Copia de CQI-23

CQI-23

Special Processes: Molding System Assessment

Version 1, 3/2014

Special Process: Molding System Assessment Facility Name: Address:

Phone Number: Fax Number: Number of Molding Employees at this Facility:

Type(s) of Molding Processes at this Facility: Process Table A Injection Molding

Captive Molder (Y/N): Commercial Molder (Y/N):

Process Table B Blow Molding

Date of Assessment:

Process Table C Vacuum Forming

Date of Previous Assessment: Process Table D Compression Molding Process Table E Transfer Molding Process Table F Extrusion Process Table G Equipment Process Table H Part Inspection & Testing Current Quality Certification(s): Date of Re-assessment (if necessary): Personnel Contacted: Name:

Title:

Phone:

Email:

Auditors/Assessors: Name:

Company:

Phone:

Email:

Number of "Not Satisfactory" Findings:

Number of "Needs Immediate Action" Findings:

Number of "Fail" Findings in the Job Audit(s):

Number of Process Table Items not meeting Minimum Requirements:

CQI-23

Special Processes: Molding System Assessment

Version 1, 3/2014

Special Process: Molding System Assessment (General Facility Overview)

Assessment

Question Number

Question

Requirements and Guidance

Objective Evidence

N/A

Section 1 - Management Responsibility and Quality Planning

1.1

1.2

To ensure readily available expertise, there shall be a dedicated and qualified molding person on the site. This individual shall be a full-time employee and the position shall be reflected in the organization chart. A Is there a dedicated and job description shall exist identifying the qualifications qualified molding professional for the position including chemical and molding on-site? knowledge. The qualifications shall include a minimum of 5 years experience in molding operation or a combination of a minimum of 5 years of formal technical education and molding experience.

Does the molder perform advanced quality planning?

The molder shall incorporate a documented advanced quality planning procedure. A feasibility study shall be performed and internally approved for each new part or process. Similar parts can be grouped into part families for this effort as defined by the molder. After the part approval process is approved by the customer, no process changes are allowed unless approved by the customer. The molder shall contact the customer when clarification of process changes is required. This clarification of process changes shall be documented.

Section 1-2, 2 of 79

Satisfactory

Not Satisfactory

Needs Immediate Action

CQI-23

Special Processes: Molding System Assessment

Version 1, 3/2014

Special Process: Molding System Assessment (General Facility Overview)

Assessment

Question Number

Question

Requirements and Guidance

Objective Evidence

1.3

The molder shall incorporate the use of a documented Failure Mode and Effects Analysis (FMEA) procedure and ensure the FMEAs are updated to reflect current part quality status. The FMEA shall be written for each part or part family or they may be process-specific and Are the molder's FMEA's up to written for each process. In any case, they shall date and reflecting current address all process steps from part receipt to part processing? shipment and all key molding process parameters as defined by the molder. A cross-functional team shall be used in the development of the FMEA. All special characteristics, as defined by the molder and its customers, shall be identified, defined, and addressed in the FMEA.

1.4

The molder shall incorporate the use of a documented Control Plan procedure and ensure the Control Plans are updated to reflect current controls. The Control Plans shall be written for each part or part family or they may be process-specific and written for each process. In any case, they shall address all process steps from part receipt to part shipment and identify all equipment used and all key molding process parameters as defined by the molder. A crossAre molding process Control functional team, including a production operator, shall Plans up to date and reflecting be used in the development of Control Plans, which current processing? shall be consistent with all associated documentation such as work instructions, shop travelers, and FMEAs. All special characteristics, as defined by the molder and its customers, shall be identified, defined, and addressed in the Control Plans. Sample sizes and frequencies for evaluation of process and product characteristics shall also be addressed consistent with the minimum requirements listed in the Process Tables.

Section 1-2, 3 of 79

N/A

Satisfactory

Not Satisfactory

Needs Immediate Action

CQI-23

Special Processes: Molding System Assessment

Version 1, 3/2014

Special Process: Molding System Assessment (General Facility Overview)

Assessment

Question Number

Question

Requirements and Guidance

Objective Evidence

To ensure all customer requirements are both understood and satisfied, the molder shall have all related molding and customer referenced standards and specifications available for use and a method to ensure that they are current. Such standards and specifications include, but are not limited to, those relevant documents published by SAE, AIAG, ASTM, General Motors, Ford, and Chrysler. The molder shall have a process to ensure the timely review, distribution, and implementation of all customer and industry engineering standards and specifications and changes based on customer-required schedule. This process shall be executed as soon as possible and shall not exceed two weeks. The molder shall document this process of review and implementation, and it shall address how customer and industry documents are obtained, how they are maintained within the molder, how the current status is established, and how the relevant information is cascaded to the shop floor within the two-week period. The molder shall identify who is responsible for performing these tasks.

1.5

Are all molding related and referenced specifications current and available? For example: SAE, AIAG, ASTM, General Motors, Ford, and Chrysler.

1.6

Are all molding related internal The molder should have a documented process and and external best practices system for maintaining best practices obtained through documented and maintained? lessons learned or from industry knowledge.

1.7

Is there a written process specification for all active processes?

The molder shall have written process specifications for all active processes and identify all steps of the process including relevant operating parameters. Examples of operating parameters include process temperatures, cycle times, etc. Such parameters shall not only be defined, they shall have operating tolerances as defined by the molder in order to maintain process control. All active processes should have a written process specification. These process specifications may take the form of work instructions, job card, start-up sheet, or other similar documents.

Section 1-2, 4 of 79

N/A

Satisfactory

Not Satisfactory

Needs Immediate Action

CQI-23

Special Processes: Molding System Assessment

Version 1, 3/2014

Special Process: Molding System Assessment (General Facility Overview)

Assessment

Question Number

Question

Requirements and Guidance

Objective Evidence

1.8

To demonstrate each process is capable of yielding acceptable product, the molder shall perform product capability studies for the initial validation of each process, after relocation of any process equipment, and after a major rebuild of any equipment. The molder shall define what constitutes a major rebuild. Initial product capability studies shall be conducted for all molding processes per line as defined in scope of Has a valid product capability work and in accordance with customer requirements. study been performed initially Capability study techniques shall be appropriate for and after process change? the molding product characteristics, e.g., molding thickness, part weight, etc. Any specific customer requirements shall be met. In the absence of customer requirements, the molder shall establish acceptable ranges for measures of capability. An action plan shall exist to address the steps to be followed in case capability indices fall outside customer requirements or established ranges.

1.9

The analysis of products and processes over time can yield vital information for defect prevention efforts. The molder shall have a system to collect, analyze, and react to product or process data over time. Does the molder collect and Methods of analysis shall include ongoing trend or analyze data over time, and historical data analysis of special product or process react to this data? Are records parameters/characteristics. The molder shall available? determine which parameters/characteristics to include in such analysis. All process control and testing records must be retained for a minimum of one calendar year after the year in which they were created.

1.10

Are internal assessments being completed on an annual basis, at a minimum, incorporating AIAG Molding System Assessment?

The molder shall conduct internal assessments on an annual basis, at a minimum, using the AIAG Molding System Assessment. Concerns shall be addressed in a timely manner.

Section 1-2, 5 of 79

N/A

Satisfactory

Not Satisfactory

Needs Immediate Action

CQI-23

Special Processes: Molding System Assessment

Version 1, 3/2014

Special Process: Molding System Assessment (General Facility Overview)

Assessment

Question Number

Question

Requirements and Guidance

Objective Evidence

1.11

The quality management system shall include a documented process for reprocessing that shall include authorization from a designated individual. The reprocessing procedure shall describe product characteristics for which reprocessing is allowed as Is there a system in place to well as those characteristics for which reprocessing is authorize reprocessing and is not permissible. All reprocessing activity shall require it documented? a new processing control sheet issued by qualified technical personnel denoting the necessary molding modifications. Records shall clearly indicate when and how any material has been reprocessed. The Quality Manager or a designee shall authorize the release of reprocessed product.

1.12

Does the Quality Department review, address, and document customer and internal concerns?

1.13

The molder shall define a process for continual improvement for each molding process identified in the Is there a continual scope of the Molding System Assessment. The improvement plan applicable process shall be designed to bring about continual to each process defined in the improvement in quality and productivity. Identified scope of the assessment? actions shall be prioritized and shall include timing (estimated completion dates). The molder shall show evidence of program effectiveness.

1.14

Does the Quality Manager or designee authorize the disposition of material from quarantine status?

The quality management system shall include a process for documenting, reviewing, and addressing customer concerns and any other concerns internal to the molder. A disciplined problem solving approach shall be used.

The Quality Manager or designee is responsible for authorizing and documenting appropriate personnel to disposition quarantine material.

Section 1-2, 6 of 79

N/A

Satisfactory

Not Satisfactory

Needs Immediate Action

CQI-23

Special Processes: Molding System Assessment

Version 1, 3/2014

Special Process: Molding System Assessment (General Facility Overview)

Assessment

Question Number

Question

Requirements and Guidance

Objective Evidence

1.15

There shall be procedures or work instructions available to molding personnel covering the molding process. These procedures or work instructions shall Are there procedures or work include methods of addressing potential emergencies instructions available to (such as power failure), equipment start-up, equipment molding personnel that define shut-down, product segregation (See 2.8), product the molding process? inspection, and general operating procedures. These procedures or work instructions shall be accessible to shop floor personnel.

