Grey RA advocates ‘lean compliance’ where principles borrowed from lean manufacturing are used to reduce and simplify processes and documentation. this results in less time spend on documentation and quality system maintenance. Quality and regulatory staff move from a ”check” role to a ”guide and train” role. And the organization moves from a reactive to a proactive approach.
During previous ‘lean’ projects, Grey RA identified 4 key areas for lean improvements:
1 – Knowledge
Regulations can have a major impact on your business. Make sure you have the required knowledge – in house or with selected partners – to understand the regulations and to monitor the regulatory agenda.
2 – Lean quality system
Make your quality system ”lean”. Only include those procedures that result in value for your customers or that are regulatory required. Your organization is changing and the outside world is too. A lean quality system ensures a limited effort to keep your quality system up to date and compliant. And it definitely facilitates external audits – unless you want to confuse the auditor.
3 – Lean documentation
Make your documentation lean. Write clear, consistent and comprehensive documentation. Imagine the benefits of a lean DHF when filing submissions… Imagine you can easily update specific documentation when changing a product. And please note: lean documentation is not about reducing the number of pages… It’s about reducing the effort to write, review, release and maintain your documentation.
To ensure lean documentation, keep the 5 C’s in mind:
- Clean – contents are relevant for the scope.
- Compact – contents cover the minimum requirements and no more.
- Consistent – sets of documents have a clear structure and ownership, no information is doubled.
- Comprehensive – documents are self explaining, even for an external reviewer.
- Compliant – last but not least…
4 – Lean mindset
Ensure a lean mindset where everyone in the organization is involved in removing waste.