CQI-23 2nd Feb 8 23Protected

CQI-23
Special Processes: Molding System Assessment

Version 2, February 2023
Special Process: Molding System Assessment
Facility Name:
Address:
Phone Number: Number of Molding Employees at this Facility:

Captive Molder (Y/N): ⃝ Yes ⃝ No Specify:
Commercial Molder (Y/N): ⃝ Yes ⃝ No Specify:

Date of Assessment: Date of Previous Assessment:
Type(s) of Molding Processes at this Facility:

Process Table A - Injection Molding Process Table E - Resin Transfer Molding (RTM)
Process Table B - Blow Molding Process Table F - Extrusion
Process Table C - Vacuum Forming Process Table G - Equipment
Process Table D - Compression Molding (SMC) Process Table H - Part Inspection & Testing
Current Quality Certification(s): Date of Re-assessment (if necessary):
Personnel Contacted: Phone: Email:

Name:
Auditors/Assessors: Phone: Email:

Name:
Number of "Not Satisfactory" Findings:
Number of "Needs Immediate Action" Findings:
Number of "Fail" Findings in the Job Audit(s):
Number of “Fail” Findings in the Process Table(s):

CQI-23
Section 1 - Management Responsibility & Quality Planning
1.1 There shall be a dedicated and qualified molding professional on site.
• To ensure readily available expertise, there shall be a dedicated and qualified molding professional on site.
• This individual shall be a full-time employee and the position shall be reflected in the organization chart.
• A job description shall exist identifying the qualifications for the position including chemical and molding knowledge.
• The qualifications shall include a minimum of 5 years experience in molding operation or a combination of a minimum of 5 years of relevant formal education and molding experience.
Needs
Not
Guidance Objective Evidence N/A Satisfactory Immediate
Satisfactory
Action
What is this person’s title?
Is this position reflected in the organizational chart?
Is there a documented job description listing all the required qualifications and responsibilities of this position?
Describe in detail this person’s educational background and practical experience.
How many years of process experience at a molding facility does this person have?
Is this individual a full-time employee at the location being audited?
Comments:
1.2 The facility shall perform advanced quality planning.
• The organization shall incorporate a documented advanced product quality planning process.
• 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 organization.
• After the part approval process is approved by the customer, no process changes are allowed unless approved by the customer.
• The organization shall contact the customer when clarification of process changes is required. This clarification of process changes shall be documented.
Needs
Not
Satisfactory
Action
Does the facility use a documented advanced quality planning process?
Does the facility perform a documented internal feasibility study for each part before processing?
If no, does the facility perform a documented internal feasibility study for similar part types or family of parts before
processing?
What is the procedure for changing the process after PPAP?

Comments:
1.3 The facilities FMEAs shall be up to date and shall reflect the current process.
• The organization shall incorporate the use of a documented Failure Mode and Effects Analysis (FMEA) 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 written for each process.
• FMEAs shall address every process step from part receipt to part shipment.
• A cross-functional team shall be used in the development of the FMEA.
• All special characteristics, as defined by the organization and its customers, shall be identified, defined, and addressed in the FMEA.
CQI-23
Needs
Not
Satisfactory
Action
Does the facility have a documented Failure Mode and Effects Analysis (FMEA) in use?
Identify the names and job function of the team members used in the development of the FMEA.
Identify if the FMEA is written for each part, part family or process specific.
Are all FMEAs consistent with all associated documentation such as control plans, work instructions and shop travelers?
Do all FMEAs include every process step from part receipt to part shipment?
Are special characteristics, as defined by the organization and its customers, identified, defined, and addressed in the FMEAs?
Provide evidence that the FMEA has been updated in response to quality issues.
Comments:
1.4 The process control plans shall be up to date and shall reflect the current process.
• The organization shall incorporate the use of a documented control plan 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.
• The control plans 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 organization.
• A cross-functional team shall be used in the development of control plans, which shall be consistent with all associated documentation such as work instructions, shop travelers, and FMEAs.
• All special characteristics, as defined by the organization and its customers, shall be identified, defined, and addressed in the control plans.
• The control plan shall detail the product and process characteristics, and controls including testing frequency and sample size.
Needs
Not
Satisfactory
Action
Does the facility have a documented control plan in use?

Identify if the control plan is written for each part, part family or process specific.
Do all control plans include every process step from part receipt to part shipment?
Does the control plan identify all key molding process parameters?
Identify the names and job function of the team members used in the development of the control plan.
Are the control plans consistent with all associated documentation such as work instructions, shop travelers, specifications
and FMEAs?
Provide evidence that sample sizes and frequencies for evaluation of process and product characteristics are addressed and
consistent with the minimum requirements.
Are special characteristics, as defined by the organization and its customers, identified, defined, and addressed in the
control plans?
Provide evidence that the control plan has been updated in response to quality issues, customer requirements and process
changes.
Comments:

CQI-23
All molding related and referenced specifications shall be up to date and available.
1.5
For example: ISO, SAE, AIAG, ASTM, General Motors, Ford, Stellantis, Toyota
• A document control system is pertinent for the handling and internal distribution of received customer specifications and to keep up to date with national or global standards related to molding processes.
• To ensure all customer requirements are understood and satisfied, the organization shall have all related molding and customer referenced standards and specifications available for use and a process to ensure that they are
current.
• The organization 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 organization 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 organization, how the current status is
established, and how the relevant information is cascaded to the shop floor within the two week period.
• The organization shall identify who is responsible for performing these tasks.
Needs
Not
Satisfactory
Action
Does the organization have all related molding and customer referenced standards and specifications available for use?
How are standards and specifications obtained?
Describe the system and timing used to maintain the standards and specifications to ensure that they are up to date.
Define that process used to review and communicate within the two week period updated standards and specifications
throughout the organization. Include the names and job functions of the responsible personnel.
Comments:
1.6 All molding related internal and external best practices shall be documented and maintained.
Needs
Not
Satisfactory
Action
Does the molder have a documented process and system for maintaining best practices obtained through lessons learned or
from industry knowledge?
Comments:
1.7 There shall be documented process instructions.
• The organization shall have written process instructions for all active parts or family of parts, including relevant part specific requirements, and 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.
• These process instructions may take the form of work instructions, job card, computer-based recipes, or other similar documents.
Needs
Not
Satisfactory
Action
Does the organization have written process instructions for all active parts or family of parts and include all relevant
operating parameters?
CQI-23
What form of process specification is used?

(These may be in the form of work instructions, job card, computer-based recipes, or other similar documents.)
Comments:
1.8 A valid product capability study shall be performed.
• To demonstrate each process is capable of yielding an acceptable product, the organization shall perform product capability studies for the initial validation of each process, after relocation of any process equipment, and after a
major change of any process or equipment.
• The organization shall define what constitutes a major change.
• Initial product capability studies shall be conducted for all molding processes per line as defined in scope of work and in accordance with customer requirements.
• Capability study techniques shall be appropriate for the molding product characteristics (e.g., molding dimension or thickness, and part weight).
• An action plan shall exist to address the steps to be followed in case capability indices fall outside customer requirements or established ranges.
Needs
Not
Satisfactory
Action
Has an initial product capability study been performed?

Are studies conducted for each molding process for each line in the facility?
Has a new study been completed after the relocation of any process equipment, major rebuild of any equipment, or any
significant change in material or process conditions?
How does the organization define what constitutes a major change?

What steps are followed when capability indices fall outside specified requirements?
Comments:
1.9 The organization shall collect, analyze, and react to product and process data over time.
• The analysis of product characteristics and processes parameters over time can yield vital information for defect prevention efforts.
• Methods of analysis shall include ongoing trend or historical data analysis of special product and process parameters.
• The organization shall determine which parameters to include in such analysis.
• SPC shall be performed on critical product and process characteristics.
Needs
Not
Satisfactory
Action
What product characteristics and process parameters are used?

How is the ongoing trend or historical data reviewed and analyzed?
How does the organization use this data to prevent future failures and improve the quality system?
Comments:
All process control and testing records must be retained for a minimum of three calendar years after the year in which they were created.
1.10
Government/customer requirements supersede this requirement if a longer time is required.
CQI-23
Needs
Not
Satisfactory
Action
What is the process to retain these records?

