Quality Plan

Customer:
ACME Inc.
Document code:
Project:
Prototype
Revision:
Order number:
#0123456 date 01 June 2007
Date:
PR0001 QP
1.4
16 August 2008
Quality Plan / Project Plan

Model
Description
Serial N
PROT
A simple prototype
001/2008
Document approval :
Editor:
Company Name
Responsibility
Name
Supplier
Area Sales Manager
A. Smith
Supplier
Quality Assurance Manager
R. Green
Customer
Project engineer
M. Brown
Customer
Project quality assurance
E. Scott
Date
F. Piraneo G.
Issued by: IFACE Industrial Automation Morbio Inferiore, Switzerland.

This document contains a Front Cover and 22 pages and two appendices.
Signature
Quality plan / Project plan
Machine Model
PROT
Page 1 of 22
Document PR0001 QP
Serial Number 001/2008

Customer ACME Inc.
Date 16 August 2008

Version 1.4
Table of contents
1. INTRODUCTION........................................................................................................................................................ 2
2. REVISION HISTORY................................................................................................................................................... 3
3. OVERVIEW............................................................................................................................................................. 4
3.1. LINE OVERVIEW.................................................................................................................................................................... 4
4. QUALITY PLAN......................................................................................................................................................... 5
4.1. CUSTOMER QUALITY REQUIREMENTS.......................................................................................................................................... 5
4.2. SUPPLIER QUALITY SYSTEM..................................................................................................................................................... 5
4.2.1. G UIDELINES COMPLIANCE........................................................................................................................................................................5
4.2.2. I NTERNATIONAL AND LOCAL STANDARDS COMPLIANCE......................................................................................................................................5
4.2.3. Q UALITY RESPONSIBILITIES...................................................................................................................................................................... 6
4.2.4. RESPONSIBILITIES................................................................................................................................................................................. 6
5. PROJECT PLAN......................................................................................................................................................... 7
5.1. PROJECT ORGANIZATION......................................................................................................................................................... 7
5.1.1. S UPPLIER PROJECT TEAM........................................................................................................................................................................7
5.1.2. CUSTOMER PROJECT TEAM......................................................................................................................................................................7
6. DOCUMENTATION..................................................................................................................................................... 9
6.1. ACME INC. REFERENCE DOCUMENTATION.................................................................................................................................... 9
6.2. SUPPLIER ISSUED DOCUMENTATION............................................................................................................................................ 9
7. DEVELOPMENT TOOLS............................................................................................................................................. 12
8. PROJECT HANDLING................................................................................................................................................ 13
8.1.1. P ROJECT PHASES............................................................................................................................................................................... 13
8.1.2. I NPUT AND OUTPUT CRITERIA................................................................................................................................................................. 15
8.2. CHANGES......................................................................................................................................................................... 16
8.3. PROJECT MILESTONES......................................................................................................................................................... 16
9. SOFTWARE CONFIGURATION MANAGEMENT.................................................................................................................... 18

9.1. DEFINITION....................................................................................................................................................................... 18
9.2. PURPOSES....................................................................................................................................................................... 18
9.3. SOFTWARE PRODUCTION IN SUPPLIER..................................................................................................................................... 18
9.4. CONFIGURATION IDENTIFICATION AND STATUS ACCOUNTING............................................................................................................ 18
9.4.1. P ROGRAM IDENTIFICATION..................................................................................................................................................................... 18
9.4.2. S OFTWARE MODULE IDENTIFICATION.........................................................................................................................................................19
9.5. CONFIGURATION CONTROL.................................................................................................................................................... 19

