CAPÍTULO II MARCO TEÓRICO
2.1. Antecedentes del estudio
2.1.1. Antecedentes internacionales
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).
1.4 2.1 2.13
Incoming components assessment procedure, covering onsite testing or acceptance of supplier testing, with criteria (if applicable).
1.4 2.3 2.11 2.12
Stock rotation system in place for First in/First out (FIFO) and shelf-life.
1.4 2.11
2.12 Environment contamination (dust) controlled (if applicable)
CQI-23
Special Processes: Molding System Assessment
Version 1, 3/2014
Item # Category/Process Steps Type of Control
Minimum Requirement Actual Condition
PROCESS TABLE C - Vacuum Forming
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 #
C2.3 Environment humidity and temperature controlled (if applicable) Automatic
C2.4 Automatic/Manual
C2.5 Plastic Sheet Stacking Manual
3.0 Forming Process
C3.1 Manual
1.4 1.6 2.7 2.11 2.12 1.4
1.6 2.7 2.11 2.12
Partial containers handling to ensure no contamination (closed container, clean environment)
1.4 1.6 2.7 2.11 2.12
1.4 1.15
2.11 There shall be a standardized startup procedure/checklist that defines things to do at start-up
Special Processes: Molding System Assessment
Version 1, 3/2014
PT C 32 of 79
Item # Category/Process Steps Type of Control
Minimum Requirement Actual Condition
PROCESS TABLE C - Vacuum Forming
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 #
C3.2 Production plan (machine, mold, materials, part quantity) Manual
C3.3 Startup check (verify process settings against setup sheet) Automatic / Manual
C3.4 Heating distance (between heater and sheet) Manual
C3.5 Sheet heating time and temperature (heating cycle, intensity) Manual
C3.6 Startup check - Secondary Equipment (trimming, assembly) 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 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 C - Vacuum Forming
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 #
C3.7 Sheet forming temperature per film supplier guidelines Automatic/Manual
C3.8 Mold temperature per film supplier guidelines Automatic/Manual
C3.9 Clamping frame closing pressure Automatic
C3.10 Mold close speed Automatic
C3.11 Plug temperature, start time and speed (if applicable) Automatic 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 1.4 1.15
2.11 2.12
Special Processes: Molding System Assessment
Version 1, 3/2014
PT C 34 of 79
Item # Category/Process Steps Type of Control
Minimum Requirement Actual Condition
PROCESS TABLE C - Vacuum Forming
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 #
C3.12 Sheet pre-stretching sequence and time (if applicable) Automatic
C3.13 Vacuum level, start time, evacuation speed and duration Automatic
C3.14 Pressure level, start time and duration (if applicable) Automatic
C3.15 Cooling temperature and time Automatic
C3.16 Ejection air (compressed) pressure and time Automatic
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 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 C - Vacuum Forming
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 #
C3.17 Manual
C3.18 Shut down procedures Manual
4.0 Quality Control
C4.1 Dimensions Manual
C4.2 Appearance (vs. boundary sample or per instruction) Manual
C4.3 Physical properties (if applicable) 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 1.4
2.11 2.12
Special Processes: Molding System Assessment
Version 1, 3/2014
PT C 36 of 79 Monitoring Frequency
Minimum Requirement Actual Condition
Once per lot
Once per lot
PROCESS TABLE C - Vacuum Forming
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)
FIFO - per Lot
Shelf life - pull for use
Continuous by controller or manual verification daily
CQI-23
Special Processes: Molding System Assessment
Version 1, 3/2014
Monitoring Frequency
Minimum Requirement Actual Condition
PROCESS TABLE C - Vacuum Forming
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 by controller or manual verification daily
Start-up and restart after long down time event
Special Processes: Molding System Assessment
Version 1, 3/2014
PT C 38 of 79 Monitoring Frequency
Minimum Requirement Actual Condition
PROCESS TABLE C - Vacuum Forming
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
At start-up
At start-up, and after long down time event
At start-up, and after long down time event
At start-up, and after long down time event
CQI-23
Special Processes: Molding System Assessment
Version 1, 3/2014
Monitoring Frequency
Minimum Requirement Actual Condition
PROCESS TABLE C - Vacuum Forming
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, and after long down time event
At start-up, and after long down time event
At start-up, and after long down time event
At start-up, and after long down time event
At start-up, and after long down time event
Special Processes: Molding System Assessment
Version 1, 3/2014
PT C 40 of 79 Monitoring Frequency
Minimum Requirement Actual Condition
PROCESS TABLE C - Vacuum Forming
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 and every 8 hours
At start-up and every 8 hours At start-up, and after long down time event
At start-up, and after long down time event
At start-up, and after long down time event
CQI-23
Special Processes: Molding System Assessment
Version 1, 3/2014
Monitoring Frequency
Minimum Requirement Actual Condition
PROCESS TABLE C - Vacuum Forming
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
Per cavity, start-up and once every 8 hours
Per cavity, start-up and once every 8 hours
Per cavity, start-up and once every 8 hours
Special Processes: Molding System Assessment
Version 1, 3/2014
PT D 42 of 79
Item # Category/Process Steps Type of Control
Minimum Requirement Actual Condition
1.0 Receiving Inspection
D1.1 Manual
D1.2 Manual
2.0 Compounding (if applicable)
D2.1 Manual
D2.2 Manual