Are you managing your Risk down to the Wire, Hire, Product or Word? Start your Risk Ledger by vising DefineTheBox a Layer1holdings.com/CRM
User Required Specifications are determined on a project-by-project basis.
Failure Mode Effect Analysis Types
FMEA-#####
Business (B-FMEA)
Device (D-FMEA)
Process (P-FMEA)
User (U-FMEA)
An excel spreadsheet is great to start a project, but the business should be retaining a Living List of Risks that could Result in the business’s Failure to Meet its Customer’s needs.
Check out our database and CRM for storing project assets as Customer centers down to the wire and registry of code Layer1holdings.com/CRM
URS-##### User Required Specifications
What’s the fastest way to generate a User Requirement? Perform a Failure Mode Effect Analysis that describes not servicing the customer.
Design the action plan to decrease risks of this failure ocurring.
Business Failure Mode Effect Analysis
BFMEA is a sublist of risks specifically affecting the business by means of customer quality impacting brand to supply chain and profitability. The BFMEA is the active list of known risks and the mitigation plan to address the risk within the User Requirements
Device Failure Mode Effect Analysis
DFMEA is a sublist of risks specifically focused on the individual devices and their failure risk identifications to personnel safety, Lead to impacts of Process Failure, Lead to a risk of Supply Chain Business Failure Modes leading to new
Refer to the manufacture hardware specifications for maintenance specifications
suppliers’ products are reviewed by physical testing during First Article Checkout of suppliers’ products Periodic review of product performance feedback is incorporated into part selection back to the User Requirements
| Severity | 1 | 2 | 3 | 4 | 5 | |||||||||||||||||||||
| Occurrence | 1 | 2 | 3 | 4 | 5 | 1 | 2 | 3 | 4 | 5 | 1 | 2 | 3 | 4 | 5 | 1 | 2 | 3 | 4 | 5 | 1 | 2 | 3 | 4 | 5 | |
| DFMEA Risk Level | R1 | R1 | R1 | R2 | R2 | R1 | R1 | R2 | R2 | R3 | R1 | R2 | R2 | R3 | R4 | R1 | R2 | R3 | R4 | R4 | R2 | R3 | R4 | R4 | R4 | |
Process Failure Mode Effect Analysis
PFMEA is a Sub list of risks specifically focused on the Process failure modes and their identifications to personnel safety, risks to supply chain, business failure modes and even Causes to Device failure Modes.
User Failure Mode Effect Analysis
Informs the requirements for creating standard operating procedures
Training should not be the only tool to keep operators safe, a training requirement can only reduce severity, occurrence or detection by 1 degree, when additional risk reductions are needed it can be addressed by alternative solutions by adding an additional user requirement or with two person authentication
Risk Metrics
Severity
Severity: The severity of a problem is the degree of harm it can cause.
Occurrence
Occurrence: The occurrence of a problem is the frequency with which it occurs.
Detection Level
Detection: Detection is the process of identifying a problem. It can involve using various methods such as monitoring, testing, and analysis.
Risk Matrix
A risk product number is a numerical value that is used to measure the overall risk associated with a particular activity or situation. It is calculated by multiplying the severity of the risk, the occurrence of the risk, and the frequency of the risk. The higher the risk product number, the greater the risk associated with the activity or situation.
Schedule a screening for Failure Mode Effect Analysis
Common Stake Holders
Department Supervisor/Operations
Department Manager
Department Maintenance Representative
Department Operations Technician
Department Quality Manager
Department Safety Representative
After Collecting the Process, Device and Business Risks, a resulting indexed set of Action Plans must be maintained to address Risk
