CAPÍTULO II MARCO TEÓRICO
2.1. Antecedentes del estudio
2.1.2. Antecedentes nacionales
All requirements given below are subordinate to customer specific requirements.
The customer may have additional requirements, e.g., inspection testing, greater frequencies, etc. When performing the job audit, the auditor shall verify molder is conforming to customer requirements.
*If minimum requirements are not met, provide supporting records to justify actual conditions.
Related Molding
System Assessment
Question #
1.4 2.1 2.13
Incoming material assessment procedure, covering onsite testing or acceptance of supplier testing, with criteria (i.e., melt flow, specific gravity, temperature recording).
1.4 2.1 2.13
Incoming components assessment procedure, covering onsite testing or acceptance of supplier testing, with criteria (if applicable).
1.4 2.1 2.13
Purging all equipment and feeding system to avoid cross contamination.
CQI-23
Special Processes: Molding System Assessment
Version 1, 3/2014
Item # Category/Process Steps Type of Control
Minimum Requirement Actual Condition
PROCESS TABLE E - Transfer Molding
All requirements given below are subordinate to customer specific requirements.
The customer may have additional requirements, e.g., inspection testing, greater frequencies, etc. When performing the job audit, the auditor shall verify molder is conforming to customer requirements.
*If minimum requirements are not met, provide supporting records to justify actual conditions.
Related Molding
System Assessment
Question #
E2.2 Manual
3.0 Storage & Handling
E3.1 Automatic/Manual
E3.2 Environment temperature and humidity for storage (if applicable). Automatic
E3.3 Automatic
1.4 2.1 2.13
Compound property verification when applicable
- For rubber and one part epoxy; preform, elongation, tensile strength, compression set, pre-cure rate, or rheology etc.
1.4 2.11 2.12
Stock rotation system in place for First in/First out (FIFO) and shelf-life.
1.4 2.11 2.12 1.4 2.11 2.12
Temperature control during shipment from material supplier to cold storage area in plant (if applicable i.e.; one part epoxies).
Special Processes: Molding System Assessment
Version 1, 3/2014
PT E 58 of 79
Item # Category/Process Steps Type of Control
Minimum Requirement Actual Condition
PROCESS TABLE E - Transfer Molding
All requirements given below are subordinate to customer specific requirements.
The customer may have additional requirements, e.g., inspection testing, greater frequencies, etc. When performing the job audit, the auditor shall verify molder is conforming to customer requirements.
*If minimum requirements are not met, provide supporting records to justify actual conditions.
Related Molding
System Assessment
Question #
E3.4 Manual
E3.5 Automatic/Manual
E3.6 Automatic/Manual
E3.7 Partial container quantity Automatic/Manual
4.0 Molding Process
1.4 2.11 2.12
Material container remains sealed during warm up to room temperature (supplier recommendation).
1.4 2.11 2.12
Time exposed to room temperature when removed from cold storage area for production. Allowable usage time after room temperature is reached.
1.4 1.6 2.11 2.12
Partial container handling to ensure no contamination (closed container, clean environment)
1.4 1.6 2.11 2.12
CQI-23
Special Processes: Molding System Assessment
Version 1, 3/2014
Item # Category/Process Steps Type of Control
Minimum Requirement Actual Condition
PROCESS TABLE E - Transfer Molding
All requirements given below are subordinate to customer specific requirements.
The customer may have additional requirements, e.g., inspection testing, greater frequencies, etc. When performing the job audit, the auditor shall verify molder is conforming to customer requirements.
*If minimum requirements are not met, provide supporting records to justify actual conditions.
Related Molding
System Assessment
Question #
E4.1 Manual
E4.2 Production plan (machine, mold, materials, part style) Manual
E4.3 Startup check (verify process settings against setup sheet) Manual
E4.4 Automatic
E4.5 Verification of preform size, or shape, or both manual
1.4 1.15
2.11 2.12
There shall be a standardized startup procedure/checklist that defines things to do at start-up
1.4 1.15
2.11 2.12 1.4 1.15
2.11 2.12 1.4 1.15
2.11 2.12
Mold cavity temperatures; variation between each cavity and set temperatures
1.4 1.15
2.11 2.12
Special Processes: Molding System Assessment
Version 1, 3/2014
PT E 60 of 79
Item # Category/Process Steps Type of Control
Minimum Requirement Actual Condition
PROCESS TABLE E - Transfer Molding
All requirements given below are subordinate to customer specific requirements.