1.16

The molder shall provide employee training for applicable molding operations. All employees, including backup and temporary employees, shall be trained. Documented evidence shall be maintained Is management providing showing the employees trained and the evidence shall employee training for molding? include an assessment of the effectiveness of the training. Management shall define the qualification requirements for each function, and ongoing or followup training shall also be addressed.

1.17

Is there a responsibility matrix to ensure that all key management and supervisory functions are performed by qualified personnel?

The molder shall maintain a responsibility matrix identifying all key management and supervisory functions and the qualified personnel who may perform such functions. It shall identify both primary and secondary (backup) personnel for the key functions (as defined by the molder). This matrix shall be readily available to management at all times.

Section 1-2, 7 of 79

N/A

Satisfactory

Not Satisfactory

Needs Immediate Action

CQI-23

Special Processes: Molding System Assessment

Version 1, 3/2014

Special Process: Molding System Assessment (General Facility Overview)

Assessment

Question Number

1.18

1.19

Question

Is there a preventive maintenance program? Is maintenance data being utilized to form a predictive maintenance program?

Requirements and Guidance

Objective Evidence

The molder shall have a documented preventive maintenance program for key process equipment (as identified by the molder). The program shall be a closed-loop process that tracks maintenance efforts from request to completion to assessment of effectiveness. Equipment operators shall have the opportunity to report problems, and problems shall also be handled in a closed-loop manner. Company data, e.g., downtime, quality rejects, first time-through capability, recurring maintenance work orders, and operator-reported problems, shall be used to improve the preventive maintenance program. Maintenance data shall be collected and analyzed as part of a predictive maintenance program.

Has the molder developed a The molder shall develop and maintain a critical spare critical spare parts list, and are parts list and shall ensure the availability of such parts the parts available to minimize to minimize production disruptions. production disruptions?

Section 1-2, 8 of 79

N/A

Satisfactory

Not Satisfactory

Needs Immediate Action

CQI-23

Special Processes: Molding System Assessment

Version 1, 3/2014

Special Process: Molding System Assessment (General Facility Overview)

Assessment

Question Number

Question

Requirements and Guidance

Objective Evidence

Section 2 - Floor and Material Handling Responsibility Does the facility ensure that the data entered in the receiving system matches the information on the customer's shipping documents?

Documented processes and evidence of compliance shall exist, e.g., shop travelers, work orders, etc. The facility shall have a detailed process in place to resolve receiving discrepancies.

2.2

Is product clearly identified and staged throughout the molding process?

Procedures for part and container identification help to avoid incorrect processing or mixing of lots. Appropriate location and staging within the facility also help to ensure that orders are not shipped until all required operations are performed. Customer product shall be clearly identified and staged throughout the molding process. Non-molded, in-process, and finished product shall be properly segregated and identified. All material shall be staged in a dedicated and clearly defined area.

2.3

Is molder using adequate There shall be a procedure that ensures a FIFO FIFO system for material and system is utilized. product?

2.4

Is lot traceability and integrity maintained throughout all processes?

2.1

Out-going lot(s) shall be traceable to the incoming lot(s). The discipline of precisely identifying lots and linking all pertinent information to them enhances the ability to do root cause analysis and continual improvement.

Section 1-2, 9 of 79

N/A

Satisfactory

Not Satisfactory

Needs Immediate Action

CQI-23

Special Processes: Molding System Assessment

Version 1, 3/2014

Special Process: Molding System Assessment (General Facility Overview)

Assessment

Question Number

2.5

Question

Are procedures adequate to prevent movement of nonconforming product into the production system?

Requirements and Guidance

Objective Evidence

The control of suspect or non-conforming product is necessary to prevent inadvertent shipment or contamination of other lots. Procedures shall be adequate to prevent movement of non-conforming product into the production system. Procedures shall exist addressing proper disposition, product identification and tracking of material flow in and out of hold area. Non-conforming hold area shall be clearly designated to maintain segregation of such material.

Section 1-2, 10 of 79

N/A

Satisfactory

Not Satisfactory

Needs Immediate Action

CQI-23

Special Processes: Molding System Assessment

Version 1, 3/2014

Special Process: Molding System Assessment (General Facility Overview)

Assessment

Question Number

Question

Requirements and Guidance

Objective Evidence

Is there a system to identify trap points in the entire process to reduce risk of mixed parts (inappropriate, unfinished or improperly molded parts)?

The molder shall have documented procedures to identify and monitor trap points for each process/equipment. Monitoring of potential trap points shall occur for every part changeover.

2.7

Are containers free of inappropriate material?

Containers handling customer product shall be free of inappropriate material. After emptying and before reusing containers, containers shall be inspected to ensure that all parts and inappropriate material have been removed. The source of inappropriate material shall be identified and addressed. This is to ensure that no nonconforming molded parts or inappropriate material contaminate the finished lot.

2.8

Unplanned or emergency downtime greatly raises the risk of improper processing. Operators shall be trained in material handling, containment action, and product Are operators trained in segregation in the event of an equipment emergency material handling, containment including power failure. Training shall be documented. action and product Work instructions specifically addressing potential segregation in the event of an types of equipment emergencies and failures shall be equipment emergency accessible to and understood by equipment operators. including power failure? These instructions shall address containment/reaction plans related to all elements of the process. Evidence shall exist showing disposition and traceability of affected product.

2.9

Is the handling, storage and packaging adequate to preserve product quality?

2.6

The molder's in-process handling and shipping process shall be assessed for risk of part damage or other quality concerns.

Section 1-2, 11 of 79

N/A

Satisfactory

Not Satisfactory

Needs Immediate Action

CQI-23

Special Processes: Molding System Assessment

Version 1, 3/2014

Special Process: Molding System Assessment (General Facility Overview)

Assessment

Question Number

Question

Requirements and Guidance

Objective Evidence

2.10

Are plant cleanliness, housekeeping, environmental and working conditions conducive to control and improved quality?

Plant cleanliness, housekeeping, environmental, and working conditions shall be conducive to controlling and improving quality. The molder should evaluate such conditions and their affect on quality. A housekeeping policy shall be clearly defined and executed.

2.11

Are process control parameters monitored per frequencies specified in Process Tables?

Process control parameters shall be monitored per frequencies specified in Process Tables. Computer monitoring equipment with alarms and alarm logs satisfy the verification requirement. A designated floor person shall verify the process parameters.

2.12

There are documented reaction plans to both out of Are out of control/specification control and out of tolerance process parameters. parameters reviewed and There is documented evidence that reaction plans are reacted to? followed.

2.13

Are Test Frequencies performed as specified in Process Tables?

2.14

Is product test equipment verified?

Test Frequencies shall be performed as specified in Process Tables. Refer to Process Tables

Test equipment shall be verified/calibrated per applicable customer specific standard or per an applicable consensus standard, e.g., ASTM, SAE, ISO, NIST, etc. Verification/calibration results shall be internally reviewed, approved and documented. Refer to Process Tables for frequency of checks.

2.15

Lighting of inspection area

Lighting in the inspection area shall be sufficient to allow the evaluation of all part surfaces. The lighting shall be arranged to preclude spot lighting, glare or shadows. There can be no moving or distracting reflections on the surfaces to be evaluated.

Section 1-2, 12 of 79

N/A

Satisfactory

Not Satisfactory

Needs Immediate Action

CQI-23

Special Processes: Molding System Assessment

Version 1, 3/2014

Section 3 - Job Audit - Finished Product Review Job Identity: Customer: Shop Order Number: Part Number: Part Description: Molding Requirements:

Question #

Job Audit Question

Related Molding System Assessment Question #

Customer or Internal Requirement

Job (Shop) Order or Reference Documentation Requirement

3.1

Is contract review and advanced quality planning, FMEA, Control Plans, etc., in place and performed by qualified individuals?

1.1 1.2 1.3 1.4 1.6

N/A

3.2

Does the molder have the proper customer specifications for the part?

1.5

N/A

3.3

Is there documented evidence of Receiving Inspection?

2.1

3.4

Is material identification (part numbers, lot numbers, contract numbers, etc.) maintained throughout the molding process?

2.2 2.3 2.4

3.5

Is the proper procedure or process specification used? Refer to Process Tables for specific parameters. List parameters that were verified in this audit in the spaces provided below.

1.5 1.6 2.1 2.11 2.13

Job Audit 13 of 79

Actual Condition (Objective Evidence)

Pass / Fail / N/A

CQI-23

Special Processes: Molding System Assessment

Version 1, 3/2014

Section 3 - Job Audit - Finished Product Review Job Identity: Customer: Shop Order Number: Part Number: Part Description: Molding Requirements:

Question #

Job Audit Question

Related Molding System Assessment Question #

Customer or Internal Requirement

Job (Shop) Order or Reference Documentation Requirement

Actual Condition (Objective Evidence)

Process #1: Process #2:

3.6

3.6.1

What are the product inspection requirements?

