Investigations usually need to ask common questions every time an event occurs to get to the “Why” (root cause and contributing factors) of the event and find effective CAPA’s to prevent recurrence.
Typical questions asked by all investigators are:
- What is the event? (and equally important is to understand is the “what is not the event?” to define the scope of investigation): This makes availability of all contextual information very important at the fingertips of the investigator. The delay in access to information leads to delay problem understanding and hence delay in scoping leading to delay in root-cause/CAPA identification.
- When did the event occurred? : Instant access to accurate time frame of the event and all associated event window is extremely important.
- How did the event occurred? : Access to batch profiles helps to identify and trace the event trajectory
- What is the impact of the event? Has it occurred before? How severely? Were other systems impacted? Site? Products? An initial impact assessment needs to be made to determine the scope of the investigation. Only when the root cause is determined, can final impact be determined.
- Why did the event occurred? : ability to correlate parameters across the process can help identify why those events could have occurred
- Is there a precedence? : has the event occurred before in past manufacturing history. What was the root-cause and CAPA identified. Why was CAPA not effective?
- How far is the event from set target? : what is the severity of deviation and how far is it from control limits? When was the last time the limits were revised? Is the event closer to older limits?
- What is the organizations’ benchmark? : Can I compare this event with similar events in other process steps within the process or across processes/products. Access to this information will help in setting effective CAPA
In most cases currently investigators spend majority of their time hunting for gathering information rather than seek answers to these routine questions that could lead to better quality of root-cause and CAPA solutions. Tools that can readily answer these questions on a readymade basis will tremendously help organizations to be more productive, proactive, economical and avoid repeated failures with ineffective CAPA.
The graphic below shows how adoption of ProcessPad help organizations get instant access to all the relevant information to seek answers to questions above.
Dr. James Blackwell, President, Founder, and Principal Consultant of The Windshire Group (a consultancy providing global CMC- chemistry manufacturing controls consulting services to life science and allied regulated industries www.windshire.org) , LLC agrees: “I’ve said many times in my career that the biggest problem I had was getting the data I needed to solve problems or make process improvements. As the industry’s first web based solution, ProcessPad is a huge advance that helps organizations maintain control of their processes, improve supply chain efficiency and consistency, and remain compliant.”
ProcessPad is built ground up by pharma and biotech professionals for continued process verification and process monitoring. Continuous trending and monitoring on a proactive and real-time basis can prevent some of these problems to occur and standardized reporting across the organization can save tremendous time performing investigations.
About ProcessPad(TM)
ProcessPad(TM) is bio+pharma process management software to manage process data in development and commercial manufacturing of biopharmaceuticals.
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