QC Process Diagram AF 0012Y Rev 10.01.2022
QC Process Diagram AF 0012Y Rev 10.01.2022
Supplier Details / Code Part No / Latest Change Core Team : Director Technical. Mgr. production, Key Contact A.Nandi (Director Technical ) Customer Engg /quality Approval date(if Reqd) :
AF 0012 Y Mfg Control chart no: QAC/CP/C/003
S-CCI INDIA PRIVATE LIMITED GC SUPER PROTECT GOLDEN YELLOW AF 0012Y Level AGM QA Phone 01493-250975-76
MFG. Location : Chopanki plant Bhiwadi Suplier/ Plant Approval Date : Other Approval / date (if reqd.) Rev -09 eff. Date 10.01.22
Characteristics
Process Name/
Part/ Process Reaction
Process Flow Diagram Number
Operation Machine
Product Process
Other Product Process Evaluation Measurement
Sample Size Sample Freq. Recording
Respon Control Plan
Description items Specification / Tolerance Technique sibility. Method
1 Raw material - ・Packaging Conditions - No damage, leakage or other ・Visual 100% Each Lot Yes, TSD No. Format Store As per List FM/PUR/01/011A Return to Supplier & ask Counter Measure Report
SC 1100 SC1950 SC1435 SC1602 SC1632 SC1315 SC1466 SC132 2-1~16 Receiving deformation of packs. Ensure FM/MAT/02/001 through -incharge WI/MAT/02/02
0 ・Package Identification complete product identification ERP WI/MAT/02/01
Preprati 2-1 丁目 2-2 2-3 2-4 2-5 2-6 2-7 2-8 RM Source Ensure supply of RM from approved
on of RM Receiving
vendor.
process
Tank 3-1~16 Raw material - As per respective Raw Material - As per Raw Material As mentioned As per Each Lot Yes QAC Testing & Supplier Report Return to Supplier & ask Counter Measure Report
3-1 3-2 3-3 3-4 3-5 3-6 3-7 3-8 inspection Inspection procedure. Inspection in M.I.S WI/QAC/ -incharge
Specification MIS.. Standard 02/002 & FM/QAC/02/005 through
WI/QAC/ ERP
4-1 4-2 4-3 4-4 4-5 4-6 4-7 4-8 02/003
RM Storage
4-1~16 Raw material - a) Packaging Conditioons a) As per work a) No Leakage No Contamination a) Visual 100% a) Each Lot a) Yes, TSD No. a) Store a)Keep bags /Containers tightly a) Keep containers cool by spraying water if exposed to
storage b) Storing Conditions instruction b) Store in Cool, Dry & well b) Visual b) Each Lot FM/MAT/02/001 through -Mgr packed fire or heat. Refer MSDSof RMs.
5-1 5-2 5-3 5-5 5-6 5-7 5-8 Weighing c) RM Kanban Label b) As per work ventilated place c) Visual Supplier COA c) Each Bag ERP b) WI/MAT/02/001 b) keep containers cool by
5-4 b) Store
instruction c) Correct Info: Lot no, Expiry b) No &WI/MAT/02/002 spraying water if exposed to fire or heat. Refer MSDS of
c) Label gen thru & Mfg date other details c) -Auto Record in WMS -Mgr c) WI/MAT/02/012 RMs.
system c) Store c) If Info not aval /Wrong Info on Bag / label. Inform to Dir
6-1 6-6 d) Pasting on RM Supr / Tech / QA
6-2 6-3 6-4 6-5 6-7 6-8 Verification &
head.
Charging Mgr
1 Prepration of Process Tank Selection and cleanliness of As per WI No Contamination Visual 100% Each Lot Yes FM/PRD/02/105 Prod.-in-charge As per WI: WI/PRD/02/015 If not OK, Re-do.
Start
7 process Tank Process Tank
Mixing
8 6~1 Charging of Bulk Charging Pump & Qty. of Material Mass Flow As per Production Blend Sheet Flow Meter 100% Each Lot Yes FM/PRD/02/105 Prod.-in-charge As per WI: WI/PRD/02/001 If Quantity Charged is less or Mor, Inform to Director
Material in Mass Flow Meter Quantity Technical.