What is the process for retention of customer specific documents with longer retention times?
Comments:
1.11 There shall be a process in place to review the monitoring systems/logs at specified intervals.
• Management or management designee shall review the monitoring systems/logs at specified intervals.
• The organization shall have reaction plans for nonconformances to process requirements.
Needs
Not
Satisfactory
Action
Define the process in place to gather and review this information.

Identify the manager or management designee reviewing the process records from the monitoring systems/logs.
Describe reaction plans for nonconformances to the written process requirements.
Comments:
1.12 Internal assessments shall be completed at a minimum once every 12 months using the latest revision of the AIAG CQI-23 Molding System Assessment.
Needs
Not
Satisfactory
Action
What is the date of the last AIAG CQI-23 Molding System Assessment?
Comments:
1.13 There shall be an internal system in place to authorize rework and it shall be documented.
• The quality management system shall include a documented process for rework that shall include authorization from the quality manager or a designated individual.
• The rework procedure shall describe product characteristics for which rework is allowed as well as those characteristics for which rework is not permissible.
• All rework activity shall require a separate rework specific process control sheet or other identification method issued by qualified technical personnel denoting the necessary molding modifications.
• Records shall clearly indicate when and how any material has been reworked.
• The rework of material shall comply with the customer’s specifications and/or requirements.
Needs
Not
Satisfactory
Action
Describe the procedure for authorizing rework of nonconforming material.

Does the rework procedure describe product characteristics that allow or not allow rework?
Did the quality manager or manager’s designee authorize the rework and determine the rework procedure?
CQI-23
How do you identify that material has been reworked?
Do the records clearly indicate when and how any material has been rework including the quality manager’s authorization of
release?
Provide evidence that the rework complies with your customer's specifications and/or requirements.
Comments:
1.14 The Quality Department shall document, review, and addressing customer and internal concerns.
• The quality management system shall include a process for documenting, reviewing, and addressing customer concerns and any other concerns internal to the organization.
• Process shall include adding to the lessons learned database.
Needs
Not
Satisfactory
Action
Describe the procedure for reviewing and addressing external customer and internal concerns.
Describe the problem solving approach that is used (e.g., 3-Legged x 5 WHY’s).
Describe the communication process used to respond to the originator.
Provide a recent example of the implementation of this procedure.
Comments:
1.15 The organization shall have a continual improvement process.
• The continual improvement process shall be designed to achieve improvements in quality and productivity.
• Identified actions shall be prioritized and shall include timing (estimated completion dates).
• The organization shall show evidence of program effectiveness.
Needs
Not
Satisfactory
Action
Describe the continual improvement process used to achieve improvements in quality and productivity.
Provide a recent example of how actions are identified, prioritized and completion dates assigned.
Describe how the organization measures the effectiveness.
Comments:
1.16 There shall be predefined personnel responsible for management of materials in quarantine area.
• Only the quality manager or designee may authorize the disposition of material from quarantine status.
Needs
Not
Satisfactory
Action
Define the process for release of material from quarantine.
List the authorized personnel with job titles.
CQI-23
Review evidence that only these persons are releasing materials from the quarantine area.
Comments:
1.17 There shall be documented procedures and/or work instructions for all processes and they shall be available to all of the organization’s personnel.
• There shall be procedures or work instructions available to personnel covering their responsibilities.
• Include “Critical/Significant/Operator Safety/High Impact” characteristics of product and Molding process in the Work Instructions.
• These documents shall include contingency procedure for addressing potential emergencies (such as power failure, water leaking, fire).
Needs
Not
Satisfactory
Action
Review the procedure/work instruction for process start-up and shut-down.

Review the procedure/work instruction for process control during operation.
What is the procedure in place to address potential emergencies?

(Such as power outage and/or equipment failure).
Review the procedures for inspection of the product, in process or after completion.
Verify that these procedures/work instructions are accessible to personnel performing the job at all times.
Comments:
1.18 The organization and management shall provide employee training.
• The organization shall provide employee training for all operations.

• All employees, including backup and temporary employees, shall be trained.
• Documented evidence shall be maintained showing the employees trained and the evidence shall include an employee assessment.
• Management shall define the qualification requirements for each function, and ongoing or follow-up training shall also be addressed.
Needs
Not
Satisfactory
Action
Review the process for initial training of all employees, including backup and temporary.
Review the process for ongoing and/or follow-up training.
Provide a recent copy of the training matrix.
Provide documented evidence that shows how the organization verifies effectiveness of training.
Comments:
1.19 Essential management and supervisory functions shall be performed by qualified personnel at all times and a matrix of these essential responsibilities shall be available for review.
• The organization shall maintain a responsibility matrix identifying all essential management and supervisory functions and list the qualified personnel who may perform such functions.
• It shall identify both primary and secondary (backup) personnel for the essential functions (as defined by the organization).
• This matrix shall be readily available to management at all times.
Needs
Not
Satisfactory
Action
CQI-23
Review and provide an example of the most recent matrix.

Confirm that the matrix includes both primary and secondary persons.
Describe how and where this information is made available.
Comments:
1.20 There shall be a preventive maintenance program and maintenance data should be utilized to form a predictive/preventive maintenance program.
• The organization shall have a documented preventive maintenance program for essential process equipment and Customer Purchased Tooling (as identified by the organization).
• 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 preventive maintenance program.
• Company shall track and report Maintenance metrics, such as Maintenance Work Order completion, MTBF (Mean Time Between Failures), MTTR (Mean Time To Repair).
• Maintenance data shall be collected and analyzed as part of a preventive maintenance program.
Needs
Not
Satisfactory
Action
Show evidence that a documented preventive maintenance program exists.

Describe the process for reporting problems.
Provide a recent example showing that the person reporting the problem received feedback after the problem was resolved.
Give a recent example of how the program was used to prevent/predict potential equipment failure.
How is the data being generated reviewed with management to improve the quality system?
Comments:
1.21 The organization shall develop a critical spare part list and the parts must be available to minimize production disruptions.
• Spare part suppliers, minimum quantity and lead times shall be documented.
Needs
Not
Satisfactory
Action
Provide the critical spare parts list.

Does the critical spare parts list include inventory, lead time and suppliers?
Describe how and when the organization updates the list.
What criteria are used to determine whether critical spare parts are kept at the facility or sourced off site?
Describe the process used to maintain minimum quantities.
Comments:
CQI-23
Section 2 - Floor and Material Handling Responsibility
2.1 The organization shall ensure that customer data entered into the receiving system matches the customer’s shipping documents.
• It is critical that all customer requirements and lot identification be correctly transferred to internal documents.
• The facility shall ensure that the data entered in the receiving system match the information on the customer's shipping documents.
• Documented processes and evidence of compliance shall exist (e.g., shop travelers, work orders).
• Sometimes the material received does not precisely correspond to customer shipping documents. The facility shall have a detailed procedure in place to resolve receiving discrepancies.
• The requirements stated above apply to captive, in-house, commercial and all involved departments.
Needs
Not
Satisfactory
Action
Describe the receiving process including listing the documentation used.

Describe the process to identify the coating requirements.
Describe the reaction process when material received does not correspond to the customer’s documents.
Comments:
2.2 Is product clearly identified and stored throughout the molding process and are lot traceability and integrity maintained?
• Procedures are required for part and container identification to avoid incorrect processing or mixing of lots.
• As received, non-molded, in-process, and finished product or material shall be properly segregated, identified, and stored in a dedicated and clearly defined area.
• Out-going lot(s) shall be traceable to the incoming lot(s).
• Component on the vehicle shall be traceable to the molding lot.
• The discipline of precisely identifying lots and linking all pertinent information to them enhances the ability to do root cause analysis and continual improvement.
Needs
Not
Satisfactory
Action
Describe the method that ensures the parts and lot numbers are correctly identified and maintained throughout the process.
Verify that received, in-process, and finished product or material is properly segregated, identified, and stored in a dedicated
and clearly defined area to maintain lots.
Comments:
2.3 Molder shall use adequate FIFO system for material and product.
Needs
Not
Satisfactory
Action
Describe the process to ensure a FIFO system is utilized.

