Quality Event Management: a challenge for the Pharmaceutical sector

The close relationship between quality and production processes

Quality is a major concern for pharmaceutical companies. Any small defect on a drug substance could lead to serious consequences. Several historical cases occurred through the 20th century leading to the creation of drug administrations (e.g. the Food and Drug Administration - "FDA") and the build-up of quality standards conditioning access to the market (i.e. guidelines regarding Good Practices grouped under the acronym "GxP").

Creating a real partnership between production and quality remains among the most important challenges.  The understanding of complex production processes as well as the perfect mastery of cGMP will make the difference.

The reality of quality events

In practice, even if procedures describe the process, which are written by experts and taught to manufacturers through robust training systems, the reality of manufacturing high-tech products inevitably leads to the occurence of unplanned events. These events trigger the quality procedure "deviation management" describing how to react when you are deviating from the correct procedure.

cGMP Part 211.100 describe that any deviation from written procedures shall be recorded and justified. Pharmaceutical industries generally describe the main steps of deviation management according to the Lean Six-sigma approach. These are the stages of the procedure :

#Step 1: Asks the description of the unplanned event.
#Step 2: Investigate regarding the origin of the "deviation" (i.e. Root Cause Analysis).
#Step 3: Assess the potential impacts.
#Step 4: Set-up adequate actions to avoid any recurrence of the situation.
 

Root cause analysis often leads to updating procedures for continuous improvement. But, the real question remains: “is it enough to improve quality?”

The business side of quality events

High quantity of deviations is often considered as a bad indicator by leadership teams, although it can characterize fast-growing and innovative companies. The deviations rate correlates with the level of maturity of teams and processes. There may come a time when deviations are not under control anymore, accumulate, start to get late, become complex or require specific expertise, a time when even the best management cannot overcome those troubles.

Therefore, from a business perspective, loss of control over deviation management can quickly lead to supply issues. Moreover, if impacted products are already on the market, it would result in difficult communication with authorities. Finally, as a recording system for quality events, deviations’ review is a critical step during the drug administration's inspections. For these reasons, quality event management constitutes an essential challenge for every pharmaceutical companies.

Avertim’s services associated to deviation management

For years, our company has built a strong expertise in quality event management by working at every step of the supply chain throughout the industry. This experience has led to long-term collaborations with customers, adapting our teams and WOWs to the client’s needs. Avertim’s experience has shown that the most efficient way to keep deviations under control is to provide external deviation experts releasing deviation pressure, allowing processes to improve and people to grow. We propose solutions at different levels:

• Deliver: Avertim has its own internal deviation academy grouping trainings, coaching and certifications to provide deviation experts to clients.
• Manage: Deviation management teams are composed of writers and managers, who coordinate work attribution and facilitate interactions between stakeholders.
• Solve: To take decisions and set priorities, it is necessary to have a clear view on both production and deviation status. For that, Avertim is recurrently developing tools in close collaboration with leadership teams.
• Advise: At a strategic level and based on its experience, Avertim provides analysis and advice based on client’s deviation data to identify trends and adequate actions to improve ways of working.

Avertim’s successes in deviation management

In 2021, these approaches have been used by Avertim to support a fast-growing company involved in the production of COVID-vaccine. At the same time, four deviation management teams were set-up in another company to support the launch of new vaccine production facilities and the revamping of older ones. One year later, in February 2022, these teams completed their 1000th deviation in support of production teams.

Deviation management at Avertim in numbers : 

• 1,5k deviations closed 
• 10 contracts signed 
• 2,7M euros saved 

Avertim also helped other companies to sharply reduce their deviation blacklog. During the past three years, more than 1500 deviations have been closed with the help of an experienced consultant team involved inside the companies. Closing these deviations helped the customer resolve supply and quality issues.

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