The customer may have additional requirements, e.g., inspection testing, greater frequencies, etc. When performing the job audit, the auditor shall verify molder is conforming to customer requirements.
*If minimum requirements are not met, provide supporting records to justify actual conditions.
Related Molding
System Assessment
Question #
E4.6 Automatic
E4.7 Fill - Fill time and peak pressure Automatic
E4.8 Hold - Hold pressure and hold time Automatic
E4.9 Cure Time Automatic
E4.10 Mold Closing speed Automatic
1.4 1.15
2.11 2.12
Plasticization - Temperature (resin chamber), Transfer Speed, and Transfer Pressure
1.4 1.15
2.11 2.12 1.4 1.15
2.11 2.12 1.4 1.15
2.11 2.12 1.4 1.15
2.11 2.12
CQI-23
Special Processes: Molding System Assessment
Version 1, 3/2014
Item # Category/Process Steps Type of Control
Minimum Requirement Actual Condition
PROCESS TABLE E - Transfer Molding
All requirements given below are subordinate to customer specific requirements.
The customer may have additional requirements, e.g., inspection testing, greater frequencies, etc. When performing the job audit, the auditor shall verify molder is conforming to customer requirements.
*If minimum requirements are not met, provide supporting records to justify actual conditions.
Related Molding
System Assessment
Question #
E4.11 Cavity surface cleanliness (no debris) manual
E4.12 Pre-heat of components - If Insert molding required Automatic
E4.13 Automatic
E4.14 Hold - Cavity pressure (if applicable) Automatic
E4.15 Part weight (if applicable) Manual
1.4 1.15
2.11 2.12 1.4 1.15
2.11 2.12 1.4 1.15
2.11 2.12
Pre-heat of resin pellets or compound - If applicable (per manufacturers recommendations)
1.4 1.15
2.11 2.12 1.4 1.15
2.11 2.12
Special Processes: Molding System Assessment
Version 1, 3/2014
PT E 62 of 79
Item # Category/Process Steps Type of Control
Minimum Requirement Actual Condition
PROCESS TABLE E - Transfer Molding
All requirements given below are subordinate to customer specific requirements.
The customer may have additional requirements, e.g., inspection testing, greater frequencies, etc. When performing the job audit, the auditor shall verify molder is conforming to customer requirements.
*If minimum requirements are not met, provide supporting records to justify actual conditions.
Related Molding
System Assessment
Question #
E4.16 Manual
E4.17 Shut down procedures Manual
5.0 Quality Control
E5.1 Part weight Manual
E5.2 Dimensions Manual
1.4 1.15
2.11 2.12
First piece approval
1.4 1.15
2.11 2.12
1.4 2.11
2.12 1.4
2.11 2.12
CQI-23
Special Processes: Molding System Assessment
Version 1, 3/2014
Item # Category/Process Steps Type of Control
Minimum Requirement Actual Condition
PROCESS TABLE E - Transfer Molding
All requirements given below are subordinate to customer specific requirements.
The customer may have additional requirements, e.g., inspection testing, greater frequencies, etc. When performing the job audit, the auditor shall verify molder is conforming to customer requirements.
*If minimum requirements are not met, provide supporting records to justify actual conditions.
Related Molding
System Assessment
Question #
E5.3 Appearance (vs. boundary sample or per instruction) Manual
E5.4 Physical properties (if applicable) Manual
1.4 2.11
2.12 1.4
2.11 2.12
Special Processes: Molding System Assessment
Version 1, 3/2014
PT E 64 of 79 Monitoring Frequency
Minimum Requirement Actual Condition
Once per lot
Once per lot
PROCESS TABLE E - Transfer Molding
The customer may have additional requirements, e.g., inspection testing, greater frequencies, etc. When performing the job audit, the auditor shall verify molder is conforming to customer requirements.