Comments:
2.4 Procedures shall be adequate to prevent movement of nonconforming product into the production system.
CQI-23
• The control of suspect or nonconforming product is necessary to prevent inadvertent shipment or contamination of other lots.
• Procedures shall be adequate to prevent movement of nonconforming product into the production system.
• Procedures shall exist addressing authorized personnel, appropriate disposition, product identification and tracking of material flow in and out of hold area.
• Nonconforming hold area shall be clearly designated to ensure segregation of such material and product.
Needs
Not
Satisfactory
Action
Where is the nonconforming holding area, and how is it identified?

Describe the procedure to prevent the unauthorized movement of nonconforming products.
Provide evidence that material movement in and out of this hold area is documented.
Comments:
2.5 For bulk processing there shall be a procedure to identify trap points throughout the entire process to reduce risk of mixed parts.
• The organization shall have documented procedures to identify and monitor all trap points for each process/equipment.
• Monitoring of potential trap points shall occur at minimum every part changeover.
• Organization shall monitor the physical separation of mirror parts between each other (RH/LH parts) or very similar design parts, to reduce risk of mixed parts.
• Trap points may include bins, part containers, loading and unloading equipment, oven belts, load hoppers and transfer belts.
Needs
Not
Satisfactory
Action
Describe the procedure to identify and monitor all trap points for each process and/or equipment.
Provide the list of trap points.
Comments:
2.6 The handling, storage and packaging shall be adequate to ensure product quality is maintained throughout the entire process.
• Handling, storage, and packaging shall be adequate to ensure product quality.

• Part cleanliness shall be maintained throughout the process.
• All parts shall be stored in a controlled environment, if applicable.
Needs
Not
Satisfactory
Action
Is packaging, including Expendable Packaging (cardboard box), customer approved?
Which process steps have dedicated in-process containers?
How are containers maintained to preserve part cleanliness?
Describe how the containers are inspected to ensure they are free of foreign material.
What is used for liner material of customer containers before packing finished goods for shipment?
(Materials like newspapers, used cardboard and bags should be avoided).
Provide a list of dedicated storage areas that avoid exposure to contamination and corrosion.
(Storage outdoors, near media blasting and corrosive processes such as acid tanks should be avoided).
CQI-23
Comments:
2.7 Each process step shall be documented and traceable.

• How does the operator verify that all process steps have been completed in specified order and in within specified time limits?
Needs
Not
Satisfactory
Action
Do you have a document (e.g., shop travelers, job sheet) that specifies all the processes for each part number/part family?
Define the procedure that ensures that all processes have been completed in the specified order.
Describe how time sensitive processes are completed in the specified time limits.
Provide documentation that this process has been followed.
Comments:
2.8 There shall be a procedure for material handling, containment action and product segregation in the event of an unplanned process interruption.
• Unplanned downtime greatly increases the risk of improper processing.

• Operators shall be trained in material handling, containment action, and product segregation in the event of an equipment emergency including power failure. Training shall be documented.
• Work instructions specifically addressing potential types of unplanned process interruptions shall be accessible to operators.
• Specific instructions shall address containment/reaction plans for each step of the process. Where processes are time critical, immediate actions are required.
• Evidence shall exist showing disposition and traceability of the affected product.
Needs
Not
Satisfactory
Action
What procedure is used to address each step of the process?
Provide all work instructions that address unplanned process interruptions.
How is the affected product traced, dispositioned and documented?
Is restart procedure validated?
Comments:
2.9 Plant cleanliness, environment, and working conditions shall be conducive to ensure product quality.
• Plant cleanliness, housekeeping, environmental, and working conditions shall be adequate to preserve product quality.
• A housekeeping procedure/policy shall be clearly defined and executed.
Needs
Not
Satisfactory
Action
Provide a copy of the housekeeping procedure/policy.
Provide a copy of the procedure used to handle dropped or spilled parts.
Describe what is done with loose parts found on the floor of the plant.
CQI-23
Define the process used to review the facility for conditions that are detrimental to quality processing such as chemical spills
and inadequate ventilation.
Comments:
2.10 Plant lighting shall be adequate in all inspection areas.

• Lighting in the part and/or process inspection areas must be adequate for the intended operation.
• Plant Lighting shall be measured with Light Meter in Lumens to determine current value with a Manufacturing Floor value range of 300 – 1000 Lux.
Needs
Not
Satisfactory
Action
How do you ensure the lighting in the part and/or process inspection areas, including loading and unloading areas, is
adequate for the intended operation?
For part inspection, how do you arrange the lighting to avoid spot lighting, glare, shadows and distracting reflections?
Comments:
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.
Needs
Not
Satisfactory
Action
Describe the process to ensure process control parameters are monitored per Process Tables.
Describe the verification process.
Who is the designated floor person that verifies the process parameters?
Comments:
2.12 Are out of control/specification parameters reviewed and reacted to?

• There are documented reaction plans to both out of control and out of tolerance process parameters.
• There is documented evidence that reaction plans are followed.
Needs
Not
Satisfactory
Action
Show evidence of the documented reaction plans to both out of control and out of tolerance process parameters.
What is the process to document evidence that reaction plans are followed?
Comments:
2.13 Are Test Frequencies performed as specified in Process Tables?

CQI-23
• Test Frequencies shall be performed as specified in Process Tables. Refer to Process Tables
Needs
Not
Satisfactory
Action
Show evidence that test frequencies are being performed as specified in the Process Tables.
Comments:
2.14 Is product test equipment verified?

• 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.
Needs
Not
Satisfactory
Action
How do you ensure calibrations are up to date?
How do you ensure new equipment has been added to the calibration list and inactive equipment has been removed?
What is the reaction plan to any failed verification?

Comments:
CQI-23
Section 3 - Job Audit - Finished Product Review
Job Identity:
Customer:
Shop Order Number:
Part Number:
Part Description:
Molding Requirements/Process:
Related
Job (Shop) Order or
Molding System Customer or Internal Actual Condition (Objective Pass / Fail /
Question # Job Audit Question Reference Documentation
Assessment Requirement Evidence) N/A
Requirement
Question #
Is contract review and advanced quality planning, FMEA, Control 1.1, 1.2
3.1 N/A
Plans, etc., in place and performed by qualified individuals? 1.3, 1.4, 1.6
Does the molder have the proper customer specifications for the
3.2 1.5 N/A
part?
3.3 Is there documented evidence of Receiving Inspection? 2.1
Is material identification (part numbers, lot numbers, contract 2.2

3.4
numbers, etc.) maintained throughout the molding process? 2.3, 2.4
Is the proper procedure or process specification used? Refer to

1.5, 1.6
3.5 Process Tables for specific parameters. List parameters that were
2.1, 2.11, 2.13
verified in this audit in the spaces provided below.
Process #1:
Process #2:
1.5 Each part may have one or more requirements determined by the molding specification. Parts must meet
3.6 What are the product inspection requirements? 2.13 each requirement. List each requirement below and validate.
2.14 (Listed below are some examples)
3.6.1 Requirement: Dimension

Test Method:
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Job Identity:
Customer:
Shop Order Number:
Part Number:
Part Description:
Related
Job (Shop) Order or
Requirement
Question #
Test frequency or quantity:
Selection of samples:
Specification:
3.6.2 Requirement: Color (if applicable)
Test Method(s):
Specification:
3.6.3 Requirement: Gloss (if applicable)
Test Method:
Specification:
3.6.4 Requirement: Flash (if applicable)
Test Method(s):
Specification:
3.6.5 Requirement: Weight (if applicable)
Test Method:
CQI-23
Job Identity:
Customer:
Shop Order Number:
Part Number:
Part Description:
Related
Job (Shop) Order or
Requirement
Question #
Specification:
Requirement: Customer Specifics
3.6.6
(Appearance, if applicable)
Test Method:
Specification:
3.6.7 Requirement: Customer Specific #1
Test Method(s):
Specification:
3.6.8 Customer Specific Requirements #2:
Test Method(s):
Specification:
Operator or Inspector Responsibilities
1.4, 1.6
3.7 Were appropriate process steps signed off?
2.2, 2.3, 2.11
Were all inspection steps, as documented in the Control Plan 1.2

