The FMEA Report

Upon completion of the FMEA worksheets, the analysis data are transferred into report format which should include, as a minimum, the following information  

Introductory Information The analyst should provide basic information in this section of the report which describes the purpose and scope of the FMEA along with any limitations imposed on the analysis as a result (i.e., items not specifically within the scope of the analysis). The scope will also identify the type of FMEA (i.t., functional or hardware). Also included in the introduction section is an explanation of the methodology used to perform the analysis such as, but not limited to drawing reviews, examination of previous analyses (if applicable), evaluation of lessons learned, use of Preliminary Hazard List and/or Preliminary Hazard Analysis, and so on. Finally, any preestablished ground rules that may have been agreed upon should be provided here. Such ground rules typically limit or further narrow the scope of the FMEA, or just a portion of it, and should therefore be explained in the introductory pages of the report. 

Definitions Section Typically, an FMEA report will contain phrases or words that are not generally associated with the everyday practice of the industrial safety professional. It is therefore important to provide definitions and explanations of terms and phrases that will be utilized in the FMEA. 

System Description The FMEA report should contain a significant amount of descriptive information pertaining to the system or subsystem(s) being evaluated. The detail of this description is obviously dependent upon the available information. However, if the project or system is well into the design phase. 

Criticality Assessment This section of the FMEA report will detail the level of system, subsystem, or component criticality (refer Chapter 2, Table 2.3). This criticality assessment is usually based on some predetermined criteria that have been agreed upon by management. When evaluating a system during an FMEA, criticality is an expression of concern over the possible effects of a failure in that system. If such failures could result in adverse effects on personnel (e.g., death, serious injury, illness) or equally undesirable effects on equipment, components or the system itself (e.g., system loss, equipment damage), then the level of criticality will reflect this assessment. 

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The circuit board components of some medical prototype devices may have to be reorganized in order to obtain a layout that will allow easy automatic assembly. Any changes must be noted in the Hardware Design Specification, and the new board must be checked against the prototype for functional equivalence. The FMEA report should be consulted to see if there are any critical components on the circuit board. If so, the manufacturer will have to make special arrangements to ensure that component traceabihty exists from supplier to circuit board to user. 

These rationales and assumptions are often not included in the FMEA report, but must be available for audit (by the Independent Safety Auditor) and must be kept for future reference. The customer needs to be aware of these data and may consider ensuring that its inclusion is captured in the contractual deliverable. For relative frequency of failure modes of electronic components, it is also possible to refer to Alessandro Brilini s Reliability Engineering Theory and Practice, 1997. If, however, failure rates cannot be apportioned in a justified way (i.e. from in-service experience of published data), then it should be justified by qualitative argument (see Table 3.3). 

It is suggested (see Section 5.1.1) that the FMEA is the ideal tool to provide the evidence for accomphshment of Goal 15 (i.e. the FMEA report is the solution). 

This documentation is usually not included in the FMEA report but is retained for reference. 

Column 5—RAC or Hazard Category. Enter the risk assessment code (RAC) or hazard category for each failure listed in column 2. An RAC is recommended however, some organizations evaluate FMEA failure only in terms of severity or criticality. In any event, the risk assessment codes or hazard categories must be clearly defined, and their definitions must be included in the FMEA report and/or physically attached to the FMEA worksheets. 

Step 5 is concerned with developing a list of crihcal items. The list is prepared to facilitate the communication of important analysis results, generally to the management personnel, and it contains information on areas such as item identification, concise statement of failure mode, criticality classification, and degree of loss effect. Finally, Step 6 is concerned with documenting the analysis. This step is equivalent in importance to all the previous steps (i.e., Step 1 to Step 5) because poor documentation can result in ineffectiveness of the FMEA process. The FMEA report includes items such as system description, ground rules, system definition, failure modes and their effects, and critical items list. 

Criticality Assessment This section of the FMEA report will detail the level of system, subsystem, or component criticality (see Chapter 2, Table 2.3). This criticality assessment is usually based on some predetermined criteria that have... 

In order demonstrate the rigor of the FMEA exercise. Table A4.1 provides a template of items to be addressed. It can thus be used, in the FMEA report, to indicate where each item can be evidenced. 

All decisions that are made in the FMEA must be documented and a final report should be written and approved by the user, the engineering department, and the QA. 

Failure Modes and Effects Analysis (FMEA) This will document a review of the effects of faiiure of the component parts of the system. This review is mainiy aimed at assessing the system hardware, interfaces and environment. This review shouid be performed on two lev-eis The first ievei reviews the possibie failure modes of each individual system and the second level assesses the possible failure modes of the combined system. The overall objective of the FMEA is to identify the potentiai weak points and then to identify how these weak points may be designed out of the system. This may be achieved by instaiiing redundancy, redesigning parts of the system, recommending procedural controls and so on. The results of this review should be documented as a FMEA Review Report or as part of a DQ Report. 

It is, therefore, very important to obtain from the customer (at a higher system level, refer Fig 1.3) a written specification defining the intent of the FMEA, the failure effects of interest, outputs to be considered and the required format of the final report. 

A code may be assigned to each effect category, which simplifies the FMEA worksheet by moving the description of each effect from the worksheet to the body of the report (SAE ARP 4761 para G.3.2). 

Any and aU critical single-point failure (CSPF) items that were identified during the FMEA should also be provided in this section. The specific failure mode and its effect(s) should be listed and discussed here. The discussion should detail any acceptance or rejection rationale to justify the recommended actions, which are provided later in the report. 

Finally, the most important element of the entire report, the FMEA, provides recommendations for management acceptance or rejection of the risk associated with any failure of any item on the critical items list. 

Once all the data have been evaluated and the PHA worksheet is completed, a formal report should be written documenting the results of the analysis. The narrative report typically includes a summary of all significant findings associated with operational risk. Recommendations for hazard elimination/control are also included in the report as well as suggestions for follow-on analyses. Although not entirely necessary, depending on the nature of the operation, process, or system, it is also useful to include a brief description of the project itself, its purpose and/or function as it relates to overall operations. The PHA/PHL worksheets are usually provided in the report as backup data to verify the report contents. Finally, the PHA report should also include a brief discussion of the methods used to develop the analysis (ETBA, FMEA, checklists, matrices, etc.), so that the reader can validate the report data, if required (Stephenson 1991). 

Data Section All supporting data used to develop the FMEA, as well as that which can assist in the presentation of the final analysis, should be included in the final FMEA report. These data can include photographs of the system, subsystem, or individual component(s) being analyzed layout drawings electrical schematics and, of course, the FMEA worksheets. 

The process change is documented in a proposal with its justification, along with the number of batches necessary and strategy (e.g., samples and data needed, extent of validation testing, and acceptance criteria) to evaluate the change [15]. In some cases, the original risk assessment (e.g., FMEA) is revisited or a new one conducted to ensure an unintentional new failure mode has not been created [71]. A formal change control report is written and approved [15]. 

The techniques used to complete PHAs inelude What-iF analyses. Explosive Safety Checklist Analyses, General Industry Checklist analyses and FMEA analyses. The information from Preliminary Hazards Analyses, previous Final Safety Analysis Report analyses. Fire Hazards Analyses, and other... 

Here a description of the key techniques involved, a reference to procedures and test schedules etc., a summary of results obtained and how they relate to the goals made in the previous section (e.g. calculated reliability figures, reports of no anomalies etc.), a top level fault tree and a representative FMEA table are detailed. 

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