The Auditors Are Coming: Are Senior Managers Ready?

Originally Published MDDI October 2002FIRST PERSON Colin Aldersley

October 1, 2002

6 Min Read
The Auditors Are Coming: Are Senior Managers Ready?

Originally Published MDDI October 2002


Colin Aldersley

The CEO and senior managers of a medical device manufacturing company can benefit from an easy-to-use model that can quickly guide executives through the firm's quality system. It can also lead them through the required quality data and, most importantly, through the requirements of the management review process. When all the pieces of the quality system have been placed into a functional business flow, senior managers can more easily evaluate their quality organization. Once this is achieved, the CEO or senior manager who is suddenly confronted by an auditor will have the tool described in this article, will be familiar with the firm's quality system, and will understand the magnitude of his or her responsibilities.


If an external auditor or FDA representative is asked what standard senior management should apply to management review, the response would likely be "the approved product design." So for the purposes of this article, the elements of the design were used as the standard for management to apply to the management review process.

In real life, management review can often become a political battle between the manufacturing and quality departments over the significance of one minor change. "One small deviation from the specifications, and the quality folks shut down production," says the manufacturing department. We have all heard the wailing, and management most often gives ground—and worries about the consequences of the decision later. When the auditor arrives, "later" becomes the moment of truth. If the management review has been performed properly, management can demonstrate that it acted expeditiously and responsibly. The senior manager can sit with the auditor and explain why a given course of action was taken.

The critical questions to answer before an audit begins are:

  • What will the auditor expect management to have done?

  • Has management met its responsibilities in management review?

  • What are management's responsibilities?

It is management's responsibility to provide documented evidence that executive management has reviewed any change in light of design verification and validation limits. It is management's responsibility to ensure that the available evidence shows that the change has not thrown the design out of the design specifications. There is also a responsibility to produce documented evidence that the design limits are still accurate.

Management also bears the responsibility to show that there is documented evidence that executive management is able to fund and conduct additional verification and validation procedures to show that a change does not affect the design's intended use. In addition, management has the responsibility to review failure analysis data to ensure that the change will not affect the failure analysis model. Additional failure studies must be adequately funded to demonstrate that the total design will not fail more often as a result of the "minor change."

Management must also know and understand why this change is to be made to this product and must review the appropriateness of the change in relation to other devices in the product mix. If management determines that the change does not apply to other products in the mix, the documentation should explain why the change does not apply.


Figure 1. The approved design can be considered the standard for the management review process. The functional units that make up the new material portion of the process model are described by the red text contained in the large arrow. The blue text below the arrow includes the quality system procedures and requirements. The black text above the arrow includes the outputs from the quality procedures, quality records, and quality data. The control column gathers the quality procedures and the quality records recommended for management review. The narrow red arrows leading from the design column and from the control column meet at the management review box. Within the management review box are the possible outputs from the review that compares the quality records with the design.(click to enlarge)

Figure 1 illustrates the raw material portion of what is essentially a generic functional model of a quality system. The complete model is made up of a number of similar, related diagrams. For example, a complete model based on the example used for the figure would also include a subassembly (in-process) diagram, an assembly (final product) diagram, a warehousing diagram, and a sales and service diagram. Each device manufacturer would have its own specific model.

Before the full scope of the management review process can be determined, it is necessary to establish the functional units that work together to provide the output for that diagram or that step in the production process. The sum total of all functional units will result in the designed product being sold to a consumer and supported for its expected life. This total model of all diagrams represents the firm's quality system. The quality system is thus the total of all documents and all data that support and prove the device's fitness for use. Management review is the actions taken at certain control points to ensure that the device meets the design criteria.

The functions illustrated in Figure 1 are self-explanatory. The actual functions are dictated by the complexity of the design and will vary from manufacturing process to manufacturing process.

It is important to establish control points where data are collected to demonstrate that the device meets its design specifications. It is also necessary to show that all devices produced are suitable for their intended use. The control points should be set to detect failures as the product moves down the production line from one processing area to the next—and from one diagram to the next. Management's responsibility is to monitor the detected failures and make certain that they are corrected.

At the control points, the quality department needs to keep track of the failures and review the resulting data to identify trends and shifts in the quality of the components being tracked. Quality can be improved by performing Pareto analyses of all failures. This failure analysis process should include a root cause analysis. Once the root cause of the problem is identified, the problem can be addressed properly.

What problems should be escalated to management review? The top four or five problems identified by Pareto analysis for a given month should be the focus of the management review. All actions initiated as a result of the previous month's review should be examined to determine whether they have been effective. All audit reports should be reviewed as well. Customer feedback should be analyzed and reviewed to make sure that the design is appropriate for its intended use. Any acute failure or change in the manufacturing process should be reviewed. If necessary, additional validation, verification, and failure analysis should be funded and performed. If senior management has performed these functions and in good faith made and documented its decisions, it has met its responsibility.


This model and its constituent diagrams are attempts to provide a tool to help senior managers understand and evaluate the data that a company's quality organization is providing. It also provides a brief overview of quality assurance analysis processes that should be provided to senior management so that the effectiveness of the company's quality system can be adequately monitored and evaluated.

Colin Aldersley, a Florida-based industry consultant, describes a functional model for organizing management's responsibilities in the event of an audit.

Copyright ©2002 Medical Device & Diagnostic Industry

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