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The Post-Audit Process: Working Towards Continual Improvement

A supplier audit is one of the most effective ways to ensure your suppliers adhere to quality standards while meeting required promise dates. In addition to uncovering nonconformities and opportunities for improvement, audits remind suppliers that they must continually strive to fully conform to applicable customer requirements, standards, and regulations

 A supplier’s response to audit findings is a critical step in the continual improvement process.   

How can you ensure a supplier's continued quality improvement after an audit? 

The months and weeks leading up to a supplier audit are often marked by the supplier's heightened focus on conformity and quality. The supplier may take extra measures to prepare for their upcoming audit in an effort to achieve a passing score. When an audit is completed and the supplier achieves a passing score, it's natural for all parties involved to breathe a sigh of relief. 

Upon completion of an audit, suppliers must investigate findings and take appropriate corrective actions as part of their process of continual improvement. 

In many cases, this requires a follow-up audit to ensure changes have been successfully implemented and that those changes are effective. This can be done by either yourself or the auditor. 

The foundation for this follow-up process begins with the closing meeting. 

Step One: Clearly summarize nonconformities during the closing meeting 

The purpose of supplier audits is to evaluate conformance and to identify riskThis means that nonconformities requiring corrective actions will frequently be identified by qualified auditors These nonconformities should be clearly and thoroughly presented by the auditor to all pertinent team members immediately upon completion of the audit. 

Audits are conducted as a series of sampling of procedures, records, employee interviews, and visual assessment.  An audit resulting in zero findings does not equate to zero risk with the supplier – it means that zero findings were identified in the chosen samples.  This is why a program of recurring audits needs to be established over time.   

Step Two: Encourage questions and feedback  

The most beneficial audits are those that are collaborative efforts between sponsor and supplier. It's important to secure the buy-in of the supplier and key employees to ensure that improvements are a top priority across the board. A skilled auditor will present findings and then take the process a step further by encouraging feedback. 

The auditor and auditee should be squarely on the same page upon completion of the closing meeting. Specifically, the auditor and supplier should agree that corrective actions will help resolve nonconformities. 

Step Three: Emphasize the need for immediate corrections 

Acting swiftly is vital to maximizing the impact of a supplier audit. Critical nonconformities must be addressed as quickly as possible. Once they are clearly identified during the closing meeting, it's important to convey a sense of urgency. In many cases, nonconformities are related to product quality and may pose a threat to the people who use end products 

Depending on the nature of the nonconformity, actions taken by suppliers may need to take the following measures: 

  • Containment, or identifying the defective component and isolating it. 
  • A risk assessment to identify affected product or users that could be negatively affected by the nonconformities. 
  • Repaircorrection, or recall of the component.  
  • Procedure, process, or design changes to eliminate recurrence. 

Step Four: Conduct a root cause investigation 

Dedicated auditors know that the continual improvement means more than having nonconformities successfully contained and corrected. They realize that a problem is likely to surface again unless its root cause is identified. There are many methodologies for conducting root cause investigations.  

One effective technique is to use the "5 Whys" technique to determine what is truly causing the problem. The technique works by repeating the question "Why?" an average of 5 times to uncover the issue's root cause. Here is an example that illustrates how sourcing components from an offshore company can ultimately lead to problems with a patient monitor: 

Problem Statement: The patient monitor is delivering inconsistent blood pressure (BP) readings. 

  • Why 1: Why is the monitor giving inaccurate BP readings? Answer: Because the BP cuff is not working properly. 
  • Why 2: Why is the BP cuff not working properly? Answer: Because the cuff has poor quality connectors that fall apart quickly. 
  • Why 3: Why does the BP cuff have poor fittings? Answer: Because the fittings were made with cheap materials. 
  • Why 4: Why were cheap materials used? Answer: Because the supplier recently switched to an offshore manufacturer. 
  • Why 5: Why was an offshore manufacturer used? Answer: To try to lower costs. 

Step Five: Develop a Corrective Action Plan (CAP) 

With the root cause of a nonconformity brought to light, it's time to map out a Corrective Action Plan (CAP). During the follow-up audit, the supplier must provide documentation and records as evidence that they have successfully implemented and demonstrated effectiveness the CAP. 

Using the patient monitor example above, a CAP may provide proof that the supplier has resumed sourcing BP fittings from their previous manufacturer. Supporting documentation could include purchase orders showing that the origin of the components and quality control reports proving consistent non-invasive blood pressure (NIBP) readouts. 

Step Six: Focus on Verification of Effectiveness (VoE) 

The best corrective action plan in the world is useless if you don't verify that the supplier’s plan is working. In particular, you need to confirm that the CAP is effectively eliminating the root causes of nonconformities so the issue does not recur in the future. This process of confirming the effectiveness of the CAP is known as Verification of Effectiveness (VoE). 

This final step often proves to be the most challenging task. Roadblocks are common, and some true nonconformities might be brushed aside as minor glitches. In other cases, auditors struggle to find the true root cause of an issue so effectiveness cannot be verified.  

Ultimately, the supplier needs to demonstrate no recurrence of the nonconformity with objective evidence and statistical reports over time. This process typically requires time, sometimes several months to ensure that nonconformities are addressed. 

For instance, if a nonconformity is part of a process that cycles once every month, then VoE requires several months to ensure that the nonconformity has been properly addressed. 

What is the most effective way to address continual improvement needs? 

Strong supplier relationships and partnerships are the cornerstone of a successful company. The single best way to remain focused on continual improvement in these areas is to seek the guidance of an experienced quality auditor. With the expertise of a skilled compliance specialist, you can achieve continual improvement without disrupting your suppliers' activities. 

To learn how you can address your continual improvement issues, contact us to schedule a no-obligation consultation. 

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