Software Validation Protocol

Software Validation Number : VAL-SV- E0170/P Revision : A

Title : Technical Devices WSM450 Wave Solder Machine Software
No. of Pages : 1 of 19
Validation Protocol

Revision History
Effective
S/N Reason for Change Revision Originator
Date
Edy Siswo
1 Initial Release 1
Susilo

Department Head Management Rep./ Effective Date

(Name / Signature / Date) Div. QA Manager (to be filled up by DCC)
(Name / Signature / Date)

F-MP-04-61 Rev. A Form Effective Date: 01-Apr-2016

Form Originator: Wahyudi
 Software Validation Number : VAL-SV- E0170/P Revision: A
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Validation Protocol

Signature Approval Matrix

This Equipment Software Validation Protocol must be reviewed and approved by all
individuals listed below, or their authorized representatives.

TITLE NAME SIGNATURE DATE

Engineer Edy Siswo Susilo

Director of Sivakumar Thanupillai
Engineering
Director of Sivakumar Thanupillai
Operational
Director of Quality Gabriel Lye Huat Ng

Review and approve by customer:

TITLE NAME SIGNATURE DATE

Spacelabs Supply
Sophie Yang
Chain Engineer

This document, with authorizing signatures, must be collected, maintained and controlled
per established Document Control Procedures.

F-MP-04-61 Rev. A Form Effective Date: 01-Apr-2016

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Validation Protocol

1.0 PURPOSE
The purpose of this document is to provide software validation protocol for Wave Solder
Machine Software.

2.0 SCOPE
This Protocol supports functional testing for software requirements identified in the
Validation Plan for WS-350PC Version 5.2.B to operate Technical Devices WSM450 Wave
Solder Machine located at OSIE Main Plant in Batam.

3.0 RESPONSIBILITY
The following matrix details the responsibilities for the Software Validation of the Technical
Devices WSM450 Wave Solder Machine

Process/TestEngineering/
Quality Assurance
Production
Task

Develop protocol N/A N/A X

Review and approve protocol X X X
Develop and revise equipment set up SOPs N/A N/A X
Execute protocol N/A N/A X
Write final report N/A N/A X
Review and approve protocol and report X X X

4.0 GENERAL DESCRIPTION

4.1 Software Validation is validated by examination and provision of objective evidence

that software specifications conform to user needs and intended uses and that
particular requirements implemented through software can be consistently fulfilled.

4.2 The Software function will be verified during operational mode and each shall be tested
as outlined in section 10.0.

4.3 There are two stages to testing software used to run the Technical Devices WSM450
Wave Solder Machine.

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Validation Protocol

4.3.1 Test ACCESS Level Function

4.3.2 Test Alarm

4.4 Technical Devices WSM450 Wave Solder Machine Operation Software

Software Version Description

WS-350PC 5.2.B Machine Operating System

5.0 FUNCTIONALITY OF SOFTWARE AND TEST CASES

5.1 Access Level Control (refer to test case in section 10.1)

5.1.1 Two operation level are available for WS-350PC Operating System Version 5.2.B:
5.1.1.1 Operator (Technician)
5.1.1.2 Admin (Engineer)

5.1.2 Password Item

Password Item Administrator Operator (Technician)

Access Log-in Screen

5.1.3 Access to Tool Bar

Access to Tool Bar Administrator Operator (Technician)

New File

Open File

Save

Parameter Setting

Lock Keyboard

Login-in

User Setting

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Validation Protocol

Access to Tool Bar Administrator Operator (Technician)

System Alarm

Temperature Profile

Chanel Setting

System Logs

Main Windows

5.1.4 Access to Switches (ON / OFF)

Access to Switches
Administrator Operator (Technician)
(ON / OFF)
Preheat #1

Preheat #2

IR Panel

Solder Pot

Air Cooling

Dancer Wave speed

Laminar Wave speed

Conveyor Width
To set pumps for Auto /

Manual
Ventilation

Finger Cleaner

Cooling Systems

Spray Fluxer

Nitrogen Option

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Validation Protocol

5.2 The channel setting can be set the high and low alarm for all the temperature function
of the machine: IR panel, Preheater #1, Preheater #2 and Solder Pot
(Refer to Test Case Section 10.2)

5.2.1 To set the high and low alarm for IR Panel temperature function of the machine:
5.2.1.1 Alarm will appear on the screen windows if the temperature reading
on IR panel exceeds the Over Forecast or Over Alarm that has been
set on the channel setting IR panel.

