How Effective is Your Internal Audit Program?

A strong internal audit program can provide executive management with an overall view of the health of the quality system. In my opinion, it is one of the most critical subsystems in the quality system. When effective audits are performed AND meaningful metrics are generated, quality system strengths and gaps become more evident to executive management.  
So how do you determine if your internal audit program is effective? It’s more than just generating non- conformances and addressing them individually. If the same non-conformance is identified in multiple audits or functions, there is a strong probability of a more systemic failure or breakdown. An effective audit program will provide systemic analysis of issues and demonstrate true corrective action for the non-conformance to eliminate future recurrence. Here are some common sense points to consider to make your internal audit program more effective:

·     The audit plan should cover all business functions, as well as interactions and interfaces within the scope of the business unit. The process interaction description required by ISO as part of the quality system is a good place to start when defining the plan.

·     Use a systemic approach for auditing, rather than individual functional or process silos. When planning the audit, you should consider the interactions and transfer of information between functions and processes. This is a common failure or omission from many audit programs.

·     The audit should cover all levels of documentation in place for the area being audited. The lower- level work instructions and forms generate records to demonstrate compliance to the higher-level processes and quality manual. When non-conformances are identified in these lower-level documents,  auditors should evaluate process interactions to determine if there is a systemic failure.

·     Audit checklists are very helpful, but should not be the only source for defining what should be evaluated during an audit. Checklists are intended to trigger the auditor’s thought process. It is important to pull the threads identified through the checklist all the way through the various levels of documentation and process.  

·     Analyze non-conformances for systemic issues, not just individual failures. This analysis should be included as an input to various audit plans to confirm adequate corrective and/or preventive actions were implemented. For example, if you audit several functional areas and identify training record or document control issues, you may need a CAPA for that business process, in addition to the individual audit non- conformances.  

·     Present data to executive management at the higher process interaction level, as well as the lower functional area. This demonstrates the impact of the quality system on the bigger business picture and can help gain greater support for quality and continuous improvement activities.

About the Author

B. Christine Park is a quality systems consultant with expertise in the implementation and remediation of sustainable and regulatory compliant quality systems. She has led the successful implementation of quality systems in large corporations, as well as small start up companies. Her industry experience and background supports compliant yet practical, pragmatic quality systems. She can be contacted at 678-480-5411 and cpark928@mindspring.com

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