Blending Kettle
9 Mixing
5-3~16 Weighing and WS-8, WS-3, WS- Grade and Quantity of Mateerial. Weighing and As per Production Blend Sheet Weighing & Checking of 100% Each Material Yes BPS with format: Prod. Sup. Calibration of Weighing Devices If Weighed Quantity is not as per BPS, do re-
Prebatching of RM 6, WS-15 Take print slip each RM as per BPS FM/PRD/02/105 and & WI/PRD/02/024 weighing, verify of each RM
SC 1326 SC1341 SC1210 SC1255 SC1259 except Bulk RM. Print slip attached in
from weighing
2-9 丁目 2- 2-11 2-12 2-13 BPS.
scale
10 6-3~16 checking & Process Tank & Checking & Batch charging system Yes, BPS with format WI/PRD/02/001 &
Grade and Quantity of Mateerial. As per Production Blend Sheet 100% Each Material Prod. Sup. Prod. Sup. To verify and ensure charging of RM
Charging of RM in Additive Mixing Charging of RM sheet & Weighing slips of No.: FM/PRD/02/105 WI/PRD//02/024 Poka as per sequence mentioned in BPS
Process Tank Tank each RM, except bulk RM Yoke Control as per
3-9 3-10 3-11 3-12 3-13 FM/QAC/02/164
Double checking of Before Charging Grade and Quantity of Mateerial. Visual Check As per Production Blend Sheet Visual Check & Tick Mark 100% Each Material Yes, BPS with format Prod. Sup. Calibration of Weighing Devices If Material & Qty. Charged is not as per BPS stop the
4-9 3-10 3-11 3-12 3- additives in BPS manually No.: FM/PRD/02/105 & WI/PRD/02/024 charging process & Inform to director Tech.
13
89 5-9 5-10 5-11 5-12 5-13 7 Start Mixing Process a)Appearance of Mixed Blend a) - a)Homogenous Mixing a)Visual Evaluation of - Each Lot a ) No Prod. a) WI/PRD/02/001 a) If Not homogenous increase mixing time
tank b) - b) Mixing Time No Suspended Particles clarity Sample from the tank b ) Recording of time Sup./Prod.Mgr b) -Timer Alarm clock is set for b ) check
c) - c) Blending Temp. b)30 Minutes after finishing b)Watch in BPS with format no: themixing time visual sample after set time alarm ring. if homogenous
addition of all RMs c)Visual, Temp. Indicator FM/PRD/02/105 c)WI/PRD/02/001 increase mixing time.
6-9 6- 6- 6-12 6-13 c)Blending Temp 50 ºC Max. c) Recording of Temp. Poka Yoke Control as per c ) If temp goes beyond
10 11 8,9,10,11,13 Mixing Format No.: FM/QAC/02/164 limit.Audio alarm will blow stop process to bring Temp. to
FM/PRD/02/105 45˚c start again
10 12 Intermediate - Complete homogeneous - As per Product Manufacturing Visual/ Testing 500ml Each Lot Yes ERP generated S.I.R QAC Test Result If not OK, Remix
sample check mixing Specification No.QAC/PS/C/003 with format No. -incharge
FM/QAC/02/109
11
14 Final Sample - As per Product Manufacturing - As per Product Manufacturing Testing 1000ml Each Lot Yes ERP generated S.I.R QAC Test Result If not okay, hold the material Inform Director Techfor
Inspection Specification No.QAC/PS/C/003 Specification No.QAC/PS/C/ 003 with format No. -incharge suitable action.