Observation/
Comments
(Pass / Fail / N/A)
End of run or long downtime, material change
CQI-23
Special Processes: Molding System Assessment
Version 1, 3/2014
Monitoring Frequency
Minimum Requirement Actual Condition
PROCESS TABLE E - Transfer Molding
The customer may have additional requirements, e.g., inspection testing, greater frequencies, etc. When performing the job audit, the auditor shall verify molder is conforming to customer requirements.
Observation/
Comments
(Pass / Fail / N/A)
Per production lot
FIFO - per Lot
Shelf life - pull for use
Continuous monitoring by controller or manual verification daily
Continuous monitoring (i.e., by chart recorder)
Special Processes: Molding System Assessment
Version 1, 3/2014
PT E 66 of 79 Monitoring Frequency
Minimum Requirement Actual Condition
PROCESS TABLE E - Transfer Molding
The customer may have additional requirements, e.g., inspection testing, greater frequencies, etc. When performing the job audit, the auditor shall verify molder is conforming to customer requirements.
Observation/
Comments
(Pass / Fail / N/A)
Continuous
Per Container
Time stamp on container from time out of cold storage to when container is opened
Continuous monitoring by controller or manual verification
CQI-23
Special Processes: Molding System Assessment
Version 1, 3/2014
Monitoring Frequency
Minimum Requirement Actual Condition
PROCESS TABLE E - Transfer Molding
The customer may have additional requirements, e.g., inspection testing, greater frequencies, etc. When performing the job audit, the auditor shall verify molder is conforming to customer requirements.
Observation/
Comments
(Pass / Fail / N/A)
At start-up
Continuous
Start-up and restart after long down time event
At start-up, and after long down time event
Continuous, at start-up and after down time event.
Special Processes: Molding System Assessment
Version 1, 3/2014
PT E 68 of 79 Monitoring Frequency
Minimum Requirement Actual Condition
PROCESS TABLE E - Transfer Molding
The customer may have additional requirements, e.g., inspection testing, greater frequencies, etc. When performing the job audit, the auditor shall verify molder is conforming to customer requirements.
Observation/
Comments
(Pass / Fail / N/A)
Continuous
Continuous
Continuous
Continuous
Continuous
CQI-23
Special Processes: Molding System Assessment
Version 1, 3/2014
Monitoring Frequency
Minimum Requirement Actual Condition
PROCESS TABLE E - Transfer Molding
The customer may have additional requirements, e.g., inspection testing, greater frequencies, etc. When performing the job audit, the auditor shall verify molder is conforming to customer requirements.
Observation/
Comments
(Pass / Fail / N/A)
Continuous
Continuous
Continuous
Continuous
Once every 8 hours*
Special Processes: Molding System Assessment
Version 1, 3/2014
PT E 70 of 79 Monitoring Frequency
Minimum Requirement Actual Condition
PROCESS TABLE E - Transfer Molding
The customer may have additional requirements, e.g., inspection testing, greater frequencies, etc. When performing the job audit, the auditor shall verify molder is conforming to customer requirements.
Observation/
Comments
(Pass / Fail / N/A)
End of production or run Start-up, and restart after down time event
Start-up and once every 4 hours. For safety critical parts, start-up and once every hour
Per cavity, start-up and once every 8 hours
CQI-23
Special Processes: Molding System Assessment
Version 1, 3/2014
Monitoring Frequency
Minimum Requirement Actual Condition
PROCESS TABLE E - Transfer Molding
The customer may have additional requirements, e.g., inspection testing, greater frequencies, etc. When performing the job audit, the auditor shall verify molder is conforming to customer requirements.
Observation/
Comments
(Pass / Fail / N/A) Per cavity, start-up and once
every 8 hours
Per cavity, start-up and once every 8 hours
Version 1, 3/2014
PT F 72 of 79
Item # Category/Process Steps Type of Control Monitoring Frequency
Minimum Requirement Actual Condition Minimum Requirement Actual Condition
1.0 Receiving Inspection
F1.1 Manual Once per lot
F1.2 Manual Once per lot
2.0 Storage & Handling
F2.1 Automatic/Manual
F2.2 Environment temperature and humidity controlled (if applicable) Automatic
F2.3 Automatic/Manual Continuous
F2.4 Partial container quantity Automatic/Manual Per Container
PROCESS TABLE F - Extrusion
All requirements given below are subordinate to customer specific requirements.
