May 1, 1996

10 Min Read
QUALITY CONTROL : Conducting Internal Audits:  Taking the Company's Pulse

Medical Device & Diagnostic Industry Magazine | MDDI Article Index

Originally published May 1996

John Sawyer

Of all the continuous improvement tools available, conducting quality audits is by far the best way for a company to ensure that its quality system is adequate and effective. Medical device companies that do not take advantage of this powerful tool often see the quality audit as a regulatory requirement to ensure compliance, rather than as an opportunity for self-assessment and improvement. These companies often rely on third-party audits to determine compliance with FDA's good manufacturing practices (GMP) regulation, or with the ISO 9000 family of quality systems standards compiled by the International Organization for Standardization (ISO). Such a reactive approach is often inappropriate.

The primary disadvantage of using third-party audits is that they check only the company's compliance level and not the system itself. Third-party auditors are often unfamiliar with the way the quality system works or the way the product or service is produced. Furthermore, performing only annual audits of a quality system may be too infrequent to avoid serious problems that could have been detected easily and corrected earlier. Third-party audits should be used only to back up the findings of a company's own audit (self-assessment) program. Many medical device companies are electing to implement a comprehensive audit program to take the pulse of the organization as a whole.

A healthy audit program consists not only of system and process audits, but also of audits designed to investigate areas of concern or interest to executive management. Such audits can be requested by management to investigate a potential problem.


The following scenario shows the importance of conducting frequent internal audits. A company's sales organization has spent considerable time and resources in developing a premier account. The sales manager feels that meeting customer expectations not only will result in more sales to this customer but also will generate more sales in the region. When the company receives a new order from this customer, however, the order-entry department enters wrong information, which results in delivery of the wrong part or system. Once the sales representative at the customer site notifies the company of the error, the manufacturing department attempts to remedy the situation. Rather than going through the usual work order system, manufacturing personnel ship an upgrade kit to the customer site, and several parts are still missing. The sales representative contacts the field service group and orders the missing parts. Then it's discovered that the system does not work because the manufacturer provided inadequate installation instructions.

Such a situation can jeopardize a relationship with a valued customer. Effective audits can minimize or eliminate the internal problems with systems or processes that lead to such errors. Some obstacles, however, must be overcome beforehand.


Maintaining Independence of the Audit Function. It is imperative that the audit function not be compromised due to lack of independence. Management must support its auditors to ensure that reported findings are corrected no matter how troublesome. Auditors must not audit an element for which they have functional responsibility. Individuals and departments within the organization must support the audit program by accommodating auditors and by responding quickly to remedy an adverse finding. It is important to remember that the organization's quality system is the auditee, not the individual or department for that functional element.

Perception of Not Being a Team Player. Auditors are sometimes considered not to be team players by others within the organization. This is usually because auditors report to management potential problems that may affect product quality or the quality system. A company can avoid this perception if management supports the independence of the audit function as a self-assessment tool.

Correcting the Cause of Problems. It is management's responsibility to ensure that the audit function has the authority to implement corrective action. An auditor should focus on measures that fix the root cause of the problem as well as correct the immediate problem. Although crisis management can fix the problem at hand, the root cause remains unresolved, and the problem resurfaces. Unfortunately, when this occurs more time and resources are necessary to fix the problem than when it originally surfaced.


Figure 1 (not available online) outlines a sample audit process. This audit program consists of four phases: preparation or planning, performance or execution, reporting, and closure.

Preparation or Planning. This is the critical phase of the audit program, which can determine whether the audit succeeds or fails. In this phase, the company decides what to audit, when to audit, and whether to use a system-, process-, or management- directed audit. The company determines the audit objective, scope, and duration; selects audit teams; and compiles checklists.

To develop an overall audit plan, the company must identify all regulatory elements and elements important to management. A company must prioritize these elements and determine the effect each may have on the organization or quality system. This will help determine how often the company should audit this element. The frequency can also be influenced by previous audit information, such as the type, number, and severity of observations. Management should approve audit plans and schedules and should communicate its commitment to the process.

Once the audit plan is completed, audit checklists need to be developed. Checklists serve as a guide for the auditor but should not be used to limit the audit to just the topics listed in them. Checklists should initially center on compliance but can also include continuous-improvement and value-added activities. Management should review checklists with the responsible department heads, and then determine who is to conduct the audit and whether any other personnel are required to assist with it.

Performance or Execution. Using the audit checklist as a guide, the auditor then conducts the audit. He or she should provide a copy of the checklist to the responsible department head before starting; this enables the department to prepare for and to support the audit.

It is important that those being audited understand the process. The auditor should note objective evidence to be used later on to support observations he or she will make during the reporting phase. Questions raised during the audit should remain relevant to its objective and scope.