5.2.1.2 Alarm will appear on the screen windows if the temperature reading
on IR panel is less than Low Forecast or Low Alarm that has been
set on the channel setting IR panel.

5.2.2 To set the high and low alarm for Preheat #1 temperature function of the
machine:
5.2.2.1 Alarm will appear on the screen windows if the temperature reading
on Preheat #1exceed the Over Forecast or Over Alarm that has
been set on the channel setting Preheat #1.

5.2.2.2 Alarm will appear on the screen windows if the temperature reading
on Preheat #1 is less than Low Forecast or Low Alarm that has been
set on the channel setting Preheat #1.

5.2.3 To set the high and low alarm for Preheat #2 the temperature function of the
machine:
5.2.3.1 Alarm will appear on the screen windows if the temperature reading
on Preheat #2 exceeds the Over Forecast or Over Alarm that has
been set on the channel setting Preheat #1.

5.2.3.2 Alarm will appear on the screen windows if the temperature reading
on Preheat #1 is less than Low Forecast or Low Alarm that has been
set on the channel setting Preheat #2.

5.2.4 To set the high and low alarm for Solder Pot temperature function of the
machine:
5.2.4.1 Alarm will appear on the screen windows if the temperature reading
on Solder Pot exceeds the Over Forecast or Over Alarm that has
been set on the channel setting Solder Pot.

5.2.4.2 Alarm will appear on the screen windows if the temperature reading
on Solder Pot is less than Low Forecast or Low Alarm that has been
set on the channel setting Solder Pot.

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Validation Protocol

5.3 The test cases shall support normal operation and Lower/Upper limit setting operation.

The tester will:

5.3.1 Read the test case for the required test established in Section 10.0.

5.3.2 Review the expected results for each line item.

5.3.3 Record the actual results in the Actual Results column.

5.3.4 Print a copy of the evidence of the actual results and write an
identification (ID) number on the document.

5.3.5 Record Pass in the Results Pass/Fail column if the actual result matches the
expected result.

5.3.6 Record Fail in the Results Pass/Fail column if the actual result does not
match the expected result.

5.3.7 Add the operator initials in the Tested By column.

5.3.8 Add the date the test was completed in the Date column.

5.4 The Engineer needs to record a Deviation Number in the Results Pass/Fail column if
the test result is Fail. The number may be locally generated by the Engineer.

5.5 All personnel involved in the execution of the protocol must be trained to the protocol.
Evidence of training shall be documented.

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Validation Protocol

6.0 EXECUTION REQUIREMENTS

6.1 Supporting Data and Results Documentation

6.1.1 All documentation supporting validation activities, including screen prints or

reports are documented with the protocol number, test case number, test step,
page of pages (when more than one page), tester initials, and date. File the
supporting documentation with each test case.

6.1.2 Hand-write all results on the test case as the information is collected. Record
explanatory notes in the comments section of the test case as necessary.
Transcription errors may be corrected by crossing out the error with a single
line, recording the corrected information, and initialling and dating the
correction in accordance with Work Instructions WI-GE-10-16, Good
Documentation Practices.

6.1.3 Any blank spaces not pertinent to the validation effort are to be marked Not
Applicable or N/A, initialled and dated.

6.1.4 All supporting data is maintained with the executed document and must be
labelled with the document number, a reference to the specific test case and
step number that the data supports, and the initials and date of the person who
collected the supporting data.

6.2 Deviations

6.2.1 All deviations encountered during the execution of this protocol are
documented.

6.2.2 For minor deviations, such as typos or missing or insufficient step instructions,
the change may be hand written on the hard copy of the test protocol, initialled,
and dated.

6.2.3 Moderate severity and major deviations are resolved and approved by Quality
Assurance. Moderate severity deviations include incomplete or modified
expected results.

6.2.4 Major deviations include system errors or expected results that were not met
must be resolved to complete this validation.

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Validation Protocol

7.0 ACCEPTANCE CRITERIA

7.1 The following general acceptance criteria apply to the overall acceptance of the
Protocol.

7.1.1 All expected results are met or deviations are resolved or have work arounds
that meet system requirements.

7.1.2 All corresponding test cases and/or data collection sheets are properly
executed and reviewed for accuracy by an appropriate reviewer.

7.1.3 All supporting documentation is attached to the Protocol.

7.2 The Responsible Equipment Engineer will confirm that all elements of the Protocol
have been fully executed.

7.2.1 Each TEST CASE was executed, signed and dated.

7.2.2 Each TEST CASE includes supporting information.

7.2.3 Failed TEST CASES are either retested or rationale added to the report stating
why the failure does not impact the VALIDATION.
If retesting is required, the applicable section in the test protocol will be
executed in its entirety.

