A training director writes in: Is GMP documentation enabling or hindering performance and compliance within your organization? When was the last time you examined the readability and usability of your SOPs from the point of view of employees? I was reminded recently of a conversation with a corporate quality auditor for one of the biggest pharmaceutical and biomanufacturing companies in the world. This auditor was an extremely well-educated and capable professional assigned to support a task force and project team charged with improving the GMP document control system. The organization had realized that its system for controlling GMP documentation was outdated and incapable of supporting rapid business growth and tighter compliance standards. Unfortunately, project team members did not examine the quality of GMP documentation flowing in and out of the system, nor did they investigate the linkages and integration with other key quality assurance systems, including GMP training, change control, or investigations. These obvious oversights were very much a reflection of the worldview and bias of the corporate quality auditor who dominated initial process improvement activities of the task force and project team. For example, investigation of GMP documentation by other departments within this organization concerned with both direction of the task force and lack of direct operator involvement in the process revealed: ¢ The majority of SOPs were written by Ph.D. developmental scientists at a 12th grade reading level. ¢ Authors were paid bonuses for writing SOP documents tied to the number of pages produced; in addition, there was no cross-checking or correlation of SOP documentation with GMP batch records or training documents and records. ¢ The average reading level of biomanufacturing operators was determined to be between the 8th and 9th grade reading level. ¢ SOPs for the growing product line exceeded 250 with the majority of documents running 50-60 pages in length. ¢ The site managing director issued an opinion that there was no connection of SOP document quality to GMP compliance. When confronted with this information, the corporate quality auditors response was: Operators need to learn to read at the 12th grade. Needless to say, it did not take long for this arrogant sound-bite to travel throughout the facility. Complaints surfaced immediately in the manufacturing, quality, and human resource departments. One manager likened the response to Marie Antoinettes statement before her beheading in the French Revolution (let them eat cake). It was not long before the organization determined a change in leadership was required for this task force and project team. A more experienced quality assurance manager with a background in GMP documentation and quality control system improvement was hired. In addition, the charter and scope of the project was enlarged to ensure documentation quality and systems integration with other key GMP systems. Finally, representatives from other departments with a critical stake in the project teams outcomes were added to task force membership. What lessons can you take from this experience? What would your frontline employees say about your SOP documentation and document control processes?