3.8
performed? 1.4
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Job Identity:
Customer:
Shop Order Number:
Part Number:
Part Description:
Related
Job (Shop) Order or
Requirement
Question #
Were steps/operations performed that were not documented in the 1.2

3.9
Control Plan? 1.4, 1.6
If additional steps were performed, were they authorized? 1.2, 1.4

3.10
(For example additional checks) 1.6, 1.10, 1.16
3.11 Does the specification allow reprocessing or rework? 1.5, 1.10
If the order was certified, did the certification accurately reflect the 2.11
3.12
process performed? 2.13
3.13 Was the certification signed by an authorized individual? 1.16
Are the parts and containers free of inappropriate objects or

3.14 2.6
contamination?
Packaging Requirements
3.15 Are packaging requirements identified? 2.6, 2.7, 2.9
Are parts packaged to minimize mixed parts or damaged (for

3.16 2.6, 2.7, 2.9
example, work flow or over-pack of container)?
Shipping Requirements
3.17 Were the parts properly identified? 2.2, 2.9
3.18 Were the containers properly labeled? 2.2, 2.9

CQI-23
PROCESS TABLE A - Injection Molding
All requirements given below are subordinate to customer specific requirements. All control and monitoring frequency requirements refer to active production in the process.
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. **Long downtime is any time over limit of specific material residence time.
Related
Molding
Item # System Category/Process Steps Type of Control Monitoring Frequency
Assessment
Question #
Minimum Pass / Fail /

Actual Condition Minimum Requirement Actual Condition
Requirement N/A
1.0 Receiving Inspection
Incoming material assessment procedure, covering onsite testing or

1.4
A1.1 acceptance of supplier testing, with criteria (e g , melt flow, specific gravity) Manual Once per lot
2.1, 2.13
per material specification.
1.4 Incoming components assessment procedure, covering onsite testing or

A1.2 Manual Once per lot
2.1, 2.13 acceptance of supplier testing, with criteria (if applicable).
2.0 Storage & Handling (If Applicable)
1.4 Verify that stock rotation system in place for First in/First out (FIFO) and FIFO - per Lot
A2.1 Automatic/Manual
2.1, 2.13 shelf-life. Shelf life - pull for use
1.4 Continuous monitoring by controller

A2.2 Environment temperature controlled. Automatic
2.11, 2.12 or manual verification daily
1.4, 1.6 Verify and document partial containers handling to ensure no

A2.3 Automatic/Manual Continuous
2.7, 2.11, 2.12 contamination (closed container, clean environment).
1.4, 1.6
A2.4 Verify and document partial container quantity. Automatic/Manual Per Container
2.7, 2.11, 2.12
3.0 Material Drying (If Applicable)
1.4 Drying temperature per resin material specifications / manufacturer

A3.1 Automatic Continuous monitoring by controller
2.11, 2.12 guidelines (per material).
1.4 Drying time per resin material specifications / manufacturer guidelines (per
A3.2 Manual Per Resin Manufacturer Guidelines
2.11, 2.12 material).
1.4
A3.3 Drying equipment (dryer dedicated or clean-out procedure in place). Manual Material change
2.11, 2.12
1.4 Drying equipment shall be sized for specific application and verified if there
A3.4 Manual Material or product change
2.11, 2.12 are any changes in material or throughput.
1.4
A3.5 Dew point. Automatic Continuous monitoring by controller
2.11, 2.12
1.4
A3.6 Moisture content per material specifications / manufacturer guidelines. Manual At start-up and once per shift
2.11, 2.12
4.0 Regrind Material (If Applicable)

CQI-23
Related
Molding
Assessment
Question #

Requirement N/A
Regrind ratio (per print, inspection standard or manufacturer guidelines).

1.4, 1.11 Once every 8 hours and at every
A4.1 Verified by feed pressure, weight or volume according to customer Automatic
2.11, 2.13 part change over
specification.
1.4, 1.11
A4.2 Dedicated regrind equipment or clean-out procedure in place. Manual Material change
2.11, 2.13
1.4, 1.11
A4.3 Fines management (de-dusting). Automatic/Manual Material change
2.11, 2.13
1.4, 1.11
A4.4 No contamination when delivering regrind to injection molding machine. Automatic/Manual Start-up and continuous
2.11, 2.13
5.0 Color Management
1.4
A5.1 Pigment blending - percent loading, if applicable. Automatic/Manual Start-up and continuous
2.11, 2.12
1.4 Color change procedure (include clean-out procedure for hopper, and
A5.2 Manual Continuous
2.11, 2.12 purging for barrel).
6.0 Molding Process
1.4, 1.15 Verify that there is a standardized startup and re-start procedure/checklist Start-up and restart after downtime
A6.1 Manual
2.11, 2.12 that defines start-up and re-start activities. event
1.4, 1.15 Verify production plan (machine, mold, materials, part quantity) is available At start-up and after long
A6.2 Manual
2.11, 2.12 and followed. downtime** event
1.4, 1.15 At start-up and after long

A6.3 Verify process parameters are per setup sheet. Manual
2.11, 2.12 downtime** event
1.4, 1.15 At start-up and after long

A6.4 Startup check - Secondary Equipment (De-gate, assembly equipment, etc.). Manual
1.4, 1.15 New mold and after mold

A6.5 Verify mold surface temperature. Automatic/Manual
2.11, 2.12 preventive maintenance
1.4, 1.15 Plastication - Temperature (barrel, nozzle, hot manifold if applicable),

A6.6 Automatic Continuous
2.11, 2.12 screw RPM, and back pressure.
Upon the occurrence of the

1.4, 1.15
A6.7 Verify melt temperature. Manual following events; New mold, and
2.11, 2.12
changing molding machine
1.4, 1.15
A6.8 Plastication - Screw recovery time. N/A Continuous
2.11, 2.12
CQI-23
Related
Molding
Assessment
Question #

Requirement N/A
1.4, 1.15
A6.9 Fill - Screw velocity or velocity profile. Automatic Continuous
2.11, 2.12
1.4, 1.15
A6.10 Fill - Fill time and peak pressure. N/A Continuous
2.11, 2.12
1.4, 1.15
A6.11 Hold - Hold pressure and hold time. Automatic Continuous
2.11, 2.12
1.4, 1.15
A6.12 Hold - Cushion. N/A Continuous
2.11, 2.12
1.4, 1.15
A6.13 Hold - Cavity pressure (if applicable). N/A Continuous
2.11, 2.12
1.4, 1.15
A6.14 Temperature Control Cooling - Coolant inlet temperature and cooling time. Automatic Continuous
2.11, 2.12
1.4, 1.15 Start-up, restart after downtime

A6.15 Verify part weight for consistency (if applicable). Manual
2.11, 2.12 event, and material lot change
1.4, 1.15 Start-up, and restart after downtime

A6.16 Conduct and document First piece approval. Manual
2.11, 2.12 event
1.4, 1.15 Material purge/evacuation of barrel with purging compound - included in

A6.17 Manual End of run or long downtime**
2.11, 2.12 unplanned and downtime procedures.
1.4, 1.15
A6.18 Verify that there are standardized Shut down procedures. Manual End of production or run
2.11, 2.12
7.0 Quality Control
1.4 Per cavity, start-up and once every

A7.1 Verify the dimensions according to product control documentation. Manual
2.11, 2.12 8 hours
1.4 Per cavity, start-up and once every

A7.2 Verify the Appearance (vs. boundary sample or per instruction). Manual
2.11, 2.12 8 hours, and last shot
1.4 Verify the physical properties (if applicable) according to product control Per cavity, start-up and once every
A7.3 Manual
2.11, 2.12 documentation. 8 hours
CQI-23
PROCESS TABLE B - Blow Molding
Related
Molding
Assessment
Question #
Minimum (Pass / Fail /

