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Process Risk Assessment Model. Robert C. Menson, PhD. What Risks Must Be Managed?. Risk to safety of patients, users, handlers. Business. Regulatory. Product liability. Intended Use/Intended Purpose.

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process risk assessment model

Process Risk Assessment Model

Robert C. Menson, PhD

what risks must be managed
What Risks Must Be Managed?

Risk to safety of

patients, users, handlers



Product liability

intended use intended purpose
Intended Use/Intended Purpose
  • Use of a Product, Process or Service in accordance with the specifications, instructions and information provided by the manufacturer

ANSI/AAMI/ISO 14971:2000, definition 2.5

pat process analytical technologies
PAT(Process Analytical Technologies)
  • Systems for the analysis and control of manufacturing processes based on timely measurement during procession of critical quality parameter and performance attributes of raw and in-process materials and processes, to assure acceptable end-product quality at the completion of the process.

FDA Subcommittee on PAT Proposed Definition

elements of the risk management process


Elements of the Risk Management Process
  • Risk Analysis
  • Risk Evaluation
  • Risk Control
  • Post-Production Information


risk assessment tools
Risk Assessment Tools
  • Risk Matrix
  • PHA= Preliminary Hazard Analysis
  • FTA=Fault Tree Analysis
  • FME(C)A=Failure Mode Effects (Criticality) Analysis
  • HAZOP=Hazard Operability Analysis
  • HACCP=Hazard Analysis and Critical Control Point
hazop model





Design Statement




haccp hazard analysis and critical control point
HACCPHazard Analysis and Critical Control Point
  • Risk Management System
    • Biological Hazards
    • Chemical Hazards
    • Physical Hazards
  • Requires
    • Prerequisite Quality System Program
    • Traditionally GMPs
risk assessment process

Map Process

1. Risk


2. ECP


3. ECP

Review Matrix

4. ECP

Action Plan

Risk Assessment Process
create sod tables
Create SOD Tables
  • Severity (S)
    • Link to end product functional failure
    • Medical Department involvement
  • Occurrence (O)
    • Use historical data
    • Similar processes products
  • Detection (D)
    • Method validation studies
    • Historical data
evaluation rules
Evaluation Rules
  • Concept of ECP:
    • A process that is in control ( i.e. does not produce significant defects) but is very difficult to verify by testing.
    • The corollary is a process with a "high" level of defects that can be detected before shipment to the end user.
  • If (S) >5 and (D) or (P) >5 then an ECP is assigned.
step 1 identify risks using process map

Risk Assessment Document

Step 1: Identify Risks Using Process Map
  • Convene participants from all relevant areas (Production, QA, QC, Packaging…)
  • Identify and rate failure modes for each process step by severity, probability, and detection
  • Assign Essential Control Points (ECP) based on ratings

Robert C. Menson, PhD 18

step 2 identify key elements of ecps

Risk Assessment Document

ECP Plan Document

Step 2: Identify key elements of ECPs
  • Migrate ECPs from Risk Assessment to ECP Plan
  • Collect relevant Information (SOP#s, Equipment used, Training documents…)
  • Assign process drivers/ owners for each ECP in the Plan

Robert C. Menson, PhD 19

step 3 compile risk review matrix

ECP Plan Document

Risk Review Matrix

Step 3: Compile Risk Review Matrix
  • Break each ECP into review tasks based on SOP’s, trainings, and other documents
  • Each item # created is a distinct action item

Robert C. Menson, PhD 20

step 4 create remedial action plan

Risk Review Matrix

Step 4: Create Remedial Action Plan
  • Prioritize each item # and assign responsibilities and completion dates
  • Track items to completion

Robert C. Menson, PhD 21