9.6. REVIEW........................................................................................................................................................................... 20
9.7. SOFTWARE REVISION CONTROL.............................................................................................................................................. 20
9.7.1. DEFECTS FOUND ON SOFTWARE............................................................................................................................................................. 20
9.7.2. FEATURES THAT HAS TO BE ADDED OR ERASED ON SOFTWARE....................................................................................................................... 20
10. ENCLOSURES...................................................................................................................................................... 22
10.1. SOFTWARE REVISION REQUEST FORM ISSUED BY SUPPLIER....................................................................................................... 22
10.2. SOFTWARE FEATURE REQUEST FORM ISSUED BY SUPPLIER....................................................................................................... 22
ACME Inc. - Good Sunshine Blvd. - Los Angeles, CA USA Phone: +1.123.987.4567 Fax: +1.123.987.4568
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Page 2 of 22
Document PR0001 QP
Date 16 August 2008
Customer ACME Inc.
Version 1.4
1. INTRODUCTION
This Quality Plan/Project Plan has been produced for ACME Inc. by IFACE.
The purpose of the plan is to define the quality requirements of the project, the responsibilities and the procedures applied
by Supplier in order to satisfy the requirements of ACME Inc., CA.
This document conforms to Pharmaceutical Industry GAMP 4 Supplier Guide Procedure for the Production of a Quality and
Project Plan.
The plan covers the activities performed by Supplier for the manufacturing and validation of the following machines:
Item
Machine type
Model
Machine serial number
A simple prototype
PROT
001/2008
All the above items will be further referred as: machine.
Machine Model
PROT
Page 3 of 22
Document PR0001 QP
Date 16 August 2008
Customer ACME Inc.
Version 1.4
2. REVISION HISTORY
Revision
Issue date
Description / Changes
Draft A
14 October 2007
1.0
23 January 2008
1.1
07 Supplierch 2008
1.2
06 May 2008
Updated serial number;
1.3
05 June 2008
Chapter 6.2 point 17 changed Disaster recovery to Backup and disaster

recovery;
1.4
16 August 2008
First draft release;
Removed references to Siemens PLC on Configuration management;

In development tool changed RS View 32 in RS View Studio;
Changed appendices numbers;
Version 1.4 notes;
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Customer ACME Inc.
Page 4 of 22
Document PR0001 QP
Date 16 August 2008
Version 1.4
3. OVERVIEW
[Suppressed]
The machine will be controlled by an Allen Bradley PLC supported by adequate HMI both interfaced with department wide
SCADA (not supplied by Supplier). Details can be found on hardware design specification documents.
Note the following:
1. [Suppressed];
3.1. LINE OVERVIEW

For a machine overview, please review the last version of the line layout document 1234-13.
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Document PR0001 QP
Date 16 August 2008
Customer ACME Inc.
Version 1.4
4. QUALITY PLAN
4.1. CUSTOMER QUALITY REQUIREMENTS
ACME requires that all automated systems, which affect regulatory compliance of their production process, must be
validated.
Supplier will carry out the activities detailed in this plan in order to produce sufficient documented evidence that the system
will consistently meet its predetermined specifications and quality attributes.
The pharmaceutical industry standard life-cycle model for the production of the control system includes the following phases:
Definition of requirements;
Supplier assessment;
Production and approval of validation plans;
Agreement of project and quality plans with the client, covering:
specification;
design;
supplier internal testing;
acceptance testing;
procedure definition;
Review and approval of documentation and evidence produced;
Sign-off and acceptance of the system as validated.
4.2. SUPPLIER QUALITY SYSTEM

For the manufacturing of the line the procedures documented on Supplier's quality manual will be applied:
Document code: MANQ01.01
Issue: 30.04.02
Revision: 1
4.2.1. GUIDELINES COMPLIANCE
Supplier will comply with the following guideline during their validation activities:
ISPE GAMP-4;
FDA regulations and current GMP guide lines.
The relevant procedures included in the GAMP-4 guideline are listed below:
Quality and project planning: Appendix M6
Production of a Functional Specification: Appendix D2
Testing of an automated system: Appendix D6
Production of software / module design specification: Appendix D4
Guidelines for document management: Appendix M10
4.2.2. INTERNATIONAL AND LOCAL STANDARDS COMPLIANCE
Manufactured machines will be compliant to the following standards:
Standard
Jurisdiction
73/23/EC
European Directive
Description
Low voltage compliance
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Customer ACME Inc.
Version 1.4
Standard
Jurisdiction
Description
89/336/EC
European Directive
Electromagnetic compatibility
Machinery
98/37/EC
European Directive
21 CFR 211.63
US federal law
Equipment design, size and location
21 CFR 211.68
US federal law
Automatic, mechanical and electronic equipment
NFPA70
US Standard
National electrical code
4.2.3. QUALITY RESPONSIBILITIES