Requirement N/A)

1.4
B1.1 acceptance of supplier testing, with criteria (e.g., melt flow, specific gravity) Manual Once per lot
2.1, 2.13

B1.2 Manual Once per lot
2.0 Storage & Handling
1.4 Verify that stock rotation system is in place for First in/First out (FIFO) and FIFO - per Lot
B2.1 Automatic/Manual
Continuous monitoring by
1.4
B2.2 Environment temperature and humidity controlled (if applicable). Automatic controller or manual
2.11, 2.12
verification daily

B2.3 Automatic/Manual Continuous
1.4, 1.6
B2.4 Verify and document partial container quantity. Automatic/Manual Per container
2.7, 2.11, 2.12
1.4 Drying temperature per resin material specifications / manufacturer Start-up and continuous by
B3.1 Automatic
2.11, 2.12 guidelines (per material). controller
1.4 Drying time per resin material specifications / manufacturer guidelines (per Start-up and once every 8
B3.2 Manual
2.11, 2.12 material). hours
1.4
B3.3 Drying equipment (dryer dedicated or clean-out procedure in place). Manual Material change
2.11, 2.12
B3.4 Manual Material or product change
1.4
B3.5 Dew point. Automatic Continuous by controller
2.11, 2.12
1.4 Start-up and once every 8

B3.6 Moisture content per material specifications / manufacturer guidelines. Manual
2.11, 2.12 hours
CQI-23
Related
Molding
Assessment
Question #

Requirement N/A)
4.0 Regrind Material (If Applicable)
Regrind ratio (per print, inspection standard or manufacturer guidelines)

1.4, 1.11 Verified by feed pressure, weight or volume according to engineering Once every 8 hours and at
B4.1 Automatic
2.11, 2.13 specification. every part change-over
No regrind of fluorine-treated parts.
1.4, 1.11
B4.2 Dedicated regrind equipment or clean-out procedure in place. Manual Material change
2.11, 2.13
1.4, 1.11 Regrind procedure in placed to avoid change in characteristics (e.g., heat
B4.3 Automatic/Manual Start-up
2.11, 2.13 history, regrind interactions, and molded history).
1.4, 1.11
B4.4 Ethylene Vinyl Alcohol (EVOH) particle size and distribution, if applicable. Manual Start-up
2.11, 2.13
1.4, 1.11 Fines management (de-dusting, filtering of fine material, avoidance of

B4.5 Automatic/Manual Material change
2.11, 2.13 contaminations from other processes, similar/dissimilar materials etc.).
1.4, 1.11 Prevention of contamination when transporting or feeding regrind to the

B4.6 Automatic/Manual Start-up and continuous
2.11, 2.13 blow mold machine.
5.0 Color Management (If Applicable)
1.4
B5.1 Pigment loading (e.g., piped in, manually done, percentage of pigment). Automatic/Manual Start-up and continuous
2.11, 2.12
1.4
B5.2 Prevention of contamination through equipment when blending. Automatic Once per shift
2.11, 2.12
B5.3 Manual At color change
6.0 Molding Process
1.4, 1.15 Verify that there is a standardized startup and re-start procedure/checklist Start-up and restart after
B6.1 Manual
2.11, 2.12 that defines start-up and re-start activities. downtime event
1.4, 1.15 Verify production plan (machine, mold, materials, part quantity) is available Start-up and restart after long
B6.2 Manual
1.4, 1.15 At start-up and restart after

B6.3 Verify process parameters are per setup sheet. Manual
2.11, 2.12 long downtime** event
1.4, 1.15 Continuous by controller or

B6.4 Monitor ambient temperature and adjust molding machine accordingly. Manual
2.11, 2.12 manual verification per shift
CQI-23
Related
Molding
Assessment
Question #

Requirement N/A)
Verify molding machine settings including but not limited to barrel and
1.4, 1.15 die/head temperature settings, parison thickness or thickness profile, pre- Start-up and restart after long
B6.5 Manual
2.11, 2.12 blow pressure and time, blow air pressure and time, mold close speed and downtime** event
clamp pressure.
1.4, 1.15 Verify secondary equipment (e.g., assembly, test equipment, drill stations, Start-up and restart after long
B6.6 Manual
2.11, 2.12 trim stations, paint). downtime** event
Continuous if automatic, or at
1.4, 1.15
B6.7 Verify cooling water temperature and flow rate. Automatic/Manual start-up and after downtime
2.11, 2.12
event.
1.4, 1.15 Verify post mold cooling part temperature or cooling media temperature
B6.8 Manual Start-up
2.11, 2.12 and cooling time for process control consistency, if applicable.
1.4, 1.15 Start-up, and restart after

B6.9 Conduct and document first piece approval. Manual
2.11, 2.12 downtime event
1.4, 1.15 Evacuation of barrel and material purge with purging compound, if
B6.10 Manual End of production run
2.11, 2.12 applicable.
1.4, 1.15
B6.11 Verify that there are standardized Shut down procedures. Manual End of production run
2.11, 2.12
Start and continuous if

automatic. Start-up and ever
1.4, 1.15
B6.12 Verify part weight for consistency. Automatic/Manual 4 hours if manual. For safety
2.11, 2.12
critical parts, start-up and
once every hour
7.0 Fluorine/Sulfonation Treatment (If Applicable)
1.4, 1.15 Start-up and restart after long

B7.1 Ensure start-up check is done according to specification. Manual
1.4, 1.15
B7.2 Confirm carrier gas function in the equipment works as specified. Automatic Continuous
2.11, 2.12
1.4, 1.15
B7.3 Confirm volume function in the equipment works as specified. Automatic Continuous
2.11, 2.12
1.4, 1.15
B7.4 Confirm treatment time function in the equipment works as specified. Automatic Continuous
2.11, 2.12
1.4, 1.15 Start-up and once every 8

B7.5 Perform neutralization and wash cycle. Manual
2.11, 2.12 hours
CQI-23
Related
Molding
Assessment
Question #

Requirement N/A)
8.0 Quality Control

B8.1 Verify the wall thickness (if applicable). Manual
2.11, 2.12 hours

B8.2 Verify the dimensions according to product control documentation. Manual
2.11, 2.12 hours

B8.3 Verify the appearance according to product control documentation. Manual
2.11, 2.12 hours
1.4 Verify the physical properties (if applicable) according to product control Start-up and once every 4
B8.4 Manual
2.11, 2.12 documentation. hours
Start-up and once every 24

1.4 hours. For safety critical parts,
B8.5 Verify the layer thickness and thickness uniformity - (multi-layer only). Manual
2.11, 2.12 start-up and once every 8
hours
Start-up and once every 24

1.4 hours. For safety critical parts,
B8.6 Verify the pinch-off integrity. Manual
2.11, 2.12 start-up and once every 8
hours
CQI-23
PROCESS TABLE C - Vacuum Forming
Related
Molding
Assessment
Question #

Requirement N/A)

1.4
C1.1 acceptance of supplier testing, with criteria (e.g., melt flow, specific gravity) Manual Once per lot
2.1, 2.13

C1.2 Manual Once per lot
C2.1 Automatic/Manual
1.4 Continuous by controller or

C2.2 Environment contamination (dust) controlled (if applicable). Automatic/Manual
2.11, 2.12 manual verification daily
1.4, 1.6 Continuous by controller or

C2.3 Environment temperature and humidity controlled (if applicable). Automatic
2.7, 2.11, 2.12 manual verification daily

C2.4 Automatic/Manual Continuous
1.4, 1.6
C2.5 Verify and document partial container quantity. Automatic/Manual Per container
2.7, 2.11, 2.12
1.4, 1.6
C2.6 Plastic Sheet Stacking. Manual Continuous
2.7, 2.11, 2.12
3.0 Forming Process
1.4, 1.15 Verify that there is a standardized startup and re-start procedure/checklist Start-up and restart after
C3.1 Manual
2.11, 2.12 that defines start-up and re-start activities. downtime event
1.4, 1.15 Verify production plan (machine, mold, materials, part quantity) is available At start-up, and after long
C3.2 Manual
1.4, 1.15 At start-up, and after long

