CQI-23

Special Processes: Molding System Assessment

Version 1, 3/2014

Special Process: Molding System Assessment

Facility Name:
Address:

Phone Number:
Fax Number: Type(s) of Molding Processes at this Facility:
Process Table A
Number of Molding Employees at this Facility: Injection Molding

Captive Molder (Y/N): Process Table B

Commercial Molder (Y/N): 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 Needs Immediate

Question Requirements and Guidance Objective Evidence N/A Satisfactory Not Satisfactory
Number Action

Section 1 - Management Responsibility and Quality Planning

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
1.1 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.

The molder shall incorporate a documented advanced

Does the molder perform
1.2
advanced quality planning?
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 47
 CQI-23
Special Processes: Molding System Assessment
Version 1, 3/2014

Special Process: Molding System Assessment (General Facility Overview)

Assessment

Question Needs Immediate

Question Requirements and Guidance Objective Evidence N/A Satisfactory Not Satisfactory
Number Action

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
1.3 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.

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 cross-
Are molding process Control
functional team, including a production operator, shall
1.4 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 47

Question
Question
Number
Are all molding related and
referenced specifications
current and available? For
1.5
example: SAE, AIAG, ASTM,
General Motors, Ford, and
Chrysler.
Are all molding related internal The molder should have a documented process and
1.6 and external best practices
documented and maintained? lessons learned or from industry knowledge.
Is there a written process
1.7 specification for all active
processes?
CQI-23
Special Processes: Molding System Assessment
Version 1, 3/2014
Special Process: Molding System Assessment (General Facility Overview)
Assessment
Needs Immediate
Requirements and Guidance Objective Evidence N/A Satisfactory Not Satisfactory
Action
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.
system for maintaining best practices obtained through
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 47
 CQI-23
Special Processes: Molding System Assessment
Version 1, 3/2014

Special Process: Molding System Assessment (General Facility Overview)

Assessment

Question Needs Immediate

Question Requirements and Guidance Objective Evidence N/A Satisfactory Not Satisfactory
Number Action

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.
1.8 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.

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
1.9 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.

Are internal assessments

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

Section 1-2, 5 of 47
 CQI-23
Special Processes: Molding System Assessment
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Special Process: Molding System Assessment (General Facility Overview)

Assessment

Question Needs Immediate

Question Requirements and Guidance Objective Evidence N/A Satisfactory Not Satisfactory
Number Action

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
1.11 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.

The quality management system shall include a

Does the Quality Department
process for documenting, reviewing, and addressing
review, address, and
1.12 customer concerns and any other concerns internal to
document customer and
the molder. A disciplined problem solving approach
internal concerns?
shall be used.

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
1.13
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.

Does the Quality Manager or

The Quality Manager or designee is responsible for
designee authorize the
1.14 authorizing and documenting appropriate personnel to
disposition of material from
disposition quarantine material.
quarantine status?

Section 1-2, 6 of 47

Question
Question
Number
Are there procedures or work
instructions available to
1.15
molding personnel that define
the molding process?
Is management providing
1.16
employee training for molding?
Is there a responsibility matrix
to ensure that all key
1.17 management and supervisory
functions are performed by
qualified personnel?
CQI-23
Special Processes: Molding System Assessment
Version 1, 3/2014
Special Process: Molding System Assessment (General Facility Overview)
Assessment
Needs Immediate
Requirements and Guidance Objective Evidence N/A Satisfactory Not Satisfactory
Action
There shall be procedures or work instructions
available to molding personnel covering the molding
process. These procedures or work instructions shall
include methods of addressing potential emergencies
(such as power failure), equipment start-up, equipment
shut-down, product segregation (See 2.8), product
inspection, and general operating procedures. These
procedures or work instructions shall be accessible to
shop floor personnel.
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
showing the employees trained and the evidence shall
include an assessment of the effectiveness of the
training. Management shall define the qualification
requirements for each function, and ongoing or follow-
up training shall also be addressed.
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 47

