Rosapeak Advisors

Part 1 – Hidden costs and signs of ineffective quality management systems

For management and board members – 5 min reading

From the perspective of a lead auditor for ISO 13485 and 9001, I am exposed to many different quality management systems and company cultures, which is sometimes thrilling and challenging depending on the company culture. The annual audit frequently creates a stress situation and the quality manager or the auditor risk to become a lightning rod for all kind of issues.

Personally, I was in the position of a quality manager for several companies in the medical device industry and have experienced the hurdles and challenges of a quality manager multiple times.

The motivation to maintain such a process framework must be reevaluated continuously. Sometimes the ISO 13485 is a legal requirement but quite frequently it serves as purely as label or a door- opener for new clients.

The process requirements of standards ISO 13485 and 9001 must ideally be streamlined with the real (business) process and should not be a parallel world (of the quality department), where only a subgroup is in charge.

These standards provide a general framework how to run a company or a general organisation, which is providing services or producing goods. The perspective of the framework is very much like that of common business administration.

Each financial controller is interested in key figures, which will trigger eventually actions and measures. The framework is based on the very intuitive “plan, do act and check” circuit.

ISO 13485 Framework (top-level) – ISO 9001 framework is similar
  1. Quality management system (company activities & risks / process and data documentation)
  2. Responsibility (organisation chart, quality policy, -objectives and reporting)
  3. Human and technical resources (including environment)
  4. Services (key processes for development and production including suppliers)
  5. Feed-back Loop including improvement (collect& evaluate data and trigger measures)

Key for an effective and cost-saving quality and business process landscape is the commitment of the management and the usability. Ideally management is a frequent user of the system and keeps the usability of the processes as ergonomic as possible. One typical risk of less ergonomic quality and business processes is of course the misuse as for every bad-designed device.

Costs of ineffective business and quality management processes are often underestimated or not evaluated at all. First signs are frustrated collaborators, which will affect the company culture in the end. It eventually leads to expensive product development, a bad selection of suppliers, additional production costs and customer complaints and in the worst case to recalls. It will also require additional human resources and training in all departments.

Hidden costs and signs of ineffective process landscape

– deviations in audits
– lower motivation of collaborators
– expensive product development
– higher production costs
– increased customer complaints
– additional human resources and trainings

If a process landscape is once ineffective and laborious it becomes a vicious circle, and more and more resources are required to keep the system running and resources for a restart, a simplification or the evaluation of additional tools are missing.

In summary, there are clear signs of ineffective business processes. The management must have a clear understanding of the business processes and evaluate its usability.

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Part 2 – selection of eQMS and tools
Part 3 – internal audit
Part 4 – management review
Written by Dr. Thomas Hug, July 2023