1.5 2.13 2.14

Each part may have one or more requirements determined by the molding specification. Parts must meet each requirement. List each requirement below and validate. (Listed below are some examples)

Requirement: Weight Test Method: Test frequency or quantity: Selection of samples: Specification: Job Audit 14 of 79

Pass / Fail / N/A

CQI-23

Special Processes: Molding System Assessment

Version 1, 3/2014

Section 3 - Job Audit - Finished Product Review Job Identity: Customer: Shop Order Number: Part Number: Part Description: Molding Requirements:

Question #

3.6.2

Job Audit Question

Related Molding System Assessment Question #

Customer or Internal Requirement

Requirement: Color Test Method(s): Test frequency or quantity: Selection of samples: Specification:

3.6.3

Requirement: Gloss Test Method: Test frequency or quantity: Selection of samples: Specification:

3.6.4

Requirement: Flash Test Method(s): Test frequency or quantity: Selection of samples: Specification:

Job Audit 15 of 79

Job (Shop) Order or Reference Documentation Requirement

Actual Condition (Objective Evidence)

Pass / Fail / N/A

CQI-23

Special Processes: Molding System Assessment

Version 1, 3/2014

Section 3 - Job Audit - Finished Product Review Job Identity: Customer: Shop Order Number: Part Number: Part Description: Molding Requirements:

Question # 3.6.5

Job Audit Question

Related Molding System Assessment Question #

Customer or Internal Requirement

Requirement: Dimension Test Method: Test frequency or quantity: Selection of samples: Specification:

3.6.6

Requirement: Appearance Test Method: Test frequency or quantity: Selection of samples: Specification:

3.6.7

Requirement: Customer Specific Test Method(s): Test frequency or quantity: Selection of samples: Specification:

Job Audit 16 of 79

Job (Shop) Order or Reference Documentation Requirement

Actual Condition (Objective Evidence)

Pass / Fail / N/A

CQI-23

Special Processes: Molding System Assessment

Version 1, 3/2014

Section 3 - Job Audit - Finished Product Review Job Identity: Customer: Shop Order Number: Part Number: Part Description: Molding Requirements:

Question #

Job Audit Question

Related Molding System Assessment Question #

Customer or Internal Requirement

Operator or Inspector Responsibilities 1.4 1.6 2.2 2.3 2.11

3.7

Were appropriate process steps signed off?

3.8

Were all inspection steps, as documented in the Control Plan performed?

3.9

Were steps/operations performed that were not documented in the Control Plan?

1.2 1.4 1.6

3.10

If additional steps were performed, were they authorized?

1.2 1.4 1.6 1.10 1.16

3.11

Does the governing specification allow reprocessing or rework?

1.5 1.10

1.2 1.4

Job Audit 17 of 79

Job (Shop) Order or Reference Documentation Requirement

Actual Condition (Objective Evidence)

Pass / Fail / N/A

CQI-23

Special Processes: Molding System Assessment

Version 1, 3/2014

Section 3 - Job Audit - Finished Product Review Job Identity: Customer: Shop Order Number: Part Number: Part Description: Molding Requirements:

Question #

Job Audit Question

Related Molding System Assessment Question #

3.12

If the order was certified, did the certification accurately reflect the process performed?

2.11 2.13

3.13

Was the certification signed by an authorized individual?

1.16

3.14

Are the parts and containers free of inappropriate objects or contamination?

2.6

Customer or Internal Requirement

Packaging Requirements 3.15

Are packaging requirements identified?

2.6 2.7 2.9

3.16

Are parts packaged to minimize mixed parts or damaged (for example, work flow or over-pack of container)?

2.6 2.7 2.9

Shipping Requirements 3.17

Were the parts properly identified?

2.3 2.9

3.18

Were the containers properly labeled?

2.3 2.9 Job Audit 18 of 79

Job (Shop) Order or Reference Documentation Requirement

Actual Condition (Objective Evidence)

Pass / Fail / N/A

CQI-23

Special Processes: Molding System Assessment

Version 1, 3/2014

PROCESS TABLE A - Injection 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.

Item #

Related Molding System Assessment Question #

Category/Process Steps

Type of Control

Minimum Requirement 1.0

Actual Condition

Monitoring Frequency

Minimum Requirement

Receiving Inspection

A1.1

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 Manual gravity).

Once per lot

A1.2

1.4 2.1 2.13

Incoming components assessment procedure, covering onsite testing or acceptance of supplier testing, with criteria (if applicable).

Manual

Once per lot

2.0

Storage & Handling (If Applicable)

A2.1

1.4 2.3 2.11 2.12

Stock rotation system in place for First in/First out (FIFO) and shelflife

Automatic/Manual

FIFO - per Lot Shelf life - pull for use

A2.2

1.4 2.11 2.12

Environment temperature controlled

Automatic

Continuous monitoring by controller or manual verification daily

A2.3

1.4 1.6 2.7 2.11 2.12

Handling of partial containers to ensure no contamination (closed container, clean environment)

Automatic/Manual

Continuous

A2.4

1.4 1.6 2.7 2.11 2.12

Partial container quantity

Automatic/Manual

Per Container

PT A 19 of 79

Actual Condition

Observation/ Comments

(Pass / Fail / N/A)

CQI-23

Special Processes: Molding System Assessment

Version 1, 3/2014

PROCESS TABLE A - Injection 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.

Item #

Related Molding System Assessment Question #

Category/Process Steps

Type of Control

Minimum Requirement 3.0

Actual Condition

Monitoring Frequency

Minimum Requirement

Material Drying

A3.1

1.4 2.11 2.12

Dryer temperature per resin manufacturer guidelines (per material)

Automatic

Continuous monitoring by controller

A3.2

1.4 2.11 2.12

Dryer time per resin manufacturer guidelines (per material)

Manual

Per Resin Manufacturer Guidelines

A3.3

1.4 2.11 2.12

Drying equipment (dryer dedicated or clean procedure in place)

Manual

Material change

A3.4

1.4 2.11 2.12

Dew point

Automatic

Continuous monitoring by controller

A3.5

1.4 2.11 2.12

Moisture analysis, if applicable, per Resin Manufacturer Guidelines

Manual

At start-up and once per shift*

4.0

Recycle (regrind) Material (If Applicable)

A4.1

1.4 1.11 2.11 2.13

Recycle ratio (per print, inspection standard or manufacturer guidelines). Verified by feed pressure, weight or volume

Automatic

Once every 8 hours and at every part change over

A4.2

1.4 1.11 2.11 2.12

Dedicated regrind equipment or cleaning procedure in place

Manual

Material change

A4.3

1.4 1.11 2.11 2.12

Fines management (de-dusting)

Automatic/Manual

Material change

A4.4

1.4 1.11 2.11 2.12

Move regrind to IMM (contamination)

Automatic/Manual

Start-up and continuous

PT A 20 of 79

Actual Condition

Observation/ Comments

(Pass / Fail / N/A)

CQI-23

Special Processes: Molding System Assessment

Version 1, 3/2014

PROCESS TABLE A - Injection 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.

Item #

Related Molding System Assessment Question #

Category/Process Steps

Type of Control

Minimum Requirement 5.0

Actual Condition

Monitoring Frequency

Minimum Requirement

Color Management

A5.1

1.4 2.11 2.12

Pigment blending - percent loading, if applicable

Automatic/Manual

Start-up and continuous

A5.2

1.4 2.11 2.12

Color change procedure

Manual

Continuous

6.0

Molding Process

A6.1

1.4 1.15 2.11 2.12

There shall be a standardized startup procedure/checklist that defines things to do at start-up

Manual

Start-up and restart after long down time event

A6.2

1.4 1.15 2.11 2.12

Production plan (machine, mold, materials, part style)

Manual

Start-up and restart and after long down time event

A6.3

1.4 1.15 2.11 2.12

Startup check (verify process settings against setup sheet)

Manual

At start-up, and after long down time event

A6.4

1.4 1.15 2.11 2.12

Startup check - Secondary Equipment (De-gate, assembly equipment, welders, etc.)

Manual

At start-up, and after long down time event

A6.5

1.4 1.15 2.11 2.12

Mold surface temperature

Automatic/Manual

Continuous if automatic, or at start-up and after down time event

A6.6

1.4 1.15 2.11 2.12

Plastication - Temperature (barrel, nozzle, hot manifold if applicable), Automatic screw RPM, and back pressure

PT A 21 of 79

Continuous

Actual Condition

Observation/ Comments

(Pass / Fail / N/A)

CQI-23

Special Processes: Molding System Assessment

Version 1, 3/2014

PROCESS TABLE A - Injection 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.