Question
Question
Number
Is there a preventive
maintenance program? Is
maintenance data being
1.18
utilized to form a predictive
maintenance program?
Has the molder developed a
critical spare parts list, and are
1.19
the parts available to minimize
production disruptions?
CQI-23
Special Processes: Molding System Assessment
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Special Process: Molding System Assessment (General Facility Overview)
Assessment
Needs Immediate
Requirements and Guidance Objective Evidence N/A Satisfactory Not Satisfactory
Action
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.
The molder shall develop and maintain a critical spare
parts list and shall ensure the availability of such parts
to minimize production disruptions.
Section 1-2, 8 of 47

Question
Question
Number
Does the facility ensure that
the data entered in the
2.1 receiving system matches the
information on the customer's
shipping documents?
Is product clearly identified
2.2 and staged throughout the
molding process?
Is molder using adequate
2.3 FIFO system for material and
product?
Is lot traceability and integrity
2.4 maintained throughout all
processes?
Are procedures adequate to
prevent movement of non-
2.5
conforming product into the
production system?
CQI-23
Special Processes: Molding System Assessment
Version 1, 3/2014
Special Process: Molding System Assessment (General Facility Overview)
Assessment
Needs Immediate
Requirements and Guidance Objective Evidence N/A Satisfactory Not Satisfactory
Action
Section 2 - Floor and Material Handling Responsibility
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.
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.
There shall be a procedure that ensures a FIFO
system is utilized.
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.
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, 9 of 47

Question
Question
Number
Is there a system to identify
trap points in the entire
process to reduce risk of
2.6
mixed parts (inappropriate,
unfinished or improperly
molded parts)?
Are containers free of
2.7
inappropriate material?
Are operators trained in
material handling, containment including power failure. Training shall be documented.
action and product
2.8
segregation in the event of an types of equipment emergencies and failures shall be
equipment emergency
including power failure?
Is the handling, storage and
2.9 packaging adequate to
preserve product quality?
CQI-23
Special Processes: Molding System Assessment
Version 1, 3/2014
Special Process: Molding System Assessment (General Facility Overview)
Assessment
Needs Immediate
Requirements and Guidance Objective Evidence N/A Satisfactory Not Satisfactory
Action
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.
Containers handling customer product shall be free of
inappropriate material. After emptying and before re-
using 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.
Unplanned or emergency downtime greatly raises the
risk of improper processing. Operators shall be trained
in material handling, containment action, and product
segregation in the event of an equipment emergency
Work instructions specifically addressing potential
accessible to and understood by equipment operators.
These instructions shall address containment/reaction
plans related to all elements of the process. Evidence
shall exist showing disposition and traceability of
affected product.
The molder's in-process handling and shipping
process shall be assessed for risk of part damage or
other quality concerns.
Section 1-2, 10 of 47
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Special Process: Molding System Assessment (General Facility Overview)

Assessment

Question Needs Immediate

Question Requirements and Guidance Objective Evidence N/A Satisfactory Not Satisfactory
Number Action

Plant cleanliness, housekeeping, environmental, and

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

Process control parameters shall be monitored per

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

There are documented reaction plans to both out of

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

Are Test Frequencies

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

Test equipment shall be verified/calibrated per

applicable customer specific standard or per an
applicable consensus standard, e.g., ASTM, SAE,
Is product test equipment
2.14 ISO, NIST, etc. Verification/calibration results shall be
verified?
internally reviewed, approved and documented.

Refer to Process Tables for frequency of checks.

Lighting in the inspection area shall be sufficient to

allow the evaluation of all part surfaces. The lighting
2.15 Lighting of inspection area 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, 11 of 47
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Special Processes: Molding System Assessment
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Section 3 - Job Audit - Finished Product Review

Job Identity:
Customer:
Shop Order Number:
Part Number:
Part Description:
Molding Requirements:

Related
Molding System Customer or Internal Job (Shop) Order or Reference Actual Condition Pass / Fail
Question # Job Audit Question
Assessment Requirement Documentation Requirement (Objective Evidence) / N/A
Question #
1.1
Is contract review and advanced quality
1.2
planning, FMEA, Control Plans, etc., in
3.1 1.3 N/A
place and performed by qualified
1.4
individuals?
1.6

Does the molder have the proper

3.2 1.5 N/A
customer specifications for the part?

