Risk Management Process

Cover

PLACE YOUR LOGO HERE

Risk Management Process

Customer : NAME OF CUSTOMER

Project : Project name
Project number : #

Processing information
Document Code 0815-Risk Version: 1.0
File: INSERT FILE NAME Author: Markus
Path: P:\INSERT PATH NAME

Responsible: Names: Date: Signature:

Author: Markus

Review: Thomas

Approval: Peter

Document ID: #
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 Risk Management Process
Reference Documents

References:

# Document ID-Number Version

1 User Requirement Specification 0815 1.0

2 Quality Project Plan 0816 1.0

LIST HERE ALL RELEVANT DOCUMENTS

# Document ID-Number Version

3 Functional Specifications 0817 2.1

4 Technical Specifications 9817 2.0

Document Section for "Action taken"

www.it-validation.eu

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 Risk Management Process
Modification List

List of Modifications:

Target
# Relevant ID (Function, Activity) Edited by version Date

Complete document Markus 1.0 1/1/2008

1
Initial generation

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 Risk Management Process
Introduction

Introduction

Structure of the Risk Management Process

Insert work steps:

Column Description

The following table states the details used for the assessment of the s-o-d ranking:
SOD Description
1
2
3
4
5

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 Risk Management Process
Risk Mgt. Process Map

Risk Process Map (ref. ICH Q9)

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Risk_Process

Risk Assessment Risk Control Risk Communication Risk Review

Current "After" Action Taken

techn
ical
Potential Effect(s) of
# Process Step Potential Failure Mode Potential Cause(s) Recommended Action Responsibility

Occurence

Occurence
Failure

Detection

Detection
Comment Comment

Severity

Severity
RPN 1

RPN 2
y/n

1 Example Process Step 1 Example Potential Failure Effect1 Cause 1

Mode1 5 4 2 40 N/A System Function: FS-0001 y System Vendor 5 2 2 20 N/A
2 Example Process Step 1 Example Potential Failure Mode Effect1 Cause 2
(Iterative, second step 1 5 2 2 20 N/A SOP "Handling of ....) n QA 5 2 1 10 N/A
example)
3 Example Process Step 1 Example Potential Failure Effect 2 Cause 1
Mode2 4 3 2 24 N/A System Function: FS-0002 y System Vendor 4 2 2 16 N/A
4 Example Process Step 2 Example Potential Failure Effect 3 Cause 3
Mode3 5 4 1 20 N/A SOP "Scale testing" n System Vendor 5 1 1 5 N/A
5 Retrieve Batch Data Loss of Data Lot Traceability Lost Back Up Process not System Function: FS-1000 (Backup
working 5 4 2 40 N/A y System Vendor and IT dept. 5 2 2 20 N/A
Function)
6 Retrieve Batch Data Loss of Data Lot Traceability Lost Back Up Process not
working 5 2 2 20 N/A SOP "Back Up" n QA / Training dept. 5 2 1 10 N/A
7 INSERT PROCESS STEP INSERT Insert Causes
4 4 3 48 N/A 4 4 3 48 N/A
8 INSERT PROCESS STEP INSERT Insert Causes
4 4 3 48 N/A 4 4 3 48 N/A
9 INSERT PROCESS STEP INSERT Insert Causes
4 4 3 48 N/A 4 4 3 48 N/A
10 INSERT PROCESS STEP INSERT Insert Causes
4 4 3 48 N/A 4 4 3 48 N/A

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Comments
I6: Markus Roemer:
RPN 1 to 18: Low
RPN 19 to 27: Medium
RPN 28 to 125: High

Q6: Markus Roemer:

RPN 1 to 18: Low
RPN 19 to 27: Medium
RPN 28 to 125: High

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 Action List (PM) Risk Communication and Project Management

Reference to
No. Recommended Action Action Type Responsibility Task Leader Project Plan
1 System Function: FS-0001 system function System Vendor name 1 WBS 89
2 SOP "Handling of ....) procedural - CustomerQA name 2 WBS 66
3 System Function: FS-0002 system function System Vendor name 3 WBS 88
4 SOP "Scale testing" procedural - CustomerSystem Vendor name 2 WBS 89
5 System Function: FS-1000 (Backup Function) system function System Vendor and IT dept. name 2 WBS 100
6 SOP "Back Up" procedural - CustomerQA / Training dept. name 5 WBS 001

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 Action List (PM) Risk Communication and Project Management

Comments
no comment
no comment
no comment
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Team Team members Task Leaders
Quality Management / Validation Tom asdf
Customer Jeff asdf
Quality Management / Validation Peter asdf
Release Manager Harry asdf
Development Jonathan asdf

Action Type
procedural - Supplier
procedural - Customer
system function
training
design modification

Audit Trail
Select Tools --> Track Changes
Select "Highlight Changes"
Select "new workbook"
Audit Trail is displayed as new workbook
Details on MS Excel
file location #N/A
Win Version Windows (32-bit) NT 5.01
Excel Version 20(Build:2)
Calculation mode Automatic