SC 1950 SC1511 SC1930 FM/QAC/02/109
12
Intermediate 2-14 2-15 2-16 19 Packaging goods - Condition and identification - No damage, Ensure identification Visual 100% Each Lot No Store - Return to
Sample Check Receiving -incharge Supplier &
ask Counter
Measure
3-14 3-15 3-16 20 Packaging goods - As per respective Packing Material - As per Packing Material inspection As mentioned in M.I.S As per Each Lot Yes QAC Testing & Supplier Return
Report to
Inspection Inspection procedure. Specification MIS. Standard WI/QAC/ FM/MAT/02/022 -incharge Report Supplier &
02/004 ask Counter
4-14 4-15 4-16 Measure
21 Packaging goods - a) Packaging Conditions a) As per work a) No Leakage No Contamination a) Visual 100% a) Each Lot a) No a) Store a)Keep bags /Containers tightly a) Keep containers
Report
Storage b) Storing Conditions instruction b) Store in Cool, Dry & well b) Visual b) Each Lot b) No -incharge packed cool by
b) As per work ventilated place b) Store b) WI/MAT/02/001 b) spraying water if
5-14 5-15 5-16 instruction -incharge &WI/MAT/02/002 exposed to fire or heat.
22 a) Cleaning & - a) No leakage, No contamination a) Cleaning & a) No visual contamination a ) Visual 100% a) Each time No Prod. a ) WI/PRD/02/017 If not OK, Re-do.
6-14 6-15 6-16 Preparation of b) No leakage, No contamination inspection b) No visual b) Visual, Borescope, b) Each Barrel -in- b) OPI/PRD/02/011
Bulk Tanker c) -- c) Marking of contamination c) Visual b) Each Pack Charge
13 b) Cleaning & Product Name, after filtration c ) WI/PRD/02/003
Preparation of bulk Quantity Batch no b) Marking of Product Name,
pack Barrels Quantity Batch no etc.
c ) Marking of bulk
Packaging goods pack
14 19 15 Filtering(25μm) Filter Unit a) No suspended Particles a) - a) No Sus.Part.25μm filter (HT). Visual a) Initial Each Lot a) Maint. Check Sheet a) Prod. a) PM Sch. a) If not okay, check filter and replace Inform Director
Final Sample b) - b) Flow of Material b) 100% b) No -incharge b) - Tech
Inspection b) Good Flow b) --Do-- b) -
15 16 Product storage Interme diate a) Correct selection of holding - Process tank wise Selection of a) Visual on screen Initial Each Lot No Prod. PLC control system, Stop Trasnfer process, clean the HT. & start again. &
20 (Transfer to HT) Holding Tank tanks. holding tanks. -incharge WI/PRD/02/016 Inform
Filtering
b) Cleanliness of Holding tanks. No suspended Particles, No mixing b) Visual Director Tech
of different products.
21
16 17 Filtering(10μm) Filter Unit a) No suspended Particles a) - a) No Sus.Part.10μm filter( FL). Visual a) Initial Each Lot a) Maint. Check Sheet a) Prod. a) PM Sch. a) If not okay, check filter and replace Inform Director
Transfer to HT b) - b) Flow of Material b) 100% b) No -incharge b) - Tech
b) Good Flow b) --Do-- b) -
17 Filtering 22 18 Filling Line Sample - No contamination, No Suspended - Spec as mentioned in Sample Visual / Karl Fischer WI/QAC/ Each Lot Yes ERP generated S.I.R QAC WI/QAC/02/016 if not ok, further flush the Material from the FL, check
Inspection Particles, ,pH, RA, ERBP Inspection Report (SIR) pH Meter, ERBP app. 02/016 with format No. -in-charge WI/QAC/02/008 again & Inform to QA Head,
Annexure1 FM/QAC/02/109 Director Tech
18 23
12 Filling of Drums & a) Filling a)Weight Setting of a) 0-0.4% by Weight a)Digital Scale Reading & Each Pack a) Barrel Filling check Prod-incharge a)WI/PRD/02/003 If filled Qty is less or more label will not be printed. Inform
Filling Line FG auto Label Machine b) FG Kanban Label Dispenser b) Correct batch no, Expiry, b)Visual sheet b) WI/PRD/02/031 to prod HOD
Sample generation b) Printing Label Generation Mfg date & other details on label b) Auto record in WMS c) WI/PRD/02/018 Poka
Inspection machine thru WMS & (top & Side label) Kanban label not Yoke Control as per
pasting generated if tare wt. out of range 100% FM/QAC/02/164
23 Fiiling of Bulk 7.8-8.2 kg. Air press of barrel filling If filled qty is found less after weighing, fill the balance.qty
Filling in Barrel & FG Auto Label
Tanker c) Process tank c) Weight As per WI m/c (5-7 kg/cm2) & confirm. In case qty filled is found more, drain out in
Generation /Bulk tanker filling
c) 0-0.5% by weight c) Weighing Bridge Each Tanker c) Weighing slip container & confirm with reweighing.