Item #

Related Molding System Assessment Question #

Category/Process Steps

Type of Control

Minimum Requirement

Actual Condition

Monitoring Frequency

Minimum Requirement

A6.7

1.4 1.15 2.11 2.12

Plastication - Melt temperature

N/A

Start-up

A6.8

1.4 1.15 2.11 2.12

Plastication - Screw recovery time

N/A

Continuous

A6.9

1.4 1.15 2.11 2.12

Fill - Screw velocity or velocity profile

Automatic

Continuous

A6.10

1.4 1.15 2.11 2.12

Fill - Fill time and peak pressure

N/A

Continuous

A6.11

1.4 1.15 2.11 2.12

Hold - Hold pressure and hold time

Automatic

Continuous

A6.12

1.4 1.15 2.11 2.12

Hold - Cushion

N/A

Continuous

A6.13

1.4 1.15 2.11 2.12

Hold - Cavity pressure (if applicable)

N/A

Continuous

A6.14

1.4 1.15 2.11 2.12

Temperature Control Cooling - Coolant inlet temperature and cooling Automatic time

PT A 22 of 79

Continuous

Actual Condition

Observation/ Comments

(Pass / Fail / N/A)

CQI-23

Special Processes: Molding System Assessment

Version 1, 3/2014

PROCESS TABLE A - Injection 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.

Item #

Related Molding System Assessment Question #

Category/Process Steps

Type of Control

Minimum Requirement

Actual Condition

Monitoring Frequency

Minimum Requirement

A6.15

1.4 1.15 2.11 2.12

Part weight (if applicable)

Manual

Once every 8 hours*

A6.16

1.4 1.15 2.11 2.12

First piece approval

Manual

Start-up, and restart after down time event

A6.17

1.4 1.15 2.11 2.12

Material purge/evacuation of barrel - included in unplanned and downtime procedures

Manual

End of run or long downtime

A6.18

1.4 1.15 2.11 2.12

Shut down procedures

Manual

End of production or run

7.0

Quality Control

A7.1

1.4 2.11 2.12

Part weight

Manual

Start-up and once every 4 hours. For safety critical parts, start-up and once every hour

A7.2

1.4 2.11 2.12

Dimensions

Manual

Per cavity, start-up and once every 8 hours

A7.3

1.4 2.11 2.12

Appearance (vs. boundary sample or per instruction)

Manual

Per cavity, start-up and once every 8 hours

A7.4

1.4 2.11 2.12

Physical properties (if applicable)

Manual

Per cavity, start-up and once every 8 hours

PT A 23 of 79

Actual Condition

Observation/ Comments

(Pass / Fail / N/A)

CQI-23

Special Processes: Molding System Assessment

Version 1, 3/2014

PROCESS TABLE B - Blow 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.

Item #

Related Molding System Assessment Question #

Category/Process Steps

Type of Control

Minimum Requirement 1.0

Actual Condition

Monitoring Frequency

Minimum Requirement

Receiving Inspection

B1.1

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 Manual gravity).

Once per lot

B1.2

1.4 2.1 2.13

Incoming components assessment procedure, covering onsite testing or acceptance of supplier testing, with criteria (if applicable).

Manual

Once per lot

2.0

Storage & Handling

B2.1

1.4 2.3 2.11 2.12

Stock rotation system in place for First in/First out (FIFO) and shelflife

Automatic/Manual

FIFO - per Lot Shelf life - pull for use

B2.2

1.4 2.11 2.12

Environment temperature and humidity controlled (if applicable)

Automatic

Continuous monitoring by controller or manual verification daily

B2.3

1.4 1.6 2.7 2.11 2.12

Partial container handling to ensure no contamination (closed container, clean environment)

Automatic/Manual

Continuous

B2.4

1.4 1.6 2.7 2.11 2.12

Partial container quantity

Automatic/Manual

Per container

3.0

Material Drying (If Applicable)

B3.1

1.4 2.11 2.12

Dryer temperature per resin manufacturer guidelines (per material)

Automatic

Start-up and continuous by controller

B3.2

1.4 2.11 2.12

Drying time per resin manufacturer guidelines (per material)

Manual

Start-up and once every 8 hours PT B 24 of 79

Actual Condition

Observation/ Comments

(Pass / Fail / N/A)

CQI-23

Special Processes: Molding System Assessment

Version 1, 3/2014

PROCESS TABLE B - Blow 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.

Item #

Related Molding System Assessment Question #

Category/Process Steps

Type of Control

Minimum Requirement

Actual Condition

Monitoring Frequency

Minimum Requirement

B3.3

1.4 2.11 2.12

Drying equipment (dryer dedicated or clean procedure in place)

Manual

Material change

B3.4

1.4 2.11 2.12

Dew point

Automatic

Continuous by controller

B3.5

1.4 2.11 2.12

Moisture content

Manual

Start-up and once every 8 hours

4.0

Recycle/Regrind Material (If Applicable)

B4.1

1.4 1.11 2.11 2.13

B4.2

Recycle ratio (per print, inspection standard or manufacturer guidelines). Verified by feed pressure, weight or volume. No regrind Automatic of fluorine-treated parts.

Once every 8 hours and at every part change-over

1.4 1.11 2.11 2.12

Regrind equipment (dedicated or cleaning procedure in place)

Manual

Material change

B4.3

1.4 1.11 2.11 2.12

Ethylene Vinyl Alcohol (EVOH) particle size and distribution

Manual

Start-up

B4.4

1.4 1.11 2.11 2.12

Fines management (de-dusting)

Automatic/Manual

Material change

B4.5

1.4 1.11 2.11 2.12

Prevention of contamination when transporting or feeding regrind to the blow mold machine

Automatic/Manual

Start-up and continuous

PT B 25 of 79

Actual Condition

Observation/ Comments

(Pass / Fail / N/A)

CQI-23

Special Processes: Molding System Assessment

Version 1, 3/2014

PROCESS TABLE B - Blow 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.

Item #

Related Molding System Assessment Question #

Category/Process Steps

Type of Control

Minimum Requirement 5.0

Actual Condition

Monitoring Frequency

Minimum Requirement

Color Management (If Applicable)

B5.1

1.4 2.11 2.12

Pigment blending - percent loading

Automatic/Manual

Start-up and continuous

B5.2

1.4 2.11 2.12

Color change procedure

Manual

At color change

6.0

Molding Process

B6.1

1.4 1.15 2.11 2.12

There shall be a standardized startup procedure/checklist that defines things to do at start-up

Manual

Start-up and restart after long down time event

B6.2

1.4 1.15 2.11 2.12

Production plan (machine, mold, materials, part quantity)

Manual

Start-up and restart and after long down time event

B6.3

1.4 1.15 2.11 2.12

Environment temperature for parison

Automatic

Continuous by controller or manual verification daily

B6.4

1.4 1.15 2.11 2.12

Verify molding machine settings including but not limited to barrel and die/head temperature settings, parison thickness or thickness profile, pre-blow pressure and time, blow air pressure and time, mold close speed and clamp pressure

Manual

Start-up and restart after long down time event

B6.5

1.4 1.15 2.11 2.12

Verify secondary equipment

Manual

Start-up and restart after long down time event

B6.6

1.4 1.15 2.11 2.12

Cooling water temperature and flow rate

Automatic/Manual

Continuous if automatic, or at start-up and after down time event.

PT B 26 of 79

Actual Condition

Observation/ Comments

(Pass / Fail / N/A)

CQI-23

Special Processes: Molding System Assessment

Version 1, 3/2014

PROCESS TABLE B - Blow 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.

Item #

Related Molding System Assessment Question #

Category/Process Steps

Type of Control

Minimum Requirement

Actual Condition

Monitoring Frequency

Minimum Requirement

B6.7

1.4 1.15 2.11 2.12

Verify post mold cooling temperature or pressure and time

Manual

Start-up

B6.8

1.4 1.15 2.11 2.12

First piece approval

Manual

Start-up, and restart after down time event

B6.9

1.4 1.15 2.11 2.12

Material purge/evacuation of barrel

Manual

End of run or long downtime

B6.10

1.4 1.15 2.11 2.12

Shut down procedures

Manual

End of production or run

7.0

Fluorine/Sulfination Treatment (If Applicable)

B7.1

1.4 1.15 2.11 2.12

Start-up check

Manual

Start-up and restart after long down time event

B7.2

1.4 1.15 2.11 2.12

Carrier gas

Automatic

Continuous

B7.3

1.4 1.15 2.11 2.12

Volume

Automatic

Continuous

B7.4

1.4 1.15 2.11 2.12

Treatment time

Automatic

Continuous

PT B 27 of 79

Actual Condition

Observation/ Comments

(Pass / Fail / N/A)

CQI-23

Special Processes: Molding System Assessment

Version 1, 3/2014

PROCESS TABLE B - Blow 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.

Item #

Related Molding System Assessment Question #

Category/Process Steps

Type of Control

Minimum Requirement

B7.5

1.4 1.15 2.11 2.12

Neutralization and wash cycle

Actual Condition

Monitoring Frequency

Minimum Requirement

Start-up and once every 8 hours

Manual

PT B 28 of 79

Actual Condition

Observation/ Comments

(Pass / Fail / N/A)

CQI-23

Special Processes: Molding System Assessment

Version 1, 3/2014

PROCESS TABLE B - Blow 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.