8.0 TEST ENVIRONMENT

8.1 The Technical Devices WSM450 Wave Solder Machine is designed for indoor use only.
8.2 The Environment is stated and validated in Technical Devices WSM450 Wave Solder
Machine Installation Protocol VAL-IQ-E-0170/P

9.0 TEST UNIT

9.1 Item shall be available to verify the test software functionality below:
PCBA after completed inserted through hole component.

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10.0 TEST CASE

10.1 Test Case Two operation level for WS-350PC Operating System Version 5.2.B.

Results
Item and Instruction Expected Results Actual Results Tested By Date
Pass/Fail

Test Case 10.1.1 : Password Item

Access by Operator
YES_____ NO_____
Operator (Technician)
Access Log-in Screen
Admin (Engineer)
Access by Admin
YES_____ NO_____

Test Case 10.1.2 : Access to Tool Bar

Access by Operator
YES_____ NO_____
Operator (Technician)
Access to Tool Bar New File
Admin (Engineer)
Access by Admin
YES_____ NO_____
Access by Operator
YES_____ NO_____
Operator (Technician)
Access to Tool Bar Open File
Admin (Engineer)
Access by Admin
YES_____ NO_____
Access by Operator
YES_____ NO_____
Operator (Technician)
Access to Tool Bar Save
Admin (Engineer)
Access by Admin
YES_____ NO_____
Access by Operator
YES_____ NO_____
Access to Tool Bar Parameter Operator (Technician)
Setting Admin (Engineer)
Access by Admin
YES_____ NO_____

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Results
Item and Instruction Expected Results Actual Results Tested By Date
Pass/Fail

Access by Operator
YES_____ NO_____
Access to Tool Bar Lock Keyboard Admin (Engineer)
Access by Admin
YES_____ NO_____
Access by Operator
YES_____ NO_____
Operator (Technician)
Access to Tool Bar Login-in
Admin (Engineer)
Access by Admin
YES_____ NO_____
Access by Operator
YES_____ NO_____
Operator (Technician)
Access to Tool Bar User Setting
Admin (Engineer)
Access by Admin
YES_____ NO_____
Access by Operator
YES_____ NO_____
Operator (Technician)
Access to Tool Bar System Alarm
Admin (Engineer)
Access by Admin
YES_____ NO_____
Access by Operator
YES_____ NO_____
Access to Tool Bar Temperature Operator (Technician)
Profile Admin (Engineer)
Access by Admin
YES_____ NO_____
Access by Operator
YES_____ NO_____
Operator (Technician)
Access to Tool Bar Channel Setting
Admin (Engineer)
Access by Admin
YES_____ NO_____
Access by Operator
YES_____ NO_____
Operator (Technician)
Access to Tool Bar System Logs
Admin (Engineer)
Access by Admin
YES_____ NO_____
Access to Tool Bar Main Windows Operator (Technician) Access by Operator
Admin (Engineer) YES_____ NO_____

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Results
Item and Instruction Expected Results Actual Results Tested By Date
Pass/Fail

Access by Admin
YES_____ NO_____

Test Case 10.1.3 : Access to Switches (ON / OFF)

Access by Operator
YES_____ NO_____
Access to Switches (ON / OFF) Operator (Technician)
Preheat #1 Admin (Engineer)
Access by Admin
YES_____ NO_____
Access by Operator
YES_____ NO_____
Access to Switches (ON / OFF) Operator (Technician)
Preheat #2 Admin (Engineer)
Access by Admin
YES_____ NO_____
Access by Operator
YES_____ NO_____
Access to Switches (ON / OFF) IR Operator (Technician)
Panel Admin (Engineer)
Access by Admin
YES_____ NO_____
Access by Operator
YES_____ NO_____
Access to Switches (ON / OFF) Operator (Technician)
Solder Pot Admin (Engineer)
Access by Admin
YES_____ NO_____
Access by Operator
YES_____ NO_____
Access to Switches (ON / OFF) Air Operator (Technician)
Cooling Admin (Engineer)
Access by Admin
YES_____ NO_____
Access by Operator
YES_____ NO_____
Access to Switches (ON / OFF) Operator (Technician)
Dancer Wave speed Admin (Engineer)
Access by Admin
YES_____ NO_____

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Results
Item and Instruction Expected Results Actual Results Tested By Date
Pass/Fail

