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Governance, risk and compliance in the life science sector: tips from our readers

The life science sector must demonstrate the most stringent, consistent levels of quality and compliance on the planet, from GLP and FDA benchmarks to ISO 17025 and ISO 13485. 

We sent out a survey to our readers in the life science profession to ask them to share their main challenges, tips and insights for driving quality in such a challenging sector.

We chose five of the responses to share with you below. 

 

life science governance risk compliance quality

 

What are the main challenges and mistakes to avoid in this sector?

 

As a small start-up, our main compliance challenge is resource and funding. We needed a simple quality management system that was cost-effective. 

                                                                                   - Carolyn Axon, Tookie
 
 
The main challenge is to ensure that the quality and regulatory requirements associated with process and product are adhered to without compromising the business's ability to produce product and make money.
                                                                        - James Halliday, Acelity
 
 
A main challenge in my opinion is to have clear, effective and measurable quality objectives. MISTAKE: Establishing objectives without taking into consideration if we can extract them from QMS procedures.
                                                                    - Eilini Tsaliki, Rontis Corporation
 
 
Lack of resources. Senior management are not interested. Quality is something to put up with, not to support. Mistakes: Auditing against processes and procedures but not the standards themselves.
                                                                                         - Gary Hartley, Athyn
 
 

The main challenge in the NHS is using limited resources wisely.

                              - Caroline Parkes, Kettering General Hospital
                                                                              NHS Foundation Trust 

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What advice and tips would you share with other quality professionals in the life science sector?

 

Seek support as soon as you can. Don't waste time trying to understand complex requirements. 

Trying to understand and keep up with compliance for a medical company is impossible when you have so much more to do. Building a QMS from scratch yourself is not impossible, but why do it when somebody can give you the templates and advise you for £250 a day? It only took one visit from our ISO consultant to set us on the right path.                                                                  

                                                                             - Carolyn Axon, Tookie
 
 

Integration and collaboration of quality personnel with every process and function of the business is absolutely essential.                                                                        

                                                                         - James Halliday, Acelity
 
 

Always keep yourself updated with the regulatory landscape.                                                          

                                                                   - Eilini Tsaliki, Rontis Corporation
 
 

Aim for Minimum Viable Product (MVP). Perfection takes a long time but products have short life spans before the 'next greatest thing ever' comes along.                                                                                       

                                                                                     - Gary Hartley, Athyn
 
 

Look outside your immediate environment for ideas. I work in the NHS but have used ideas from the aerospace and motor industries. Also I'm a member of the CQI, which gives a broader perspective. Engage with your staff, support them and encourage them to take responsibility for quality in their work. Have cake at meetings. I'm always thinking of the patient experience, even though we have limited patient contact.

                                 - Caroline Parkes, Kettering General Hospital
                                                                                 NHS Foundation Trust 
 
 
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What are your priorities for the next year?

 

To improve our customer feedback channels and reach ISO 13485 certification.                                                                  

                                                                            - Carolyn Axon, Tookie
 
 

Maintaining quality and regulatory compliance during a period of significant change, brought about by external influences such as the EU Medical Device Regulation and the possible effects of Brexit.                                                                      

                                                                                 - James Halliday, Acelity
 
 

We're transitioning to the new MDR.                                                      

                                                                  - Eilini Tsaliki, Rontis Corporation
 
 

Find the shortest possible route to compliance and keep everything as simple and easy to follow as is humanly possible.                                                                                      

                                                                                     - Gary Hartley, Athyn
 
 

Maintaining accreditation for my laboratory. Maintaining patient safety. Improving patient experience. Ensuring staff in the laboratory are engaged with quality in all areas of their work.

                              - Caroline Parkes, Kettering General Hospital
                                                                              NHS Foundation Trust 

 

What to do next

The common quality problem of lack of resources is evidenced in the responses here. 60% of the quality professionals in our 2018 GRC benchmarking survey also felt they were allocated inadequate resources to do their jobs. 

Other key hurdles were also identified as:

  • Dovetailing the quality agenda with the core business goals of product and profit
  • Gaining senior management support
  • Setting clear, actionable objectives 

But these should be seen as interconnected, not discrete problems. New Business & Marketing Director Michael Ord comments that: 

 

Lack of measurable quality objectives just compounds the historic problems faced by quality teams. By developing quality goals with clear, tangible effects on finance or product development, life science quality professionals can strengthen their voice at board level and secure the resources they need to do their jobs.

 

1. If you feel you aren't allocated sufficient resources: your business might not have a fully developed 'culture of quality'. Try our '8 Culture of Quality Tips' document for ideas to engage your colleagues and take the first steps to deepening the impact of quality on your business.

The 'integration and collaboration' recommended by James, and Caroline's advice for seeking inspiration from other sectors and the CQI should also be considered. These all form the core of a functioning quality culture.

 

2. If your quality procedures aren't aligning with the rest of the business: follow Gary and Eilini's advice of focusing on the quality standards themselves. Standards like ISO 13485 are designed to integrate with your entire business, not to be the responsibility of just one department. Try our free standard toolkits for a deeper understanding, whether you're aiming for accreditation or already have it.

 

3. If management aren't interested in quality: a robust quality management strategy with clear goals is key. Try our free playbook for guidance on winning buy-in, assembling a support team, building a plan, and more.

 

4. If all of the above: consider extra support like one of our GRC workshops. Our upcoming business intelligence workshop focuses on identifying and tracking core quality metrics the whole business can support.   

 

5. Need more inspiration? Sodexo implemented an electronic quality management system to integrate and automate their pharmaceutical quality processes. Download the case study here:

sodexo case study qualsys

Tags: GxP Pharmaceutical Regulation, ISO 13485, Quality Culture, ISO 17025, Playbooks, Culture of Excellence