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As anyone who has ever experienced the quality registration process can verify, implementing a quality standard and undergoing the third party audit process to maintain it can be an overwhelming task. Clearly, as registrar auditors move from the checklist-driven audit approach of TS-16949:1999 to the process-driven approach of QS-9000 and TS-16949:1999 to the process-driven approach of the TS-16949:2002, some concern exists over what to expect from the automotive process approach to auditing. As suppliers begin to experience the automotive process approach during their third party assessments, documents such as Annex 5 of the TS-16949 Rules 2nd Edition can provide valuable insight for those suppliers.
While Annex 5 of the Rules 2nd Edition applies directly to the registrar auditor, suppliers can use Annex 5 to gain insight to the automotive process approach to auditing and what to expect from it. Annex 5 identifies five basic steps to process auditing: 1) identification of the organization's processes; 2) analysis of these processes; 3) prioritization of the audit activities; 4) finalization of the audit plan; and 5) conducting the audit itself. The registrar auditor must use these steps to prepare and conduct the process audit.
Suppliers must remember that the automotive process approach to auditing is a horizontal approach. It keeps the customer's needs in line of sight as it looks at the inputs and outputs of the process. The process approach begins and ends with the customer. The process approach understands that a process is a set of related and/or interacting activities that transform an input into an output. The process approach audit looks at the linkages within the organization to see if they are working or not. If they are not working, the process approach audit identifies opportunities for improvement within the supplier's system.
The fact that the process approach always keeps the customer needs in sight and has a focus on process interaction is very different from the checklist-driven approach of the past. Suppliers who are used to checklists and the comfort of their predictability may have a difficult time in adapting to the process approach audit. The process approach audit may lead the registrar auditor down many different audit trails as the auditor looks at the input, outputs and linkages of the supplier's processes.
Suppliers should prepare for the automotive process audit by identifying its own internal processes. The processes identified should focus on those processes that add value to the product, that support customer requirements, and any other processes deemed to support the first two. The supplier can utilize information such as that provided to their registrar for their readiness review to help identify the processes that will be audited. Process maps, control plans and diagrams of their systems also help to identify processes for the internal audit. Finally, the supplier should make sure that the processes that are identified address all of the requirements of TS-16949:2002.
When the registrar auditor analyzes processes for the internal audit, the auditor does so with consideration for the products and/or services that the supplier provides to the customer. The auditor also assesses risks to the customer. The auditor uses documentation that the supplier provides such customer complaints, rejections, customer scorecards, and quality reports to help in determining customer risk. The supplier should use this same type of data to prepare for their third party assessment.
Interfaces for inputs and outputs to the processes are also be reviewed. Auditors look closely at these interfaces, as it is not unusual for a breakdown in the process to occur at the process linkages. In addition, the auditor will identify related processes or group processes that can be audited concurrently in order to help to provide a more timely and effective internal audit. The supplier can gain great insight to its own process interrelationships through detailed process maps of its processes.
Prioritizing the process audit activities is extremely important, as it will directly affect the effectiveness of the audit in identifying conformance to the standard and opportunities for improvement. Customer requirements, including customer-specific quality management system requirements, are usually reviewed first when the auditor prioritizes the process audit. Suppliers may find the IAOB website, www.iaob.org, useful as a quick link to many customer-specific quality management system requirements.
Follow-up issues from previous third party audits conducted by the registrar, customer second party audits and visits, and the supplier's own internal audits provide the auditor useful information when prioritizing the process audit. If the supplier has had issues in these areas, the supplier should expect those issues to be part of the process audit. The auditor also plans for time to verify corrective action for all significant customer issues, such as special statuses and rejections, as part of the process audit schedule. Finally, the auditor plans time to verify implementation of corrective action for any major or minor findings from the previous audit.
Another area the auditor uses when prioritizing the process audit is customer satisfaction and/or complaint status, including customer reports and scorecards. If there are issues, the supplier should be aware that the registrar auditor will focus on these areas as part of the process audit. If there are no issues, then the supplier should expect the process audit plan to reflect more time to be spent in general review of the processes. The supplier should also expect the auditor to verify corrective actions for any significant customer rejections. As the automotive process approach to auditing focuses on the needs of the customer, the supplier should fully understand that if the customer is having issues with the supplier, then the auditor will focus on those issues.
Finally, the auditor uses key indicators and trends of the supplier's metrics when prioritizing the process audit. These metrics and indicators are what the supplier uses to manage its business. The metrics, key indicators and trends must cover a minimum of 12 months of data. Trends over longer time periods may also be useful in prioritizing the process audit depending upon the product or services provided to the customer. The prioritization should provide a value-add to the supplier when the process audit is conducted. Issues of customer satisfaction always represent areas of potential improvement, so the auditor will focus on this area when prioritizing the process audit. Again, the supplier should be aware that the process audit focuses on customer needs and areas of concern.
Once the registrar auditor has prioritized the audit plan, the auditor completes the final audit plan. The final audit plan includes the sequence and process steps to be audited. When finalizing the internal audit plan, the auditor does focus on all things equally. The auditor follows the prioritization plan that was completed. It is not unusual for the auditor to adjust the finalized initial audit plan after reviewing the supplier's key metrics once the auditor arrives on site.
As part of the finalization of the process audit plan, the auditor makes sure that all levels of the organization are interviewed. The interview partners will range from top site management to the hourly workers. Interview partners include individuals who input to the process, conduct the process itself, and those who receive output from the process.
When conducting the audit, the auditor will spend the bulk of the time out on the manufacturing floor. The process audit examines the processes where they occur. As the process audit focuses more on the process and less on documentation, the amount of time spent in a conference room environment is diminished. The auditor also interviews the auditee in their normal working environment. If the auditee does not normally work with senior management or a crowd observing them, the auditor may request that a crowd not be present during the process audit.
During the process audit, objective evidence of both compliance and noncompliance to the TS-16949:2002 requirements is recorded. The evidence of noncompliance, of course, helps the supplier with identifying the root cause of the nonconformance and with implementing corrective action. The evidence of compliance helps the supplier by documenting best practices or even possible areas for continuous improvement.
The bottom line is that customers at the OEM manufacturing and assembly centers want warranty reduction, elimination of supplier disruptions, significant improvement in delivered part quality, and continual improvement of the supply base quality systems. Process audits implemented using the automotive process approach are viewed as a way to help move the supply base towards those goals. Becoming familiar with the same rules that a registrar uses, such as Annex 5 of the Rules 2nd Edition, will help the supplier understand what to expect during a process audit and to help them make the transition from a checklist-driven approach to the process-driven approach.