ABSTRACT

Procedures and implementing documents within a company are most often utilized to communicate requirements and instructions within the company that are necessary to meet corporate policy, implement safety and comply with regulatory requirements. A typical hierarchy of governing documents begins with corporate-level requirements that are flowed down to the various organization levels within the company where they are incorporated into procedures and implementing documents. Successful strategies for governing procedures and implementing documents must include defined processes for developing and reviewing procedures, stakeholder participation, procedure change control, configuration management and ensuring that the current versions of procedures and other implementing documents are readily accessible within the company. The absence of an adequate process for governing procedures can result in multiple and incorrect versions of procedures being used simultaneously and organization-level procedures becoming disassociated with corporate-level requirements. A well-defined procedure management process contributes to a company’s ability to proactively manage compliance risk.