Our client is the world leader in Functional Respiratory Imaging (FRI) research and development. Its organization remains relatively small. To win a new customer, the company needed to be ISO 13485 compliant. This involved building a Quality Management System. Moreover, they had to meet specific norms of the medical device regulation. They contacted QbD to come up with a lean solution. Overhead was to be kept at a minimum.
The QMS dilemma
Companies aiming to become norm compliant face two options.
- Either they choose for a standard implementation, forcing them to overturn all existing routines and procedures.
- Or they go for a customised solution to maintain their current operation methods as much as possible. They merely fine-tune or adapt procedures where norms and regulations explicitly demand adjustments.
The challenges of customisation
QbD’s Quickscan revealed that our client preferred a lean and scalable Quality Management System. They wished to reduce overhead as much as possible. This clearly pointed in the direction of a customised solution. Customisation involved specific challenges for the QbD consultants. It required a deep understanding of our company’s working methods and processes to check whether they met every norm. A number of their internal processes diverged from the current routines of big pharmaceutical companies. So we needed to find flexible solutions enabling lean implementation.
An intensely collaborative approach
To ensure a customized and lean implementation of the QMS, we designed a detailed plan of action. This process comprises 6 crucial steps:
- Everything started with deep listening. QbD interviewed key people at the company to get a thorough understanding of their standard procedures.
- We put their heads together to close-read and discuss the norms. The rationale behind specific clauses was analysed.
- The team mapped the current workflow of our client with post-its. Extra post-its were added to highlight gaps: missing activities required by the norm.
- Together we reshuffled the post-its of both current and newly required activities to create a smooth flow.
- Each procedure was documented with detailed information from the departments involved.
- The concerned departments reviewed all processes. We adapted when necessary. Sometimes this required several correction rounds.
A triple phased process
The Quickscan resulted in a report and action plan, sealed by a contractual agreement. The setting up of the QMS took a little more than 2 months. It entailed three phases.
- In Phase I we built the general standard structure of the Quality Management System. This involved the organisation and implementation of the various modules: document management, CAPA management…
- Phase II focused on the specific aspects of Medical Device product realisation (chapter 7 of ISO 13485: 2016).
- In Phase III we verified everything we had built. Did everything comply with the norms? Did we need to fill in small remaining gaps? QbD sent a complete overview of the work .
The secrets of success
Lean implementation of a customised QMS requires intense consultation. Our client always made sufficient time for this. The QbD team worked on site. This embedded approach strongly enhanced collaboration.
Open communication proved to be a critical success factor. Both our client’s and QbD’s players were always prepared to listen and consider the other’s viewpoints and interests.
Moreover, the QbD team at our client’s company could firmly build on QbD’s previous experiences. Whenever they met a particularly demanding challenge they could rely on QbD colleagues who had overcome similar problems.
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