Not Your Normal SOP

Abstract:The establishment and following of standard operating procedures helps organizations comply with quality, safety and regulatory requirements. Traditionally, SOPs are long paper documents that detail standard approaches to business activities, but shorter presentations that use multiple forms of media will produce better understanding which will lead to better compliance. Pharmaceutical company Roche Carolina Inc. initiated a project to reduce mistakes and improve regulatory compliance by overhauling its SOPs. The company created videos to instruct workers in physical, manual and some computer tasks. The project team developed error checking procedures and eliminated procedures that added no value. A document management system was developed using Microsoft SharePoint, controlling the review and revision of procedures electronically and creating a centralized repository for employee comments as well as the procedures …

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Good reference to take our SOPs to the next level.
--Ricardo, 11-14-2011


Great!
--D.King, 06-08-2011


While this is absolutely fabulous from a human factors engineering perspectives, I don't understand how you justify it from a business perspective given the non-trivial and continuous validation requirement under 21 CFR 11; SOPs, work instructions and their documentation artifacts are (at least on the medical device side) part of your quality records. Have you done a cost-benefit analysis that shows this makes sense?
--GM Samaras, 06-08-2011


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