Quality planning, risk analysis, and compliance support
FMEA, DVP&R, inspection planning, and regulatory traceability. We build the documentation that connects your design to verification evidence and keeps auditors satisfied.
Request engineering supportProblems we solve
Quality documentation gaps create audit findings, customer complaints, and launch delays. We help teams get their verification story straight.
- FMEA is outdated or missing entirely
- Requirements aren't traced to verification activities
- Inspection plans don't match current drawing revisions
- Design changes bypass risk assessment
- Audit findings repeat because root causes aren't addressed
- Compliance documentation is scattered across systems
- Test coverage gaps discovered late in development
What you receive
Documented outputs that satisfy auditors and support your design release process.
FMEA worksheets
Design and Process FMEAs with severity, occurrence, and detection ratings. Action items tracked to closure.
DVP&R plans
Design Verification Plan & Report linking requirements to test methods, sample sizes, and pass/fail criteria.
Inspection plans
Receiving, in-process, and final inspection documentation with gauging requirements and acceptance criteria.
Compliance matrices
Traceability from regulatory requirements or standards clauses to design features and verification evidence.
Verification reports
Test results documentation with data, analysis, and conclusions supporting design release.
Our approach
Systematic process that builds traceability from requirements through risk analysis to verification.
Requirements review
We map your product requirements, regulatory obligations, and customer specifications to build a complete picture of what needs verification.
Risk analysis
Systematic identification of failure modes, their effects, and causes. We prioritize based on severity and detectability, not assumptions.
Verification planning
Define test methods, sample sizes, and acceptance criteria that demonstrate compliance. Link each requirement to its verification activity.
Documentation
Produce audit-ready deliverables that trace from requirement through risk analysis to verification evidence.
Standards we work with
Experience across automotive, aerospace, and medical device quality frameworks.
ISO 9001
Quality management systems requirements
IATF 16949
Automotive quality management system
AS9100
Aerospace quality management systems
FDA QSR (21 CFR 820)
Medical device quality system regulation
Representative engagements
Examples of quality and compliance challenges we've helped clients resolve.
Challenge
Product launch stalled due to incomplete PPAP documentation and unresolved FMEA action items.
Approach
Conducted gap analysis against IATF 16949 requirements. Updated DFMEA and PFMEA with current design. Created inspection plan aligned with control plan.
Outcome
PPAP package approved on resubmission. Customer audit completed without major findings.
Challenge
New product lacked traceability from requirements to test evidence. Certification audit approaching.
Approach
Built requirements traceability matrix linking specifications to design outputs. Developed DVP&R with clear pass/fail criteria. Executed verification testing.
Outcome
Certification audit passed. Verification package became template for subsequent products.
Common questions
What's the difference between DFMEA and PFMEA?
Design FMEA (DFMEA) analyzes potential failures in the product design itself. Process FMEA (PFMEA) analyzes failures that could occur during manufacturing. Both are typically required, and they should reference each other.
Can you update existing FMEAs or do you start from scratch?
We can work either way. If you have existing FMEAs, we review them against current design, update ratings, and address open actions. If starting fresh, we develop them in collaboration with your engineering team.
How do you handle multiple regulatory frameworks?
We create a unified compliance matrix that maps requirements from multiple standards. This avoids duplication while ensuring all frameworks are addressed. Common in automotive/aerospace crossover products.
Do you perform actual testing or just planning?
We focus on planning and documentation. For test execution, we can coordinate with your test lab or recommend qualified facilities. We then document results and conclusions.
What format do deliverables come in?
FMEAs typically in Excel or your preferred FMEA software format. DVP&R and inspection plans in Excel or your PLM template. Compliance matrices in a format that integrates with your requirements management system.
Need help with quality documentation?
Tell us about your compliance challenge. We'll review your requirements and outline a clear path forward.
Request engineering support