IBA Harmonizes Quality Systems, Introduces On-Line Audits

No one can accuse IBA (Chicago; www.iba-worldwide.com) of thinking small. The company's relentless growth strategy—it recently doubled EtO sterilization capacity for medical devices at its Belgium facility—and purchase of SteriGenics and Griffith Micro Science in 1999 has catapulted the firm into the ranks of the world's leading suppliers of most sterilization methodologies and services. Operating 47 sites in 12 countries, IBA claims to have a 34% market share in medical device sterilization. Lisa Foster, vice president of corporate quality assurance for IBA North America, has set herself the task of folding the company's far-flung operations into a cohesive one-stop shop for sterilization services. She views IBA's efforts to harmonize quality systems at its worldwide facilities and to enable on-line audits as significant steps in that direction.

Harmonization of quality systems was a priority item for Foster when she was plucked from SteriGenics and appointed vice president in 1999. "We had standardized QS at SteriGenics sites throughout the world since 1992," says Foster, noting that it was a valuable tool for a contract sterilizer processing the same products at facilities in different states and countries. The SteriGenics document served as a template, but it required extensive rewriting to incorporate ISO 9000:2000.

"The new ISO standard is very different from the previous one, even when it comes to numbering the elements, and we had to organize our policy manual in the same format," says Foster. "And ISO 9000: 2000 is very focused on monitoring customer satisfaction. Which is not to say that we weren't already doing that, but now we had to establish procedures [that complied with the standard]."

The document, which was implemented in January at facilities in North America and Thailand, contains a policy manual that itemizes QS procedures common to all sterilization methodologies, and process procedures that detail validation and regulation requirements relevant to a specific technology and business unit. The framework draft is based on medical sterilization processes "because they are the most stringent," says Foster. "Then, we either removed or added [clauses] as necessary." The harmonization effort has been enthusiastically received by IBA's larger North American clients, whose products are processed at multiple facilities, but it also benefits the smaller customers, according to Foster.

"It has certainly been a selling point for the big customers, who appreciate that they can walk into any North American IBA facility and use the same form. But even if you're just using facilities in Corona and Hayward [CA], for example, you can write one sterilization specification and be done with it," says Foster. The initiative has also benefited internal operations. "I know from where I sit that they're doing the same thing in Charlotte[NC] and in Corona," she says. "I don't have to worry that they're writing their own procedures."

Foster and Hans Aeschlimann, her counterpart for IBA Europe and Asia, currently are wrestling with language issues before rolling out the harmonized QS at European facilities. Industry is extremely eager to see the system implemented overseas, according to Foster. "On the EtO side, in particular, Griffith purchased companies one at a time, and because of language barriers and so forth, these firms maintained their individual quality systems," she explains. IBA's European program will introduce a common policy manual and QS level procedures for the facilities, with some variations in the work instructions in the policy procedures section. Foster expects the harmonization of European facilities to be completed in 2002.

Taking Audits On-Line

IBA's North American operations are also readying a system that will allow device manufacturers to perform on-line audits.

"Device manufacturers are required to audit contract sterilizers," says Foster, "but many are not doing so. In our Corona facility, for example, we have close to 400 customers, yet we average about 58 customer audits a year." Travel expenses are one of the primary reasons that companies forego audits, she adds, "so we decided to make them available, down to process procedures, on the Internet." IBA in North America is considering adding other features to the controlled-access Web site, notably making batch records accessible on-line.

This service will benefit both smaller companies, which can't always absorb the cost or inconvenience of having key employees away from the office, and larger firms that have numerous vendors to audit. The latter "can do a desk audit in their office instead of coming here and reading procedures for a day," says Foster.

At the time of writing, the on-line audits were undergoing beta testing. Foster expects the service to go live by the end of June 2001.

Norbert Sparrow