Good to Great- Audit quality system effectiveness to propel your organization

Quality Systems audits provide a great opportunity for an organization to reinforce its strengths and minimize its weaknesses.

Throughout the process, auditors play the major role in maximizing the value of the audit. Auditors who go the extra mile and provide complete assessments of the quality systems’ effectiveness are the ones who make the real difference.

Let’s start with the basics of a quality systems audit. A quality management system (QMS), according to the ISO 9000 series of standards, adopts a process approach. The system is designed to incorporate various processes and subprocesses that support the overall process.

In its entirety, the system (the process) follows the plan-do-check-act (PDCA) cycle. The check stop includes several processes with the objective to "monitor and measure processes and product against policies, objectives and requirements for the product and report the results."1

To achieve the objectives of the check process, ISO 9001 requires that internal audits determine:

- Conformance.
- Effectiveness.2
- Auditing for conformance checks the organization’s status against its quality management manual and procedures, while auditing for effectiveness tests the quality system’s ability to achieve objectives.

Needless to say, the latter step provides more value. But, it also is the more difficult part. Challenges include:

- Knowledge. Auditing for effectiveness requires extensive knowledge and experience in the industry to which the audited organization belongs. This might not be a problem in the case of internal audits. But in external audits, auditors should either limit their audits to their field of expertise or supplement the audit team with subject matter experts.
- Time. Auditing for effectiveness requires time to study the organization’s processes, collect data and examine the processes’ ability to achieve objectives. To account for this, the auditor must exercise caution in planning his or her audits. First, sufficient time should be allocated. An audit plan must consider the size and complexities of the audited organization. Second, auditors should use their time wisely, focusing on what is critical.
- Politics. Reporting deficiencies in the system itself is usually more difficult than reporting deficiencies in compliance with the system. This is because quality systems are usually developed by top management. The elements of pride and ego could play a role in putting pressure on auditors. This is especially true with internal audits.
Despite the challenge, auditing for effectiveness provides organizations with valuable opportunities that should not be missed. Continual improvement is solely based on the organizations’ ability to identify the root cause of errors and correct them. Auditing is one of the key processes that help organizations improve and excel.

Here are some tips for establishing a better process for auditing for effectiveness:

- Prepare for audits with an extensive review of the audited organization’s mission and objectives.
- Get the right team. The audit team should possess adequate technical knowledge in the audited organization.
- During the opening meeting, communicate the audit objectives with extra emphasis on the effectiveness.
- Link all the findings to organizational objectives.
- Put more emphasis on the internal auditing processes rather than relying on external audits that are usually limited in time.
- Auditing for effectiveness is the real test for auditors. Good auditors do a great job checking for compliance.

Outstanding auditors make a more genuine change by auditing for effectiveness.

Here are a couple examples in which effectiveness was audited in an organization:

- The process of selecting and evaluating suppliers failed to provide the organization with a reliable source of materials. It was found that 40% of the evaluated and approved suppliers have supplied defective materials.
- A management review failed to make the necessary changes to the organization’s QMS. In three consecutive management review records, top management advised the training department to conduct an extensive training program for new hires to be able to operate the newly purchased equipment. It was confirmed that the training department did not conduct the training.

References
International Organization for Standardization, ISO 9001:2008—Quality management system, clause 0.2.
International Organization for Standardization, ISO 9001:2008—Quality management system, clause 8.2.2.

Article Credits: QP