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:

Sl.No 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:

Sl.No 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:

Sl.No 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(Inj.Pressure)

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