If information becomes available during the audit that suggests other problems, the auditor should determine whether it can be evaluated in a separate audit or whether it is critical to the area being audited and therefore should be reviewed as part of the audit being conducted. It is the auditor's responsibility to keep the audit within its objective and scope.

After completing an audit, the auditor should review the results with the department head to ensure that he or she understands what was observed and what will be reported. The auditor should resolve questions or concerns as long as they do not detract from the overall audit results.

Reporting. The third phase of the audit process is the audit report. In this report, the auditor communicates to management potential or identified observations that indicate weaknesses in the process or quality system. When preparing the audit report, the auditor should present observations in order of importance. This ensures that major findings are resolved promptly, minor ones as time and resources allow.

Auditors should avoid making recommendations to the affected department that may shift responsibility for resolution from that department to the auditor. Although an auditor may advise the affected department on various methods and processes that may help correct the finding, the department is responsible for implementing measures that correct deficiencies. The auditor's only role in the solution is to identify the findings and report them to management. The purpose of reporting audit findings is to continually improve processes rather than punish or reprimand individuals. Audit reports should be issued to the responsible personnel who will implement corrective action, and to management for review and allocation of resources.

Closure. During the closure phase, the auditor works with the department audited to identify the corrective action necessary to resolve audit report findings. The time frame for providing corrective action should be agreed on prior to issuing the audit report. When the auditor receives the proposed corrective action, he or she should determine whether it remedies the findings.

Corrective action responses should address why the problem occurred; the root cause of the problem; the action necessary to correct the problem; the action necessary to prevent recurrence; the effects, if any, of the problem on other products or areas; and the action necessary to correct those effects. The auditor then tracks the corrective action process to ensure that all elements are corrected as outlined in the audited area's response.

When the audited area completes its corrective actions, the auditor performs a follow-up audit to review the effectiveness of those corrective actions. The follow-up audit reviews only the findings in the audit report. Depending on the results of the follow-up audit, the auditor either closes the audit or requests further corrective actions. This process continues until the auditor can verify that all corrective actions are adequate.


An audit system enables a company to improve its efficiency and effectiveness throughout its operations. The company will be able to do the following:

Meet Customer Expectations. Through audits of areas such as the design process and sales order entry, a company can identify methods of ensuring that customer requirements are properly addressed throughout product design, sales, and installation and service of the product. This assists the marketing and sales departments to ensure that the company has a viable product that will satisfy its customers.

Increase Productivity. Audits of manufacturing and inspection processes increase production by decreasing the time it takes to move a system through manufacturing.

Increase Efficiency. As a result of the audits, a company can identify and correct redundancies. It provides an opportunity for a company to refine and improve its quality systems. The audit allows it to identify obstacles that hamper its systems and cause problems. The end result is that the company can streamline its processes to make them more effective.

Improve Product Quality. Audits of areas such as the design process can ensure that new designs are developed that meet customer expectations and that verification and validation activities result in error- free designs. Audits of production and process controls ensure that once a design is released for manufacturing, all necessary travelers, operation sheets, and process instructions accompany the product. Ensuring that all manufacturing documentation is developed in conjunction with the design process allows for continued improvements in product quality.

Improve Product Reliability. Audits can also identify areas where reliability measurements and testing would be beneficial to the organization. Audits can help management determine whether to establish a formal reliability function. Continual review of data coupled with audits can significantly improve products. Such improvements can provide the impetus for companies to evaluate older product types in order to minimize service activity.

Identify Effective Operations and Systems. Implementing an audit program can help companies identify effective operations and processes that can be used as process models for other areas. Cross-functional teams can resolve findings that result in faster, more comprehensive corrective actions. Cross-functional teams can also identify outside operations and systems that can assist in resolving issues.

Using the audit program as an aid to improving processes has allowed OEC Medical Systems to achieve a compliance level that resulted in a favorable GMP inspection and successful completion of ISO 9001 registration within a three-month period. Recently, the company's quality system received certification of Annex II of the European Union Medical Device Directive, allowing OEC to affix the CE mark to its product under self-declaration guidelines.

Medical device manufacturers must keep in mind that their customers are the users of their products. FDA is a regulatory body and is not concerned about how manufacturers fare in the marketplace. Audit programs that concentrate on improvement to meet customer needs result in a quality system that also meets regulatory requirements.

Customers expect a reliable, quality product. Meeting customer needs, providing a quality product, and providing a reliable product are all sound reasons for manufacturers to implement an effective quality audit program aimed at self-assessment. Continuous improvement not only provides benefits for customers, but makes the organization more productive and effective.

A quality audit program is the best method for checking a company's pulse. Periodic checkups will keep it healthy and growing.

John Sawyer is lead assessor and manager of regulatory engineering for OEC Medical Systems (Salt Lake City).

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