Access by Operator
YES_____ NO_____
Access to Switches (ON / OFF) Operator (Technician)
Laminar Wave speed Admin (Engineer)
Access by Admin
YES_____ NO_____
Access by Operator
YES_____ NO_____
Access to Switches (ON / OFF) Operator (Technician)
Conveyor Width Admin (Engineer)
Access by Admin
YES_____ NO_____
Access by Operator
YES_____ NO_____
Access to Switches (ON / OFF) To Operator (Technician)
set pumps for Auto / Manual Admin (Engineer)
Access by Admin
YES_____ NO_____
Access by Operator
YES_____ NO_____
Access to Switches (ON / OFF) Operator (Technician)
Ventilation Admin (Engineer)
Access by Admin
YES_____ NO_____
Access by Operator
YES_____ NO_____
Access to Switches (ON / OFF) Operator (Technician)
Finger Cleaner Admin (Engineer)
Access by Admin
YES_____ NO_____

Comments:

Signature below (Verified by:) indicates data entered is accurate and complete.

Verified by: Date:

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10.2 Test Case Alarm

Results
Item and Instruction Expected Results Actual Results Tested By Date
Pass/Fail

Test Case Alarm 10.2.1 : Test Alarm IR Panel

Is the job name displayed at the
Open a job file by click new open bottom of the main screen?
The job name will be displayed at
file icon. Example Model 670-0982-
the bottom of the main screen.
05 YES_____ NO_____

Setting Over Forecast IR is 25C.

Set temperature IR on the

parameter setting 224C, with a Actual temperature higher 25C than Is IR Panel Over Forecast alarm
25C over forecast on the channel set temperature. displayed on below corner left side?
setting.
IR Panel Over Forecast alarm YES_____ NO_____
While test please ensure that the displayed on below corner left side.
actual temperature showing on the
main screen windows is over than
250C.
Setting Over Alarm IR is 40C.

Set temperature IR on the

parameter setting 210C, with a
40C over alarm on the channel
setting.
While test please ensure the actual
temperature showing on the main
screen windows is over than
250C.
Setting Low Forecast IR is 15C.
Set temperature IR on the
parameter setting 265C, with a
15C low forecast alarm on the
F-MP-04-61 Rev. A
Actual temperature higher 40C than
set temperature.
IR Panel Over Alarm displayed on
below corner left side.
Actual temperature lower 15C than
set temperature.
IR Panel Low Forecast Alarm
displayed on below corner left side.
Is IR Panel Over Alarm displayed on
below corner left side?
YES_____ NO_____
Is IR Panel Low Forecast Alarm
displayed on below corner left side?
YES_____ NO_____
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Results
Item and Instruction Expected Results Actual Results Tested By Date
Pass/Fail

channel setting.

While test please ensure the actual

temperature showing on the main
screen windows is lower than
250C.
Setting Low Alarm IR is 20C.

Set temperature IR on the Actual temperature lower 20C than Is IR Panel Low Alarm displayed on
parameter setting 270C, with a set temperature. below corner left side?
20C low forecast alarm on the
channel setting. IR Panel Low Alarm displayed on YES_____ NO_____
below corner left side.
While test please ensure the actual
temperature is lower than 250C.

Test Case 10.2.2 : Test Alarm Preheat 1

Setting Over Forecast Preheat 1
is 20C.

Set temperature Preheat 1 170C,
with a 20C over forecast on the
channel setting.
While test please ensure that the
actual temperature showing on the
main screen windows is over than
190C.
Setting Over Alarm Preheat 1 is
30C.
Actual temperature higher 20C than
set temperature.
Preheat 1 Over Forecast alarm
displayed on below corner left side.
Actual temperature higher 30C than
set temperature.
Is Preheat 1 Over Forecast alarm
displayed on below corner left side?
YES_____ NO_____
Is Preheat 1 Over Alarm displayed on
below corner left side?

Set temperature Preheat 1 on the Preheat 1 Over Alarm displayed on YES_____ NO_____
below corner left side.
parameter setting 160C, with a
30C over alarm on the channel
setting.

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Results
Item and Instruction Expected Results Actual Results Tested By Date
Pass/Fail

While test please ensure that the

actual temperature showing on the
main screen windows is over than
190C
Setting Low Forecast Preheat 1
is 25C.

Set temperature Preheat 1 on the

Actual temperature lower 25C than Is Preheat 1 Low Forecast Alarm
parameter setting 215C, with a
set temperature. displayed on below corner left side?
25C low forecast alarm on the
channel setting. Preheat 1 Low Forecast Alarm YES_____ NO_____
displayed on below corner left side.
While test please ensure that the
actual temperature showing on the
main screen windows is lower than
190C
Setting Low Alarm Preheat 1 is
30C.

