Revamp FDA SOP

In most companies, individual SOP development is handled in isolation, usually by functional unit, creating a departmental “silo effect,” as well as overlap and inconsistencies between SOPs. Furthermore, traditional approaches to developing SOPs, at best, can only capture explicit knowledge related to the activities in question – that is, information that is already documented and formalized elsewhere. The problem with these approaches is evident when you consider that not all organizational knowledge is explicit: tacit knowledge refers to the informal and undocumented information that plays a role in your company’s day-to-day operations. It includes the skills, experience, and expertise that are often difficult to locate and formalize. When tacit knowledge is left out of SOP development and documentation, key information and decision-points can be overlooked. The resulting representation of company activities is both inaccurate and incomplete, and can have serious compliance/manufacturing implications for employees who rely on precise information in order to perform effectively.

To overcome these challenges, IQCDS professionals go beyond traditional attitudes to SOP development by taking a holistic, hands-on approach to discovering and documenting your Standard Operating Procedures. Consistent with our methodical, proven approach to process discovery, our SOP Development methodology is process-centric and cross-functional; it is designed to reduce inconsistency and overlap both within and between company procedures. By involving process Subject Matter Experts (SMEs) and employees across the organization, our team is able to capture and formalize tacit knowledge so that it is documented and transferable as your organization evolves. To discuss possible SOP Improvements please contact us at (949) 235-6037 or email us at info@iqcds.com.