Is there documented evidence of

3.3 2.1
Receiving Inspection?

Is material identification (part numbers, lot

2.2
numbers, contract numbers, etc.)
3.4 2.3
maintained throughout the molding
2.4
process?

Is the proper procedure or process 1.5

specification used? Refer to Process 1.6
3.5 Tables for specific parameters. List 2.1
parameters that were verified in this audit 2.11
in the spaces provided below. 2.13

Job Audit 13 of 47
 CQI-23
Special Processes: Molding System Assessment
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Section 3 - Job Audit - Finished Product Review

Job Identity:
Customer:
Shop Order Number:
Part Number:
Part Description:
Molding Requirements:

Related
Molding System Customer or Internal Job (Shop) Order or Reference Actual Condition Pass / Fail
Question # Job Audit Question
Assessment Requirement Documentation Requirement (Objective Evidence) / N/A
Question #
Process #1:

Process #2:

1.5 Each part may have one or more requirements determined by the molding specification.
What are the product inspection
3.6 2.13 Parts must meet each requirement. List each requirement below and validate.
requirements?
2.14 (Listed below are some examples)

3.6.1 Requirement: Weight

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

Job Audit 14 of 47
 CQI-23
Special Processes: Molding System Assessment
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Section 3 - Job Audit - Finished Product Review

Job Identity:
Customer:
Shop Order Number:
Part Number:
Part Description:
Molding Requirements:

Related
Molding System Customer or Internal Job (Shop) Order or Reference Actual Condition Pass / Fail
Question # Job Audit Question
Assessment Requirement Documentation Requirement (Objective Evidence) / N/A
Question #

3.6.2 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 47
 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:

Related
Molding System Customer or Internal Job (Shop) Order or Reference Actual Condition Pass / Fail
Question # Job Audit Question
Assessment Requirement Documentation Requirement (Objective Evidence) / N/A
Question #
3.6.5 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 47
 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:

Related
Molding System Customer or Internal Job (Shop) Order or Reference Actual Condition Pass / Fail
Question # Job Audit Question
Assessment Requirement Documentation Requirement (Objective Evidence) / N/A
Question #
Operator or Inspector Responsibilities

1.4
1.6
Were appropriate process steps signed
3.7 2.2
off?
2.3
2.11

Were all inspection steps, as documented 1.2

3.8
in the Control Plan performed? 1.4

1.2
Were steps/operations performed that
3.9 1.4
were not documented in the Control Plan?
1.6

1.2
1.4
If additional steps were performed, were
3.10 1.6
they authorized?
1.10
1.16

Does the governing specification allow 1.5

3.11
reprocessing or rework? 1.10

Job Audit 17 of 47
 CQI-23
Special Processes: Molding System Assessment
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Section 3 - Job Audit - Finished Product Review

Job Identity:
Customer:
Shop Order Number:
Part Number:
Part Description:
Molding Requirements:

Related
Molding System Customer or Internal Job (Shop) Order or Reference Actual Condition Pass / Fail
Question # Job Audit Question
Assessment Requirement Documentation Requirement (Objective Evidence) / N/A
Question #
If the order was certified, did the
2.11
3.12 certification accurately reflect the process
2.13
performed?

Was the certification signed by an

3.13 1.16
authorized individual?

Are the parts and containers free of

3.14 2.6
inappropriate objects or contamination?

Packaging Requirements

2.6
3.15 Are packaging requirements identified? 2.7
2.9

Are parts packaged to minimize mixed 2.6

3.16 parts or damaged (for example, work flow 2.7
or over-pack of container)? 2.9

Shipping Requirements

2.3
3.17 Were the parts properly identified?
2.9
2.3
3.18 Were the containers properly labeled?
2.9

Job Audit 18 of 47
 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.

