Risk has always been essential to ensuring quality in pharmaceutical and medical device manufacturing. But with the latest version of ISO 9001, risk is now officially part of the management system standard.
One of the biggest changes in ISO 9001:2015 is the replacement of preventive action with risk-based thinking requirements in context, leadership and planning sections.
Experts will say risk-based thinking is a watered-down version of more robust risk management processes, but the guiding principles are the same. Identify your hazards, consider the potential consequences and take action as necessary.
With that in mind, let’s look at 3 critical areas life sciences companies can integrate risk to improve quality and safety.
- Supplier Quality Management
The global market for contract manufacturing in pharmaceuticals is projected to exceed $94 billion in the next 5 years, with medical device contract manufacturing to reach $90 billion by 2020.
With so many life sciences companies outsourcing elements of manufacturing, effective supplier quality management has never been more important. And yet, for many companies suppliers represent a huge blind spot in terms of risk.
- Which suppliers are mission-critical in terms of how the materials or components they provide fit into your manufacturing process.
- Individual supplier performance and past compliance history.
- Status of corrective actions assigned to suppliers.
A cloud-based Quality Management System (QMS) can make it easier to track this type of information. This type of system allows you to benchmark suppliers by risk, send corrective action requests and track high-risk problems related to suppliers from start to finish.
- Corrective and Preventive Action (CAPA)
Many life sciences companies struggle with quality problems because of ineffective processes around Corrective and Preventive Action (CAPA). The entire point of the CAPA process is to reduce risk, and yet there’s still a tendency to treat it as another box to check for compliance.
So what does a risk-based corrective action process look like?
- Each CAPA request gets a risk assessment in order to prioritize which ones need to be handled immediately.
- You create customized workflows for different types of CAPAs, ensuring they get routed to the right people who complete them on time.
- A final verification step that goes beyond just checking that the action is complete, assessing residual risk to evaluate effectiveness.
- Complaint Handling
Effectively managing customer complaints and post-market feedback is a critical part of reducing risk for pharmaceutical and medical device manufacturers. Fast complaint handling helps you better meet customer needs, comply with regulatory requirements and adapt to market changes.
But how do you know which complaints need priority action, and which ones need to be escalated up the chain of command? QMS tools help reduce risk by allowing you to:
- Assess each complaint received with an internally developed risk matrix to filter out high-risk issues.
- Create customized decision trees based on company policies and regulatory requirements to standardize how employees handle different types of complaints.
- Track individual complaints to ensure timely resolution.
- Integrate with production systems to pinpoint the location of other potentially defective products.
While risk-based thinking may sound fuzzy in the context of new ISO standards, the idea behind it is quite simple. Applying risk as a standardized measuring stick across different processes simplifies decision-making, providing a clearer path forward for turning risks into opportunities.