Module 7: Risk analysis, FMEA & HACCP

MODULE

7
RISK ANALYSIS
FMEA and HACCP

Taiwan PDA Training - Simon Rusmin, Aug 2006

 Module 7: Risk analysis, FMEA & HACCP

Risk and Mitigation

 What are  How to
the risks in mitigate the
fetching risks?
the cat?

Taiwan PDA Training - Simon Rusmin, Aug 2006

 Module 7: Risk analysis, FMEA & HACCP

Risk Management
STEP 1- RISK ASSESSMENT
 What might go wrong? (Risk identification)
 What is the likelihood it will go wrong? (Risk Analysis)
 What are the consequences and how severe? Could we know
of the risk? (Risk Evaluation)

STEP 2: RISK CONTROL

 Is the risk acceptable? (Risk Acceptance)
 If not what can we do to make it acceptable? (Risk Reduction)

STEP 3: RISK COMMUNICATION & REVIEW

 Who need to know about the Risk Assessment and Control?
(Risk Communication)
 Will the situations change later? (Risk Review)

Taiwan PDA Training - Simon Rusmin, Aug 2006

 Module 7: Risk analysis, FMEA & HACCP

ICH Q9 Quality Risk Management

1. Introduction
2. Scope
3. Principles of Quality Risk Management
(QRM)
4. Quality Risk Management Process
5. Risk Management Tools
6. Integration of QRM process into Industry
and Regulatory Operations
7. Glossary
8. References

Taiwan PDA Training - Simon Rusmin, Aug 2006

 Module 7: Risk analysis, FMEA & HACCP

What is Risk, for Whom, & How

DEFINITION (modified from ICH Q9)
 RISK is the probability of harms to happen.
 STAKEHOLDER is the object/person effected by harms.
 RISK MANAGEMENT is to understand risk and to mitigate
the risk to an acceptable level.

PRINCIPLE of QUALITY RISK MANAGEMENT (from ICH Q9)

 Quality risk management should be based on scientific
knowledge.
 The ultimate goal is to protect the patients.
 The level of efforts should be commensurate with the
level of risks.

Taiwan PDA Training - Simon Rusmin, Aug 2006

 Module 7: Risk analysis, FMEA & HACCP

Taiwan PDA Training - Simon Rusmin, Aug 2006

 Module 7: Risk analysis, FMEA & HACCP

US-FDA Risk Management Initiatives

 Product Development & Manufacturing
● Risk-based to Current Good Manufacturing Practice
● Process Analytical Technology
● Risk-based New Product Application (CMC)
● Risk-based Site Selection for Premises Inspection

 Clinical Study and Drug Safety

● Pre-marketing Risk Assessment
● Development of Risk Minimization Action Plans
(RiskMap)
● Good Pharmaco-vigilance and Pharmaco-epidemiological
Assessment

Taiwan PDA Training - Simon Rusmin, Aug 2006

 Module 7: Risk analysis, FMEA & HACCP

Risk Management in
non-pharma Industry
 In non-pharmaceutical industry, competition is very
high: Customer demands constantly change and new
products are developed fast.
 New Product strategy integrates with customers
requirements, long term sales, product/process
designs, process improvement, marketing and customer
services to assure customer satisfaction.
 The final objectives of the above activities are fulfilling
customer needs with high quality products and services.
 RISK MANAGEMENT is built into all these activities.
 The non-pharmaceutical quality system is referred to as
the “modern” quality system in the 21th Century
initiative.
Taiwan PDA Training - Simon Rusmin, Aug 2006
 Module 7: Risk analysis, FMEA & HACCP

Risk Analysis in Continuous Improvement

 Continuous improvement mechanism is solving

problems* (problem statement, cause of problem, finding
solution, implementing solution, evaluate results).
 Tools in finding causes of problems (brainstorming,
process mapping, cost-benefit analysis, force field analysis, pareto
chart, fishbone diagram)
 Tools of risk analysis (PHA, HAZOP, FTA, FMEA, FEMECA,
HACCP)
 Results of Risk Analysis are used to improve
process and to set up control to prevent further
problems. (control points, control methods – SOPs)

* A problem is “I cannot get what I want”

Taiwan PDA Training - Simon Rusmin, Aug 2006

 Module 7: Risk analysis, FMEA & HACCP

Taiwan PDA Training - Simon Rusmin, Aug 2006

 Module 7: Risk analysis, FMEA & HACCP

FMEA
 FMEA (Failure Mode and Effect Analysis) is an engineering
technique used to define, identify, and eliminate potential
failures, problems, error etc from design, system, process,
and services before reaching the customers.

 Process of conducting FMEA

● Analyze process steps (process mapping).
● Describe desired quality characteristics of output at each step.
● Identify known or potential failures to fulfill the desired.
● Prioritize according to Risk Priority Number = failure’s
(frequency of occurrence) X (severity of consequence) X
(difficulty of detection) -using values from 1 to 10 for each.
● Follow up with corrective and preventative actions.

 FMEA is applied to Product Design, Process Design,

Processing, and Servicing the Customers.