Related
Molding
Observation/
Item # System Category/Process Steps Type of Control Monitoring Frequency
Comments
Assessment
Question #

Minimum Requirement Actual Condition Minimum Requirement Actual Condition (Pass / Fail /
N/A)

1.0 Receiving Inspection

1.4 Incoming material assessment procedure, covering onsite testing or

A1.1 2.1 acceptance of supplier testing, with criteria (i.e., melt flow, specific Manual Once per lot
2.13 gravity).
1.4
Incoming components assessment procedure, covering onsite
A1.2 2.1 Manual Once per lot
testing or acceptance of supplier testing, with criteria (if applicable).
2.13

2.0 Storage & Handling (If Applicable)

1.4
2.3 Stock rotation system in place for First in/First out (FIFO) and shelf- FIFO - per Lot
A2.1 Automatic/Manual
2.11 life Shelf life - pull for use
2.12
1.4 Continuous monitoring by
A2.2 2.11 Environment temperature controlled Automatic controller or manual
2.12 verification daily

1.4
1.6
Handling of partial containers to ensure no contamination (closed
A2.3 2.7 Automatic/Manual Continuous
container, clean environment)
2.11
2.12

1.4
1.6
A2.4 2.7 Partial container quantity Automatic/Manual Per Container
2.11
2.12

PT A 19 of 47
 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.

Related
Molding
Observation/
Item # System Category/Process Steps Type of Control Monitoring Frequency
Comments
Assessment
Question #

Minimum Requirement Actual Condition Minimum Requirement Actual Condition (Pass / Fail /
N/A)

3.0 Material Drying

1.4
Continuous monitoring by
A3.1 2.11 Dryer temperature per resin manufacturer guidelines (per material) Automatic
controller
2.12
1.4
Per Resin Manufacturer
A3.2 2.11 Dryer time per resin manufacturer guidelines (per material) Manual
Guidelines
2.12
1.4
A3.3 2.11 Drying equipment (dryer dedicated or clean procedure in place) Manual Material change
2.12
1.4
Continuous monitoring by
A3.4 2.11 Dew point Automatic
controller
2.12
1.4
A3.5 2.11 Moisture analysis, if applicable, per Resin Manufacturer Guidelines Manual At start-up and once per shift*
2.12

4.0 Recycle (regrind) Material (If Applicable)

1.4
1.11 Recycle ratio (per print, inspection standard or manufacturer Once every 8 hours and at
A4.1 Automatic
2.11 guidelines). Verified by feed pressure, weight or volume every part change over
2.13

1.4
1.11
A4.2 Dedicated regrind equipment or cleaning procedure in place Manual Material change
2.11
2.12

1.4
1.11
A4.3 Fines management (de-dusting) Automatic/Manual Material change
2.11
2.12

1.4
1.11
A4.4 Move regrind to IMM (contamination) Automatic/Manual Start-up and continuous
2.11
2.12

PT A 20 of 47
 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.

Related
Molding
Observation/
Item # System Category/Process Steps Type of Control Monitoring Frequency
Comments
Assessment
Question #

Minimum Requirement Actual Condition Minimum Requirement Actual Condition (Pass / Fail /
N/A)

5.0 Color Management

1.4
A5.1 2.11 Pigment blending - percent loading, if applicable Automatic/Manual Start-up and continuous
2.12
1.4
A5.2 2.11 Color change procedure Manual Continuous
2.12

6.0 Molding Process

1.4
1.15 There shall be a standardized startup procedure/checklist that Start-up and restart after long
A6.1 Manual
2.11 defines things to do at start-up down time event
2.12

1.4
1.15 Start-up and restart and after
A6.2 Production plan (machine, mold, materials, part style) Manual
2.11 long down time event
2.12

1.4
1.15 At start-up, and after long
A6.3 Startup check (verify process settings against setup sheet) Manual
2.11 down time event
2.12

1.4
1.15 Startup check - Secondary Equipment (De-gate, assembly At start-up, and after long
A6.4 Manual
2.11 equipment, welders, etc.) down time event
2.12

1.4
Continuous if automatic, or at
1.15
A6.5 Mold surface temperature Automatic/Manual start-up and after down time
2.11
event
2.12

1.4
1.15 Plastication - Temperature (barrel, nozzle, hot manifold if applicable),
A6.6 Automatic Continuous
2.11 screw RPM, and back pressure
2.12

PT A 21 of 47
 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.

