Format #
Issue No 1
Control Plan Process Audit Check Sheet Rev. Date 1-Aug-24
Date (Origin) 1-Aug-24
Rev No 0
Date: Part Number / Name/ Tool No: Process:
Shift: Batch No: Shift Handover
Time: Machine Ton/No.: Operator: Yes: No:
[Link] Control Plan Process Check points Observations Status
1 Drawing Details
2 Previous audit NC status
Are the CP / FMEA up to date and reflecting current
3 Inputs processing? Safety / Critical / Special / Characteristics
Identification
Implementation of corrective actions & Minitoring of counter
4 measures and effectiveness taken against customer
complaints & Horizontal deployment.
Implementation of corrective actions & Minitoring of counter
5 measures and effectiveness taken against in house top
rejections
Raw material traceability ( GRN / supplier)
6 Inward Of RM
Raw material as per customer drawing / Bom / Control Plan /
JED
7 QA clearance of raw material
Incoming material assessment , covering onsite testing or
acceptance of supplier testing, with criteria.
7.1 Incoming Inspection
Material Test certificate and conformity of the results to ref.
standard.
Incoming components assessment procedure, covering
7.2 onsite testing or acceptance of supplier testing, with criteria
(if applicable).
8 Preservation of raw material
Storage of Raw
material
Handling of partial used material bags to ensure no
8.1
contamination , Moisture, Identification
9 Issue of RM Stock rotation system in place for First in/First out (FIFO)
Pre-heating equipment (Dryer/Hopper dedicated or clean
Loading of RM in bin /
10 procedure in place)
Hopper / Dryer
Preservation of raw material in shop floor.
Plastic Raw Material Monitoring of pre-heating temperature & Time per resin
11
Pre - Heating manufacturer guidelines (Per material)
12 Preservation of mould
Mould Loading
Mould loaded as per control plan and verifcation of mould
12.1
loading
Moisture analysis, if applicable, per Resin Manufacturer
13
Guidelines
There shall be a standardized startup procedure/checklist
13.1
that defines things to do at start-up
13.2 Production plan (machine, mold, materials, part style)
Startup check (verify process settings against Standard
13.3
proess sheet)
Are process control parameters monitored per frequencies
13.4
specifiedin process tables?
Are there procedure or work instructions avilable to define
13.5 the molding process?(Equipment start-up, equipment shut
down,potential emergencies(such as power failure)
13.6 Is Lighting of production area & inpection area adequate
Is there a preventive maintenance plan for machine and
13.7
mold?
Preventive maintenance validity ( Date ./Due dates according
13.8
to plan)
13.9 Reporting of problem or breakdown done and closed looped?
13.1 Daily maintenance as per established checklists
Format #
Issue No 1
Control Plan Process Audit Check Sheet Rev. Date 1-Aug-24
Date (Origin) 1-Aug-24
Rev No 0
Date: Part Number / Name/ Tool No: Process:
Shift: Batch No: Shift Handover
Time: Machine Ton/No.: Operator: Yes: No:
[Link] Control Plan Process Check points Observations Status
13.11 Poke Yoke monitoring is followed
Has the moulder developed a critical spare list, and are the
13.12
spares available to minmize production distruptions?
Are plant cleanliness,housekeeping, environmental and
13.13 working conditions conducive to controland improved
quality?
13.14 Display of limit samples near machine and identification.
Are the Control plans up to date and reflecting current
13.15 Moulding processing?
Are the PFMEA's up to date and reflecting current
13.16
processing?
13.17 Implementation of control methods as per Control plan
Implementation of process controls ( prevention /Detection )
13.18
as per PFMEA
Does the QA incharge or Plant head authorize the disposition
13.19
of material from quarantine status?
4M change management monitoring & updating in display
13.2
board. Display of 4m Procedure and abnormal procedure
Handling of abnormal situation , Safe & Healthy Working
13.21
place
Are first aid and fire fighting equipment are in working
13.22
condition
13.23 OEE
13.24 Rejection / Re- work levels
Product identification and traceability in shop floor ( WO
13.25
/Batch no wise )
Is there a dedicated and qualified moulding professional on-
13.26
site?
13.27 Operator working as per operation standard / control plan
13.28 Handling of rejection parts.
13.29 On the job training details
14 measurement of products ( inspection as per control plans )
instruments / gauges as defined in control plans ( evaluation
14.1
method)
First off inspection &
Last Off Inspection
14.2 Valid calibration reports for the above
Applicable MSA study results for the above referred
14.3
instruments /gauges.
15 Measurement of products ( inspection as per control plans )
Inprocess Inspection
15.1 Process capability ( Cp, Cpk)
Format #
Issue No 1
Control Plan Process Audit Check Sheet Rev. Date 1-Aug-24
Date (Origin) 1-Aug-24
Rev No 0
Date: Part Number / Name/ Tool No: Process:
Shift: Batch No: Shift Handover
Time: Machine Ton/No.: Operator: Yes: No:
[Link] Control Plan Process Check points Observations Status
16 Last off inspection Evidence of last of report and sample
RM & Insert return to Handling of partial used material bags to ensure no
16
stores. contamination , Moisture, Identification
Handling of parts to ensure no contamination , part damage,
17 Storage of WIP
Identification of parts and FIFO
Were all inspection steps, as documented in the Control Plan
18
performed?
Were steps/operations performed that were not documented
18.1
in the Control Plan?
18.2 Secondary operation If additional steps were performed, were they authorized?
Are the parts and bins free of inappropriate objects or
18.3
contamination?
18.4 Handling of rejection parts.
19 Final inspection measurement of products ( inspection as per control plans )
20 Are packaging requirements identified?
20.1 Packing & Labelling Is packing standard defined and done as per standard
Are parts packaged to minimize mixed parts or damaged (for
20.2
example, work flow or over-pack of container)?
Were the parts properly identified and stored proeprly?
Storage
22
( at Despatch area )
Stock rotation system in place for First in/First out (FIFO)
23 Despatch to customer Before dispatch dock audit was done?
AUDITEE: AUDITOR:
Total Nc:
Observations:
Total
Note: (+) = positive observation; (--)= Non conformance ; (OI) = Opportunity for improvement
Format #
Issue No 1
Process Audit Summary Rev. Date 1-Aug-24
Date (Origin) 1-Aug-24
Rev No 0
SL No. Category /Process Step Checking Method Frequency Standard Actual A Shift Actual B Shift Status
1
Monitoring of Material Pre-heating as per
guidelines or Approved parameter
2 Moisture analysis at start -up
3 Hopper dedicated or clean procedure in place
4
Master batch loading,if applicable monitoirng
and ratio of master batch & mixing method.
5 Production Plan
6
Material purge / evacuation of barrel -included
in unplanned and downtime procedures
7 Mold surface temperature
8
Temperature (Barrel, Nozzel, Zones,Hot
manifold if applicable)
9 Melt Temperature
10 Screw recovery time(Refilling Time)
11 Screw velocity
12 Fill-Screw velocity (Inj. Speed)
13 Fill-time (Inj. Time )
14 Fill-peak pressure([Link])
15 Hold-Hold time
16 Hold-Hold pressure
17 Hold -Cushion
18 Hold cavity pressure(Tonnage)
19 Part Weight
20 Shot Weight
AUDITEE:
Total Nc:
AUDITOR:
Total Observations:
Note: (+) = positive observation; (--)= Non conformance ; (OI) = Opportunity for improvement