Taiwan PDA Training - Simon Rusmin, Aug 2006

 Module 7: Risk analysis, FMEA & HACCP

Ranking of Risks
Rank OCCURANCE SERVERITY DETECTION

1 Almost never No effect Almost certain

2 Remote Very slight effect Very high
3 Very slight Slight effect High
4 Slight Minor effect Moderately high
5 Low Moderate effect Medium
6 Medium Significant effect Low
7 Moderately high Major effect Slight
8 High Extreme effect Very slight
9 Very high Serious effect Remote

Almost certain Hazardous effect Impossible

10

Taiwan PDA Training - Simon Rusmin, Aug 2006

 Module 7: Risk analysis, FMEA & HACCP

Extreme Ratings


Taiwan PDA Training - Simon Rusmin, Aug 2006

 Module 7: Risk analysis, FMEA & HACCP

FMEA Generic Form

Taiwan PDA Training - Simon Rusmin, Aug 2006

 Module 7: Risk analysis, FMEA & HACCP

HACCP
 HACCP= Hazard Analysis & Critical Control Point

 First used by Pillsbury in the early 1970s to achieve

high assurance of food quality for the space
program.
 In 1987 the NACMCF * was formed, advising the
use of HACCP. * National Advisory Committee on Microbial
Criteria for Foods.
 Now, HACCP regulation has been adopted by the
FDA and USDA for food processing (Equivalence to
CGMP).

Taiwan PDA Training - Simon Rusmin, Aug 2006

 Module 7: Risk analysis, FMEA & HACCP

Seven Principles of HACCP

HACCP is a systematic approach to the
identification, evaluation, and control of food safety
hazards based on the following seven principles:

1. Conduct hazard analysis

2. Determine the critical control points (CCPs)
3. Establish critical limits (i.e. specifications)
4. Establish monitoring procedures
5. Establish corrective actions
6. Establish verification procedures (i.e. auditing)
7. Establish record-keeping and documentation
procedures

Taiwan PDA Training - Simon Rusmin, Aug 2006

 Module 7: Risk analysis, FMEA & HACCP

Seven-Step HACCP -1
 Conduct a hazard analysis. Prepare a list of steps in
the process where significant hazards can occur
and describe the preventive measures.
 Identify the Critical Control Points (CCPs) in the
process.
 Establish critical limits for preventive measures
associated with each identified CCP.
 Establish CCP monitoring requirements. Establish
procedures for using the results of monitoring to
adjust the process and maintain control.

Taiwan PDA Training - Simon Rusmin, Aug 2006

 Module 7: Risk analysis, FMEA & HACCP

Seven-Step HACCP -2
 Establish corrective actions to be taken when
monitoring indicates that there is a deviation from
an established critical limit.
 Establish effective record-keeping procedures that
document the HACCP system.
 Establish procedures for verification that the
HACCP system is working correctly.

Taiwan PDA Training - Simon Rusmin, Aug 2006

 Module 7: Risk analysis, FMEA & HACCP

Implementing HACCP

 In the food industry HCCP is implemented fully to be in

compliance with regulations. It is integrated into the
overall quality management system.
 The steps are:
● Define the products to be analyzed..
● Create production process flow chart.
● Perform Hazard Analysis for each step of the process &
define whether the step is Critical Control Point (CCP) –
Worksheet-1
● Establish control method of each CCP, and
● Design the program for Monitoring and Auditing each
CCP – Worksheet-2

Taiwan PDA Training - Simon Rusmin, Aug 2006

 Module 7: Risk analysis, FMEA & HACCP

HACCP Worksheet - 1

Taiwan PDA Training - Simon Rusmin, Aug 2006

 Module 7: Risk analysis, FMEA & HACCP

HACCP Worksheet -2

Taiwan PDA Training - Simon Rusmin, Aug 2006

 Module 7: Risk analysis, FMEA & HACCP

HACCP Application in
Pharmaceutical Manufacturing
 HACCP is applicable to pharmaceutical
manufacturing, especially for microbiological
contamination hazard to provide a knowledge-base
for designing microbial contamination controls
 The HACCP program can be comprehensive by
evaluating the whole manufacturing operation, or
specific by implementing only on specific
operations.
 The program requires a knowledgeable
microbiologist to perform the evaluation of
microbial contamination hazards.

Taiwan PDA Training - Simon Rusmin, Aug 2006

 Module 7: Risk analysis, FMEA & HACCP

Example
 Study manufacturing flow chart and facility design
layout drawings.
 Visit the sites where the process steps are
conducted and observe the operations.
 Identify known or potential hazards of microbial
contamination contributed by:
● Design and construction of the facility and
equipment
● Operations performed by machines and
● Operations performed by persons.
 Score each hazard contributed by the three sources
as: 0 =no hazard, 1 = slightly hazardous, 2 =
hazardous, 3 = very hazardous.
 Plan for corrections/modification, adding control
measures, or training of personnel.
Taiwan PDA Training - Simon Rusmin, Aug 2006
 Module 7: Risk analysis, FMEA & HACCP

Example Worksheet

Taiwan PDA Training - Simon Rusmin, Aug 2006