Item #

Related Molding System Assessment Question #

Category/Process Steps

Type of Control

Minimum Requirement 8.0

Actual Condition

Monitoring Frequency

Minimum Requirement

Quality Control

B8.1

1.4 2.11 2.12

Part weight

Manual

Start-up and once every 4 hours. For safety critical parts, start-up and once every hour

B8.2

1.4 2.11 2.12

Wall thickness (if applicable)

Manual

Start-up and once every 4 hours

B8.3

1.4 2.11 2.12

Dimensions

Manual

Start-up and once every 4 hours

B8.4

1.4 2.11 2.12

Appearance

Manual

Start-up and once every 4 hours

B8.5

1.4 2.11 2.12

Physical properties (if applicable)

Manual

Start-up and once every 4 hours

B8.6

1.4 2.11 2.12

Layer thickness and thickness uniformity - (multi-layer only)

Manual

Start-up and once every 24 hours. For safety critical parts, start-up and once every 8 hours

B8.7

1.4 2.11 2.12

Pinch-off integrity

Manual

Start-up and once every 24 hours. For safety critical parts, start-up and once every 8 hours

PT B 29 of 79

Actual Condition

Observation/ Comments

(Pass / Fail / N/A)

CQI-23

Special Processes: Molding System Assessment Version 1, 3/2014

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 mo *If minimum requirements are not met, provide supporting records to justify actual conditions.

Item #

Related Molding System Assessment Question #

Category/Process Steps

Type of Control

Minimum Requirement 1.0

Receiving Inspection

C1.1

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 Manual gravity).

C1.2

1.4 2.1 2.13

Incoming components assessment procedure, covering onsite testing or acceptance of supplier testing, with criteria (if applicable).

2.0

Manual

Storage & Handling

C2.1

1.4 2.3 2.11 2.12

Stock rotation system in place for First in/First out (FIFO) and shelflife.

Automatic/Manual

C2.2

1.4 2.11 2.12

Environment contamination (dust) controlled (if applicable)

Automatic/Manual

PT C 30 of 79

Actual Condition

CQI-23

Special Processes: Molding System Assessment Version 1, 3/2014

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 mo *If minimum requirements are not met, provide supporting records to justify actual conditions.

Item #

Related Molding System Assessment Question #

Category/Process Steps

Type of Control

Minimum Requirement

C2.3

1.4 1.6 2.7 2.11 2.12

Environment humidity and temperature controlled (if applicable)

Automatic

C2.4

1.4 1.6 2.7 2.11 2.12

Partial containers handling to ensure no contamination (closed container, clean environment)

Automatic/Manual

C2.5

1.4 1.6 2.7 2.11 2.12

Plastic Sheet Stacking

Manual

3.0

C3.1

Forming Process 1.4 1.15 2.11 2.12

There shall be a standardized startup procedure/checklist that defines things to do at start-up PT C 31 of 79

Manual

Actual Condition

CQI-23

Special Processes: Molding System Assessment Version 1, 3/2014

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 mo *If minimum requirements are not met, provide supporting records to justify actual conditions.

Item #

Related Molding System Assessment Question #

Category/Process Steps

Type of Control

Minimum Requirement

C3.2

1.4 1.15 2.11 2.12

Production plan (machine, mold, materials, part quantity)

Manual

C3.3

1.4 1.15 2.11 2.12

Startup check (verify process settings against setup sheet)

Automatic / Manual

C3.4

1.4 1.15 2.11 2.12

Heating distance (between heater and sheet)

Manual

C3.5

1.4 1.15 2.11 2.12

Sheet heating time and temperature (heating cycle, intensity)

Manual

C3.6

1.4 1.15 2.11 2.12

Startup check - Secondary Equipment (trimming, assembly)

Manual

PT C 32 of 79

Actual Condition

CQI-23

Special Processes: Molding System Assessment Version 1, 3/2014

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 mo *If minimum requirements are not met, provide supporting records to justify actual conditions.

Item #

Related Molding System Assessment Question #

Category/Process Steps

Type of Control

Minimum Requirement

C3.7

1.4 1.15 2.11 2.12

Sheet forming temperature per film supplier guidelines

Automatic/Manual

C3.8

1.4 1.15 2.11 2.12

Mold temperature per film supplier guidelines

Automatic/Manual

C3.9

1.4 1.15 2.11 2.12

Clamping frame closing pressure

Automatic

C3.10

1.4 1.15 2.11 2.12

Mold close speed

Automatic

C3.11

1.4 1.15 2.11 2.12

Plug temperature, start time and speed (if applicable)

Automatic

PT C 33 of 79

Actual Condition

CQI-23

Special Processes: Molding System Assessment Version 1, 3/2014

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 mo *If minimum requirements are not met, provide supporting records to justify actual conditions.

Item #

Related Molding System Assessment Question #

Category/Process Steps

Type of Control

Minimum Requirement

C3.12

1.4 1.15 2.11 2.12

Sheet pre-stretching sequence and time (if applicable)

Automatic

C3.13

1.4 1.15 2.11 2.12

Vacuum level, start time, evacuation speed and duration

Automatic

C3.14

1.4 1.15 2.11 2.12

Pressure level, start time and duration (if applicable)

Automatic

C3.15

1.4 1.15 2.11 2.12

Cooling temperature and time

Automatic

C3.16

1.4 1.15 2.11 2.12

Ejection air (compressed) pressure and time

Automatic

PT C 34 of 79

Actual Condition

CQI-23

Special Processes: Molding System Assessment Version 1, 3/2014

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 mo *If minimum requirements are not met, provide supporting records to justify actual conditions.

Item #

Related Molding System Assessment Question #

Category/Process Steps

Type of Control

Minimum Requirement

C3.17

1.4 1.15 2.11 2.12

First piece approval

Manual

C3.18

1.4 1.15 2.11 2.12

Shut down procedures

Manual

4.0

Quality Control

C4.1

1.4 2.11 2.12

Dimensions

Manual

C4.2

1.4 2.11 2.12

Appearance (vs. boundary sample or per instruction)

Manual

C4.3

1.4 2.11 2.12

Physical properties (if applicable)

Manual

PT C 35 of 79

Actual Condition

CQI-23

Special Processes: Molding System Assessment Version 1, 3/2014

TABLE C - Vacuum Forming

etc. When performing the job audit, the auditor shall verify molder is conforming to customer requirements.

Monitoring Frequency

Minimum Requirement

Actual Condition

Once per lot

Once per lot

FIFO - per Lot Shelf life - pull for use

Continuous by controller or manual verification daily

PT C 36 of 79

Observation/ Comments

(Pass / Fail / N/A)

CQI-23

Special Processes: Molding System Assessment Version 1, 3/2014

TABLE C - Vacuum Forming

etc. When performing the job audit, the auditor shall verify molder is conforming to customer requirements.

Monitoring Frequency

Minimum Requirement

Actual Condition

Continuous by controller or manual verification daily

Continuous

Continuous

Start-up and restart after long down time event PT C 37 of 79

Observation/ Comments

(Pass / Fail / N/A)

CQI-23

Special Processes: Molding System Assessment Version 1, 3/2014

TABLE C - Vacuum Forming

etc. When performing the job audit, the auditor shall verify molder is conforming to customer requirements.

Monitoring Frequency

Minimum Requirement

Actual Condition

At start-up, and after long down time event

At start-up, and after long down time event

At start-up

At start-up

At start-up, and after long down time event

PT C 38 of 79

Observation/ Comments

(Pass / Fail / N/A)

CQI-23

Special Processes: Molding System Assessment Version 1, 3/2014

TABLE C - Vacuum Forming

etc. When performing the job audit, the auditor shall verify molder is conforming to customer requirements.

Monitoring Frequency

Minimum Requirement

Actual Condition

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

PT C 39 of 79

Observation/ Comments

(Pass / Fail / N/A)

CQI-23

Special Processes: Molding System Assessment Version 1, 3/2014

TABLE C - Vacuum Forming

etc. When performing the job audit, the auditor shall verify molder is conforming to customer requirements.

Monitoring Frequency

Minimum Requirement

Actual Condition

At start-up, and after long down time event

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

PT C 40 of 79

Observation/ Comments

(Pass / Fail / N/A)

CQI-23

Special Processes: Molding System Assessment Version 1, 3/2014

TABLE C - Vacuum Forming

etc. When performing the job audit, the auditor shall verify molder is conforming to customer requirements.

Monitoring Frequency

Minimum Requirement

Actual Condition

Start-up, and restart after down time event

End of production or run

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

PT C 41 of 79

Observation/ Comments

(Pass / Fail / N/A)

CQI-23

Special Processes: Molding System Assessment Version 1, 3/2014

PROCESS TABLE D - Compression 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 mo *If minimum requirements are not met, provide supporting records to justify actual conditions.

Item #

Related Molding System Assessment Question #

Category/Process Steps

Type of Control

Minimum Requirement 1.0

Receiving Inspection

D1.1

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 Manual gravity, temperature recording).

D1.2

1.4 2.1 2.13

Incoming components assessment procedure, covering onsite testing or acceptance of supplier testing, with criteria (if applicable).