The customer may have additional requirements, e.g., inspection testing, greater frequencies, etc. When performing the job audit, the auditor shall verify molder is conforming to customer requirements.
*If minimum requirements are not met, provide supporting records to justify actual conditions.
Related
Incoming material assessment procedure, covering onsite testing or acceptance of supplier testing, with criteria (i.e., melt flow, specific gravity).
1.4 2.1 2.13
Incoming components assessment procedure, covering onsite testing or acceptance of supplier testing, with criteria (if applicable).
1.4 2.11 2.12
Stock rotation system in place for First in/First out (FIFO) and
shelf-life FIFO - per Lot
Shelf life - pull for use
1.4 2.11 2.12
Continuous monitoring by controller or manual verification daily 1.4
1.6 2.11 2.12
Partial container handling to ensure no contamination (closed container, clean environment)
1.4 1.6 2.11 2.12
CQI-23 Special Processes: Molding System Assessment
Version 1, 3/2014
Item # Category/Process Steps Type of Control Monitoring Frequency
Minimum Requirement Actual Condition Minimum Requirement Actual Condition
PROCESS TABLE F - Extrusion
All requirements given below are subordinate to customer specific requirements.
The customer may have additional requirements, e.g., inspection testing, greater frequencies, etc. When performing the job audit, the auditor shall verify molder is conforming to customer requirements.
*If minimum requirements are not met, provide supporting records to justify actual conditions.
Related 3.0 Material Drying (If Applicable)
F3.1 Dryer temperature per resin manufacturer guidelines (per material) Automatic
F3.2 Dryer time per resin manufacturer guidelines (per material) Manual
F3.3 Drying equipment (dryer dedicated or clean procedure in place) Manual Material change
F3.4 Dew point Automatic Continuous by controller
F3.5 Moisture content Manual
4.0 Recycle/Regrind Material (if Applicable)
F4.1 Automatic
F4.2 Regrind equipment (dedicated or cleaning procedure in place) Manual Material change
1.4 2.11 2.12
Start-up and continuous by controller.
1.4 2.11 2.12
Start-up and once every 8 hours
Recycle ratio (per print, inspection standard or manufacturer
guidelines). Verified by feed pressure, weight or volume. Once every 8 hours and at
every part change-over
1.4 1.11
2.11 2.12
Version 1, 3/2014
PT F 74 of 79
Item # Category/Process Steps Type of Control Monitoring Frequency
Minimum Requirement Actual Condition Minimum Requirement Actual Condition
PROCESS TABLE F - Extrusion
All requirements given below are subordinate to customer specific requirements.
The customer may have additional requirements, e.g., inspection testing, greater frequencies, etc. When performing the job audit, the auditor shall verify molder is conforming to customer requirements.
*If minimum requirements are not met, provide supporting records to justify actual conditions.
Related
F4.3 Fines management (de-dusting) Automatic/Manual Material change
F4.4 Automatic/Manual Start-up and continuous
5.0 Color Management (If Applicable)
F5.1 Pigment blending - percent loading Automatic/Manual Start-up and continuous
F5.2 Color change procedure Manual At color change
6.0 Extrusion Process
F6.1 Manual
F6.2 Production plan (machine, mold, materials, part quantity) Manual
F6.3 Manual
F6.4 Verify secondary equipment Manual
1.4
Prevention of contamination when transporting or feeding regrind to the extrusion machine.
1.4
There shall be a standardized startup procedure/checklist that
defines things to do at start-up Start-up and restart after long
down time event
1.4 1.15
2.11 2.12
Start-up and restart after long down time event
1.4 1.15
2.11 2.12
Verify molding machine settings including but not limited to barrel and head/die temperature settings, screw speed, screw cooling temperature (if applicable), as well as settings for down stream processes
Start-up and restart after long down time event
1.4 1.15
2.11 2.12
Start-up and restart after long down time event
CQI-23 Special Processes: Molding System Assessment
Version 1, 3/2014
Item # Category/Process Steps Type of Control Monitoring Frequency
Minimum Requirement Actual Condition Minimum Requirement Actual Condition
PROCESS TABLE F - Extrusion
All requirements given below are subordinate to customer specific requirements.
