Templates and records · IATF 16949 · Clause 8.3.5.2
Process FMEA (PFMEA) template for IATF 16949
The analysis that anticipates how each process step could fail, what the effect would be and which control prevents or detects it. The control plan flows from it.
In one sentence
The process FMEA analyses, step by step along the flow chart, the possible failure modes, their effects and causes, the prevention and detection controls and the priority for action, because IATF 16949 requires it among the outputs of manufacturing process design (8.3.5.2) and as the basis for the control plan; the method is set by the customer, and today it is almost always that of the 2019 AIAG-VDA handbook.
- Where the standard requires it
- IATF 16949 · Clause 8.3.5.2 Clauses are those of IATF 16949:2016, which always applies together with ISO 9001:2015. The AIAG and VDA manuals cited are industry references that apply when the customer requires them; they are not part of the standard.
- Type of information
- Mandatory document Mandatory output of process design (8.3.5.2); a living document that is maintained
- Who fills it in
- Multidisciplinary team Process engineering, production, quality and maintenance; the facilitator knows the method
- When
- During process design Before PPAP, and reviewed after changes, complaints, nonconformities and field failures
- How long it is kept
- Part life + 1 year For part approvals, tooling records, product and process design records, purchase orders and contracts: for as long as the part is active in production and service, plus one calendar year, unless the customer or a regulatory agency specifies otherwise (7.5.3.2.1).
What the standard requires
What IATF 16949 demands and what it leaves to your judgement
IATF lists the process FMEA among the outputs of manufacturing process design, alongside the flow chart and the control plan, and requires the risk analysis to be reviewed in light of lessons learned, complaints and field failures (6.1.2.1). In problem solving it requires the FMEA to be updated when the cause reveals an unanalysed risk (10.2.3).
The standard does not prescribe a method. The AIAG-VDA handbook, published in 2019, organises the analysis into seven steps —planning, structure, function, failure, risk, optimisation and documentation— and replaces the risk priority number with a high, medium or low action priority that gives more weight to severity.
What customers usually require in their CSRs is the specific method and how special characteristics are marked.
Structure
Fields the template should include
- Scope: part, process, plant and analysis team
- Process step according to the flow chart and work element (machine, person, material, environment)
- Function of the step and product or process characteristic
- Failure mode, effect in the plant and at the customer, and cause
- Severity, occurrence and detection using the method’s tables
- Current prevention and detection controls
- Action priority and special characteristics
- Optimisation actions, owner, deadline and re-rating
- Review and link to the control plan
Example
Example: one row of the FMEA for a nut welding operation
Company, people and figures are fictitious: the example only shows what a properly completed record looks like.
| Field | Content |
|---|---|
| Step | OP 40 · projection welding of an M8 nut onto a seat bracket (fictitious part) |
| Function | Join the nut with a minimum push-out torque of 40 N·m |
| Failure mode | Nut welded with insufficient push-out torque |
| Effect | At the customer, the seat bolt comes loose during assembly · severity 8 |
| Cause | Electrode worn beyond the replacement interval · occurrence 5 |
| Current controls | Prevention: electrode change every 3,000 welds · Detection: torque test on 1 part per shift · detection 6 |
| Action priority | High |
| Action | Automatic counter that locks the machine when the weld limit is reached, plus current monitoring on every cycle · process engineering · 30 April |
| Re-rating | Severity 8 · occurrence 2 · detection 3 · low priority |
| Control plan | 100% current monitoring with a reaction plan is added |
At the audit
Mistakes auditors commonly flag
- An FMEA produced once for PPAP and never reviewed after complaints or changes.
- FMEA steps that do not match the flow chart or the control plan.
- Occurrence or detection ratings lowered without any real control in place.
- Actions on high-priority risks that have been open for months.
- A “family” FMEA that does not capture the specifics of the line being audited.
In Kimobox
How this record is kept in Kimobox
- 1The process FMEA is linked to its control plan within the system itself.
- 2Changing one prompts a review of the other.
- 3Optimisation actions have an owner and a date, with an alert if they slip.
- 4Process nonconformities and complaints are linked to the FMEA that needs reviewing.
Frequently asked questions
What people ask us before getting started
Do I have to use the AIAG-VDA FMEA?
If the customer requires it in its CSRs, yes, and most manufacturers do. If not, the organisation may keep another method, provided it analyses failure modes, effects, causes and controls and prioritises actions.
What is action priority?
The high, medium or low rating that replaces the risk priority number in the AIAG-VDA handbook. It comes from combining severity, occurrence and detection in a table that gives more weight to severity, so that a serious risk is not masked by good detection.
How does it relate to the control plan?
The control plan contains the controls the FMEA assumes are in place and those it adds. If the FMEA relies on a control that is not in the plan, or vice versa, the chain breaks, and the auditor spots it by comparing the two documents.
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Sources
Where each figure comes from
References to the official text in force. If a standard is revised, this page is updated and the review date says so.
- IATF 16949:2016 — Quality management system requirements for automotive production and relevant service parts organizations IATF · First edition, October 2016
- AIAG & VDA FMEA Handbook (industry reference, not part of the standard) AIAG and VDA · First edition, 2019
- IATF 16949 Sanctioned Interpretations and FAQs IATF Global Oversight · Continuously updated