24 Final Packaging - HDPE Barrel, No Leakage No - HDPE Barrel(200,210l) No Leakage Visual 100% Each Pack Yes Prod. WI/PRD/02/003. If loose capping, reseal /repack.
24 Contamination Proper closing, No Contamination Proper closing. Filling & Packg. Sheet -incharge
Final Packaging Sealing, Checking of grades & Correct name, B.No other,details,
other markings Cap Sealing intact with No.
25 25 Filled product - a) Packaging Conditions a) As per work a) No Leakage No Contamination a) Visual 100% a) Each Lot a) No a) Store a)Keep bags /Containers tightly Keep containers cool by spraying water if exposed to fire
storage b) Storing Conditions instruction b) Store in Cool, Dry & well b) Visual b) Each Lot b) No -incharge packed or heat.
b) As per work ventilated place Inform to Dir Tech / QA head
instruction
26 26 Pre Delivery Audit - Packaging Condition - No Leakage. No Dent on barrels Visual n=5 Each Lot No Exec. PDIWI/QAC/02/009 If not meeting Specification,Reject it. Inform to QAC head
PDAC Check / can Correct /legible Random QAC , & Director Technical
Batch no, Mfg Date, expiry date QAC-incharge
on barrels, Seal intactness ok.
no tear off Kanban Label As per
PDAC check list
27 27 Shipping - Conformation of Product name - As per Purchase Order Visual 100% Each Pack Yes, ERP System Prod. - If not matching, correct &Verify it
& quantity -incharge
S.no Revision no Date Detail of Revision Approved by Symbol Prepared By Approved by Page no
1 5 15.10.2016 FG Label and WMS Introduced 1 of 1
2 6 21.10.2019 Verification of RM before charging and Reaction Plan Updated
3 7 25.12.2019 Updated Poka Yoke & mention of Time in BPS Process Receving Storage Movement Inspection
4 8 05.02.2020 Poka Yoke And Reaction Plan Revised
5 9 10.01.2022 Testing Method and Frequency Updated in Poka Yoke List DIR. TECH. AGM QAC DIR. TECH. FM/QAC/02/006 Rev. No.:02 Dated: 20.12.2019
Material Name Material Code MANUFACTURING QUALITY CONTROL CHART Prototype Prelaunch
Supplier Details / Code Part No / Latets Change Key Contact A.Nandi (Director Technical ) Mfg Control chart no:
Core Team : Director Technical. Mgr. production, AGM QA
S-CCI INDIA PRIVATE LIMITED GC SUPER PROTECT GOLDEN YELLOW AF 0012Y Level Phone 01493-250975-76 QAC/CP/C/003
MFG. Location : Chopanki plant Bhiwadi Suuplier/ Plant Approval Date : Other Approval / date (if reqd.) Rev . 07 eff. Date 25.12.19
Characteristics Method
Process Name/
Part/ Process
Process Flow Diagram Number
Operation
Product
Other Control Product Process Evaluation Measurement
Sample Size Sample Freq. Process
Respon
Recording
Description items Method Specification / Tolerance Technique sibility.