2.0

Manual

Compounding (if applicable)

D2.1

1.4 2.1 2.13

Purging all equipment and feeding system to avoid cross contamination.

D2.2

1.4 2.1 2.13

Process parameter verification: - For SMC, Doctor box blade height, glass chopper speed, additives, Manual carrier film speed, compaction pressure etc. - For rubber, mixer RPM, temperature, additives etc. PT D 42 of 79

Manual

Actual Condition

CQI-23

Special Processes: Molding System Assessment Version 1, 3/2014

PROCESS TABLE D - Compression 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 mo *If minimum requirements are not met, provide supporting records to justify actual conditions.

Item #

Related Molding System Assessment Question #

Category/Process Steps

Type of Control

Minimum Requirement

D2.3

1.4 2.1 2.13

Glass fiber distribution and density verification(for SMC).

Manual

D2.4

1.4 2.1 2.13

Compound property verification when applicable: - For SMC, viscosity, initial sheet thickness etc. - For rubber preform, elongation, tensile strength, compression set, pre-cure rate, or rheology etc.

Manual

3.0

Storage & Handling

D3.1

1.4 2.11 2.12

Using a FIFO (First In - First Out) system for compound/preform, shelf life storage.

Manual

D3.2

1.4 2.11 2.12

Environment temperature and humidity for preform storage (if applicable).

Automatic

D3.3

1.4 2.11 2.12

Compound floor time (e.g.., sheet rolls in SMC and rubber compound).

Manual

PT D 43 of 79

Actual Condition

CQI-23

Special Processes: Molding System Assessment Version 1, 3/2014

PROCESS TABLE D - Compression 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 mo *If minimum requirements are not met, provide supporting records to justify actual conditions.

Item #

Related Molding System Assessment Question #

Category/Process Steps

Type of Control

Minimum Requirement

D3.4

1.4 2.11 2.12

Prevention of contamination by lubricants such as silicone, mold release such as calcium carbonate or oil from the pressurization system.

Manual

D3.5

1.4 1.6 2.7 2.11 2.12

Partial containers handling to ensure no contamination (closed container, clean environment)

Automatic/Manual

D3.6

1.4 2.11 2.12

Sheet shrinkage confirmation (for SMC)

Manual

4.0

D4.1

Molding Process 1.4 1.15 2.11 2.12

There shall be a standardized startup procedure/checklist that defines things to do at start-up

PT D 44 of 79

Manual

Actual Condition

CQI-23

Special Processes: Molding System Assessment Version 1, 3/2014

PROCESS TABLE D - Compression 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 mo *If minimum requirements are not met, provide supporting records to justify actual conditions.

Item #

Related Molding System Assessment Question #

Category/Process Steps

Type of Control

Minimum Requirement

D4.2

1.4 1.15 2.11 2.12

Production plan (machine, mold, materials, part style)

Manual

D4.3

1.4 1.15 2.11 2.12

Startup check (verify process settings against setup sheet)

Manual

D4.4

1.4 1.15 2.11 2.12

Cavity surface temperature verification

Automatic/Manual

D4.5

1.4 1.15 2.11 2.12

Verification of preform size, or shape, or both

Manual

D4.6

1.4 1.15 2.11 2.12

Verification of charge pattern (for SMC)

Manual

PT D 45 of 79

Actual Condition

CQI-23

Special Processes: Molding System Assessment Version 1, 3/2014

PROCESS TABLE D - Compression 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 mo *If minimum requirements are not met, provide supporting records to justify actual conditions.

Item #

Related Molding System Assessment Question #

Category/Process Steps

Type of Control

Minimum Requirement

D4.7

1.4 1.15 2.11 2.12

Cavity surface cleanliness (no debris)

Manual

D4.8

1.4 1.15 2.11 2.12

Mold closing speed

Automatic

D4.9

1.4 1.15 2.11 2.12

Cavity temperature

Automatic

D4.10

1.4 1.15 2.11 2.12

Post molding cooling (for SMC) - prevent deformation

Manual

D4.11

1.4 1.15 2.11 2.12

First piece approval

Manual

PT D 46 of 79

Actual Condition

CQI-23

Special Processes: Molding System Assessment Version 1, 3/2014

PROCESS TABLE D - Compression 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 mo *If minimum requirements are not met, provide supporting records to justify actual conditions.

Item #

Related Molding System Assessment Question #

Category/Process Steps

Type of Control

Minimum Requirement

D4.12

1.4 1.15 2.11 2.12

5.0

Shut down procedure

Manual

Quality Control

D5.1

1.4 2.11 2.12

Part weight

Manual

D5.2

1.4 2.11 2.12

Dimensions

Manual

D5.3

1.4 2.11 2.12

Appearance

Manual

D5.4

1.4 2.11 2.12

Physical properties (if applicable)

Manual

PT D 47 of 79

Actual Condition

CQI-23

Special Processes: Molding System Assessment Version 1, 3/2014

PROCESS TABLE D - Compression 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 mo *If minimum requirements are not met, provide supporting records to justify actual conditions.

Item #

Related Molding System Assessment Question #

Category/Process Steps

Type of Control

Minimum Requirement

PT D 48 of 79

Actual Condition

CQI-23

Special Processes: Molding System Assessment Version 1, 3/2014

BLE D - Compression Molding

tc. When performing the job audit, the auditor shall verify molder is conforming to customer requirements.

Monitoring Frequency

Minimum Requirement

Actual Condition

Once per lot

Once per lot

End of run or long downtime, material change At start-up, and after long down time event, material change

PT D 49 of 79

Observation/ Comments

(Pass / Fail / N/A)

CQI-23

Special Processes: Molding System Assessment Version 1, 3/2014

BLE D - Compression Molding

tc. When performing the job audit, the auditor shall verify molder is conforming to customer requirements.

Monitoring Frequency

Minimum Requirement

Actual Condition

Hourly

Per production lot

Pull for use

Continuous and manually verify daily

Pull for use PT D 50 of 79

Observation/ Comments

(Pass / Fail / N/A)

CQI-23

Special Processes: Molding System Assessment Version 1, 3/2014

BLE D - Compression Molding

tc. When performing the job audit, the auditor shall verify molder is conforming to customer requirements.

Monitoring Frequency

Minimum Requirement

Actual Condition

Every eight hours

Continuous

Per lot (just before use)

Start-up and restart after long down time event

PT D 51 of 79

Observation/ Comments

(Pass / Fail / N/A)

CQI-23

Special Processes: Molding System Assessment Version 1, 3/2014

BLE D - Compression Molding

tc. When performing the job audit, the auditor shall verify molder is conforming to customer requirements.

Monitoring Frequency

Minimum Requirement

Actual Condition

At start-up

At start-up, and after long down time event

At startup and re-start

Each cycle

Each cycle

PT D 52 of 79

Observation/ Comments

(Pass / Fail / N/A)

CQI-23

Special Processes: Molding System Assessment Version 1, 3/2014

BLE D - Compression Molding

tc. When performing the job audit, the auditor shall verify molder is conforming to customer requirements.

Monitoring Frequency

Minimum Requirement

Actual Condition

Each cycle

Continuous

Continuous

Each cycle

Start-up, and restart after down time event

PT D 53 of 79

Observation/ Comments

(Pass / Fail / N/A)

CQI-23

Special Processes: Molding System Assessment Version 1, 3/2014

BLE D - Compression Molding

tc. When performing the job audit, the auditor shall verify molder is conforming to customer requirements.

Monitoring Frequency

Minimum Requirement

Actual Condition

End of production or run

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 Per cavity, start-up and once every 8 hours Per cavity, start-up and once every 8 hours

PT D 54 of 79

Observation/ Comments

(Pass / Fail / N/A)

CQI-23

Special Processes: Molding System Assessment Version 1, 3/2014

BLE D - Compression Molding

tc. When performing the job audit, the auditor shall verify molder is conforming to customer requirements.

Monitoring Frequency

Minimum Requirement

Actual Condition

PT D 55 of 79

Observation/ Comments

(Pass / Fail / N/A)

CQI-23

Special Processes: Molding System Assessment Version 1, 3/2014

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 mo *If minimum requirements are not met, provide supporting records to justify actual conditions.

Item #

Related Molding System Assessment Question #

Category/Process Steps

Type of Control

Minimum Requirement 1.0

Receiving Inspection

E1.1

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 Manual gravity, temperature recording).

E1.2

1.4 2.1 2.13

Incoming components assessment procedure, covering onsite testing or acceptance of supplier testing, with criteria (if applicable).

2.0

E2.1

Manual

Compounding and Preforming (if applicable) 1.4 2.1 2.13

Purging all equipment and feeding system to avoid cross contamination.

PT E 56 of 79

Manual

Actual Condition

CQI-23

Special Processes: Molding System Assessment Version 1, 3/2014

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 mo *If minimum requirements are not met, provide supporting records to justify actual conditions.

Item #

Related Molding System Assessment Question #

Category/Process Steps

Type of Control

Minimum Requirement

E2.2

1.4 2.1 2.13

3.0

Compound property verification when applicable - For rubber and one part epoxy; preform, elongation, tensile strength, compression set, pre-cure rate, or rheology etc.

