Quality Plans Are Not Static

If you are a life sciences manufacturer, your quality and business objectives have likely changed since the beginning of the year. The emergence of COVID-19 has disrupted the priorities of many medical product manufacturers.
 
Although the pace of change this year has been unique, shifting quality objectives are nothing new. Mergers & acquisitions, new products, new regulations and changes to global demand also generate constant adjustments.

You Need a Plan

Many global regulators require a manufacturer be able to demonstrate Quality Planning as a core capability of their quality management system.
 
“The problem,” notes Sparta Vice President of Digital Innovation Stephen McCarthy, “is that many manufacturers don’t sufficiently value or prioritize the process.”
 
As a result, they sometimes fall into a common cycle:

  • They focus on Quality Planning and produce some clear targets for improvement.
  • They invest in Quality to meet a specific challenge.
  • Their quality performance improves.
  • They shift focus—and resources—to a different target.
  • Without attention, adherence to the Quality Plan decreases.
  • Quality suffers, triggering quality issues, customer complaints, and so on.
  • They react by reinvesting in Quality and the Quality Planning process.
  • … and the cycle continues.

As you can imagine, this cycle doesn’t help productivity or efficacy. By contrast, a well-defined and consistently executed Quality Planning process can help you—

  • Identify quality objectives
  • Shift priorities and resources quickly when those objectives change
  • Maintain compliance and consistent quality during such changes

A Perfect Plan

“A comprehensive Quality Planning process occurs on multiple levels of your organization and involves quality data from a wide variety of sources,” explains McCarthy. “It is a key part of any robust quality management system. And when used proactively, it can help Life Sciences manufacturers increase agility and meet the kinds of rapid shifts we’re seeing now.”
 
“For example, as a company develops a COVID-19 vaccine, very rapidly,” McCarthy continued, “A primary objective for that manufacturer will shift to supply chain continuity. As that company, manufactures a billion doses of vaccine, another manufacturer has to prepare to get a billion syringes into the supply chain, or that vaccine cannot be delivered to the population.”
 
Manufacturers must be ready for this level of demand. Many have already experienced such changes, such as demand waning for some products with the cancellation of elective surgeries, while demand surging for ventilators and personal protective equipment.

A Simple Framework

Whatever the size or scope of your organization, the framework for a successful Quality Planning process applies.

Set your quality objectives. When you establish and review quality objectives, keep three principles in mind:

  • Align quality and overall business objectives. To build a strong business case for quality objectives, make sure they also support the needs of manufacturing, IT and other departments.
  • Define based on core Quality Imperatives. There are traditionally five proven, over-arching objectives commonly shared by Quality Leaders in Life Science companies.
  • Refine objectives, as a planned business activity. Industry trends, supply chain complexity and technical innovations—not to mention emerging health needs—demand constant vigilance and agility.

Make objectives ‘SMART,’ and cascade throughout the business, cross-functionally.
 
Detail and delegate responsibilities at every level of your organization. For example, the Chief Quality Officer will be responsible for ensuring that set policies and standards are maintained across the entire business. The VP of Quality will be tasked with securing the necessary resources to support you’re the Quality Plan. The Quality Director or Manager of each business unit and each site must establish and regularly review and update processes to meet the Quality Plan and document compliance with those procedures.
 
Document requirements, standards, testing methods, and procedure for changes to the plan.
 
Define methods for measuring success. Determine which resources will inform your Quality Planning process and how you will collect that data. Also decide how you will evaluate the achievement of your objectives—and the need to update them.