1 Raw material ・Packaging Conditions As per List FM/PUR/01/011A No damage, leakage or other ・Visual 100% Each Lot - Store Yes, TSD No. Format
SC 1100 SC1950 SC1435 SC1602 SC1632 SC1315 SC1466 SC132 2-1~16 Receiving WI/MAT/02/02 deformation of packs. Ensure -incharge FM/MAT/02/001 through
0 ・Package Identification WI/MAT/02/01 complete product identification ERP
Preprati 2-1 丁目 2-2 2-3 2-4 2-5 2-6 2-7 2-8 RM Source Ensure supply of RM from approved
on of RM Receiving
vendor.
process
Tank 3-1~16 Raw material As per respective Raw Material Testing & Supplier Report As per Raw Material As mentioned As per Each Lot - QAC Yes
3-1 3-2 3-3 3-4 3-5 3-6 3-7 3-8 inspection Inspection procedure. Inspection in M.I.S WI/QAC/ -incharge
Specification MIS.. Standard 02/002 & FM/QAC/02/005 through
WI/QAC/ ERP
4-1 4-2 4-3 4-4 4-5 4-6 4-7 4-8 02/003
RM Storage
4-1~16 Raw material a) Packaging Conditioons a)Keep bags /Containers tightly a) No Leakage No Contamination a) Visual 100% a) Each Lot a) As per work a) Store a) Yes, TSD No.
storage b) Storing Conditions packed b) Store in Cool, Dry & well b) Visual b) Each Lot instruction -incharge FM/MAT/02/001 through
5-1 5-2 5-3 5-5 5-6 5-7 5-8 Weighing c) RM Kanban Label b) WI/MAT/02/001 &WI/MAT/02/002 ventilated place c) Visual Supplier COA c) Each Bag b) As per work b) Store ERP
5-4
c) WI/MAT/02/012 c) Correct Info: Lot no, Expiry instruction -incharge b) No
& Mfg date other details c) Label gen thru c) Store c) -Auto Record in WMS
WMS Pasting on Supr /
6-1 6-6 RM pack /bag Magr
6-2 6-3 6-4 6-5 6-7 6-8 Scanning &
Charging 1 Prepration of Selection and cleanliness of As per WI: WI/PRD/02/015 No Contamination Visual 100% Each Lot As per WI Prod.-in- Yes FM/PRD/02/105
Start
7 process Tank Process Tank charge
Mixing
8 6~1 Charging of Bulk Qty. of Material As per WI: WI/PRD/02/001 As per Production Blend Sheet Flow Meter 100% Each Lot Mass Flow Prod.-in- Yes FM/PRD/02/105
Material in Quantity charge
Blending Kettle
9 Mixing Grade and Quantity of Mateerial. As per Production Blend Sheet 100% Each Material
5-3~16 Weighing and Calibration of Weighing Devices & Weighing & Scanning of Weighing and QR Prod.-in- Yes BPS with format:
Prebatching of RM WI/PRD/02/024 each RM as per BPS Code Generation charge FM/PRD/02/105 and
SC 1326 SC1341 SC1210 SC1255 SC1259 except Bulk RM. Print slip attached in
2-9 丁目 2- 2- 2-12 2-13 BPS.
10 11 6-3~16 Scanning & Grade and Quantity of Mateerial. WI/PRD/02/001 & WI/PRD//02/024 As per Production Blend Sheet Batch charging system 100% Each Material Scanning & Prod.-in- Yes, BPS with format
Charging of sheet & Weighing slips of Charging of RM charge No.: FM/PRD/02/105
RM ,additives in each RM, except bulk RM
3-9 3-10 3- 3-12 3-13 Process Tank
11
Double checking of Grade and Quantity of Mateerial. Calibration of Weighing Devices & As per Production Blend Sheet Visual Check & Tick Mark 100% Each Material Visual Check Prod.-in- Yes, BPS with format
4-9 3-10 3- 3-12 3-13 additives WI/PRD/02/024 in BPS manually charge No.: FM/PRD/02/105
11
89 5-9 5-10 5- 5-12 5-13 7 Start Mixing a)Appearance of Mixed Blend a)WI/PRD/02/001 a)Homogenous Mixing a)Visual Evaluation of - Each Lot a) - Prod- a ) No
11 b) - b) - No Suspended Particles clarity Sample from the tank b) Mixing Time incharge b ) Recording of time
c) - c)WI/PRD/02/001 b)30 Minutes after finishing b)Watch c) Blending Temp. in BPS with format no:
addition of all RMs c)Visual, Temp. Indicator FM/PRD/02/105
6-9 6- 6- 6-12 6-13 c)Blending Temp 50 ºC Max. c) Recording of Temp.
