Compliance programs, from SEC to FDA, require senior management review of policies and procedures to gauge and verify effectiveness. The key is avoiding the minutiae. Use these tips:
1. Flowcharts. Focus on process flowcharts rather than turning to details. Look at a flowchart for each process; ensure that checkpoints in the process are clear and match any automated approvals. If you are not including a process flowchart in each of your SOPs, why? People find it easier to follow along visually rather than plodding through page after page of detailed steps.
2. Organizational charts. Match accountabilities in each policy or procedure with your organizational chart; ensure that roles and responsibilities are clear to the individuals who currently hold those positions.
3. Staff responsibilities. Line workers generally have no real decision-making authority or ability to inform themselves of the risks and requirements involved in processes and controls. Make sure your SOPs do not hold line workers accountable for an overall SOP – individual steps within the processes are fine.
5. Find gaps. Trace a flowchart to find gaps in overall business processes; identify each policy and/or procedure in play (for instance, from the need for a chemical through the chemical being ordered, then received, quality checked, inventoried, and so on). Are there any process components not covered? What about decision points? Are there opportunities such as automated inventory management system that could speed things up and improve control?
For more practical management best practices when it comes to quality systems compliance, review my seminars and toolkits: Effective Compliance and Quality Systems Oversight for Executives and Best Practices for your Quality System Management Review.
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