In my early days learning about risk management and quality oversight, I was advised to develop a "helicopter view" of the "landscape", before zooming in on the details. To develop the "helicopter view", I found it very useful to literally build overviews of whatever subject was forming my "landscape". This was applicable to practically everything I wanted to learn - systems, processes, organisations. It enabled me to identify connections between systems, processes and organisations, as well as potential risk areas.

When I became a QP and RP, the first thing I wanted to understand was the supply chain of the products I was responsible for. Convincing the Supply Chain Department that they could safely provide me with all the information without me poking my critical QP nose into their business proved a little challenging, but slowly I got the bits of information I wanted, to improve my understanding of what I was actually responsible for - what I was signing for when I released each product batch, and how the Supply Chain Department was supporting me in fulfilling my QP and RP responsibility of ensuring continuity of medicines to patients who need them.

Some product supply chains were relatively straightforward - one raw material supplier, in-house active ingredient / drug substance manufacture, progressing to in-house bulk drug product manufacture and then to final packaging. Some were fascinatingly complicated - multiple raw material suppliers, different manufacturing sites involved in drug substance and drug product manufacture, multiple testing sites for different stages of production, multiple final packaging sites and multiple storage locations before distribution to customers.

The more I learned, the more intrigued I became. Happily, I had the opportunity to transition from QA to Supply Chain, to be part of the business discussions and understand the complexities that result in supply chains that might not seem logical from QA perspective, but are necessary from business considerations. My QA background gave me more depth to my role in ensuring successful launch of new products to the market, while my experience in supply chain added more breadth to my QA work in later projects.

My practice of piecing together supply chain overviews to develop this "helicopter view" has served me very well the last couple of decades, allowing me to quickly grasp the complexities of bringing a new product to the market, or gain a good estimate of the risk areas of a company that I'm working for.

I've managed to highlight business and quality risks with this "supply chain overview" approach and proposed actions to the managers involved, to reduce or mitigate the risks as well as put some QA support mechanisms in place.

My advice to all QA teams is to first get a high-level understanding of what the supply chain of the company is. Knowing how materials flow into and through the company to result in finished drug product in the hands of patients who need them is the first step in managing the quality risks associated with maintaining continuity of supply of the finished drug product, which is ultimately the responsibility of QPs and RPs, with the support of their QA teams.