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Blog

Facilitation is the Key to Successful FMEAs

By Robert Smith, October 19, 2017

The Failure Modes and Effects Analysis (FMEA) is a versatile risk management tool that has been around for several decades, first used by the US Armed Forces in 1949. It started gaining popularity in the 1960’s with its use in the aerospace industry during the Apollo missions. FMEA has been called the “swiss army knife” of risk management. FMEA is focused on problem prevention, rather than problem solving. It is used to identify the factors that can lead to failure and recommend mitigation strategies to prevent failures or detect the early onset of failures.

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GEP In Projects – To Practice, Or Not To Practice?

By Bob Perry, October 17, 2017

As responsible Project Managers, we need to deliver maximum benefits realization to our project stakeholders on each project.  The key to maximum benefits realization is clearly delineating stakeholder requirements and assuring these requirements are satisfied throughout the project lifecycle.  A critical component for assuring stakeholder requirements are satisfied is following good engineering practice (GEP).  While GEP is an expectation in the life sciences industries, the basic GEP elements required as a basis for GxP (good “anything” practice) quality guidelines and regulations compliance can, and should be, applied to all projects.

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I Stuck my Hand in the Stopper Bowl

By Daisy Chew, October 12, 2017

A tale of why read and acknowledge is a failed method of operator training.

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The Data Life Cycle

By John Hannon, October 10, 2017

The ISPE Good Practice Guide on Records and Data Integrity defines a data life cycle consisting of:  Creation — Processing — Review, Reporting, and Use — Retention and Retrieval — Destruction

A robust data integrity program ensures data integrity across this entire life cycle. Such a program would include a risk-based analysis of all data flows to identify, assess, mitigate, and communicate potential data integrity issues. Systems supporting the data integrity should be validated for their intended use, and boundaries for the data should be identified. Throughout the data process, data must be secured from modification or deletion by unauthorized personnel, and changes to the data must be captured in audit trails or through appropriate procedures.

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What do NASA Missions and Pharmaceutical Manufacturing have in common?

By Dan Miller, October 5, 2017

NASA recently ended a 20 year 5-Billion-mile space journey as its Cassini space probe burned up in Saturn’s atmosphere (NASA.gov Cassini Mission Site). This $3.26 billion joint venture with ESA (the European Space Agency) opened our eyes to the ringed planet. Completing the mission was no small feat, and the 260 scientists as well as the thousands of engineers and project managers responsible will go largely unnamed. Recognition from fellow colleagues and a nod from the general population is likely all this successful group will receive. It’s hard to show gratitude for something difficult to understand. For the majority of the group, their work began several years before launch in the design and planning phases. They had to determine exactly what they needed to accomplish and then set out to achieve established objectives. They would look to off-the-shelf solutions as well as rely on their skills, experience, and education to bridge any gaps in technology. Technology that had to perform flawlessly for 20+ years. No stopping by the parts room to make a repair or having the OEM supply a needed hardware upgrade.

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Are You Ready? Major Changes Coming to Europe MDR and IVDR

By John Henchion, September 28, 2017

Introduction: One of the major focuses this year at the RAPs Convergence in DC was implementation timelines for the EU Medical Device Directive and the In Vitro Device Regulations.

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Spare Parts: The Hidden Cost of Maintaining Equipment

By Erik Zengel, September 26, 2017

 

If you own or manage any equipment, you maintain an inventory of spare parts. How have you determined what to keep in your warehouse?

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From Dragon to Chameleon

By John Hannon, September 21, 2017

Implementing a Serialization Database Across an Entire Enterprise.

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Maximizing the Impact of Factory Acceptance Testing

By Keith Weseli, September 19, 2017

 

Your equipment is ordered.  The schedule is set.  The team travel plans are made. But are you ready to maximize your experience at the original equipment manufacturer’s factory floor?  This post will review some key points to consider in maximizing the Factory Acceptance Testing (FAT) as part of the overall verification process.

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Where to Draw the Line?

By John Henchion, September 11, 2017

What is an appropriate level of GMPs for a supplier manufacturing site?

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