With so many in manufacturing operations concerned about efficiency, why weren’t more people at the WBF 2007 conference in May? Some attendees wondered that out loud during the Baltimore meeting. Many expressed a positive outlook, at least about their own operations, and took home knowledge to help increase profits. Use these summary observations to improve what you do.

Standards offer savings in manufacturing operations, make training easier, and enhance regulatory compliance, says Dr. Paul McKenzie, vice president and general manager of LSCC, technical operations, in the worldwide medicines group of Bristol-Myers Squibb. At the company’s large-scale multi-product bulk biologics manufacturing facility under construction, McKenzie will use ISA-88, ISA-95, and ASTM E55 standards, cutting work out of processes and tying together manufacturing and laboratory operations and analysis. He says pharmaceutical firms should move from:

• A documentation focus to a data focus;
• Having standard operating procedures (SOPs) to understanding critical process parameters; and
• Following SOPs to measure process capabilities.

Developing and using software libraries for projects saves on validation, simplifies I/O checkout, standardizes look and feel across systems, and reduces training for operators and maintenance staff, says Jack E. Greene, associate director of laboratory and process automation systems, Alkermes Inc. “We spent a lot of money upfront to get this right, but using libraries of software functions has saved a moderate fortune over the years,” perhaps $2 million, equal to an entire plant expansion, to date, Greene says.

Because engineers like facts, many have a tough time embracing S88.01, which is about procedures and coordination, says Lynn W. Craig, former chairman of the ISA-88 committee and president of MAA Inc. (Manufacturing Automation Associates). Craig, on the committee working to integrate S88 and ISA-95, says using such standards helps define concepts and structures, and provides abstract models and terminology. It helps define procedural control functionality and links that with manufacturing operations management (what to do and when to do it), by focusing on the level between operations management and basic control, he says.

Meeting organizers also advise using standards (included with ISA membership), getting free knowledge by attending these meetings (see www.wbf.org), and helping a standards committee create new intelligence (see www.isa.org/standards).

mhoske@reedbusiness.com