The Project Manager of Supplier will ensure the implementation of this Quality Plan/Project Plan by Supplier.
4.2.4. RESPONSIBILITIES
See section 5.1.1 Supplier project team.
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Customer ACME Inc.
Version 1.4
5. PROJECT PLAN
5.1. PROJECT ORGANIZATION
5.1.1. SUPPLIER PROJECT TEAM
The roles of the project team members qualified to the job for Supplier are as follows:
Company
Name
Function
Reference
Person Name
Responsibility
Supplier
General Manager
GM
[Suppressed]
Approbation of contractual and economical feature

of the furniture.
Supplier
Project Manager
PM
[Suppressed]
Report to GM of contractual and economical

features of the furniture;
Interface between Supplier and ACME's team;

Report to ACME project's status;
Interface between Supplier mechanical / electrical
engineering teams and ACME;
Supplier
Mechanical Engineer
ME
[Suppressed]
Report to PM about the mechanical work-inprogress;
Manage the mechanical engineering team;

Approbation of mechanical design of the machines;
Interface between mechanical engineering team
and manufacturing team;
between mechanical
engineering teams;
Interface
Supplier
Automation Dept.
Manager
ADM
[Suppressed]
and
electrical
Report to PM about the electrical and software

work-in-progress;
Manage the electrical engineering team;

Manage the software engineering team;
Approbation of electrical and software design of the
machines;
Interface
between
engineers teams;
Supplier
Electrical Engineer
EE
[Suppressed]
mechanical
and
electrical
Report to ADM about the electrical work-inprogress;
Issue electrical schematics;

Perform electrical acceptance tests;
Supplier
Automation Engineer
AE
[Suppressed]
Report to ADM about the software work-in-progress;

Design and test of all software aspects of the
machines;
Assist to FAT and SAT phases;

Supplier
Quality Assurance
QA
[Suppressed]
Supplier
Editor
[Suppressed]
Approbation of all quality related documentation;

Superintend to all quality related aspects of the
manufacturing of the machine;
Report to PM about the documentation related

work-in-progress;
Issue of all project's documentation;

5.1.2. CUSTOMER PROJECT TEAM
Company Name
[Suppressed]
Responsibility
Project engineer
Person Name
[Suppressed]
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Document PR0001 QP
Date 16 August 2008
Customer ACME Inc.

Company Name
Page 8 of 22
Version 1.4
Responsibility
Person Name
[Suppressed]
Validation engineer
[Suppressed]
[Suppressed]
Project QA
[Suppressed]
ACME Inc.
Process equipment
[Suppressed]
ACME Inc.
QA
[Suppressed]
ACME Inc.
ETS
[Suppressed]
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Customer ACME Inc.
Version 1.4
6. DOCUMENTATION
6.1. ACME INC. REFERENCE DOCUMENTATION
Item
Document code
Rev
US1257-T-0B0382
04
[Suppressed]
Description
US1257-T-0A0507
03
[Suppressed]
US1257-T-090508
03
[Suppressed]
US1257-T-060509
03
[Suppressed]
US1257-T-030512
03
[Suppressed]
US1257-T-012345
02
Training policy
US1257-T-001984
01
[Suppressed]
US1257-T-001971
03
[Suppressed]
Deleted
N/A
Deleted
10
US1257-T-001969
03
[Suppressed]
6.2. SUPPLIER ISSUED DOCUMENTATION

The documentation will be issued on three sets following the logical grouping of the machines:
1.
First group;
2.
Second group;
3.
Third group.
Item
Document
Layout drawings and P&ID
including:
Equipment layout in
plan and side views;
Connection points for

all utilities, drain etc;
Interconnection for all

disciplines, electrical,
piping etc;
Equipment
dimensions and
machine feet layout;
Equipment load;
Utility and power;
Consumption (Peak
and mean values);
Cycle times;
Utility connections
type and dimension.
Issues
Support
ACME revision / approval request
One for the whole line
Electronic
Paper
Approval
Quality and project plan
Electronic
Paper
Approval
Functional design specification
One for each machine