Set temperature Preheat 1 on the

Actual temperature lower 30C than Is Preheat 1 Low Alarm displayed on
parameter setting 220C, with a
set temperature. below corner left side?
30C low forecast alarm on the
channel setting. Preheat 1 Low Alarm displayed on YES_____ NO_____
below corner left side.
While test please ensure that the
actual temperature showing on the
main screen windows is lower than
190C

Test Case 10.2.3 : Test Alarm Preheat 2

Setting Over Forecast Preheat 2 Actual temperature higher 20C than Is Preheat 2 Over Forecast alarm
is 20C. set temperature. displayed on below corner left side?

Set temperature Preheat 2 on the Preheat 2 Over Forecast alarm YES_____ NO_____
displayed on below corner left side.
parameter setting 180C, with a

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Results
Item and Instruction Expected Results Actual Results Tested By Date
Pass/Fail

20C over forecast on the channel

setting.

While test please ensure that the

actual temperature showing on the
main screen windows is over than
200C.
Setting Over Alarm Preheat 2 is
30C.

Set temperature Preheat 2 on the

Actual temperature higher 30C than Is Preheat 2 Over Alarm displayed on
parameter setting 170C, with a
set temperature. below corner left side?
30C over alarm on the channel
setting. Preheat 2 Over Alarm displayed on YES_____ NO_____
below corner left side.
While test please ensure that the
actual temperature showing on the
main screen windows is over than
200C.
Setting Low Forecast Preheat 2
is 15C.

Set temperature Preheat 2 on the

Actual temperature lower 15C than Is Preheat 2 Low Forecast Alarm
parameter setting 215C, with a
set temperature. displayed on below corner left side?
15C low forecast alarm on the
channel setting. Preheat 2 Low Forecast Alarm YES_____ NO_____
displayed on below corner left side.
While test please ensure that the
actual temperature showing on the
main screen windows is lower than
200C.
Setting Low Alarm Preheat 2 is Actual temperature lower 30C than Is Preheat 2 Low Alarm displayed on
30C. set temperature. below corner left side?

Set temperature Preheat 2 on the Preheat 2 Low Alarm displayed on YES_____ NO_____
below corner left side.
parameter setting 230C, with a
30C over forecast on the channel

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Results
Item and Instruction Expected Results Actual Results Tested By Date
Pass/Fail

setting.

While test please ensure that the

actual temperature showing on the
main screen windows is lower than
200C.

Test Case 10.2.4 : Test Alarm Solder Pot

Setting Over Forecast Solder Pot
is 10C.

Set temperature Solder Pot on the Actual temperature higher 10C than Is Solder Pot Over Forecast
parameter setting 257C, with a set temperature. alarm displayed on below corner
10C over forecast on the channel left side?
setting. Solder Pot Over Forecast alarm
displayed on below corner left YES_____ NO_____
While test please ensure that the side.
actual temperature showing on the
main screen windows is over than
267C.
Setting Over Alarm Solder Pot is
16C.

Set temperature Solder Pot on the Is Solder Pot Over Alarm

parameter setting 251C, with a
16C over alarm on the channel
setting.
While test please ensure that the
actual temperature showing on the
main screen windows is over than
267C.
Setting Low Forecast Solder Pot
is 25C.
Set temperature Solder Pot on the
Actual temperature higher 16C than
set temperature.
displayed on below corner left
side?
Solder Pot Over Alarm displayed
on below corner left side. YES_____ NO_____
Actual temperature lower 25C than Is Solder Pot Low Forecast Alarm
set temperature. displayed on below corner left
side?
Solder Pot Low Forecast Alarm
displayed on below corner left

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Results
Item and Instruction Expected Results Actual Results Tested By Date
Pass/Fail

parameter setting 292C, with a set

25C low forecast alarm on the
channel setting.
YES_____ NO_____
side.
While test please ensure that the
actual temperature showing on the
main screen windows is lower than
267C.
Setting Low Alarm Solder Pot is
45C.

Set temperature Solder Pot on the Is Solder Pot Low Alarm

parameter setting 312C, with a set
45C over forecast on the channel
setting.
While test please ensure that the
actual temperature showing on the
main screen windows is lower than
267C.
Actual temperature lower 45C than
set temperature.
displayed on below corner left
side?
Solder Pot Low Alarm displayed
on below corner left side. YES_____ NO_____

Noted / Comments:

Signature below (Verified by:) indicates data entered is accurate and complete.

Verified by: Date:

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