A manufacturer of blood testing devices was scheduled to undergo an ISO audit of its Quality Management System (QMS). The successful completion of the audit would allow the company to sell its products to the European market.
As part of the ISO 13485 certification program, a cross-functional team of regulatory, R&D, and production experts had developed 26 procedural documents that defined the standards and policies of its QMS. But as the audit approached, management realized that there was a gap in the audit preparation. In order to make certification more likely, the team needed a way to clearly communicate the QMS to the auditor. Toward that end, the team recognized the need to illustrate the key process interdependencies, inputs, and outputs for each of the 26 procedures; as such an illustration would visually depict who had to do what and when, to ensure successful performance of the QMS.
The in-house team attempted to develop the required document map. However, due to the complexity of the task, especially when trying to coordinate activities across functions, they produced a document map of the document management process that resembled the proverbial “spaghetti bowl.” With less than one month to go before the audit, the company engaged Integrated Project Management Company, Inc. (IPM) to help.
IPM was retained to facilitate the cross-functional team’s effort to create a process map that would simplify, rather than complicate, the audit process.
IPM conducted process mapping workshops over the course of a week, during which participants used a range of techniques and best practices. By the end of the sessions, the team had drafted, validated, and finalized a document map of the document management process that clearly showed the interrelationships among all 26 quality management processes, and integrated the roles of external parties (customers, contract manufacturers, and regulatory agencies).
The key to success was having each participant discuss, and then graphically portray, how the procedure for which he or she was personally responsible interacted with all the other procedures. The exercise gave participants an understanding of the entire QMS, enabling the team to conceptualize an orbital layout for the QMS documents. The graphic portrayal served as a roadmap to quickly navigate the QMS, and clearly illustrated which processes were related to production, design and development, tools, administrative, and improvement areas. The document map also became a useful training tool for employees.
The high-level document map created by the team served as an effective tool for orienting the ISO 13485 auditor to the company’s QMS and document management process. The auditor complimented the QMS team on the clarity and simplicity of the document map. The company passed the audit and began selling their product in Europe.
Service: Regulatory & Quality
Industry: Life Sciences