About this template
FMEA – Failure Mode and Effects Analysis 2026/2027 is an editable template package for companies that need to identify failure modes, analyze effects and causes, and plan and follow up on improvement measures. The package is adaptable for Process FMEA (PFMEA), Design FMEA (DFMEA), service processes, and other operational analyses. It combines Word and PDF documents with an Excel register that calculates conventional RPN and shows responsibilities, control history, and revision status.
You get a practical starting point for cross-functional analysis meetings, clear decision protocols, and traceable action follow-up – without having to build the entire structure yourself.
Version 1.0 • 2026/2027. The methodological basis has been compared with IEC 60812:2018 and public information from SIS/SEK. The templates are proprietary working documents, not a copy of the IEC standard, licensed AIAG-VDA tables, a certification basis that automatically shows compliance, or a safety assessment of an actual system.
What's included in the FMEA package
| Document | Content | Format |
|---|---|---|
| FMEA – working method and analysis plan | Roles, scope, functions, failure modes, effects analysis, causes, preventive controls, S/O/D assessment, and decision process. | DOCX + PDF |
| Analysis and decision protocols | Meeting assignments, risk selection, action decisions, verification references, and approval of residual risk. | DOCX + PDF |
| Detailed user guide | Overview of the workflow, calculation examples, Excel instructions, pitfalls, checkpoints, and sources. | DOCX + PDF |
| FMEA – Working Sheet (English) | English working document for international project teams in Swedish operations. Not a complete translation of all Swedish documents. | DOCX + PDF |
| FMEA risk register and actions | Professional Excel workbook with six sheets, calculated RPN, status, dashboard, and follow-up. | XLSX |
A total of nine files: four Word (DOCX), four searchable PDF, and one Excel (XLSX), compiled in a ZIP. Swedish is the primary language; a practical English working document is included.
Who are the FMEA templates for?
The templates are suitable for manufacturing companies, workshops, design departments, quality managers, production engineers, and process owners who need to analyze risk of failure and document decisions. FMEA is useful when introducing a new product or production process, during process changes, recurring deviations, supplier changes, or preventive improvement work.
Excel – six sheets with real functionality
| Sheet | Function |
|---|---|
| Overview | Shows number of registered failure modes, flagged high severity, open and overdue actions, and registered revisions. |
| FMEA register | 120 prepared rows for function, failure mode, effect, cause, controls, S/O/D, RPN, proposed actions, and residual risk. |
| Actions | 100 entries for responsibility, due date, actual verification evidence, status, and approval. |
| Assessment scales | Illustrative explanations for S/O/D 1–10; to be replaced by the organization's decided method. |
| Revision log | 50 rows for document changes, reason, decision, and next review. |
| Instructions | Step-by-step completion, limitations, and links to sources. |
Excel automatically calculates conventional RPN = S × O × D and the corresponding score after action when you fill in values 1–10. Here, S stands for severity, O for occurrence, and D for detection difficulty (higher D is worse detection). An example with S=8, O=4, and D=6 gives an RPN of 192; if a verified action leads to a new assessment of S=8, O=2, D=3, the RPN becomes 48. These figures are decision support, not approvals.
How to create a traceable failure mode and effects analysis
- Describe the analysis object: specify product, process, functions, scope, and version designation.
- Gather the right expertise: involve, for example, engineering, production, quality, and maintenance based on the actual risk.
- Identify failure modes: analyze how a step could fail, the effects of the failure, and possible root causes.
- Document existing controls: distinguish between preventive measures and controls that detect the failure.
- Assess S/O/D: use common criteria and document assumptions. RPN is created automatically.
- Select risk actions: always prioritize serious effects and any safety and customer requirements, not just high RPN.
- Verify the effect: record evidence, person responsible, date, and new assessment only after the action has shown an effect.
- Decide and archive: document residual risk, authorized approver, and when the analysis should be reviewed.
FMEA, IEC 60812, and Swedish requirements
IEC 60812:2018 describes how FMEA and FMECA can be planned, executed, documented, and maintained. The standard is general and covers, among other things, hardware, software, and processes. FMEA is not an independent general legal requirement for all Swedish companies. However, mandatory requirements may follow from applicable legislation and agreements for a specific product, industry, or activity.
For medical devices, automotive suppliers, safety-critical systems, and machinery, specialized standards, customer requirements, or safety analyses may be required. This package does not provide automatic compliance with IEC, ISO, AIAG-VDA, or IATF 16949 and cannot replace professional safety assessments. The IEC standard text itself is not included in the purchase.
Common mistakes to avoid
- Mixing failure mode, effect, and root cause in a single unclear field.
- Equating two different risks because their RPN happens to be the same.
- Ignoring very serious effects that have a low probability value.
- Changing risk scores after a planned action without actual verification.
- Claiming that common RPN categories correspond to AIAG-VDA Action Priority.
- Leaving decisions on residual risk without a named responsible person.
- Failing to update FMEA after design or process changes or new deviations.
Common questions about FMEA
What is an FMEA?
FMEA, Failure Mode and Effects Analysis, is a structured method to identify how a product or process can fail, assess consequences, and prioritize preventive improvements.
What is the difference between PFMEA and DFMEA?
PFMEA analyzes possible errors in the process implementation. DFMEA analyzes failures related to a product or design function. Both need to be adapted to their actual requirements.
Is FMEA mandatory according to ISO 9001?
There is no general requirement for all operations to use this specific spreadsheet or FMEA method to work in a risk-based manner. Check your applicable standard version and customer requirements.
How is RPN calculated?
Excel multiplies severity S, occurrence O, and detectability D, using assessments 1–10. It yields a number between 1 and 1000 when all values are present.
Can Excel approve a risk automatically?
No. A low RPN is not equivalent to a low actual risk. A competent person must evaluate serious effects and applicable requirements.
Is AIAG-VDA Action Priority included?
No. No licensed AP table or automatic AP calculation is included. A customer-adapted FMEA approach may require other materials.
Is there an English version?
Yes, a separate English working sheet is included for international teams. The main Swedish templates and the user guide are not included as complete English translations.
Format, price, and digital delivery
Delivered as a ZIP file with 4 DOCX, 4 PDF, and 1 XLSX. Standard price 79 SEK. No physical shipping. For automatic digital delivery after purchase, the ZIP file must be linked to the correct variant in Shopify's Digital Products.
Official sources
- IEC – IEC 60812:2018, Failure modes and effects analysis
- SIS – SS-EN IEC 60812, Reliability – Failure mode and effects analysis
Disclaimer: An FMEA template does not replace licensed standards, customer-specific regulations, technical testing, CE assessment, or specialist expertise where required. The method and scales must be adapted and documented by the party responsible for the operation.
