To start, it is important to define the differences in our definition of an Effectiveness Audit Program Review versus an In-Depth Audit Program Review.
An Effectiveness Review is performed to determine if the auditing program is generally meeting the quality standard and satisfying the requirements of your customer or third party auditor. Whereas an In-Depth Audit Review takes your audit program to the next level and determines if your audits are effectively driving improvements in health and safety, quality, and profitability.
To begin the in-depth review, form a small cross functional team. The team should be comprised of different disciplines for each of the different audit types you are reviewing. For Example, Process and Error Proofing may include Quality, Manufacturing, Engineering, and Maintenance, but Safety may include EH&S, Human Resources, Manufacturing, and Maintenance.
Each team should use data and their process knowledge to determine high risk areas and form questions to monitor the process controls in the identified areas. Likewise, questions that are not adding value to high risk areas should be removed from the audit checklists. We recommend reviewing the following data:
For Process and Error Proofing Audit Review
For Health and Safety Audit Review
Compare this data to your current audit checklist to determine if you are asking the necessary questions to drive improvements. Each checklist question should correlate back to a control for the issues identified during your data analysis. If the team cannot identify a control for an issue, further process evaluation and corrective action may be required.
To aid development of valuable questions, we recommend structuring your questions in a What, How, Why, and Reaction Plan format:
WHAT process control requires monitoring:
Look for safety, quality or efficiency critical operations – Is there a potential quality escape point (i.e. visual inspection), or a step in the process that can significantly impact efficiency (i.e. in-process rework). Are the employees performing tasks that have potential safety impacts (i.e. grinding, sanding, chemical use, etc.)
HOW do I audit the control:
If you cannot explain how to audit, you may not have adequate controls in place to prevent the process from becoming a risk. Further process evaluation is needed.
WHY am I auditing this control:
If you cannot explain why you are auditing this item, you may need to develop a better question (specific and measurable) or remove this question from the audit checklist if it does not add value.
What is the REACTION if the control method is non-compliant/non-conforming:
What is the recommended immediate action for reacting to a non-compliance. This action should stop the non-compliant condition or, at a minimum, bring awareness of the non-compliance to individuals with the authority to contain and correct the condition.
Once you have revised your audit checklist, the team should hold a short review with the Management Team to discuss changes to the questions and what the desired outcome of the changes will be. This will help Management lead the improvements within your facility and assist in future improvements to your process audit program.
For additional information on continuous improvement of your process auditing program, visit our informational website and download our Guide to Implementing Layered Process Auditing or the Top 5 LPA Mistakes
For additional information on audit question development, Contact Us. One of our quality professionals will reach out to answer questions and discuss your system needs.