The Supply Chain
Quality Physician Heal Thyself: Taking a Quality Approach to Supplier Audit Programs
Gerard Pearce
Doctors can make the worst patients, and quality professionals can focus so closely on suppliers’ quality that they miss opportunities for improvement in their own programs. By applying basic quality principles in the evaluation of suppliers, improved efficiency and effectiveness will have an impact well beyond the supplier quality function.
The following quality fundamentals should be incorporated in your supplier audit program to maximize the effectiveness of your audit team:
• Add checkpoints along the way. Because the audit process is time sensitive, backtracking after an audit has been performed is time-consuming and not always effective—ask any busy auditor about a supplier audit two weeks ago. Even changes made prior to an audit can have a major impact on the availability and efficiency of your audit team. Therefore, the addition of checkpoints in the audit process will allow you to zero in on all of the prerequisites of a successful audit. Basic questions such as, “Has another division of our company already performed an audit we can use?” and “Are there any areas [such as special processes] that require added attention?” will help with auditor coordination, and produce audits with more “teeth.”
• Put the audit process in context. It is important to look at the audit process flow in the context of overall supplier control—i.e., the big picture. Many companies have developed an overall risk management strategy that impacts and will be impacted by the supplier audit process. For example, a risk management strategy will help determine higher-priority supplier audits. Likewise, results of the audit process will have an impact outside the audit process, such as the action required from a major supplier finding that could result in a change in risk status, a stop in production or a product recall.
• Perform a FMEA on the process. With a well-defined supplier audit process, a failure mode and effects analysis (FMEA) is an excellent way to prepare for exceptions that invariably occur. This disciplined approach to identifying and preventing possible failures can save an enormous amount of time spent in escalation, back-tracking and rework. It can address situations such as what happens if a supplier refuses an audit, what happens if inadequate evidence is obtained during the audit, and what happens if a supplier is unresponsive. In performing a FMEA, you will map the entire process, showing every step, listing every critical feature. You will determine possible failure modes for each critical feature, as well as their effects (like having to revisit a supplier). Then you will rate the severity, occurrence and detection of the failure and take appropriate preventative action.
• Add measurements and targets. Another quality fundamental is the use of data to improve decisions and identify sources of variation. There are many aspects of an audit program that may be monitored for control and improvement. These include team optimization (e.g., no dead time, grouping audits for reduced travel), on-target audit dates, audit report turnaround and corrective action closure. Note that the tracking of such parameters should allow for exceptions, such as an unusually large or complex supplier requiring more onsite audit time.
• Don’t inspect quality in. If supplier audits are viewed in isolation, there can be a tendency to focus on the finished product, as opposed to the process that created it. If an audit report is incomplete or poorly written, there is a natural tendency to opt for greater screening, or inspection. By looking further upstream in the process, you are more likely to determine the source of variation, for example, inadequate auditor preparation, or lack of supplier guidance. This may lead to the addition of a checkpoint (see above) that will save back-tracking, rework, and reoccurrence.
• Think CAPA. For an audit team, the urgency of the next audit creates pressure to quickly fix any problems that arise and move on. This approach covers the need for containment, but does not address the broader aspects of corrective action/preventative action (CAPA). With a well-defined process and suitable measurements in place, it becomes easier to identify and address the real problem source (not just the symptom). It also provides opportunities to spot potential problems and take action to prevent them from happening. The process owner must “think CAPA” when addressing problems and evaluating the process for effectiveness.
By applying all of these fundamentals, your supplier audit process will be well placed to meet the increasing demands of the supplier quality function. Like other parts of your quality organization, the process should be subject to regular review and performance against goals. A more effective process will deliver better performance of your audit team, better visibility of supply chain risks to your entire operation and improved value from the supplier quality function.