The customer may have additional requirements, e.g., inspection testing, greater frequencies, etc. When performing the job audit, the auditor shall verify molder is conforming to customer requirements.
*If minimum requirements are not met, provide supporting records to justify actual conditions.
Related
F6.5 Mold surface temperature Automatic/Manual
F6.6 Extrusion Head Pressure Automatic Start-up and continuous
F6.7 Vacuum level (if applicable) Automatic Start-up and continuous
F6.8 Coolant inlet temperature (if applicable) Automatic Start-up and continuous
F6.9 Manual
F6.10 Manual End of run or long downtime
F6.11 Shut down procedures Manual End of production or run
1.4 1.15
2.11 2.12
Continuous if automatic, or at start-up and after down time event.
First piece approval Start-up, and restart after
down time event
1.4 1.15
2.11 2.12
Material purge/evacuation of barrel - included in unplanned and downtime procedures
1.4 1.15
2.11 2.12
Version 1, 3/2014
PT F 76 of 79
Item # Category/Process Steps Type of Control Monitoring Frequency
Minimum Requirement Actual Condition Minimum Requirement Actual Condition
PROCESS TABLE F - Extrusion
All requirements given below are subordinate to customer specific requirements.
The customer may have additional requirements, e.g., inspection testing, greater frequencies, etc. When performing the job audit, the auditor shall verify molder is conforming to customer requirements.
*If minimum requirements are not met, provide supporting records to justify actual conditions.
Related
7.0 Quality Control
F7.1 Thickness Manual
F7.2 Layer thickness/thickness uniformity (multi-layer only) Manual
F7.3 Layer adhesion (multi-layer only) Manual
F7.4 Dimensions Manual
F7.5 Appearance (vs. boundary sample or per instruction) Manual
F7.6 Physical properties (if applicable) Manual
1.4 2.11
2.12
Per cavity, start-up and once every 8 hours. For safety critical parts, start-up and once every hour
1.4 2.11
2.12
Per cavity, start-up and once every 8 hours. For safety critical parts, start-up and once every 4 hours.
1.4 2.11
2.12
Per cavity, start-up and once every 8 hours. For safety critical parts, start-up and once every hour 1.4
2.11 2.12
Per cavity, start-up and once every 8 hours
1.4 2.11
2.12
Per cavity, start-up and once every 8 hours
1.4 2.11
2.12
Per cavity, start-up and once every 8 hours
CQI-23 Special Processes: Molding System Assessment
Version 1, 3/2014
Item # Equipment Type Extrusion Verification Frequency Comment
1.0 PROCESS EQUIPMENT
G1.1 2.14 Mold Temperature Controller X X X X X X Once per shift N/A
G1.2 2.14 Filters, if applicable X X X X X X N/A
G1.3 2.14 Thermocouple X X X X X X Per Preventive Maintenance Annual
G1.4 2.14 Injection Mold Machine X Per Preventive Maintenance Every 5 years
G1.5 2.14 Mold X X X X X X Per Preventive Maintenance N/A
G1.6 2.14 Blow mold machine X Per Preventive Maintenance Every 5 years
G1.7 2.14 Vacuum molding machine X Per Preventive Maintenance N/A
G1.8 2.14 Compression molding machine X X Per Preventive Maintenance N/A
G1.9 2.14 Extrusion machine X Per Preventive Maintenance Every 5 years
G1.10 2.14 Dryer X X X X Per Preventive Maintenance N/A
G1.11 2.14 Regrinder X X X Per Preventive Maintenance N/A
G1.12 2.14 Hot Runner Controller X Per Preventive Maintenance N/A
G1.13 2.14 Cavity Pressure Sensor X Per Preventive Maintenance N/A
G1.14 2.14 Hydraulic Pressure Transducer X X Per Preventive Maintenance N/A
G1.15 2.14 X X Per Preventive Maintenance N/A
PROCESS TABLE G - Equipment
All requirements given below are subordinate to customer specific requirements.
