article