group
Electronic
Paper
Approval
Hardware design specification

group
Electronic
Paper
Approval
Software module design

specification
Electronic
Paper
Approval
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Customer ACME Inc.
Version 1.4
Item
Document
Issues
Support
Software design specification

group
Electronic
Paper
Approval
Traceability matrix

group
Electronic
Paper
Review
Hardware acceptance test

specification

group
Electronic
Paper
Review
SW module test specification

group
Electronic
Paper
Review
10
SW integration test specification

group
Electronic
Paper
Review
11
System software acceptance

test specifications

group
Electronic
Paper
Review
12
FAT test protocol
Electronic
Paper
Approval
13
Software list

group
Electronic
Paper
Review
14
Instrument list

group
Electronic
Paper
Review
15
Historian tag list

group
Electronic
Paper
Review
16
Configuration management
Electronic
Paper
Review
17
Backup and disaster recovery

group
Electronic
Paper
Review
18
Screen navigation procedure

group
Electronic
Paper
Review
19
Alarm list

group
Electronic
Paper
Review
20
IQ test protocol

group
Electronic
Paper
Approval
21
OQ test protocol

group
Electronic
Paper
Approval
22
HMI manual

group
Electronic
Paper
Approval
23
Training documentation

group
Electronic
Paper
Review
24
Hardcopies of application
software & Backup of
application software

group
Electronic
Paper
25
Operator's and maintenance

manual containing also:
Size changeover
instructions;
Spare part lists;
Electrical schematics with
complete part list, PLC I/O
and electrical cabinet layout;
Pneumatic schematics;
List of lubricants with
potential product contact.

group
Electronic
Paper
Review
26
Allen Bradley system manuals
Electronic
Review
Review
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Document PR0001 QP
Date 16 August 2008
Customer ACME Inc.

Item
Document
Page 11 of 22
Version 1.4
Issues
Support
27
List of components

group
Electronic
Paper
Review
28
Data sheets (for all components

on P&ID)

group
Paper
Review
28
Certificates:
FDA approved
gaskets;
Material certificates
(surfaces in product
contact);
Passivation
certificate;
Filter certificate.

group
Paper
Review
29
Progress report
Each month
Electronic
Review
30
Modification report and log

group
Electronic
Paper
Review
31
Commissioning test protocol

(SAT test plan)

group
Electronic
Paper
Review
32
Built version report
Electronic
Paper
Review
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Document PR0001 QP
Date 16 August 2008
Customer ACME Inc.
Version 1.4
7. DEVELOPMENT TOOLS
The items listed below will be used as development tools during this project:
Tool name
Manufacturer or
software house
Release
OpenOffice
Sun
2.4
RSLogix 5000
Allen-Bradley
Actual
PLC Code production and testing
RSView Studio
Allen-Bradley
Actual
Machine HMI design
Performed task
Production of documentation
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Customer ACME Inc.
Version 1.4
8. PROJECT HANDLING
8.1.1. PROJECT PHASES
The project is made in several tasks; diagram has been drawn to underline the activities that can be performed concurrently.
Phase 1
issue
Phase 2
Functional design specifications
issue
Phase 3.1
Hardware design specifications
issue
Phase 4.1
Software module design specifications
issue
Phase 3.2
Hardware design
Phase 4.2
Software design specifications
issue
Phase 3.3
Hardware manufacturing
Phase 4.3
Software modules design
Phase 3.4
Hardware post manufacturing testing
Phase 4.4
Software modules bench testing
Phase 4.5
Software integration
Phase 4.6
Software integration bench testing
Phase 4.7
HMI design
Phase 4.8
HMI bench test
Phase 5
Software and hardware integration
Phase 6
Software field test
Phase 7
Internal testing and verification of IQ test
protocol
Phase 8
User's documentation issue
Phase 9
Internal testing and verification of OQ test
protocol
Phase 10
F.A.T. at Supplier's facility
Phase 11
S.A.T. at ACME's facility
Phase 12
S.A.T. and commissioning at ACME facility
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Customer ACME Inc.
Date 16 August 2008

Version 1.4
Description of each phase:

