FMEA Excel Template | PFMEA and DFMEA Worksheets with Rpn Scoring | Risk Analysis Spreadsheet | Medical Device Iso 13485 Fda 820

----------------------------------------
FMEA TEMPLATE PACKAGE. 11 PROFESSIONAL DOCUMENTS
Built for Medical Device Manufacturers by a Quality Professional
----------------------------------------

Stop building your FMEA program from scratch. This complete, review-ready
kit gives your Quality and R&D teams everything they need to run a
defensible FMEA program the first time. from procedure through training
deck through control plan traceability.

Aligned with: ISO 13485:2016 · FDA 21 CFR Part 820 · ISO 14971:2019 ·
AIAG-VDA FMEA · IEC 62366-1 (Use FMEA)

----------------------------------------
📦 WHAT'S INCLUDED. 11 DOCUMENTS
----------------------------------------

📄 QA-FMEA-001 | FMEA Procedure (SOP). Word
Full standard operating procedure covering scope, roles, rating
scales, 6-step process, records requirements, and approval signatures.

📊 QA-FMEA-002 | Design FMEA (DFMEA) Worksheet. Excel
30 data rows, auto-calculating RPN and Action Priority formulas,
color-coded risk scale, data validation (1-10), and a complete Rating
Scales reference tab built into the same workbook.

📊 QA-FMEA-003 | Process FMEA (PFMEA) Worksheet. Excel
Process-specific column structure (process step, process function)
with the same auto-calculating RPN, AP formulas, and data validation.

📊 QA-FMEA-004 | RPN Scoring Guide + Interactive Calculator. Excel
Full Severity, Occurrence, and Detection reference tables on one
sheet. Separate interactive calculator tab. enter S, O, D and
instantly see your RPN and Action Priority.

📊 QA-FMEA-005 | Action Item Tracking Log. Excel
50-row log with auto-generated action IDs, status dropdown
(Open / In Progress / Completed), revised RPN formulas, and a
Dashboard summary tab showing open vs. closed counts at a glance.

📄 QA-FMEA-006 | FMEA Training Guide. Word
8-chapter guide covering FMEA concepts, all three rating scales,
RPN methodology, the 8-step process, a worked catheter hub DFMEA
example, common mistakes, and a conformance matrix.

📄 QA-FMEA-007 | FMEA Summary Report Template. Word
Executive-level report template with risk statistics tables, top 10
risk items summary, open action item tracker, risk acceptance
statement, and approval signature block.

📑 QA-FMEA-008 | FMEA Training Deck. PowerPoint
14-slide professional presentation with navy/gold branding covering
FMEA types, rating scales, RPN calculation, the 8-step process,
worked example, and a completion checklist slide.

📊 QA-FMEA-009 | Use FMEA Worksheet. Excel
IEC 62366-1 aligned worksheet for human factors and use error
analysis. Includes dropdown menus for Use Error Category (8 types)
and Hazard Category (10 types), plus a reference tab.

📊 QA-FMEA-010 | Control Plan Linkage Matrix. Excel
Links every FMEA failure mode directly to its control plan entry,
inspection method, sample size, frequency, acceptance criteria, and
verification record. Traceability from risk to control in one view.

📄 QA-FMEA-011 | Quick Reference Card. Word
Landscape one-pager. All three full S/O/D rating scales, the 8-step
process, and a 15-point completion checklist. side by side for
posting in your team's workspace or including in training folders.

----------------------------------------
✅ WHY THIS PACKAGE WORKS
----------------------------------------

✔ Built by a working Director of Production in medical device
manufacturing. not a generic template mill
✔ All four FMEA types covered: Design, Process, System, and Use
✔ Consistent navy and gold professional branding throughout
✔ Excel formulas are live. RPNs and Action Priority calculate
automatically as you fill in S, O, D values
✔ Author/creator metadata set to "Operational Playbook" on every file
✔ Compatible with Microsoft Office 365, Office 2016+, and LibreOffice

----------------------------------------
👥 WHO THIS IS FOR
----------------------------------------

→ Quality Assurance Managers and Engineers
→ R&D and Design Engineers conducting DFMEAs
→ Manufacturing Engineers running PFMEAs
→ Regulatory Affairs professionals building Technical Files or 510(k)s
→ Medical device startups building their QMS from scratch
→ Quality consultants supporting multiple clients
→ ISO 13485 or FDA QSR auditors needing conformance-aligned examples

----------------------------------------
📥 INSTANT DOWNLOAD DETAILS
----------------------------------------

- Delivered as a ZIP file containing all 11 documents
- Available immediately after purchase. no waiting
- Formats: .docx (Word), .xlsx (Excel), .pptx (PowerPoint)
- Replace all bracketed placeholders [ ] with your company's
information before first use
- No subscription needed. Works in the desktop apps you already own
- Personal or organizational use. one purchase, one organization

----------------------------------------
⚠️ PLEASE NOTE
----------------------------------------

Due to the digital nature of this product, all sales are final.
If you have a question about fit before purchasing, please message
the shop. happy to answer.

These templates are starting frameworks. Your organization remains
responsible for validating all content against your specific
regulatory requirements, device classification, and QMS procedures.

Pair this with the regulated-niche sister sku.

The CAPA Quality System Template Pack (in this same shop) is the corrective-action side of the same Quality Systems framework. FMEA identifies failure modes before they happen, CAPA handles the investigation and corrective action when one slips through. Same regulated-industry environments, same documentation discipline, complementary use cases.

For the document-control layer that sits above both, see the Document Control System Template Pack (in this same shop), master document register, change request workflow, training matrix, the records framework your FMEA and CAPA outputs live inside.