10 11 8,9,10,11,13 Mixing Format No.:
FM/PRD/02/105
10 12 Intermediate Complete homogeneous Test Result As per Product Manufacturing Visual/ Testing 500ml Each Lot - QAC Yes ERP generated S.I.R
sample check mixing Specification No.QAC/PS/C/003 -incharge with format No.
FM/QAC/02/109
11
14 Final Sample As per Product Manufacturing Test Result As per Product Manufacturing Testing 1000ml Each Lot - QAC Yes ERP generated S.I.R
Inspection Specification No.QAC/PS/C/003 Specification No.QAC/PS/C/ 003 -incharge with format No.
SC 1950 SC1511 SC1930 FM/QAC/02/109
12
Intermediate 2-14 2-15 2-16 19 Packaging goods Condition and identification - No damage, Ensure identification Visual 100% Each Lot - Store No
Sample Check Receiving -incharge
3-14 3-15 3-16 20 Packaging goods As per respective Packing Material Testing & Supplier As per Packing Material inspection As mentioned in M.I.S As per Each Lot - QAC Yes
Inspection Inspection procedure. Report Specification MIS. Standard WI/QAC/ -incharge FM/MAT/02/022
02/004
4-14 4-15 4-16
21 Packaging goods a) Packaging Conditions a)Keep bags /Containers tightly a) No Leakage No Contamination a) Visual 100% a) Each Lot a) As per work a) Store a) No
Storage b) Storing Conditions packed b) Store in Cool, Dry & well b) Visual b) Each Lot instruction -incharge b) No
b) WI/MAT/02/001 &WI/MAT/02/002 ventilated place b) As per work b) Store
5-14 5-15 5-16 instruction -incharge
22 a) Cleaning & a) No leakage, No contamination a ) WI/PRD/02/017 a) No visual contamination a ) Visual 100% a) Each time a) Cleaning & Prod. No
6-14 6-15 6-16 Preparation of b) No leakage, No contamination b) OPI/PRD/02/011 after filtration b) Visual, Borescope, b) Each Barrel inspection -in-
Bulk Tanker c) -- c) b) No visual contamination c) Visual b) Each Pack c) Marking of Charge
13 b) Cleaning & WI/PRD/02/003 after filtration Product Name,
Preparation of bulk b) Marking of Product Name, Quantity Batch no
pack Barrels Quantity Batch no etc.
c ) Marking of bulk
Packaging goods pack
14 19 15 Filtering(25μm) a) No suspended Particles a) PM Sch. a) No Sus.Part.25μm filter (HT). Visual a) Initial Each Lot a) - a) Prod. a) Maint. Check Sheet
Final Sample b) - b) - b) 100% b) Flow of Material -incharge b) No
Inspection b) Good Flow b) --Do--
15 16 Product storage a) Correct selection of holding PLC control system, WI/PRD/02/016 Process tank wise Selection of a) Visual on screen Initial Each Lot - Prod. No
20 (Transfer to HT) tanks. holding tanks. -incharge
Filtering
b) Cleanliness of Holding tanks. No suspended Particles, No mixing b) Visual
of different products.
21
16 17 Filtering(10μm) a) No suspended Particles a) PM Sch. a) No Sus.Part.10μm filter( FL). Visual a) Initial Each Lot a) - a) Prod. a) Maint. Check Sheet
Transfer to HT b) - b) - b) 100% b) Flow of Material -incharge b) No
b) Good Flow b) --Do--
17 Filtering 22 18 Filling Line Sample No contamination, No Suspended WI/QAC/02/016 Spec as mentioned in Sample Visual / Karl Fischer WI/QAC/ Each Lot - QAC Yes ERP generated S.I.R
Inspection Particles, ,pH, RA, ERBP WI/QAC/02/008 Inspection Report (SIR) pH Meter, ERBP app. 02/016 -in-charge with format No.