Manual

Storage & Handling

E3.1

1.4 2.11 2.12

Stock rotation system in place for First in/First out (FIFO) and shelflife.

Automatic/Manual

E3.2

1.4 2.11 2.12

Environment temperature and humidity for storage (if applicable).

Automatic

E3.3

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).

Automatic

PT E 57 of 79

Actual Condition

CQI-23

Special Processes: Molding System Assessment Version 1, 3/2014

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 mo *If minimum requirements are not met, provide supporting records to justify actual conditions.

Item #

Related Molding System Assessment Question #

Category/Process Steps

Type of Control

Minimum Requirement

E3.4

1.4 2.11 2.12

Material container remains sealed during warm up to room temperature (supplier recommendation).

E3.5

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 Automatic/Manual reached.

E3.6

1.4 1.6 2.11 2.12

Partial container handling to ensure no contamination (closed container, clean environment)

Automatic/Manual

E3.7

1.4 1.6 2.11 2.12

Partial container quantity

Automatic/Manual

4.0

Molding Process

PT E 58 of 79

Manual

Actual Condition

CQI-23

Special Processes: Molding System Assessment Version 1, 3/2014

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 mo *If minimum requirements are not met, provide supporting records to justify actual conditions.

Item #

Related Molding System Assessment Question #

Category/Process Steps

Type of Control

Minimum Requirement

E4.1

1.4 1.15 2.11 2.12

There shall be a standardized startup procedure/checklist that defines things to do at start-up

Manual

E4.2

1.4 1.15 2.11 2.12

Production plan (machine, mold, materials, part style)

Manual

E4.3

1.4 1.15 2.11 2.12

Startup check (verify process settings against setup sheet)

Manual

E4.4

1.4 1.15 2.11 2.12

Mold cavity temperatures; variation between each cavity and set temperatures

Automatic

E4.5

1.4 1.15 2.11 2.12

Verification of preform size, or shape, or both

manual

PT E 59 of 79

Actual Condition

CQI-23

Special Processes: Molding System Assessment Version 1, 3/2014

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 mo *If minimum requirements are not met, provide supporting records to justify actual conditions.

Item #

Related Molding System Assessment Question #

Category/Process Steps

Type of Control

Minimum Requirement

E4.6

1.4 1.15 2.11 2.12

Plasticization - Temperature (resin chamber), Transfer Speed, and Transfer Pressure

Automatic

E4.7

1.4 1.15 2.11 2.12

Fill - Fill time and peak pressure

Automatic

E4.8

1.4 1.15 2.11 2.12

Hold - Hold pressure and hold time

Automatic

E4.9

1.4 1.15 2.11 2.12

Cure Time

Automatic

E4.10

1.4 1.15 2.11 2.12

Mold Closing speed

Automatic

PT E 60 of 79

Actual Condition

CQI-23

Special Processes: Molding System Assessment Version 1, 3/2014

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 mo *If minimum requirements are not met, provide supporting records to justify actual conditions.

Item #

Related Molding System Assessment Question #

Category/Process Steps

Type of Control

Minimum Requirement

E4.11

1.4 1.15 2.11 2.12

Cavity surface cleanliness (no debris)

manual

E4.12

1.4 1.15 2.11 2.12

Pre-heat of components - If Insert molding required

Automatic

E4.13

1.4 1.15 2.11 2.12

Pre-heat of resin pellets or compound - If applicable (per manufacturers recommendations)

Automatic

E4.14

1.4 1.15 2.11 2.12

Hold - Cavity pressure (if applicable)

Automatic

E4.15

1.4 1.15 2.11 2.12

Part weight (if applicable)

Manual

PT E 61 of 79

Actual Condition

CQI-23

Special Processes: Molding System Assessment Version 1, 3/2014

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 mo *If minimum requirements are not met, provide supporting records to justify actual conditions.

Item #

Related Molding System Assessment Question #

Category/Process Steps

Type of Control

Minimum Requirement

E4.16

1.4 1.15 2.11 2.12

First piece approval

Manual

E4.17

1.4 1.15 2.11 2.12

Shut down procedures

Manual

5.0

Quality Control

E5.1

1.4 2.11 2.12

Part weight

Manual

E5.2

1.4 2.11 2.12

Dimensions

Manual

PT E 62 of 79

Actual Condition

CQI-23

Special Processes: Molding System Assessment Version 1, 3/2014

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 mo *If minimum requirements are not met, provide supporting records to justify actual conditions.

Item #

Related Molding System Assessment Question #

Category/Process Steps

Type of Control

Minimum Requirement

E5.3

1.4 2.11 2.12

Appearance (vs. boundary sample or per instruction)

Manual

E5.4

1.4 2.11 2.12

Physical properties (if applicable)

Manual

PT E 63 of 79

Actual Condition

CQI-23

Special Processes: Molding System Assessment Version 1, 3/2014

TABLE E - Transfer Molding

c. When performing the job audit, the auditor shall verify molder is conforming to customer requirements.

Monitoring Frequency

Minimum Requirement

Actual Condition

Once per lot

Once per lot

End of run or long downtime, material change

PT E 64 of 79

Observation/ Comments

(Pass / Fail / N/A)

CQI-23

Special Processes: Molding System Assessment Version 1, 3/2014

TABLE E - Transfer Molding

c. When performing the job audit, the auditor shall verify molder is conforming to customer requirements.

Monitoring Frequency

Minimum Requirement

Actual Condition

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)

PT E 65 of 79

Observation/ Comments

(Pass / Fail / N/A)

CQI-23

Special Processes: Molding System Assessment Version 1, 3/2014

TABLE E - Transfer Molding

c. When performing the job audit, the auditor shall verify molder is conforming to customer requirements.

Monitoring Frequency

Minimum Requirement

Actual Condition

Time stamp on container from time out of cold storage to when container is opened Continuous monitoring by controller or manual verification

Continuous

Per Container

PT E 66 of 79

Observation/ Comments

(Pass / Fail / N/A)

CQI-23

Special Processes: Molding System Assessment Version 1, 3/2014

TABLE E - Transfer Molding

c. When performing the job audit, the auditor shall verify molder is conforming to customer requirements.

Monitoring Frequency

Minimum Requirement

Actual Condition

Start-up and restart after long down time event

At start-up

At start-up, and after long down time event

Continuous, at start-up and after down time event.

Continuous

PT E 67 of 79

Observation/ Comments

(Pass / Fail / N/A)

CQI-23

Special Processes: Molding System Assessment Version 1, 3/2014

TABLE E - Transfer Molding

c. When performing the job audit, the auditor shall verify molder is conforming to customer requirements.

Monitoring Frequency

Minimum Requirement

Actual Condition

Continuous

Continuous

Continuous

Continuous

Continuous

PT E 68 of 79

Observation/ Comments

(Pass / Fail / N/A)

CQI-23

Special Processes: Molding System Assessment Version 1, 3/2014

TABLE E - Transfer Molding

c. When performing the job audit, the auditor shall verify molder is conforming to customer requirements.

Monitoring Frequency

Minimum Requirement

Actual Condition

Continuous

Continuous

Continuous

Continuous

Once every 8 hours*

PT E 69 of 79

Observation/ Comments

(Pass / Fail / N/A)

CQI-23

Special Processes: Molding System Assessment Version 1, 3/2014

TABLE E - Transfer Molding

c. When performing the job audit, the auditor shall verify molder is conforming to customer requirements.

Monitoring Frequency

Minimum Requirement

Actual Condition

Start-up, and restart after down time event

End of production or run

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

PT E 70 of 79

Observation/ Comments

(Pass / Fail / N/A)

CQI-23

Special Processes: Molding System Assessment Version 1, 3/2014

TABLE E - Transfer Molding

c. When performing the job audit, the auditor shall verify molder is conforming to customer requirements.

Monitoring Frequency

Minimum Requirement

Actual Condition

Per cavity, start-up and once every 8 hours Per cavity, start-up and once every 8 hours

PT E 71 of 79

Observation/ Comments

(Pass / Fail / N/A)

CQI-23

Special Processes: Molding System Assessment Version 1, 3/2014

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.

Item #

Related Molding System Assessment Question #

Category/Process Steps

Type of Control

Minimum Requirement 1.0

Actual Condition

Monitoring Frequency

Minimum Requirement

Receiving Inspection

F1.1

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 Manual gravity).

Once per lot

F1.2

1.4 2.1 2.13

Incoming components assessment procedure, covering onsite testing or acceptance of supplier testing, with criteria (if applicable).

Manual

Once per lot

2.0

Storage & Handling

F2.1

1.4 2.11 2.12

Stock rotation system in place for First in/First out (FIFO) and shelflife

Automatic/Manual

FIFO - per Lot Shelf life - pull for use

F2.2

1.4 2.11 2.12

Environment temperature and humidity controlled (if applicable)

Automatic

Continuous monitoring by controller or manual verification daily

F2.3

1.4 1.6 2.11 2.12

Partial container handling to ensure no contamination (closed container, clean environment)

Automatic/Manual

Continuous

F2.4

1.4 1.6 2.11 2.12

Partial container quantity

Automatic/Manual

Per Container

PT F 72 of 79

Actual Condition

Observation/ Comments

(Pass / Fail / N/A)

CQI-23

Special Processes: Molding System Assessment Version 1, 3/2014

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.

