Documenting a Failure Investigation

Medical Device & Diagnostic Industry Magazine
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An MD&DI October 1997 Column

HELP DESK

Anita Thibeault, president of Anita Thibeault & Associates (Rogers, AR) and an MD&DI editorial advisory board member, explains how to properly document an investigation of a product, process, or quality system failure.

What is the proper way to document a failure investigation and the proper method of linking all failure investigations to a company's quality system?

FDA's quality system regulation includes requirements for failure investigations in several subsections of 21 CFR 820. The most commonly referenced section for failure investigations is the one dealing with complaints, section 820.198. However, there are others that include requirements for failure investigations, namely 820.90 on nonconforming product and 820.100 on corrective and preventive actions. Complaints, described in section 820.198, usually involve failure of a product. Section 820.90 deals with disposition of nonconforming product, requiring manufacturers to evaluate the need for an investigation of the problem. Section 820.100 deals with failure investigations for products, processes, and quality system element failures.

Despite all these mentions, there is no specific language in the regulation on what information is required for the documentation of the performance of a failure investigation. The regulation does state that causes of nonconformances relating to product, processes, and the quality system must be investigated and corrected in a manner that prevents the problem's recurrence. The corrective action chosen must be verified or validated to ensure that it is effective and does not adversely affect finished devices. Information on the cause of the problem must be disseminated to those directly responsible for ensuring product quality or problem prevention. The regulation, under section 820.100, requires that the activities and their results be documented.

The intent of the regulation is that manufacturers conduct investigations to a degree commensurate with the significance and risk of the nonconformance. Some times a very in-depth investigation is necessary and at other times a simple investigation can be performed and tools applied to monitor the problem in the future.

Proper documentation of a failure investigation should include the following information, at a minimum:

Unique Identification of the Failure Investigation. Investigators should use some element such as title, date, report number, or control number. This is necessary to trace the information and to monitor the status of the investigation. They should also identify the product, item, process, or quality system being investigated.

Description of the Problem. Investigators should either directly state or reference a complaint or nonconformance report. This information is used to trace the investigation to a reported problem and to provide historical data for future trend analysis.

Level of Necessary Investigation. Investigators need to decide whether an investigation will be simple, in-depth, or something in between, and explain their choice of approach. Not all problems require the same depth of investigation, so it is important that investigators state the reason for the level of investigation performed. This will help reviewers understand the investigation's results and conclusions. This information also provides historical data for future analysis.

Investigation Method, Procedures, Tests, and Inspections. During later analyses, reviewers will need to understand how the data were obtained. Without such information they will not be able to understand the foundation of the investigation or what the data mean. Omission of such information is analogous to omission of calibration on a tool used to measure a characteristic necessary for product acceptance.

Tools Used in the Investigation and Their Unique Identification. This information is used to trace each tool's calibration to ensure that the data are valid and can support the objective evidence.

Description of Examined Documentation, Components, Parts, Labeling, Packaging, and Processes. To analyze future problems, reviewers need to understand exactly what information was used to investigate a problem. Understanding such information helps reviewers make sense out of the collected data and conclusions. This information also provides the objective evidence necessary to support compliance with standards and regulations.

The Results of All Testing, Inspections, and Examinations. Such records substantiate the conclusions and the recommended corrective actions. This information can be attached to the failure investigation or referenced to a location where the records are maintained.

Analysis of the Results and the Analysis Methods. This information supports the conclusions and the recommended corrective actions. To use the information in the future, whether for analysis of other problems or for support of compliance to standards or regulations, reviewers need to know the method of analysis.

Cross-References to Other Failure Investigations, Complaints, Nonconformance Reports, and Other Sources Applicable to the Analysis. This information is necessary to establish links to the quality system and also to provide complete information for system analysis. For analysis of the quality system, it is necessary to evaluate system elements, such as problem identification and correction, for effectiveness. By combining related information concerning all kinds of failures, reviewers can determine the effectiveness of the higher-level system element. This information is then used to improve the quality system.

Signature of All Persons Who Investigated the Problem and Dates They Performed Tests and Examinations. Signatures and dates can be used in future analysis, either to support compliance to a standard or regulation or to identify investigators who can clarify data.

Actual Results of the Testing and Examinations. To provide a complete documentation package of an activity, investigators should include the actual data collected. Such data provide additional information on data collection and recording. This information can be used in later evaluations and to support compliance to standards and regulations.

Report of the Conclusions to Demonstrate Adequate Closure. Such documentation allows reviewers as well as technical personnel to understand the results of the investigation and the relationship to proposed corrective actions.

Recommendations for Corrective Actions to Prevent Recurrence of the Problem. When investigators have completed their work and analyzed the results, they should recommend a solution to the problem. This supports the corrective and preventive action quality system element and ensures quality system effectiveness.

Formal Acceptance and Closure of the Failure Investigation. This activity and subsequent documentation of its performance ensure that the activity was performed, reviewed, accepted, and completed. For a quality system to be effective, each activity must be performed correctly and meet system requirements. By formally reviewing all investigation files for completeness, soundness of data, and conclusions, reviewers can prove compliance with the quality system elements and standards and regulations.

Additional information, determined by whether the investigation requires root cause analysis and by the extent of the risk of problem recurrence, may be added.

The steps listed above are needed to provide complete information about the problem and to serve as a repository of information that can be used by other personnel and external auditors and assessors. Reviewers need such information to understand the cause of the problem and the choice of the corrective action as well as to prove that the company's own procedures were followed and that voluntary standards and regulations are being met.

A company's quality system should have cross-links between all its elements in the appropriate places. Failure investigations can be linked to various elements of the quality system by using procedures that state requirements for failure investigations and formal closure of activities. For example, if a complaint is received and the evaluation determines that a failure investigation is required, the quality system should include a procedure to govern failure investigations, their performance, the documentation required, and the management of the investigations. Typical management techniques include the creation of an official record for each investigation through the use of a log that records a unique number to identify the open investigation. This log is then used to manage the failure investigation by monitoring its status until it is formally closed. There should be rules for failure investigations that state acceptable time frames for performance and closure. Because real life is not perfect, the procedure should also include methods that can be used to extend time frames.

If this type of failure investigation procedure is used, then other quality system procedures, such as nonconformance handling, corrective and preventive actions, quality recordkeeping, document control, calibration handling, facility maintenance, and equipment maintenance, should include requirements for using the failure investigation procedure. Once these requirements are stated, the next step is to explain how to implement the failure investigation. The failure investigation procedure should also cross-reference all other procedures that refer to it to provide complete quality system linkage. The other quality system procedures should also state that formal closure of the investigation is required to complete the activity covered by the specific quality system procedure being used.

If a central database is used for all quality-related data, the failure investigation control number and its information can be related to all other data collected. If the database contains the cross-references listed in the failure investigation record, these data can be used to sort the database to find all links to a particular investigation or vice versa.

"Help Desk" solicits questions about the design, manufacture, regulation, and sale of medical products and refers them to appropriate experts in the field. A list of topics previously covered can be found in our Help Desk Archives. Send questions to Help Desk, MD&DI, 11444 W. Olympic Blvd., Ste. 900, Los Angeles, CA 90064, fax 310/445-4299, e-mail [email protected]. You can also use our on-line query form.

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