Annexure1 FM/QAC/02/109
12
23 Filling of Drums & a)Weight a)WI/PRD/02/003 a) 0-0.4% by Weight a)Digital Scale Reading & 100% Each Pack Setting of Prod- a) Barrel Filling check
18
Filling Line FG auto Label b) FG Kanban Label b) WI/PRD/02/031 b) Correct batch no, Expiry, b)Visual Dispenser incharge sheet
Sample generation Mfg date & other details on label Label Generation b) Auto record in WMS
Inspection (top & Side label) Kanban label not thru WMS &
generated if tare wt. out of range pasting
23 7.8-8.2 kg. Air press of barrel filling
Filling in Barrel & FG
m/c (5-7 kg/cm2)
Auto Label
Generation
24 Final Packaging HDPE Barrel, No Leakage No WI/PRD/02/003. HDPE Barrel(210l) No Leakage Visual 100% Each Pack - Prod. Yes
24 Contamination Proper closing, No Contamination Proper closing. -incharge Filling & Packg. Sheet
Final Packaging Sealing, Checking of grades & Correct name, B.No other,details,
other markings Cap Sealing intact with No.
25 Filled product a) Packaging Conditions a)Keep bags /Containers tightly a) No Leakage No Contamination a) Visual 100% a) Each Lot a) As per work a) Store a) No
25
storage b) Storing Conditions packed b) Store in Cool, Dry & well b) Visual b) Each Lot instruction -incharge b) No
ventilated place b) As per work
instruction
25
Characteristics Method
Process Name/
Part/ Process
Process Flow Diagram Number
Operation
Product
Other Control Product Process Evaluation Measurement
Sample Size Sample Freq. Process
Respon
Recording
Description items Method Specification / Tolerance Technique sibility.
26 Pre Delivery Audit Packaging Condition PDIWI/QAC/02/009 No Leakage. No Dent on barrels Visual n=5 Each Lot - Exec. No
26
PDAC Check / can Correct /legible Random QAC ,
Batch no, Mfg Date, expiry date QAC-
on barrels, Seal intactness ok. incharge
no tear off Kanban Label As per
PDAC check list
27 27 Shipping Conformation of Product name - As per Purchase Order Visual 100% Each Pack - Prod. Yes, ERP System
& quantity -incharge
35
Production
Reaction
Machine
Plan
- a) Keep containers cool by spraying water if exposed to fire or heat. Refer MSDSof RMs.
b) keep containers cool by
spraying water if exposed to fire or heat. Refer MSDS of RMs.
c) If Info not aval /Wrong Info on Bag / label. Inform to Dir Tech / QA
head.
Charging Pump & If Quantity Charged is less or Mor, Inform to Director Technical.
Mass Flow Meter
WS-8, WS-3, WS- If Weighed Quantity is not as per BPS, do re-weighing, scanning of each RM
6, WS-15
Process Tank & If charging Qty is not as per BPS or RM is not in sequence, Scanning will not happen of
Additive Mixing next RM & charging process will stop.
Tank
Before Charging If Material & Qty. Charged is not as per BPS stop the charging process & Inform to
director Tech.
- If not okay, hold the material Inform Director Techfor suitable action.
- Return to
Supplier &
ask Counter
Measure
- Return
Report to
Supplier &
ask Counter
Measure
- a) Keep containers
Report
cool by
b) spraying water if
exposed to fire or heat.
Filter Unit a) If not okay, check filter and replace Inform Director Tech
b) -
Interme diate Stop Trasnfer process, clean the HT. & start again. & Inform
Holding Tank Director Tech
Filter Unit a) If not okay, check filter and replace Inform Director Tech
b) -
- if not ok, further flush the Material from the FL, check again & Inform to QA Head,
Director Tech
a) Filling If filled Qty is less or more label will not be printed. Inform to prod HOD
Machine
b) Printing
machine
45
Reaction
Machine
Plan
- If not meeting Specification,Reject it. Inform to QAC head & Director Technical
Approved by Page no
1 of 1
55