Process FMEA Form



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Description of Form

Process/Operation - Enter the name of the process. Examples: milling, grinding, aligning, inspecting, plating, packaging, assembly, leak test, and so on.

Part/Assembly Name - Enter the name(s) of the part(s) made by this process. If there are many, list them on a separate page. This ensures that whoever reviews the FMEA form will know exactly which parts have been considered.

Part/Assembly Number - Enter the number(s) of the part(s) listed.

Engineer - Enter the full name of the person who drafts the FMEA form. This person is usually the engineer responsible for designing and developing the manufacturing process.

Plant/Place/Supplier - Indicate where the process is performed.

FMEA Number - Enter a sequential number to identify the FMEA. This may be obtained from the FMEA facilitator.

Page - Enter as indicated.

Dates - Enter the date the FMEA was completed. Enter revision dates on the revised pages, as well as the first page.

Description, Specification and Part(s) - Enter a description of the process and the specifications (or a reference to them) describing the process requirements. Also enter a description of the part(s) subjected to the process, if the process description could be misunderstood without it.

Potential Failure Modes - A process-related failure mode is a deviation from specification caused by a change in the variables influencing the process. Some examples are: bent, blistered, burred, discolored, misaligned, omitted, over/under size, porous, rough, tight/loose, warped, wrinkled. Enter all possible failure modes. Usually, a complete understanding of the product drawing and spec sheet is sufficient for identification of failure modes.

Potential Causes of Failure Mode - Any change in a variable influencing the process which causes the process to produce an out-of-spec product. This column is basically a listing of variables involved in the process and their operating limits. Enter all possible causes, using personal experience, documented cases, rumored histories and input from others.

For clarity, group related causes together. For example, if contamination is a potential cause, list all possible contaminants and their sources together.

In-Place and Planned Cause Preventions or Detections - Describe the measures established to prevent or detect a cause, or to detect the deviation in the product.

Effectiveness - A subjective estimate of how effectively the prevention or detection measure eliminates potential failure modes. It quantifies judgment of the soundness of the process design or inspection procedure, the validity of a capability study, and so on. Based on a scale of 1 to 10, shown:
RankingCriteria
VerbalRate of Cause Occurrence
1The prevention or detection measure is sufficient. The spec will be met consistently.1 in ____
2 and 3There's a small chance that the spec will not be met.1 in ____
4, 5, and 6Moderate chance.1 in ____
7 and 8High chance.1 in ____
9Very high chance.1 in ____
10The prevention or detection measure is completely ineffective.1 in ____

Note: The rate of occurrence that is appropriate for each ranking will vary depending on the product.

Recommended Actions to Eliminate Cause or Enhance Prevention or Detection - Enter ideas on how to improve a feature of the process if its effectiveness ranking is unfavorable.

Responsibility for Action Accepted by - Enter the name of the individual on the process FMEA review team who has the authority to implement the corrective action.

Committed Completion Date - Enter the date by which the corrective action will be implemented. When this cannot be determined, use, for example, the date by which a new process will be tested, measurements analyzed, capability study started, and so on. Enter a note describing which event the date refers to.

Actual Completion Date - Enter the date when the corrective action was implemented.

Remarks - Enter references to related recommended actions, as well as information that documents traceability, such as identification of memoranda, letters and reports which document the progress and completion of a corrective action.