Related
Molding
Observation/
Item # System Category/Process Steps Type of Control Monitoring Frequency
Comments
Assessment
Question #

Minimum Requirement Actual Condition Minimum Requirement Actual Condition (Pass / Fail /
N/A)
1.4
1.15
A6.7 Plastication - Melt temperature N/A Start-up
2.11
2.12

1.4
1.15
A6.8 Plastication - Screw recovery time N/A Continuous
2.11
2.12

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 Temperature Control Cooling - Coolant inlet temperature and cooling
A6.14 Automatic Continuous
2.11 time
2.12

PT A 22 of 47
 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.

Related
Molding
Observation/
Item # System Category/Process Steps Type of Control Monitoring Frequency
Comments
Assessment
Question #

Minimum Requirement Actual Condition Minimum Requirement Actual Condition (Pass / Fail /
N/A)
1.4
1.15
A6.15 Part weight (if applicable) Manual Once every 8 hours*
2.11
2.12

1.4
1.15 Start-up, and restart after
A6.16 First piece approval Manual
2.11 down time event
2.12

1.4
1.15 Material purge/evacuation of barrel - included in unplanned and
A6.17 Manual End of run or long downtime
2.11 downtime procedures
2.12

1.4
1.15
A6.18 Shut down procedures Manual End of production or run
2.11
2.12

7.0 Quality Control

1.4 Start-up and once every 4

A7.1 2.11 Part weight Manual hours. For safety critical parts,
2.12 start-up and once every hour

1.4
Per cavity, start-up and once
A7.2 2.11 Dimensions Manual
every 8 hours
2.12
1.4
Per cavity, start-up and once
A7.3 2.11 Appearance (vs. boundary sample or per instruction) Manual
every 8 hours
2.12
1.4
Per cavity, start-up and once
A7.4 2.11 Physical properties (if applicable) Manual
every 8 hours
2.12

PT A 23 of 47
 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.

Related
Molding
Observation/
Item # System Category/Process Steps Type of Control Monitoring Frequency
Comments
Assessment
Question #

Minimum Requirement Actual Condition Minimum Requirement Actual Condition (Pass / Fail /
N/A)

1.0 Receiving Inspection

1.4 Incoming material assessment procedure, covering onsite testing or

B1.1 2.1 acceptance of supplier testing, with criteria (i.e., melt flow, specific Manual Once per lot
2.13 gravity).
1.4
Incoming components assessment procedure, covering onsite
B1.2 2.1 Manual Once per lot
testing or acceptance of supplier testing, with criteria (if applicable).
2.13

2.0 Storage & Handling

1.4
2.3 Stock rotation system in place for First in/First out (FIFO) and shelf- FIFO - per Lot
B2.1 Automatic/Manual
2.11 life Shelf life - pull for use
2.12

1.4 Continuous monitoring by

B2.2 2.11 Environment temperature and humidity controlled (if applicable) Automatic controller or manual
2.12 verification daily

1.4
1.6
Partial container handling to ensure no contamination (closed
B2.3 2.7 Automatic/Manual Continuous
container, clean environment)
2.11
2.12

1.4
1.6
B2.4 2.7 Partial container quantity Automatic/Manual Per container
2.11
2.12

3.0 Material Drying (If Applicable)

1.4
Start-up and continuous by
B3.1 2.11 Dryer temperature per resin manufacturer guidelines (per material) Automatic
controller
2.12
1.4
Start-up and once every 8
B3.2 2.11 Drying time per resin manufacturer guidelines (per material) Manual
hours
2.12

PT B 24 of 47
 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.