C3.3 Verify process parameters are per setup sheet. Automatic / Manual
1.4, 1.15
C3.4 Verify heating distance (between heater and sheet). Manual At start-up
2.11, 2.12
1.4, 1.15
C3.5 Verify Sheet heating time and temperature (heating cycle, intensity). Manual At start-up
2.11, 2.12
CQI-23
PROCESS TABLE C - Vacuum Forming
Related
Molding
Assessment
Question #

Requirement N/A)
1.4, 1.15 Ensure startup check - Secondary Equipment (trimming, assembly) is done At start-up, and after long
C3.6 Manual
2.11, 2.12 according to specification. downtime** event

C3.7 Verify sheet forming temperature per film according to supplier guidelines. Automatic/Manual

C3.8 Verify mold temperature per film according to supplier guidelines. Automatic/Manual

C3.9 Verify clamping frame closing pressure. Automatic

C3.10 Verify mold close speed. Automatic

C3.11 Verify plug temperature, start time and speed (if applicable). Automatic

C3.12 Verify sheet pre-stretching sequence and time (if applicable). Automatic
1.4, 1.15
C3.13 Verify vacuum level, start time, evacuation speed and duration. Automatic At start-up and every 8 hours
2.11, 2.12
1.4, 1.15
C3.14 Verify pressure level, start time and duration (if applicable). Automatic At start-up and every 8 hours
2.11, 2.12

C3.15 Verify cooling temperature and time. Automatic

C3.16 Verify ejection air (compressed) pressure and time. Automatic

C3.17 Conduct and document first piece approval. Manual
2.11, 2.12 downtime event
1.4, 1.15
C3.18 Verify that there are standardized Shut down procedures. Manual End of production or run
2.11, 2.12
4.0 Quality Control
1.4
C4.1 Verify the dimensions according to product control documentation. Manual Start-up, once every 8 hours
2.11, 2.12
1.4 Start-up, once every 8 hours,

C4.2 Verify the appearance (vs. boundary sample or per instruction). Manual
2.11, 2.12 and last piece
1.4 Verify the physical properties (if applicable) according to product control
C4.3 Manual Start-up, once every 8 hours
2.11, 2.12 documentation.
CQI-23
PROCESS TABLE D - Compression Molding (SMC)
Related
Molding
Assessment
Question #

Requirement N/A)

1.4
D1.1 acceptance of supplier testing, with criteria (e.g., flow, specific gravity, Manual Once per lot
2.1, 2.13
temperature recording) per material specification.

D1.2 Manual Once per lot
2.0 Compounding (if applicable)
1.4 End of run or downtime,

D2.1 Purging all equipment and feeding system to avoid cross contamination. Manual
2.1, 2.13 material change
Process parameter verification: At start-up, and after long

1.4
D2.2 - doctor box blade height, glass chopper speed, additives, carrier film Manual downtime** event, material
2.1, 2.13
speed, compaction pressure etc. change
1.4
D2.3 Glass fiber distribution and density verification. Manual Hourly
2.1, 2.13
Compound property verification using technical data sheet as reference

1.4
D2.4 when applicable: Manual Per production lot
2.1, 2.13
- viscosity, initial sheet thickness, etc.
1.4 Verify that a stock rotation (First In - First Out) system is in place for FIFO - per Lot
D3.1 Manual
2.11, 2.12 compound/preform.
1.4
D3.2 Verify the shelf life of compound/preform. Manual Before each use
2.11, 2.12
1.4 Environment temperature and humidity controlled for preform storage (if
D3.3 Automatic controller or manual
2.11, 2.12 applicable).
verification daily
Verify there is no contamination of partial containers. Label partial

1.4, 1.6
D3.4 container accordingly and store in proper environment (closed container, Automatic/Manual Continuous
2.7, 2.11, 2.12
clean environment).
1.4, 1.6
D3.5 Verify and document partial container quantity. Automatic/Manual Per Container
2.7, 2.11, 2.12
CQI-23
Related
Molding
Assessment
Question #

Requirement N/A)
Controlling compound/preform floor time per molding schedule (e.g.,

molding plan and material have same volume, sheet rolls in SMC,
1.4 procedures for how unfinished/unused rolls are controlled).
D3.6 Manual Each use
2.11, 2.12
Resealed SMC material for storing and handling controlled to ensure no
contamination (closed container, clean environment).
Manual - by procedure
1.4 Prevention control of contamination by lubricants such as silicone, mold Every eight to twelve hours
D3.7 or inspect for physical
2.11, 2.12 release such as calcium carbonate or oil from the pressurization system. depending on shift time
contaminate source.
1.4
D3.8 Sheet shrinkage verification if applicable. Manual Per lot (just before use)
2.11, 2.12
4.0 Molding Process
1.4, 1.15 Verify that there is a standardized startup procedure/checklist that defines
D4.1 Manual At start-up
2.11, 2.12 start-up activities.
1.4, 1.15 Verify production plan (machine, mold, materials, part style) is available
D4.2 Manual At start-up
2.11, 2.12 and followed.
1.4, 1.15
D4.3 Verify process parameters are per setup sheet. Manual At start-up
2.11, 2.12

D4.4 Startup check - Secondary Equipment (De-gate, assembly equipment, etc.). Manual
1.4, 1.15 Cavity surface temperature verification (e.g., could be a reference point on
D4.5 Automatic/Manual At startup and re-start
2.11, 2.12 the tool).
Automatic: Each cycle.

1.4, 1.15
D4.6 Verify the charge pattern. Automatic/Manual Manual: At start-up, every 8
2.11, 2.12
hours
1.4, 1.15
D4.7 Verify the cavity surface for cleanliness (no debris on both sides). Manual At start-up, and every 8 hours
2.11, 2.12
1.4, 1.15
D4.8 Mold closing speed controlled per process sheet. Automatic Continuous
2.11, 2.12
1.4, 1.15
D4.9 Cavity temperature controlled per process sheet. Automatic Continuous
2.11, 2.12
CQI-23
Related
Molding
Assessment
Question #

Requirement N/A)
1.4, 1.15
D4.10 Verify the cavity surface temperature. Manual At start-up, and every 8 hours
2.11, 2.12
1.4, 1.15 Start-up and per frequency

D4.11 Verify part weight for consistency (if applicable). Manual
2.11, 2.12 defined by supplier afterwards
1.4, 1.15 Ensure post molding cooling according to process parameters defined in
D4.12 Manual Each cycle
2.11, 2.12 process setup sheet - prevent deformation.
1.4, 1.15 Start-up, and after downtime

D4.13 Conduct and document first piece approval. Manual
2.11, 2.12 event
1.4, 1.15
D4.14 Verify that there are standardized Shut down procedures. Manual End of production run
2.11, 2.12
5.0 Quality Control
1.4 Per cavity, start-up, and once

D5.1 Verify the dimensions according to product control documentation. Manual
2.11, 2.12 every 8 hours
1.4 Per cavity, start-up and once

D5.2 Verify the appearance according to product control documentation. Manual
2.11, 2.12 every 8 hours
1.4 Verify the other physical properties according to product control Per cavity, start-up and once
D5.3 Manual
2.11, 2.12 documentation. every 8 hours
CQI-23
PROCESS TABLE E - Resin Transfer Molding (RTM)
Related
Molding
Assessment
Question #

Requirement N/A)

1.4
E1.1 acceptance of supplier testing, with criteria (e.g., cure time, viscosity, Manual Once per lot
2.1, 2.13
specific gravity) per material specification.

