Evaluation or assessment of suppliers is a crucial process, but requirements vary across industries. What is standard in ISO or GLP may not be what you need for GMP/GDP or GCP. How do you navigate through this complex landscape of requirements and expectations? And how do you ensure that your organization's mission does not rest on shaky ground?
It's time to explore the value of due diligence and choice when it comes to supplier relationships. The questions are many, and the answers could be crucial to your organization's future. Whatever your sector, you may have to deal with limited internal resources and, at best, a wide range of services/goods/systems from the market. In a governmental/regional/municipal organization, the Law on Public Procurement (LOU) comes in as an extra, "joker", in the game. A basic principle within one's own quality/management system is to consider carefully before building on one's business idea by relying on someone else's foundation.
Challenges and lessons from the industry
Traditionally, the quality department, and possibly the SME (subject matter expert), has had the main responsibility for supplier assessment in Life Sciences, but there are challenges that can arise, especially around GxP requirements that are not negotiable. By sharing some experiences and tips, the road to successful collaboration with suppliers can be made easier. In addition, you will get advice on how to avoid delays and increased costs. Sounds interesting, doesn't it?
5 tips for a smoother path to successful collaboration
- Regardless of the industry, there should be clarity in what the purchasing process looks like internally and how it links in with other processes in the management system/quality system. A useful exercise to do is to map the process for purchasing together with that for supplier evaluation. Then you will see what the interfaces are between the processes and what legislation we are dealing with, in an educational way. Risk assessment, remote evaluation and audit will also be easier to prioritize. Do you know what your purchasing process looks like and how it aligns with other systems?
- An important reminder to senior management is that responsibility for regulatory compliance, especially GMP, is shared. This means that departments other than quality, which run projects involving supplier evaluation, also need to have a good knowledge of the regulations. This challenges the quality organization to look beyond its own horizons and is likely to lead to a better outcome from a holistic perspective. How can you ensure that departments other than quality have sufficient regulatory knowledge to contribute to a successful project?
- A cost-effective tip is to include quality issues in the market analysis to clearly specify the requirements towards suppliers early in the procurement process. This is particularly important in public procurement and LOU compliance. Are you and your company working to improve the outcome of the procurement process with the early inclusion of quality issues in the market analysis?
- Many suppliers today are prepared for the fact that customers may want to audit and evaluate them. It is important to point out that contracts and quality agreements have a significant impact on how you as a customer can comply with internal and external requirements over time. Normally, contracts allow for an annual visit, but there may be restrictions on the number of people and the length of the visit. To ensure a smooth process, it is important to plan time windows for the first audit and any follow-up audits in the contract. In case of major events, a targeted audit, also known as 'for cause', can be carried out. Having a clear matrix or table of responsibilities in the contract is wise, both in terms of internal and external requirements on ourselves. In the future, it is likely to be important to be able to demonstrate that these requirements have been carefully followed over time, both to customers and authorities. How can you ensure that contracts and quality agreements are designed in a way that allows for effective monitoring and compliance with internal and external requirements in the long term?
- Evaluating suppliers can be costly for small to medium-sized enterprises, especially if the suppliers have many customers. It can be challenging to free up internal resources for evaluation and to get time with the supplier. One solution can be to buy evaluation services on the market, either as ready-made reports or as services. In addition, there are associations such as Quac in Mälardalen where smaller companies collaborate and share knowledge in the field. Is it really sustainable for small to medium-sized enterprises to evaluate suppliers themselves with limited resources and time?
Future thoughts, reflections & final thoughts
Looking to the future, it is crucial to reflect on how supplier evaluation can shape the way forward for the life sciences industry. By sharing insights and experiences, we aim to create an environment where successful collaborations can thrive and grow. Jointly exploring and exchanging knowledge opens the door to continuous quality improvement in the industry, equipping us to face future challenges with greater confidence and commitment.
