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4 Hidden Risks in Life Sciences Manufacturing

April 26, 2017 / by Rachel Beavins Tracy

Pharmaceutical and idea-2.jpgmedical device manufacturing is all about managing risk. How do you take a product from concept or molecule to finished product in a way that minimizes risks to patients and the company?

Organizations tend to focus on a standard set of risk tools, relying on things like Failure Modes and Effects Analysis (FMEA), risk matrices and the Risk Register to ensure risks are caught before they become problems.

And while these tools are incredibly valuable to risk management in general, sometimes it’s the process or system itself that creates hidden risks.

In today’s post, we’ll look at 4 of these risks, and how companies can address them. 

  1. Inadequate Complaint Handling

Every year, hundreds of life science companies receive citations around complaint handling from the U.S. Food and Drug Administration (FDA). In no other industry is it as important that companies have procedures in place for receiving, reviewing and evaluating complaints. Drop the ball just once and you could be looking at a major crisis (recall), versus properly managing the release of product before it reaches consumers.

So, what’s the solution? Integrating your Complaint Handling system with the quality management system as a whole, end to end. An integrated Complaint Handling solution allows you to:

  • Centralize records of all incoming complaints and route them to the appropriate parties.
  • Assess the risk of individual complaints using decision tree questions to determine what needs immediate attention.
  • Immediately identify recurring exceptions during the intake process to escalate appropriately.
  • Link complaints to corrective actions, helping resolve problems faster while generating a complete history of the complaint.
  1. Ineffective Corrective Action

This is another area that results in hundreds of citations annually for FDA-regulated companies. Corrective action is of critical importance in medical device and pharmaceutical manufacturing, and not having good processes in place means something will eventually fall through the cracks.

Automated GMP Compliance Management Software can help, enabling companies to:

  • Create automated workflows for different types of corrective action requests, so you can streamline and expedite the process.
  • Set delegation rules for when key personnel aren’t at work, plus escalation rules to notify supervisors for when people don’t meet deadlines.
  • Filter corrective action requests by risk so you can address high-risk items first (and not just those that were entered into the system earlier).
  1. Data Silos

One of the biggest challenges life sciences companies face today is a lack of integration among key quality and safety processes. Many organizations still use manual spreadsheets or even paper-based systems, while others use a hodgepodge of point solutions to manage individual tasks such as corrective action, equipment maintenance and audits.

This means related data that companies could be mining for trends and predictive analysis remains trapped in separate silos. Even if they wanted to analyze their data in this way, the time it takes to aggregate the information means it might not be actionable by the time you’re finished.

To increase visibility into their processes, risk and performance, companies should look to integrate safety and quality data from areas such as:

  • Document Control.
  • Employee Training.
  • Audit Management.
  • Corrective Action.
  • Risk Management
  • Customer Complaints.
  • Calibration and Maintenance tracking.
  • Supplier Quality Management.
  1. Documentation Problems

Documentation and recordkeeping is a big problem for life sciences industries, as some of the earlier points in this post highlight. Hidden risks to watch out for in this area include: 

  • Access issues: Common problems here include multiple people sharing logins and lack of control over who can alter or delete data.
  • Document control gaps: Many companies rely on email chains and server files rather than an automated Document Control system, but this can lead to versioning issues and other mistakes. Just consider how much you might lose if you placed a large order based on an outdated specification.
  • Audit trail problems: Creating and reviewing audit trails that track the timeline of how cGMP data is created, modified or deleted is required for FDA compliance, and Data Integrity is one area where companies struggle.
  • Maintenance records: Regulators have handed out many warning letters over a failure to keep adequate records of equipment maintenance.

The FDA won’t hesitate to ding you for any number of problems mentioned in this post. But the truth is, these issues run much deeper than regulatory risk alone. Designing more reliable processes and systems is about quality and safety—for patients, consumers, employees and the organization as a whole.

Your guide to better document control

Topics: Life Sciences