DOC. NO.

: PV 2502
ISSUE NO.: 2
DATE : 25-09-07
PAGE : 1
MOD NO.: 509
TITLE PROCESS VALIDATION: SOLDERING PROCESS

Issu Date Mod Page No’s Change Summary Reissue/

e No No.: Partial
1 31-01-07 ----- All pages Initial Issue -----
Included Annexure II Performance
qualification (PQ) for Part number
1A 21-04-07 485 Pages 1 & 6 (10-302 &10-303). Partial Issue
Revalidation only for second generation
- 2023211001 (P/N: 10-0294) due to
change in design & part numbers as per
ECO # 215-1784. Removed OQ results
of in Annexure – I & addressed in
All Pages, Annexure –III. Included Performance
Annexure – I qualification (PQ) in Annexure II for Part
2 25-09-07 509 & II number (10-0294). Reissue
 DOC. NO.: PV 2502
ISSUE NO.: 2
DATE : 25-09-07
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TITLE PROCESS VALIDATION: SOLDERING PROCESS

1.0 Equipment / Process to be validated:

1.1. Make & Model : Hako 936
1.2. Asset No: PE 200, PE 197, PE/SS/04
1.3. PI 6691, PI 6546, PI 6521, PI 6534

2.0 Process product Change control No. :

First release (If any changes are made in the above equipment or in the material,
we may have to re address the validation. i.e., Re-Validation)
Revalidation: Re-validation is only due
to the release of second generation & change in design, part numbers, etc as per
ECO # 215-1784.

3.0 Objective:
OCI has a soldering process in the Sensor assembly line (P/N: 10-0302, 10-0303,
10-0294, 10-0295). This procedure is for the validation of the soldering process as
described in the Process Instructions (PI: 6691, PI 6546, PI 6521, PI 6534).
The assembly involving hand-soldering must be evaluated to assure that each solder joint
consistently meets the established acceptance criteria. Various part numbers use the
same materials in the soldering process and thus this can be qualified on any one of the
part numbers.

4.0 Reference Documents:

4.1. PI: 6691, PI 6546, PI 6521, PI 6534
4.2. QI: 5518, QI 5444, QI 5432, QI 5438
4.3. Process validation master plan – FL 9238, FL 9263, FL 9264, FL 9265.
4.4. Calibration No / Instructions.: 398, 399 / QI 5047

5.0 Validation Plan:

The soldering stations were installed earlier and all requirements for the equipments
were met & successfully commissioned and trials conducted by when installed the
equipment to satisfaction.

The IQ procedure will assure that the Soldering Stations used for the sensor assemblies
meet specification and the locations at which they are installed are suitable for operation &
they operate according to manufacturer’s specifications. This will be confirmed by visual
verification, measurement of specified parameters, performing basic operations of the
apparatus (e.g., turning the power on), set to a temperature and control established.

The OQ procedure will face-up the ability of each Soldering process to consistently
solder components to meet established acceptance criteria for each respective sub-
assembly (Emitter & Detector). Each subassembly will be soldered with same consumables
(e.g.,
Soldering Wire, Rosin flux, etc.) using established ranges of temperature settings
(Optimum,
Lower and Higher Settings).
 DOC. NO.: PV 2502
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Soldering operations will be done from the minimum set-up temperature till maximum set-up
temperature to establish the limits.
The test to verify the good soldering will be the integrity of the solder by visual inspection
and
manipulation of the soldered part (i.e. to check if the parts are securely joined to each
other).
Solder joints should be smooth, Solder area should cover entire intended connection,
Soldered components are not burned or otherwise damaged after soldering, Soldered
components are firmly & securely fixed together without sharp solder projections, spikes or
dry solder.

The performance qualification will be done after the operation qualification results are
studied
and optimum set-up of temperature is established. Production samples from various trained
personnel who operate the equipment will be taken over several times of days and
soldering
integrity will be investigated. Sufficient examples will be taken and recorded to cover all the
performance variables like shift, personnel, batch number of the materials, and the team
assesses the performance by recording all the observations. Set-up will be set to optimum
levels after performance qualification.

(Validation team Protocol approval sign off)

Members: 1.

DOC. NO.:
 ISSUE NO.: PV 2502
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TITLE PROCESS VALIDATION: SOLDERING PROCESS

INSTALLATION QUALIFICATION RESULTS:

Installation Checklist:

Sl.No: REQUIREMENT SOURCE STATUS

1. Electrical supply Per existing set-up Confirmed

2. Position of equipment Per existing set up Confirmed

and seating of operator

3. Operation of Safety Face mask, fume absorber Confirmed

features for all the equipments

4. Calibration of soldering Calibration records Available

equipment

The Solder equipment was verified and found to be installed correctly for the required
process.

(Validation team IQ results approval sign off)

Members: 1.
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OPERATIONAL QUALIFICATION RESULTS:

Verified that the equipment is connected in order.

Performed test soldering with various temperature settings and recorded the results:

Based on the observations arrived at the limits & optimum settings of temperature.

1. Optimum temperature = 280 ˚C

2. Lower limit temperature = 270 ˚C

3. Upper limit temperature = 290˚C

Refer Annexure – I for the results (P/N: 10-0302, 10-0303 & 10-0295).
Refer Annexure – III for (P/N: 10-0294), re-validation results
Revalidation: The soldering quality at all the above three settings were found to be
satisfactory
for soldering process of 2023211001 (P/N: 10-0294).
Note: As we have done earlier Validation for 10-0294 old revision, it has been
decided by the team to start with the 260 ˚C for Operational Qualification
& found satisfactory results.

Result: Operational qualification was performed satisfactorily and Limits were set for the
production process

Issues / Comments: Though the soldering was found to be ok for temperature upto 310 ˚C,
it was decided to have upper limit of 290 ˚C as “sleeve burnt” was
observed for temperatures above 310˚C.

(Validation team OQ results approval sign off)

Members: 1.
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PERFORMANCE QUALIFICATION RESULTS :

Normal productions of part number 10-0302 & 10-0303 were done with the optimum,
Lower limit & upper limit conditions. A week production was completed and parts were
subjected
to the inspection as per the QI: 5518.
The results for P/N: 10-0302 & 10-0303 were recorded, Ref Annexure – II (Page: 1)
Day: 20-04-2007
Quantity: 9868 #, (P/N: 10-0302, 10-0303 )
Part Number: 10-0302 & 10-0303.

Re-validation for P/N: 10-0294: Normal production were done with the optimum, Lower limit
&
upper limit conditions and parts were subjected to the inspection as per the QI 5432.
PQ results for P/N; 10-0294 were recorded, Ref Annexure – II (Page: 2)
Quantity: 315 #, (P/N: 10-0294)
Part Number: 10-0294
Performance qualification could not be carried out for the product P/N: 10-0295 as there was
no
production currently being done.
The same will be done when the production is resumed later and following data will be
updated.
Observation of lot from QI line: The process has established process capability.
The master validation plan has been updated and the revalidation requirements have been
established. All production, Quality and final product audit personnel have been trained and
training records have been suitably upgraded.
(Validation team PQ results approval sign off):

Members: 1.

FINAL REPORT :
We have reviewed the requirement of the protocol, the IQ, OQ and PQ reports and approved
the
process having met the requirement and the process of soldering is Validated. The report has
been
recorded in the document control process.
Re-validation for 2023211001 (P/N: 10-0294) OQ and
PQ reports has reviewed & approved.
(Validation team FINAL report approval sign off)

Sr.Manager production :
Sr.Manager quality :

Head Manufacturing :
Head Quality :