E1.2 Manual Once per lot
2.0 Preforming (if applicable)
1.4 End of run or long

E2.1 Purging all equipment and feeding system to avoid cross contamination. Manual
2.1, 2.13 downtime**, material change
E3.1 Automatic/Manual
1.4 Environment temperature and humidity controlled for preform storage (if
E3.2 Automatic controller or manual
2.11, 2.12 applicable).
verification daily
1.4 Temperature control during shipment from material supplier to cold storage Continuous monitoring (e.g.,
E3.3 Automatic
2.11, 2.12 area in plant (if applicable e.g., one part epoxies). by chart recorder)
Time stamp on container from

1.4 Material container remains sealed during warm up to room temperature
E3.4 Manual time out of cold storage to
2.11, 2.12 (supplier recommendation) if applicable.
when container is opened
Time exposed to room temperature when removed from cold storage area Continuous monitoring by
1.4
E3.5 for production. Allowable usage time after room temperature is reached, if Automatic/Manual controller or manual
2.11, 2.12
applicable. verification
Verify there is no contamination of partial containers (part A material and

1.4, 1.6
E3.6 part B material, or one part epoxy). Label partial container accordingly and Automatic/Manual Continuous
2.11, 2.12
store in proper environment (closed container, clean environment).
1.4, 1.6
E3.7 Verify and document partial container quantity. Automatic/Manual Per Container
2.11, 2.12
4.0 Molding Process
1.4, 1.15 Verify that there is a standardized startup procedure/checklist that defines Start-up and restart after long
E4.1 Manual
2.11, 2.12 start-up activities. downtime** event
CQI-23
PROCESS TABLE E - Resin Transfer Molding (RTM)
Related
Molding
Assessment
Question #

Requirement N/A)
1.4, 1.15 Verify production plan (machine, mold, materials, part number) is available
E4.2 Manual At start-up
2.11, 2.12 and followed.

E4.3 Verify process parameters are per setup sheet. Manual

E4.4 Startup check - Secondary Equipment (De-gate, assembly equipment, etc.). Manual
1.4, 1.15 Mold cavity temperatures; variation between each cavity and set Continuous, at start-up and
E4.5 Automatic
2.11, 2.12 temperatures, if applicable. after downtime event.
1.4, 1.15 Verify the preform size, or shape, or both to dimensional requirement, if
E4.6 Manual Continuous
2.11, 2.12 applicable.
1.4, 1.15
E4.7 Verify flow rate and amount of material by weight or volume. Automatic Continuous
2.11, 2.12
1.4, 1.15
E4.8 Verify cure time and total cycle time. Automatic Continuous
2.11, 2.12
1.4, 1.15
E4.9 Verify cavity and core surface cleanliness (no debris) before next cycle. manual Continuous
2.11, 2.12
1.4, 1.15
E4.10 Pre-heat of components, if applicable. Automatic Continuous
2.11, 2.12
1.4, 1.15
E4.11 Verify part weight for consistency (if applicable). Manual Once every 4 hours*
2.11, 2.12

E4.12 Conduct and document first piece approval. Manual
2.11, 2.12 extended downtime event
1.4, 1.15
E4.13 Verify that there are standardized Shut down procedures. Manual End of production or run
2.11, 2.12
5.0 Quality Control
1.4
E5.1 Verify dimensions according to product control documentation. Manual Start-up, once every 8 hours
2.11, 2.12
1.4 Start-up, once every 8 hours,

E5.2 Verify appearance (vs. boundary sample or per instruction). Manual
2.11, 2.12 and last piece
1.4 Verify physical properties (if applicable) according to product control

E5.3 Manual Start-up, once every 8 hours
2.11, 2.12 documentation.
CQI-23
PROCESS TABLE F - Extrusion
Related
Molding
Assessment
Question #

Requirement N/A)

1.4
F1.1 acceptance of supplier testing, with criteria (e.g., melt flow, specific gravity) Manual Once per lot
2.1, 2.13

F1.2 Manual Once per lot
F2.1 Automatic/Manual
1.4
F2.2 Environment temperature and humidity controlled (if applicable). Automatic controller or manual
2.11, 2.12
verification daily
F2.3 Automatic/Manual Continuous
2.11, 2.12 contamination (closed container, clean environment).
1.4, 1.6
F2.4 Verify and document partial container quantity. Automatic/Manual Per Container
2.11, 2.12
1.4 Drying temperature per resin material specifications / manufacturer Start-up and continuous by
F3.1 Automatic
2.11, 2.12 guidelines (per material). controller.
1.4 Drying time per resin material specifications / manufacturer guidelines (per Start-up and once every 8
F3.2 Manual
2.11, 2.12 material). hours
1.4
F3.3 Drying equipment (dryer dedicated or clean-out procedure in place). Manual Material change
2.11, 2.12
F3.4 Manual Material or product change
1.4
F3.5 Dew point. Automatic Continuous by controller
2.11, 2.12
1.4 Start up and once every 8

F3.6 Moisture content per material specifications / manufacturer guidelines. Manual
2.11, 2.12 hours
4.0 Regrind Material (if Applicable)

CQI-23
Related
Molding
Assessment
Question #

Requirement N/A)
Regrind ratio (per print, inspection standard or manufacturer guidelines).
1.4, 1.11 Once every 8 hours and at
F4.1 Verified by feed pressure, weight or volume according to customer Automatic
2.11, 2.13 every part change-over
specification.
1.4, 1.11
F4.2 Dedicated regrind equipment or clean-out procedure in place. Manual Material change
2.11, 2.12
1.4, 1.11
F4.3 Fines management (de-dusting). Automatic/Manual Material change
2.11, 2.12
1.4, 1.11 Prevention of contamination when transporting or feeding regrind to the

F4.4 Automatic/Manual Start-up and continuous
2.11, 2.12 extrusion machine.
5.0 Color Management (If Applicable)
1.4
F5.1 Pigment blending - percent loading. Automatic/Manual Start-up and continuous
2.11, 2.12
F5.2 Manual At color change
6.0 Extrusion Process
1.4, 1.15 Verify that there is a standardized startup procedure/checklist that defines Start-up and restart after long
F6.1 Manual
2.11, 2.12 start-up activities. downtime** event
1.4, 1.15 Verify that production plan (machine, die, materials, part quantity) is Start-up and restart after long
F6.2 Manual
2.11, 2.12 available and followed. downtime** event
1.4, 1.15 Start-up and restart after long

F6.3 Verify process parameters are per setup sheet. Manual
1.4, 1.15 Verify secondary equipment (e.g., cooling tanks, cut stations, dozing Start-up and restart after long
F6.4 Manual
2.11, 2.12 stations). downtime** event
Continuous if automatic, or at
1.4, 1.15
F6.5 Verify die temperature or extruded material temperature. Automatic/Manual start-up and after downtime
2.11, 2.12
event.
1.4, 1.15
F6.6 Verify extrusion head pressure, head temperature, barrel temperature. Automatic Start-up and continuous
2.11, 2.12
1.4, 1.15
F6.7 Vacuum level (if applicable). Automatic Start-up and continuous
2.11, 2.12
1.4, 1.15
F6.8 Verify coolant tank temperature (if applicable). Automatic Start-up and continuous
2.11, 2.12
CQI-23
Related
Molding
Assessment
Question #

Requirement N/A)
F6.9 Conduct and document first piece approval. Manual
2.11, 2.12 extended downtime event
1.4, 1.15 Material purge/evacuation of barrel - included in unplanned and downtime

F6.10 Manual End of run or long downtime**
2.11, 2.12 procedures.
1.4, 1.15
F6.11 Verify that there are standardized Shut down procedures. Manual End of production or run
2.11, 2.12
7.0 Quality Control
Per each outlet from the die,

1.4 start-up and once every 8
F7.1 Verify the thickness. Manual
2.11, 2.12 hours. For safety critical parts,
start-up and once every hour

F7.2 Verify the layer thickness/thickness uniformity (multi-layer only). Manual

F7.3 Verify the layer adhesion (multi-layer only). Manual
1.4 Per each outlet from the die,

F7.4 Verify the dimensions according to product control documentation. Manual
2.11, 2.12 start-up, once every 8 hours