Phase
Name

issue
Redaction, review and approval of FDS (Functional design specifications) for the three
groups of machines:
1. Group 1;
2. Group 2;
3. Group 3.
.1
Hardware design specifications

issue
Redaction, review and approval of HDS (Hardware Design Specifications) for the three
groups of machines as detailed on phase 2.
.2
Hardware design
.3
Hardware manufacturing
.1
Software module design

specifications issue
Redaction, review and approval of SMDS (Software Modules Design Specifications) for the
three machines as detailed on phase 2.
.2
Software design specifications

issue
Redaction, review and approval of SDS (Software Design Specifications) for the three
machines as detailed on phase 2; this document contains the integration specification of
the software modules and design specifications for HMI;
.3
Software modules design
.6
.7
Software modules bench testing

Software integration
Software integration bench testing
HMI design
Design of all needed software modules.

Bench testing of the software modules designed on phase 4.3.
Note: Bench testing will be carried out with a real PLC CPU with simulated I/Os.
Integration of software modules on three machine's program.
Bench testing of software modules integration.
Note: Bench testing will be carried out with a real PLC CPU with simulated I/Os.
Design of HMI.
Bench testing of HMI.
Note: Bench testing will be carried out with real PLC CPU and real HMI. A Windows 2003
test server will be configured to test the active directory authentication feature. The same
Win2003 test server will be used on phases 5 10.
Software and hardware integration
Integration test where bench tested software will be loaded on machine's CPU and HMI;
the functionality of each I/O of each machine will be tested.
Software field test
Software field test on machines prior to FAT where each functionality of the machines will
be tested.
Internal testing and verification of

IQ test protocol
IQ protocol issue, test on machine, review and approval for the three machines as detailed
on phase 2.
User's documentation issue

8
Internal testing and verification of

OQ test protocol
10
F.A.T. at Supplier's facility

S.A.T. at ACME's facility
11
Testing by Supplier automation engineers of the wirings manufactured on phase 3.3.
HMI bench test

.8
Manufacturing of the three electrical cabinets and machine's on board wiring as detailed on
wiring schematics issued on phase 3.2.
Hardware post manufacturing

testing
.5
Redaction of wiring schematics for the three electrical cabinets as detailed in phase 2.
.4
.4
4
Redaction, review and approval of project's quality plan (this document).
Functional design specifications

issue
2
Details
User's documentation issue and review; documents like:
HMI operator's guide;
Troubleshooting;
Operator's training manuals;

will be issued on this phase.
OQ protocol issue, test on machine, review and approval for the three machines as
detailed on phase 2.
ACME FAT of the three machine group with the support of the FAT documentation.
ACME SAT of the three machine group with the support of the FAT documentation.
Note: ACME has to prepare and configure the Windows2003 Server station to properly test
the active directory authentication feature.
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Phase
12
Name
Version 1.4
Details
S.A.T. and commissioning at ACME SAT and commissioning of the three machine group with the presence of Supplier
facility
engineers; operators and first aid engineers will be trained with training manuals prepared
on phase 8.
8.1.2. INPUT AND OUTPUT CRITERIA

This section highlights the timing that exists between the various project phases. The input and output criteria are reported
for every phase of the project. The input criteria represents the necessary requirements in order to start that phase of the
project. The output criteria represents the necessary requirements in order to conclude that phase of the project.
The individuals and abbreviations involved in this project are listed in sections 5.1.1.
Phase
Issue
Review
Appr
Procedure
Input
Output
PM
QA
M6 Quality and project

planning
Order confirmation
Approved Quality Plan
PM
QA
D1 Production of a functional
specification
User's Requirements
Specifications
Quality Plan
Approved FDS
RTM update
3.1
AE
ADM
PM
D3 Production of hardware
design specification
FDS
Approved HDS
RTM update
3.2
EE
ME
ADM
PM
N.A.
HDS
Electrical schematics
Pneumatical schematics
3.3
EE
ADM
PM
N.A.
Electrical schematics
Pneumatical schematics
Untested machine's hardware
3.4
EE
ADM
PM

specification
Untested machine's hardware
Tested machine's hardware
4.1
AE
ADM
PM
D4 Production of software /
module design specification
FDS
Approved SMDS
4.2
AE
ADM
PM
D4 Production of software /
design specification
FDS / SMDS
Approved SDS
RTM update
4.3
AE
ADM
PM
D5 Guidelines for the

