Ep 5: Internal Audit and Management Review of the Quality Management System

Internal Audit of a QMS

For internal audits, the quality management system is reviewed in its entirety at least once annually by one or more individuals within quality and or operations.  

The internal auditor or auditors will evaluate the documents within the system, looking for up to date information about the quality operations for each program, completeness and accuracy in record keeping for operations, scheduled and performed training, scheduled and completed maintenance, traceability of measuring devices and overall calibration of equipment subject to calibration, and any sampling, testing and trending of results for products or services produced by the organization.

Where an organization is audited against ISO for the quality management system, the internal audit should be against the ISO code, with the quality management system lined up so that the internal auditor can understand how each document in the quality management system meets the appropriate clause, or clauses of that code.

In an ISO internal audit, any gaps found in the ability for the quality management system to meet the ISO requirements would be considered a non-conformance or error in the system.

Management Review of a QMS

In contrast to the internal audit, a management review is performed by Top Management and does not go through each document of the quality management system, but instead is a top line review of programs, inputs, outputs, key stakeholder needs, risks and opportunities, planning, improvements and any organizational structural updates to the organization.

Where we expect to find non-conformances during the internal audit of the quality management system, those non-conformances are presented to Top Management during the management review so that quality personnel can be certain that top decision makers are aware of how the quality management system is functioning, and that all corrections and corrective actions are properly communicated.

A well-run management review will take feedback not only from the internal audit, but also from overall assessments of the program from quality assurance and quality control personnel.

Critical Quality Metrics and Key Performance Indicators

Now that we have defined the internal audit and the management review, we need to connect the critical quality metric and key performance indicators within each of these reviews to make sure that these reviews focus directly on the sources of quality within operations.

For both the internal audit and the management review, we need to cover all of the critical quality metrics and key performance indicators.

For the internal audit, we must make sure that the critical quality metrics and key performance indicators are carefully reviewed, and this may require that we start with auditing these, and then audit the remainder of the program afterwards.

Internal Auditing Key Performance Indicators

In addition to the critical quality metrics, we need to internally audit key performance indicators for quality assurance operations.

When we are internally auditing key performance indicators, we expect to be looking at mathematical calculations such as sums, percentages, averages, complaints per million pounds, or other meaningful representation of operations.

What we are internally auditing is that the data that went into those calculations are accurate and up-to-date, that the mathematical formulas are properly set up, and that the results are properly completed.

We should also see some trending charts or graphs, and during the internal audit we are looking to make sure that trending charts or graphs are complete, legible, and accurately representative of the data.

Management Review of the Critical Quality Metrics

When we turn our attention from the internal audit to the management review of the same information, the emphasis should be on a big picture overview and analysis of the conclusions from internal audits. In this we mean that during the performance of internal audits prior to management review, the internal audit team should be primarily focused on evaluating the quality control metrics carefully, and checking the key performance indicators are ready for management review.

For the management review, we need to superficially check that the internal audit included that close check of the critical quality metrics, but management review does not need to duplicate the close review of the actual checks, since the internal audit, if properly done, already did those close checks.

Management Review of Key Performance Indicators

Since key performance indicators are the high level measurements that we are operating correctly at a high level of quality, when we get to the management review of key performance indicators, we are performing one of the most important checks that an organization can perform.

Our previously performed internal audit of this information should be confirmed that the information is correct, and presented in the manner that top management requested, and if those conditions have been met, top management should be able to complete the review of the data, and make highly informed decisions about the direction of the organization and operations.

As such, the management review of key performance indicators should be a deep dive into that information.

Conclusions for Internal Auditing and Management Review of the QMS

With our critical quality metrics and key performance indicators fully implemented in our quality management system, we have properly established quality controls and quality assurance measurements in operations.

When we are conducting internal audits and management reviews of those measurements, along with the rest of the quality management system, we can be confident that all of those measurements are properly documented, up-to-date, accurate and that they have been communicated to the quality personnel and top management.