The customer may have additional requirements, e.g., inspection testing, greater frequencies, etc. When performing the job audit, the auditor shall verify molder is conforming to customer requirements.
* When historical results show capability, test frequency may be reduced.
Related Molding System
Assessment Question #
Injection Molding Blow
Molding Vacuum
Forming Compression
Molding Transfer Molding
Calibration / Certification Frequency *
Included in Preventative Maintenance Plan
Once per month or per preventive maintenance
Valve Gate Controller, if applicable
Version 1, 3/2014
PT G 78 of 79
Item # Equipment Type Extrusion Verification Frequency Comment
PROCESS TABLE G - Equipment
All requirements given below are subordinate to customer specific requirements.
The customer may have additional requirements, e.g., inspection testing, greater frequencies, etc. When performing the job audit, the auditor shall verify molder is conforming to customer requirements.
* When historical results show capability, test frequency may be reduced.
Related Molding System
Assessment Question #
Injection Molding Blow
Molding Vacuum
Forming Compression
Molding Transfer Molding
Calibration / Certification Frequency *
Included in Preventative Maintenance Plan
2.0 SECONDARY EQUIPMENT
G2.1 2.14 X X X X Per Preventive Maintenance N/A
G2.2 2.14 Conveyers X X X X X X Per Preventive Maintenance N/A
G2.3 2.14 Degater/Trim Operation X X X X X X Per Preventive Maintenance N/A
G2.4 2.14 Cutter X Per Preventive Maintenance N/A
G2.5 2.14 Robot X X X X X Per Preventive Maintenance At Installation
G2.6 2.14 Oven, if applicable X X X X Per Preventive Maintenance Annual
G2.7 2.14 Cooling Fan, if applicable X X Per Preventive Maintenance Annual
G2.8 2.14 End of arm tooling X X X X X Per Preventive Maintenance N/A
3.0
G3.1 2.14 Cure Testing, if applicable X X Per lot Annual
G3.2 2.14 Leak Testing, if applicable X X X At start up and per shift Every 6 months
G3.3 2.14 Color X X Before each use Annual
G3.4 2.14 Gloss X X Before each use Annual
G3.5 2.14 Weight X X X At start up Annual
G3.6 2.14 Dimensions X X X X X X At start up Every 6 months
G3.7 2.14 Moisture X X X X X X Per Manufacturer Guidelines Every 6 months
G3.8 2.14 Performance, if applicable X X X X X X Per Manufacturer Guidelines Annual
Generic fixtures (cooling, heat forming, if applicable)
MINIMUM REQUIRED TESTING CAPABILITY
CQI-23 Special Processes: Molding System Assessment
Version 1, 3/2014
Item # Category/Process Steps Monitoring Frequency Observation/Comments
Dimension, Weight, Appearance, Minimum Requirement Actual Condition (Pass / Fail / N/A)
1.0 General
Dimensions Appearance Performance
H1.1 100%
H1.2 1.4
H1.3 1.4 Cracks, Weld line/Knit lines, and Whitening/ stress mark First off and last off
H1.4 1.4 Part identification First off
H1.5 1.4 Manufacturing information
H1.6 1.4 Dimensional check (e.g., Go-no go, Plug and Ring gage) First off and once per shift
H1.7 1.4 Wall thickness Per process table
H1.8 1.4 General - Weight, Resin, Components, Porosity/Voids (if applicable) First off
H1.9 1.4 Performance Per customer specifications
H1.10 1.4 Environmental Per customer specifications
PROCESS TABLE H - Part Inspection and Testing
All requirements given below are subordinate to customer specific requirements.
The customer may have additional requirements, e.g., inspection testing, greater frequencies, etc. When performing the job audit, the auditor shall verify molder is conforming to specifications or other requirements.
Note that not all tests are applicable to all molding processes.
Related Molding System Assessment
Question #
1.42.9 Procedures are in place to prevent damage to the finish or part during the inspection and packaging processes
Appearance (flash, color and gloss, short shots, splay/burns, blister, sink marks, gate vestige, and other molding defects) of the molding shall be verified per specification and applications manual
First off by quality and 100%
by operator
Daily Production Meeting Review