production, control and review of
software
SMDS
Untested software modules
SMDS
Tested software modules
SDS
Untested machine's PLC

programs
Untested machine's PLC

programs
Bench tested machine's PLC

programs
SDS
Untested HMI design
Untested HMI design
Tested HMI design
4.4
AE
ADM
PM

software
SW module test specs
4.5
4.6
AE
AE
ADM
ADM
PM
PM

software
software
Integration test specification
4.7
4.8
AE
AE
ADM
ADM
PM
PM

software
software
Integration test specification
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Phase
Issue
Review
Appr
Procedure
Version 1.4
Input
Output
Tested machine's hardware

5
AE
ADM
PM

specification
Bench tested machine's PLC

programs
Untested Hardware and

software integration
Tested HMI design

6
AE
ADM
PM
System software acceptance

test specifications
Untested Hardware and

software integration
Tested hardware and software

integration
ME,
ADM,
PM
QA
D6 Testing of an Automated
System
Approved HDS
Approved IQ test protocols
ME,
ADM,
PM
QA
Internal procedures to be
referenced
Approved FDS
Approved HDS
Approved SDS
ME,
ADM,
PM
QA
System
Approved SDS
10
AE,
ADM,
PM
PM
GM
System
Fully working machines
11
AE
PM
PM
System
FAT accepted machines
System
First SAT accepted machines
12
AE
PM
PM
Instrument list;
Historian tag list;
Screen navigation
procedure;
Disaster recovery;
HMI manual;
Training documentation;
Approved OQ
Built version report
FAT approval form
FAT accepted machines
SAT approved form
First SAT accepted
machines
Final SAT accepted

machines
Operator's training
certificates
8.2. CHANGES
For any change on this project involving:
Budget;
Time schedule;
Functionality;
Contract liability;
the procedures SOP-XX-007 and US1257-T-041382 issued by ACME has to be followed.
8.3. PROJECT MILESTONES

Milestone
Notes
Purchase order
Documentation package 1
Equipment layout in plan and side view;

Correct and complete interconnection data for all disciplines, electrical, piping, etc;
Equipment dimensions and machine feet layout;
Equipment load;
P&ID;
Utility consumption.
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Milestone
Version 1.4
Notes
Approved commissioning protocol;

Approved FAT protocol;
Approved IQ test protocol;
Approved OQ test protocol;
Training documentation;
Material certificates for surfaces in product contact;

Wiring diagram;
Electrical item list with tag and manufacturer's name and model;
Data sheets for all components on P&ID;
List of all components;
Identification list of instruments, sensors and gauges;
Operation and maintenance manual;
As-built P&ID;
Spare parts list.
FAT
Punch fix and packing
Shipment
Delivery to ACME
Installation in ACME
Alignment
Startup
IQ
OQ and training
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Version 1.4
9. SOFTWARE CONFIGURATION MANAGEMENT

9.1. DEFINITION
As Software Configuration Management (SCM) can be defined a set of activities designed to control change by identifying
the work products that are likely to change, establishing relationships among them, defining mechanisms for managing
different versions of these work products, controlling the changes imposed, and auditing and reporting on the changes
made1. Briefly SCM is a methodology to control and manage a software development project.
9.2. PURPOSES
The purposes can be identified as:
Configuration Identification: What code are we working with?
Configuration Control: Controlling the release of a product and its changes;
Status Accounting: Recording and reporting the status of components;
Review: Ensuring completeness and consistency among components;
Build Management: Managing the process and tools used for builds;
Process Management: Ensuring adherence to the organization's development process;
Environment Management: Managing the software and hardware that host our system;
Teamwork: Facilitate team interactions related to the process;
Defect Tracking: making sure every defect has traceability back to the source.
9.3. SOFTWARE PRODUCTION IN SUPPLIER

On Supplier production environment the software generally created are application programs for PLC and HMI.
Application program for PLC has to be created using the best suitable language for the purpose of the software unit and the
PLC's capabilities.
For a logical network, ladder is the best choice, for a state machine ST (structured text) is perfect. The choice as above as to
be deal with the PLC's capabilities.
Allen Bradley PLC offers as sole language the ladder and most maintenance engineers refuse any other additional
language, thus leading the writing and maintenance of complex software units (like state machines and communication
protocols) a trivial task.
On HMI rarely a real programming task is needed but we'll speak about page layout design. When a local HMI script is
needed, software engineer has to deal with the panel capabilities that usually offers VBScript for WindowsCE based panels.
9.4. CONFIGURATION IDENTIFICATION AND STATUS ACCOUNTING

