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CONDUCTING GOOD INTERNAL AUDITS
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Besides establishing measurements and goals for dramatic improvement, the key quality management process that must exist in the ISO 9001:2000 paradigm is auditing first for effectiveness and then for compliance (instead of auditing just for compliance). To assess implementation of ISO 9001:2000 in an organization, the lead auditors, as well as the internal auditors, must look into both effectiveness and compliance. The compliance aspect of the audits gained priority early on because the excessive emphasis on documentation made it easy to check. Having a priority on compliance keeps the audit specific, objective, and unchallenged. However, the ISO 9001:2000 standards focus on effectiveness, reduced emphasis on documentation, and increased leverage for the auditee gives auditors a new challenge. To conduct audits that will truly be useful to the organization, the auditor must be experienced in performing audits well, proven in working in his or her chosen industry, and motivated to make a positive difference. Good auditors are driven to make a difference in their auditing jobs. They learn quickly to analyze many different processes for their inputs, methods, outputs, and intent of use. Auditors must also be able to ask questions about how the user is trying to improve the process in terms of cost, cycle time, and quality. After systematically assessing the compliance of a process in terms of inputs, process steps, and outputs, the auditor must ask questions that relate to the soundness of the process (i.e., how well the process works). Does the process produce the desired results If it does not, the auditor must be able to probe further to guide the operator or the user in seeing what has gone wrong. If the auditor can help a user to understand the process better, identify disconnects in the process, and recognize opportunities for changing the process for the better, then the auditor has performed a good job. The interesting point is that in such audits, the auditee is the one who discovers noncompliances (with the auditor s help, of course).
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BENEFITS OF INTEGRATING ISO 9001 AND SIX SIGMA
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Forces leadership to make the ISO 9001 quality management system a tool for improving the profitability Reorients the leadership in understanding the ISO 9001 system as a bureaucratic paper monster to a value-added tool for running the business Promotes dramatic process improvement results Builds on previously learned tools Links performance to profitability, thus creating opportunities for sharing benefits with employees Forces leadership and employees to think outside the box and to set aggressive goals Requires innovation for achieving planned results Creates excitement about the corporate quality initiative instead of a test to pass for achieving certification Boosts customer perception of the company, as Six Sigma integrated with ISO 9001 is designed to produce superior results and better customer service
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The time has come to look at ISO 9001 or an equivalent quality management system from the right perspective as a system promoting quality thinking in order to manage the business for improving performance. The intent was lost in the race to achieve a certificate, which led to frustration over insignificant changes in performance. Companies adopted the path of least resistance, and auditors conducted audits with minimum aggravation for fear of losing clients or to gain more clients by being an easy registrar. Companies developed procedures to record what workers did to achieve compliance to the standards requirements, instead creating procedures that outlined what workers should be doing to achieve expected results. Even internal auditors conducted audits using standard checklists and found no noncompliances against the simple procedures they were auditing.
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In other words, ISO 9001 was implemented without its intent, and this led to stagnant quality management systems that companies longed to abandon. Such systems became boring and burdensome to sustain. With the continual improvement requirement added in the revised version of the ISO standards, the intent to create value is now explicitly stated. Six Sigma can facilitate the value intent of ISO 9001:2000. Companies that are implementing Six Sigma independently of the ISO 9001 infrastructure are finding themselves wasting resources with redundant processes. They are finding it difficult to maintain their Six Sigma initiatives. Teaming up with Six Sigma and the ISO 9001:2000 standards is the right choice.
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