1.4
F7.5 Verify the appearance (vs. boundary sample or per instruction). Manual start-up, once every 8 hours,
2.11, 2.12
and last piece
1.4 Verify the physical properties (if applicable) according to product control Per each outlet from the die,
F7.6 Manual
2.11, 2.12 documentation. start-up, once every 8 hours
CQI-23
PROCESS TABLE G - Equipment
All requirements given below are subordinate to customer specific requirements.
* When historical results show capability, test frequency may be reduced.
Related
Molding Resin Minimum
Injection Blow Vacuum Compressi Minimum Calibration / Included in Preventative
Item # System Equipment Type Transfer Extrusion Verification Comment
Molding Molding Forming on Molding Certification Frequency * Maintenance Plan
Assessment Molding Frequency
Question #
1.0 PROCESS EQUIPMENT
G1.1 2.14 Temperature controllers X X X X X X Once per shift Annual
Per Preventive
G1.2 2.14 Filters, if applicable X X X X X X N/A
Maintenance
Per Preventive
G1.3 2.14 Thermocouples X X X X X X Annual
Maintenance
Per Preventive Per Manufacturer Guidelines

G1.4 2.14 Injection mold machine X
Maintenance or every 5 years
Per Preventive
G1.5 2.14 Mold X X X X X X N/A
Maintenance

G1.6 2.14 Blow mold machine X
Per Preventive
G1.7 2.14 Vacuum molding machine X N/A
Maintenance

G1.8 2.14 Compression molding machine X
G1.9 2.14 Resin transfer molding machine X

G1.10 2.14 Extrusion machine X
Per Preventive
G1.11 2.14 Dryer, if applicable X X X N/A
Maintenance
Per Preventive
G1.12 2.14 Grinder, if applicable X X X N/A
Maintenance

G1.13 2.14 Mixer, if applicable X X

G1.14 2.14 Hot runner controller X
G1.15 2.14 Cavity pressure sensor X Once per shift N/A
Valve Gate controller, if Per Preventive

G1.16 2.14 X N/A
applicable Maintenance
2.0 SECONDARY EQUIPMENT
Generic fixtures (cooling, heat Per Preventive

G2.1 2.14 X X X X X X N/A
forming, if applicable) Maintenance
CQI-23
PROCESS TABLE G - Equipment
* When historical results show capability, test frequency may be reduced.
Related
Molding Resin Minimum
Injection Blow Vacuum Compressi Minimum Calibration / Included in Preventative
Item # System Equipment Type Transfer Extrusion Verification Comment
Molding Molding Forming on Molding Certification Frequency * Maintenance Plan
Assessment Molding Frequency
Question #
Per Preventive
G2.2 2.14 Conveyors X X X X X X N/A
Maintenance
Degater/Trim operation, if Per Preventive

G2.3 2.14 X X X X X X N/A
applicable Maintenance
Per Preventive
G2.4 2.14 Cutter, if applicable X X X X X X N/A
Maintenance
Per Preventive
G2.5 2.14 Robot, if applicable X X X X X X Installation
Maintenance
Per Preventive
G2.6 2.14 Oven, if applicable X X X X X X N/A
Maintenance
Per Preventive
G2.7 2.14 Cooling fan, if applicable X X X X X X N/A
Maintenance
Per Preventive
G2.8 2.14 End of arm tooling, if applicable X X X X X X N/A
Maintenance
MINIMUM REQUIRED TESTING

3.0
EQUIPMENT
G3.1 2.14 Cure testing, if applicable X X X Per lot Annual
G3.2 2.14 Leak testing, if applicable X X X At start up Every 6 months
G3.3 2.14 Color, if applicable X X X X Before each use Annual
G3.4 2.14 Gloss, if applicable X X X X Before each use Annual
G3.5 2.14 Weight, if applicable X X X Before each use Annual
G3.6 2.14 Dimensions, if applicable X X X X X X Before each use Annual
Per Manufacturer
G3.7 2.14 Moisture, if applicable X X X Annual
Guidelines
Per Manufacturer
G3.8 2.14 Performance, if applicable X X X X X X Annual
Guidelines
CQI-23
PROCESS TABLE H - Part Inspection and Testing
The customer may have additional requirements, e.g., inspection testing, greater frequencies, etc. When performing the job audit, the auditor shall verify molder is conforming to specifications or other
requirements.
Note that not all tests are applicable to all molding processes.
Related
Molding
Item # System Category/Process Steps Monitoring Frequency Observation/Comments
Assessment
Question #
(Pass /
Dimension, Weight, Appearance, Performance Minimum Requirement Actual Condition
Fail / N/A)
1.0 General
Dimensions
Appearance
Performance
1.4 Procedures are in place and implemented to prevent damage to the finish
H1.1 100%
2.9 or part during the inspection and packaging processes.
Appearance (flash, color and gloss, short shots, splay/burns, blister, sink
First off and last off by quality
H1.2 1.4 marks, gate vestige, weld line/knit lines, and other molding defects) of the
and 100% by operator
molding shall be verified per specification and applications manual.
H1.3 1.4 Cracks, whitening/stress mark First off and last off by quality
H1.4 1.4 Part identification First off by quality
H1.5 1.4 Dimensional check (e.g., Go-no go, Plug and Ring gage) First off and once per shift
H1.6 1.4 Wall thickness Per process table
H1.7 1.4 General - Weight, Resin, Components, Porosity/Voids (if applicable) First off
H1.8 1.4 Performance Per customer specifications

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CQI-23

Special Processes: Molding System Assessment

Special Process: Molding System Assessment

Phone Number: Number of Molding Employees at this Facility:

Commercial Molder (Y/N): ⃝ Yes ⃝ No Specify:

Type(s) of Molding Processes at this Facility:

Process Table B - Blow Molding Process Table F - Extrusion

Process Table C - Vacuum Forming Process Table G - Equipment

Current Quality Certification(s): Date of Re-assessment (if necessary):

Personnel Contacted: Phone: Email:

Auditors/Assessors: Phone: Email:

Number of "Not Satisfactory" Findings:

Number of "Needs Immediate Action" Findings:

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

Number of “Fail” Findings in the Process Table(s):

Section 1 - Management Responsibility & Quality Planning

1.1 There shall be a dedicated and qualified molding professional on site.

Section 1 - Management Responsibility & Quality Planning

1.2 The facility shall perform advanced quality planning.

Does the facility use a documented advanced quality planning process?

What is the procedure for changing the process after PPAP?

Section 1 - Management Responsibility & Quality Planning

Section 1 - Management Responsibility & Quality Planning

Does the facility have a documented control plan in use?

Section 1 - Management Responsibility & Quality Planning

How are standards and specifications obtained?

Section 1 - Management Responsibility & Quality Planning

Section 1 - Management Responsibility & Quality Planning

1.7 There shall be documented process instructions.

What form of process specification is used?

Section 1 - Management Responsibility & Quality Planning

1.8 A valid product capability study shall be performed.

Has an initial product capability study been performed?

How does the organization define what constitutes a major change?

Section 1 - Management Responsibility & Quality Planning

What product characteristics and process parameters are used?

Section 1 - Management Responsibility & Quality Planning

What is the process to retain these records?

Section 1 - Management Responsibility & Quality Planning

Define the process in place to gather and review this information.

Section 1 - Management Responsibility & Quality Planning

Section 1 - Management Responsibility & Quality Planning

Describe the procedure for authorizing rework of nonconforming material.

How do you identify that material has been reworked?

Section 1 - Management Responsibility & Quality Planning

Section 1 - Management Responsibility & Quality Planning

1.15 The organization shall have a continual improvement process.

Section 1 - Management Responsibility & Quality Planning

Section 1 - Management Responsibility & Quality Planning

Review the procedure/work instruction for process start-up and shut-down.

What is the procedure in place to address potential emergencies?

Section 1 - Management Responsibility & Quality Planning

1.18 The organization and management shall provide employee training.

• The organization shall provide employee training for all operations.

Section 1 - Management Responsibility & Quality Planning

Review and provide an example of the most recent matrix.

Section 1 - Management Responsibility & Quality Planning

Show evidence that a documented preventive maintenance program exists.

Section 1 - Management Responsibility & Quality Planning

Provide the critical spare parts list.

Section 2 - Floor and Material Handling Responsibility

Describe the receiving process including listing the documentation used.

Section 2 - Floor and Material Handling Responsibility

Section 2 - Floor and Material Handling Responsibility