9.4.1. PROGRAM IDENTIFICATION
Each application program is identified with the serial number of the machine and the release number.
The release 1.0 of the application program will be released after the successful FAT. The other release numbering follows
the following indications:
Major releases are generated when program is accepted after the FAT and when features are added;
Minor releases are generated in case of bug fixes.
Daily snapshots are also generated at the end of the day and the snapshot date is added at the end of file name or in the
most appropriate field of the source code in ISO format, like: YYYYMMDD.
1
Roger Pressman, Software Engineering: A Practitioner's Approach
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Document PR0001 QP
Date 16 August 2008
Customer ACME Inc.
Version 1.4
Program file name is built as: <type><Machine serial number>-<phase><rel>-<snapshot date>.<ext>.

<type> field is the program type definition: P as PLC application program and D as HMI design application.
<phase> can be:
w as working snapshot of the indicated release but modifications are in progress;
b bench integration test has to be performed on this release;
m machine test has to be performed on this release;
e as experimental version prior to release; indicates a quite stable code where extensive tests are in progress on
machine;
absence of any letter or symbol indicates that the program is stable and released.
<ext> of the file depends on programming environment capabilities and can be a compressed archive like .zip, .rar or .ace or
proprietary file format like .rss or .hmi.
Putting all together:
P00001-1.0-20071110.zip refers as the first version of PLC application program for the machine S/N 00001
released on 10 November 2007;
D00001-w0.5-20071009.ace refers as a pre-release version snapshot on 09 October 2007 of the HMI program of
the above machine.
9.4.2. SOFTWARE MODULE IDENTIFICATION
Identification of software module is quite different from whole program identification due to more limited capabilities in
version indication of many application program IDEs; in such case we can have three release indicators:
<major>.<minor>.<phase>
Major is the major release of the module; as application program, a major release is issued the first time the program leave
the factory or when functionality has been introduced;
Minor is the minor release of the module; a minor release is issued in case of bug fixes or small optimizations; minor
release is always one digit long;
phase can be:
0 - Stable, released;
1 - To be tested on the machine (may be bench tested or not depending if the block can be bench tested);
2 - To be bench tested (if possible, otherwise this phase is skipped);
3 - Edit phase.
When a module is written for the first time, his release will be: 1.0.3; when a module is declared fully working on the machine
and released for the first time, the release will be: 1.0.0.
Version number: 1.1.1 indicates that the block is a bench tested block and has to be tested on the machine; block is based
on 1.0.0 release and has been modified for minor changes like code optimizations.
9.5. CONFIGURATION CONTROL

Heading each module, a log of each change will be inserted if allowed by IDE; otherwise a separate log will be updated.
The log indicates:
ACME Inc.;
Process name PLC program;
Processor type the module has been written for;
Author's name and Author's employer;

Machine Model
PROT
Page 20 of 22
Document PR0001 QP

Customer ACME Inc.
Date in format DD-MMM-YYYY;
Revised by Revision author's name and Revision author's employer;
Revision date in format DD-MMM-YYYY.
Date 16 August 2008

Version 1.4
9.6. REVIEW
Each module will be tested separately on a test CPU (possibly equal to the CPU is planned to be mounted) against a
module test specification, issued following the requirements of software modules design specifications.
Once the module passed the test it will be integrated following the software design specification document.
9.7. SOFTWARE REVISION CONTROL