Item #

Related Molding System Assessment Question #

Category/Process Steps

Type of Control

Minimum Requirement 3.0

Actual Condition

Monitoring Frequency

Minimum Requirement

Material Drying (If Applicable)

F3.1

1.4 2.11 2.12

Dryer temperature per resin manufacturer guidelines (per material)

Automatic

Start-up and continuous by controller.

F3.2

1.4 2.11 2.12

Dryer time per resin manufacturer guidelines (per material)

Manual

Start-up and once every 8 hours

F3.3

1.4 2.11 2.12

Drying equipment (dryer dedicated or clean procedure in place)

Manual

Material change

F3.4

1.4 2.11 2.12

Dew point

Automatic

Continuous by controller

F3.5

1.4 2.11 2.12

Moisture content

Manual

Start up and once every 8 hours

Recycle ratio (per print, inspection standard or manufacturer guidelines). Verified by feed pressure, weight or volume.

Automatic

Once every 8 hours and at every part change-over

Regrind equipment (dedicated or cleaning procedure in place)

Manual

Material change

4.0

Recycle/Regrind Material (if Applicable)

F4.1

1.4 1.11 2.11 2.13

F4.2

1.4 1.11 2.11 2.12

PT F 73 of 79

Actual Condition

Observation/ Comments

(Pass / Fail / N/A)

CQI-23

Special Processes: Molding System Assessment Version 1, 3/2014

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.

Item #

Related Molding System Assessment Question #

Category/Process Steps

Type of Control

Minimum Requirement

Actual Condition

Monitoring Frequency

Minimum Requirement

F4.3

1.4 1.11 2.11 2.12

Fines management (de-dusting)

Automatic/Manual

Material change

F4.4

1.4 1.11 2.11 2.12

Prevention of contamination when transporting or feeding regrind to the extrusion machine.

Automatic/Manual

Start-up and continuous

5.0

Color Management (If Applicable)

F5.1

1.4 2.11 2.12

Pigment blending - percent loading

Automatic/Manual

Start-up and continuous

F5.2

1.4 2.11 2.12

Color change procedure

Manual

At color change

6.0

Extrusion Process

F6.1

1.4 1.15 2.11 2.12

There shall be a standardized startup procedure/checklist that defines things to do at start-up

Manual

Start-up and restart after long down time event

F6.2

1.4 1.15 2.11 2.12

Production plan (machine, mold, materials, part quantity)

Manual

Start-up and restart after long down time event

F6.3

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

Manual

Start-up and restart after long down time event

F6.4

1.4 1.15 2.11 2.12

Verify secondary equipment

Manual

Start-up and restart after long down time event

PT F 74 of 79

Actual Condition

Observation/ Comments

(Pass / Fail / N/A)

CQI-23

Special Processes: Molding System Assessment Version 1, 3/2014

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.

Item #

Related Molding System Assessment Question #

Category/Process Steps

Type of Control

Minimum Requirement

Actual Condition

Monitoring Frequency

Minimum Requirement

F6.5

1.4 1.15 2.11 2.12

Mold surface temperature

Automatic/Manual

Continuous if automatic, or at start-up and after down time event.

F6.6

1.4 1.15 2.11 2.12

Extrusion Head Pressure

Automatic

Start-up and continuous

F6.7

1.4 1.15 2.11 2.12

Vacuum level (if applicable)

Automatic

Start-up and continuous

F6.8

1.4 1.15 2.11 2.12

Coolant inlet temperature (if applicable)

Automatic

Start-up and continuous

F6.9

1.4 1.15 2.11 2.12

First piece approval

Manual

Start-up, and restart after down time event

F6.10

1.4 1.15 2.11 2.12

Material purge/evacuation of barrel - included in unplanned and downtime procedures

Manual

End of run or long downtime

F6.11

1.4 1.15 2.11 2.12

Shut down procedures

Manual

End of production or run

PT F 75 of 79

Actual Condition

Observation/ Comments

(Pass / Fail / N/A)

CQI-23

Special Processes: Molding System Assessment Version 1, 3/2014

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.

Item #

Related Molding System Assessment Question #

Category/Process Steps

Type of Control

Minimum Requirement 7.0

Actual Condition

Monitoring Frequency

Minimum Requirement

Quality Control

F7.1

1.4 2.11 2.12

Thickness

Manual

Per cavity, start-up and once every 8 hours. For safety critical parts, start-up and once every hour

F7.2

1.4 2.11 2.12

Layer thickness/thickness uniformity (multi-layer only)

Manual

Per cavity, start-up and once every 8 hours. For safety critical parts, start-up and once every 4 hours.

F7.3

1.4 2.11 2.12

Layer adhesion (multi-layer only)

Manual

Per cavity, start-up and once every 8 hours. For safety critical parts, start-up and once every hour

F7.4

1.4 2.11 2.12

Dimensions

Manual

Per cavity, start-up and once every 8 hours

F7.5

1.4 2.11 2.12

Appearance (vs. boundary sample or per instruction)

Manual

Per cavity, start-up and once every 8 hours

F7.6

1.4 2.11 2.12

Physical properties (if applicable)

Manual

Per cavity, start-up and once every 8 hours

PT F 76 of 79

Actual Condition

Observation/ Comments

(Pass / Fail / N/A)

CQI-23

Special Processes: Molding System Assessment Version 1, 3/2014

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.

Item #

Related Molding System Assessment Question #

1.0

Equipment Type

Injection Molding

Blow Molding

Vacuum Forming

Compression Molding

Transfer Molding

Extrusion

Verification Frequency

Calibration / Certification Frequency *

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

Once per month or per preventive maintenance

N/A

G1.3

2.14

Thermocouple

X

X

X

X

X

X

G1.4

2.14

Injection Mold Machine

X

G1.5

2.14

Mold

X

G1.6

2.14

Blow mold machine

G1.7

2.14

Vacuum molding machine

G1.8

2.14

Compression molding machine

G1.9

2.14

Extrusion machine

G1.10

2.14

Dryer

X

X

X

G1.11

2.14

Regrinder

X

X

X

G1.12

2.14

Hot Runner Controller

G1.13

2.14

G1.14 G1.15

Per Preventive Maintenance

Annual

Per Preventive Maintenance

Every 5 years

Per Preventive Maintenance

N/A

Per Preventive Maintenance

Every 5 years

Per Preventive Maintenance

N/A

Per Preventive Maintenance

N/A

X

Per Preventive Maintenance

Every 5 years

X

Per Preventive Maintenance

N/A

Per Preventive Maintenance

N/A

X

Per Preventive Maintenance

N/A

Cavity Pressure Sensor

X

Per Preventive Maintenance

N/A

2.14

Hydraulic Pressure Transducer

X

Per Preventive Maintenance

N/A

2.14

Valve Gate Controller, if applicable

X

Per Preventive Maintenance

N/A

X

X

X

X

X

X X X

X

X X

PT G 77 of 79

Included in Preventative Maintenance Plan

Comment

CQI-23

Special Processes: Molding System Assessment Version 1, 3/2014

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.

Item #

Related Molding System Assessment Question #

2.0

Equipment Type

Injection Molding

Blow Molding

Vacuum Forming

Compression Molding

Transfer Molding

Extrusion

Verification Frequency

Calibration / Certification Frequency *

X

Per Preventive Maintenance

N/A

SECONDARY EQUIPMENT

G2.1

2.14

Generic fixtures (cooling, heat forming, if applicable)

X

X

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

Per Preventive Maintenance

At Installation

G2.6

2.14

Oven, if applicable

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

X

X

X

X

X

X

X

X

Per Preventive Maintenance

N/A

X

X

Per lot

Annual

At start up and per shift

Every 6 months

Before each use

Annual

Before each use

Annual

At start up

Annual

MINIMUM REQUIRED TESTING CAPABILITY

3.0 G3.1

2.14

Cure Testing, if applicable

G3.2

2.14

Leak Testing, if applicable

X

G3.3

2.14

Color

X

G3.4

2.14

Gloss

X

G3.5

2.14

Weight

X

X

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

X

X X X X

PT G 78 of 79

Included in Preventative Maintenance Plan

Comment

CQI-23

Special Processes: Molding System Assessment Version 1, 3/2014

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.

Item #

Related Molding System Assessment Question #

Category/Process Steps

Dimension, Weight, Appearance, 1.0

Monitoring Frequency

Minimum Requirement

General Dimensions Appearance Performance

H1.1

1.4 2.9

Procedures are in place to prevent damage to the finish or part during the inspection and packaging processes

100%

H1.2

1.4

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

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

Daily Production Meeting Review

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

PT H 79 of 79

Actual Condition

Observation/Comments

(Pass / Fail / N/A)