Case Study Confirms Risk Management Basis for Cost and Performance Improvements

BOSTON & SAN FRANCISCO, April 10, 2009 – Crimson Life Sciences, a division of TransPerfect, today announced the publication of Getting More for Less: The Alchemy of Risk Management, a detailed case study that documents the successful performance of the industry’s first ISO 14971-certified risk management system.

Documented Evidence: Risk Management is Good Management
In July of 2006, Crimson completed an extensive Gap Analysis with Dr. Harvey Rudolph, Global Program Manager at Underwriters Laboratories, a 25-year FDA veteran (CDRH), and an original author of ISO 14971. In 2008, Crimson became the first company to successfully register to ISO 14971 – the de facto risk management standard for the medical device industry.  Now, over a year later, the company has published some surprising results.

Crimson’s President, Marc H. Miller, explains, “Since Crimson was founded nearly 18 years ago, we’ve operated from a philosophy of ‘an ounce of prevention is worth a pound of cure.’ So, a formal risk management system made good business sense to us. Working through a gap analysis with Dr. Harvey Rudolph and UL, we were able to identify the ‘missing links’ that make a formal system so beneficial.”

“Beneficial” may be an understatement. In 2008, the first year following the system’s full implementation, Crimson logged a substantial 36% improvement in its already-impressive accuracy rates. Observes Kai Simonsen, VP of Production and Quality Systems at Crimson, “Our accuracy rates were already 50% better than the industry average, so a 36% improvement is really quite striking.” Crimson’s translation accuracy rate now ranks an impressive 75% better than the industry average. Added Martin Finke, Director of QA for Crimson, “Because our accuracy rates are determined using the only Notified Body-endorsed audit method, we have a very high degree of confidence in these results.” In fact, Crimson carries the only Notified Body endorsement for audit of legacy translations. Over the past two years, Crimson has conducted dozens of audits for manufacturers, encompassing 20+ languages and over 1 million translated words.

Crimson’s ability to apply risk management principles to process design and project strategy has been equally beneficial. Explains Simonsen, “When appropriately implemented, a formal risk management system enforces a certain mind-set and approach in the organization. In our case, we’ve realized process innovations that enable us to improve quality while reducing service cost.” Improved quality at a lower cost is the elusive “alchemy” documented in the Crimson case study.

Click here to request your copy of Getting More for Less: The Alchemy of Risk Management.

About Crimson Life Sciences
Crimson is a division of TransPerfect Translations and is the world’s largest translation practice devoted exclusively to Class II and Class III medical devices and List A and List B IVDs. Crimson is the world’s first translation firm registered to ISO 13485, ISO 14971, and ISO 9001. TransPerfect, registered to ISO 9001 and EN 15038, is the world’s largest privately held language services provider with 56 offices worldwide.