On Supplier reality just one software engineer at a time works on a single PLC or HMI application program thus making the
use of an automated software revision control system an overkill. Latest versions of application programs can be found on
Supplier's main software repository.
9.7.1. DEFECTS FOUND ON SOFTWARE
Starting from project phase 62, when a mechanical or software engineer find a defect on a machine mounting an
experimental version of an application program and a software bug is suspected, it issue a Software revision request form
with the following informations indicated:
Date and time the defect occurred;
Name of the person who found the defects;
Role of the person who found the defects;
If the defect is reproducible or not;
Informations useful to reproduce the defect;
Additional useful notes.
At periodical interval, the software engineer responsible for the machine or the automation department manager reviews and
assign all the generated Software revision request form (Enclosure 10.1) for the debug.
When the software engineer acts on the Software revision request form it fills up the action performed and indicates the
status of the request and if the bug has been fixed.
This form will be filled in Italian and will be available for review.
9.7.2. FEATURES THAT HAS TO BE ADDED OR ERASED ON SOFTWARE
When a new feature of the software is needed a Software feature request form (Enclosure 10.2) has to be filled up,
indicating:
Date and time of the request;
Name of the person who made the request;
Role of the person who made the request;
Detailed information of the request;
References to external document like electrical schematics, pneumatic drawing or P&ID;
Additional useful notes.
At periodical interval, the software engineer responsible for the machine or the automation department manager reviews and
assign all the generated Software feature request form.
This form will be filled in Italian and will be available for review.
2
Starting from project phase 10 and beyond, an incident report will be filled in English and handled as indicated on FAT test plan.
Machine Model
PROT

Customer ACME Inc.
Page 21 of 22
Document PR0001 QP
Date 16 August 2008
Version 1.4
When the software engineer acts on the Software feature request form it evaluates the actions to be performed like:
Discharged Not applicable, impossibility to be implemented or others;
Bug Minor change has to be performed on software modules; automation engineer or automation department
manager issue a Software revision request form;
Major change needed on software modules or software modules integration Appropriate documentation has to be
revised to incorporate the requested change and a new version of the involved unit(s) has to be issued.
Machine Model
PROT

Customer ACME Inc.
Page 22 of 22
Document PR0001 QP
Date 16 August 2008
Version 1.4
10. ENCLOSURES
10.1. SOFTWARE REVISION REQUEST FORM ISSUED BY SUPPLIER
10.2. SOFTWARE FEATURE REQUEST FORM ISSUED BY SUPPLIER.

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#0123456 date 01 June 2007

Quality Plan / Project Plan

Area Sales Manager

Quality Assurance Manager

Project quality assurance

Issued by: IFACE Industrial Automation Morbio Inferiore, Switzerland.

Quality plan / Project plan

Serial Number 001/2008

Date 16 August 2008

9. SOFTWARE CONFIGURATION MANAGEMENT.................................................................................................................... 18

9.5. CONFIGURATION CONTROL.................................................................................................................................................... 19

Quality plan / Project plan

Serial Number 001/2008

Date 16 August 2008

Customer ACME Inc.

Machine serial number

All the above items will be further referred as: machine.

Quality plan / Project plan

Serial Number 001/2008

Date 16 August 2008

Customer ACME Inc.

Updated serial number;

Chapter 6.2 point 17 changed Disaster recovery to Backup and disaster

First draft release;

Removed references to Siemens PLC on Configuration management;

Changed appendices numbers;

Version 1.4 notes;

Quality plan / Project plan

Serial Number 001/2008

3.1. LINE OVERVIEW

Quality plan / Project plan

Serial Number 001/2008

Date 16 August 2008

Customer ACME Inc.

Production and approval of validation plans;

Agreement of project and quality plans with the client, covering:

supplier internal testing;

Review and approval of documentation and evidence produced;

Sign-off and acceptance of the system as validated.

4.2. SUPPLIER QUALITY SYSTEM

FDA regulations and current GMP guide lines.

Quality plan / Project plan

Serial Number 001/2008

Date 16 August 2008

Customer ACME Inc.

Equipment design, size and location

Automatic, mechanical and electronic equipment

National electrical code

4.2.3. QUALITY RESPONSIBILITIES

Quality plan / Project plan

Serial Number 001/2008

Date 16 August 2008

Customer ACME Inc.

Approbation of contractual and economical feature

Report to GM of contractual and economical

Interface between Supplier and ACME's team;

Report to PM about the mechanical work-inprogress;

Manage the mechanical engineering team;

Report to PM about the electrical and software

Manage the electrical engineering team;

Report to ADM about the electrical work-inprogress;

Issue electrical schematics;