April 29, 2022 PAO-04-022-CL-12
Quality assurance has to run from end to end when it comes to pharmaceutical products, or they cannot be approved for distribution. So, it may seem somewhat strange that supply chains are not subject to more rigorous, systemized scrutiny.
The global food industry has learned the consequences of failed supply chain vigilance the hard way, as contamination issues and other scandals have brought companies into the spotlight. In recent years, most major food retailers have digitalized their supply chain quality management and monitoring, in order to lessen the risk of standards slipping.
Quality and safety are just as critical for pharmaceutical companies, and a huge part of maintaining quality is ensuring that standards are upheld right along the supply chain. However, the manual processes followed by the vast majority of pharma organizations are fraught with risk, as well as being costly due to their labor intensity.
Digitalizing end-to-end supply chain quality monitoring and reporting offers several major advantages. The companies listed below reveal some insights into what has been achieved across the food industry by digitalizing the quality management of their global supply chains. These examples, based on case studies from a Rephine partner, offer some inspirations for equivalent transformations in pharma.
The Big Table Group owns and operates the Las Iguana, Bella Italia, and Café Rouge restaurant brands. It was keen to restore growth and capitalize on post-pandemic demand but lacked visibility down its supply chain.
The company undertook a digital mapping exercise that identified 900 additional / previously invisible suppliers. The firm’s quality assurance data is now managed digitally, and a digital risk scoring system heightens accuracy, covering all the company’s suppliers. The company also now captures supplier documentation digitally, such as policies on modern slavery, animal welfare, food safety, and so on.
As well as improving risk mitigation across the end-to-end supply chain, The Big Table Group has been able to streamline new supplier approval and demonstrate responsible operations.
In most pharmaceutical firms, risk management is still predominantly performed manually using spreadsheets, but in the future, firms will be expected to monitor all of their suppliers, not just key suppliers, and to do this continuously and in real time, rather than via a one-time “snapshot” every two to three years.
As part of its plan to highlight and foster best practice across its fresh produce supply chain, U.K. supermarket brand Waitrose introduced a Responsible Efficient Production Index.
It digitized performance assessment at farm level, based on a scoring system of assessments, and established a centralized communication system with individual suppliers to promote continuous improvement. Today, the retailer benefits from more consistent data collection across its farms; insights into the relative strengths and weaknesses in the supply chain; and faster feedback/responsiveness.
The pharma industry has lessons to learn from Waitrose’s enhanced ability to share best practice. Driving up supply chain transparency is encouraged by many regulators, even if it is not yet practiced in semi-regulated or non-regulated markets.
Hello Fresh is a recipe box delivery brand. It realized that its supplier data was unstructured, which made it difficult to assess compliance. It also wanted an easier way to regularly follow up with key suppliers about quality issues.
The firm digitized its remote supplier auditing and assessment, supply chain mapping, and specifications management, with KPI tracking across all suppliers. Today, it can access and react to real-time data, and this improved visibility and sense of control should allow it to develop further sustainability initiatives.
Pharmaceutical companies could apply similar digital mapping to the different components of the supply chain of a drug product and track these more continuously.
Oddbox is a fruit and vegetable box delivery firm that aims to reduce food waste. The company was undergoing rapid growth and needed to monitor risk across its entire supply chain. It has now mapped its supply chain digitally and streamlined supplier audit management to create a single view of quality issues. This should mean that it can continue to grow without concerns about diminishing standards.
Pharmaceutical organizations are looking for greater visibility and control, especially when they undergo periods of growth and change. Digitalization could help to boost clarity and order as converging supply chains are streamlined.
Major U.K. retailer Tesco obtains its milk directly from a group of 600 dairy farmers known as the Tesco Sustainable Dairy Group (TSDG). To fulfill Tesco’s strict quality criteria, the firm needed to demonstrate performance against a quarterly scoring system covering issues such as the health and welfare of dairy herds and their carbon footprint.
Tesco’s main aims were to digitize real-time data capture from farmers and to monitor key aspects of the scoring system. It now has access to detailed supply chain quality data that allow it to identify and reward its top 5% of farmers in near real time, support its claims about the quality and provenance of its dairy products, and target any underperforming farms with tailored action plans.
The pharma industry is assigning increased value and prominence to CSR and carbon reduction, and it too needs to have evidence to back up its claims.
Karro is a leading U.K. pork processor that wanted to accelerate the supplier/farm approvals process. As well as critical documentation capture, Karro has digitized its questionnaires and risk assessments for supplier selection and life cycle management and on-site audits to assess site security, animal welfare, transportation management, and so on.
Accurate farm and supplier data now enable Karro to benchmark its suppliers and view on-demand insights about performance improvements.
The pharma industry could benefit from a similar focus on quality at all levels — for instance, ensuring that GMP standards are met for all materials, packaging, and services used in medicines.
Winterbotham Darby is a U.K. food supplier supplying chilled Mediterranean and plant-based products to the retail, food service, and B2B sectors. It works with over 800 suppliers and requires transparency right along the supply chain — from manufacturing / primary processing right back to farmer and grower.
The company is now capturing critical information centrally about everything from use of antibiotics and pesticides to water usage and animal welfare — data that it can share with customers and use to deliver on agreed strategies, supported by factual evidence. All of this enhances customer confidence.
Pharma still has a long way to go to confidently capture and evaluate its supplier data, but this gives it the potential to move straight to best practice — learning from the experiences of the food industry.
The experience of the food industry clearly shows that competitive advantage can be gained by smarter supply chain quality management.
If the start and end points are clear, driving the transformation needn’t be onerous. Companies should set up a multidisciplinary taskforce that includes personnel from Quality, Procurement, and IT, as well as a Supply Chain representative if possible and representation from Regulatory.
Simply selecting an electronic quality management system (QMS) will barely scratch the surface, however. Real transformation requires a detailed understanding of the global corporate picture. Plus, any new capability must be able to exchange data with the company’s legacy systems.
The demand for greater supply chain transparency and evidence-based quality claims is already strong: within two to three years, such expectations will be greater still — and in many cases mandatory. Delaying the transformation to digital is not an option for those who want to steal a march on tomorrow.
Gaëlle Jaron leads the digital services business of Rephine, including Rephine Catena™, its new end-to-end digital global pharma supply chain quality management solution. Rephine Ltd is a firm of deeply experienced GMP auditors that proactively help pharmaceutical companies around the world with their supply-chain quality assurance.