Risk Management Basics : Protecting Profits and Product Safety in Medical Product Industries Through Risk-Based Decision-Making in Change Control, Deviation Investigations and Corrective/Preventative Action Programs

by Desain, Carol; Sutton, Charmaine Vercimak

• ISBN13: 9780929870557
• ISBN10: 0929870557
• Format: Paperback
• Copyright: 2000-11-01
• Publisher: Advanstar Marketing Services
• More Book Details
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Table of Contents

Introduction	1	(6)
Section I - Determining Risk For Products And Processes During Development
Product Risk Analysis	7	(18)
Risk Analysis in the Product Lifecycle	8	(1)
Performing Product Risk Analysis	8	(2)
Severity and Probability Rankings	10	(1)
Risk Level Matrix	10	(2)
Product Hazard Identification and Severity Ranking Assignment	12	(1)
Cause Identification and Probability Ranking Assignment	13	(2)
Overall Risk Assignment	15	(1)
The Product Risk Analysis Report	16	(1)
Routine Use of the Risk Analysis Report	16	(2)
Risk minimization during product development	16	(1)
Risk-based decision making during routine operations	17	(1)
Risk-based decisions when product and process changes are proposed	17	(1)
Keeping the Risk Analysis Report Current	18	(1)
Retrospective Risk Analysis	18	(1)
Product and Process Risks	19	(6)
Product Risk Analysis Report	21	(1)
Phase II: Bottom-Up Risk Analysis Table	22	(3)
Process Hazard Analysis And Critical Control Point Identification	25	(10)
HACCP	26	(1)
Process Control Points vs. Critical Control Points	27	(1)
Performing Process Hazard Analysis and Critical Control Point Identification	27	(1)
Critical process identification	27	(2)
Critical process hazard analysis and critical control point determination	28	(1)
Support process hazard analysis and CCP identification	29	(1)
Process flow hazard analysis and CCP identification	29	(1)
Essential Control Points: An Opportunity	29	(1)
Control Point Limits	30	(1)
Process Validation	30	(1)
Identification of CCPs and ECPs in Routine Processing	30	(5)
Process Control Point Evaluation Record	31	(4)
Section II - Risk Management System Basics
Risk-Based Decision Making For Information Monitoring Programs In Operations	35	(16)
Types of Information Monitoring Programs	37	(1)
Monitoring Control Standards: Distinguishing Data-of-Compliance from Data-of-Exception Observations	38	(1)
Data-of-Exception Observations: Preliminary Investigation Requirements	39	(2)
Confirmation	39	(1)
Triage	40	(1)
Preliminary investigation records and notification	41	(1)
Information Monitoring Program Development	41	(2)
Normal operating conditions, alert limits, action limits, and specifications	43	(1)
Information Monitoring Program Implementation, Training, and Data Entry Management	43	(1)
Data-of-Compliance Trending	44	(7)
Out-of-Specification Result Observation and Preliminary Investigation Record	45	(2)
Environmental Monitoring Program Document Example	47	(4)
Risk-Based Decision Making For Post-market Feedback Information Monitoring Programs	51	(12)
Monitoring Programs for Post-Market Feedback Information	52	(2)
Complaint monitoring for adverse events	52	(2)
Preliminary Evaluation of Complaints	54	(3)
Complaint review and information gathering	54	(1)
Complaint triage	55	(2)
Decision trees	57	(1)
Preliminary evaluation records and notification	57	(1)
Action Implementation	57	(1)
Actions Taken Before Investigations Are Complete	57	(1)
Trending Data-of-Exception and Data-of-Compliance Observations	58	(1)
Actions Taken in the Market	58	(1)
Risk Analysis Updates with Post-Market Information	59	(4)
Decision Record: Data-of-Exception Observations from Post-Market Feedback Information	61	(2)
Risk-Based Decision Making In Formal Investigation, Action Identification, and Authorization	63	(18)
Formal Investigation Criteria	64	(1)
Formal Investigation Teams	64	(1)
Formal Investigation Team Meetings	65	(1)
The Formal Investigation Process	66	(15)
Investigation initiation and problem definition	66	(1)
Gathering of information for problem characterization	67	(1)
Determine and verify cause	68	(2)
Action analysis and action authorization	70	(1)
Action implementation and follow-up	71	(3)
Information Gathering for Investigations in Operations	74	(1)
Formal Investigation Record	75	(3)
Action Review Record	78	(1)
Regulatory Review Record	79	(2)
Risk-Based Decision Making In Action Implementation and Effectiveness Assessments	81	(8)
Action Planning	82	(2)
Direct action implementation	82	(1)
Action implementation planning	83	(1)
Action tracking records, logs, and notifications	83	(1)
When Action Is Required Before the Investigation Is Complete	84	(1)
Actions Required by Regulatory Authorities for Distributed Products	84	(5)
Action Implementation Planning Protocol	86	(3)
Section III - Managing For Safety And Profit
Why Things Go Wrong: Accident Theories In Innovative/Technologically Complex Industries	89	(12)
Types of Accidents	90	(2)
Accident Theories	92	(1)
High Reliability Theory Perspective on Organizations	93	(1)
Normal Accident Theory Perspective on Organizations	94	(1)
High Reliability vs. Normal Accidents	95	(1)
Accidents-of-Management	96	(3)
Normalization of deviance	96	(1)
Information reporting variables	97	(1)
Summit fever	98	(1)
Crisis and stress	99	(1)
Management Is Responsible for the Decision-Making Environment	99	(2)
Managing Risk-Based, Decision-Making Groups to Protect Profits And Product Safety	101	(18)
Segregation of Technical Risk-Based Decision Makers from Business Risk-Based Decision Makers	102	(2)
Symptoms of business culture dominance	103	(1)
Risk-Based Decision-Making Group Organization, Performance, Training, and Monitoring	104	(5)
Establish a clear, focused mission for the group	104	(1)
Establish work input, work flow, work conduct, and output criteria	105	(1)
Train and develop risk-based decision-making groups	105	(1)
Integrate information between risk-based decision-making groups	106	(1)
Monitor and control of group performance	107	(2)
Decision-Making Meeting Controls	109	(3)
Agenda consistency	109	(1)
Meeting notification and preparation requirements	110	(1)
Information quality, analysis, and presentation requirements	110	(1)
Rules of conduct	111	(1)
Rules for decision-making	111	(1)
Group leadership	112	(1)
Leadership from Management	112	(7)
Be an advocate for risk-based decision-making	112	(1)
Accept conflict and confrontation as essential to risk-based decision-making	113	(1)
Avoid cultures of blame	113	(1)
Know when to seize authority and when to let go	114	(1)
Consider the cultural influences beyond the corporation	115	(1)
Provide confidence and optimism	115	(1)
Stay connected	115	(1)
Monitor group performance	115	(2)
When management fails	117	(1)
The extra challenges of innovative technologies	117	(2)
Organizational Design: A New Approach	119	(18)
A New Organizational ``Chart''	120	(2)
People-Based vs. Function-Based Organizational Designs	122	(1)
Establish Functional Units-of-Operation for the Organization	123	(1)
Establish Roles and Responsibilities for Functional Units-of-Operation	124	(1)
Designate Authority and Responsibility	125	(1)
Managing the Responsible Worker	125	(12)
Business Units, Quality System Components, and Functional Units-of-Operation	127	(3)
Quality System Component Documents: Format and Content Guidelines	130	(1)
Example Quality System Component Document	131	(3)
Example Quality System Component Document	134	(3)
Glossary	137	(8)
Index	145