Related
Molding
Observation/
Item # System Category/Process Steps Type of Control Monitoring Frequency
Comments
Assessment
Question #

Minimum Requirement Actual Condition Minimum Requirement Actual Condition (Pass / Fail /
N/A)
1.4
B3.3 2.11 Drying equipment (dryer dedicated or clean procedure in place) Manual Material change
2.12
1.4
B3.4 2.11 Dew point Automatic Continuous by controller
2.12
1.4
Start-up and once every 8
B3.5 2.11 Moisture content Manual
hours
2.12

4.0 Recycle/Regrind Material (If Applicable)

1.4
Recycle ratio (per print, inspection standard or manufacturer
1.11 Once every 8 hours and at
B4.1 guidelines). Verified by feed pressure, weight or volume. No regrind Automatic
2.11 every part change-over
of fluorine-treated parts.
2.13

1.4
1.11
B4.2 Regrind equipment (dedicated or cleaning procedure in place) Manual Material change
2.11
2.12

1.4
1.11
B4.3 Ethylene Vinyl Alcohol (EVOH) particle size and distribution Manual Start-up
2.11
2.12

1.4
1.11
B4.4 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
B4.5 Automatic/Manual Start-up and continuous
2.11 the blow mold machine
2.12

PT B 25 of 47
 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.

Related
Molding
Observation/
Item # System Category/Process Steps Type of Control Monitoring Frequency
Comments
Assessment
Question #

Minimum Requirement Actual Condition Minimum Requirement Actual Condition (Pass / Fail /
N/A)

5.0 Color Management (If Applicable)

1.4
B5.1 2.11 Pigment blending - percent loading Automatic/Manual Start-up and continuous
2.12
1.4
B5.2 2.11 Color change procedure Manual At color change
2.12

6.0 Molding Process

1.4
1.15 There shall be a standardized startup procedure/checklist that Start-up and restart after long
B6.1 Manual
2.11 defines things to do at start-up down time event
2.12

1.4
1.15 Start-up and restart and after
B6.2 Production plan (machine, mold, materials, part quantity) Manual
2.11 long down time event
2.12

1.4
1.15 Continuous by controller or
B6.3 Environment temperature for parison Automatic
2.11 manual verification daily
2.12

1.4 Verify molding machine settings including but not limited to barrel
1.15 and die/head temperature settings, parison thickness or thickness Start-up and restart after long
B6.4 Manual
2.11 profile, pre-blow pressure and time, blow air pressure and time, down time event
2.12 mold close speed and clamp pressure

1.4
1.15 Start-up and restart after long
B6.5 Verify secondary equipment Manual
2.11 down time event
2.12

1.4
Continuous if automatic, or at
1.15
B6.6 Cooling water temperature and flow rate Automatic/Manual start-up and after down time
2.11
event.
2.12

PT B 26 of 47
 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.

Related
Molding
Observation/
Item # System Category/Process Steps Type of Control Monitoring Frequency
Comments
Assessment
Question #

Minimum Requirement Actual Condition Minimum Requirement Actual Condition (Pass / Fail /
N/A)
1.4
1.15
B6.7 Verify post mold cooling temperature or pressure and time Manual Start-up
2.11
2.12

1.4
1.15 Start-up, and restart after
B6.8 First piece approval Manual
2.11 down time event
2.12

1.4
1.15
B6.9 Material purge/evacuation of barrel Manual End of run or long downtime
2.11
2.12

1.4
1.15
B6.10 Shut down procedures Manual End of production or run
2.11
2.12

7.0 Fluorine/Sulfination Treatment (If Applicable)

1.4
1.15 Start-up and restart after long
B7.1 Start-up check Manual
2.11 down time event
2.12

1.4
1.15
B7.2 Carrier gas Automatic Continuous
2.11
2.12

1.4
1.15
B7.3 Volume Automatic Continuous
2.11
2.12

1.4
1.15
B7.4 Treatment time Automatic Continuous
2.11
2.12

PT B 27 of 47
 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.

Related
Molding
Observation/
Item # System Category/Process Steps Type of Control Monitoring Frequency
Comments
Assessment
Question #

Minimum Requirement Actual Condition Minimum Requirement Actual Condition (Pass / Fail /
N/A)
1.4
1.15 Start-up and once every 8
B7.5 Neutralization and wash cycle Manual
2.11 hours
2.12

PT B 28 of 47
 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.

Related
Molding
Observation/
Item # System Category/Process Steps Type of Control Monitoring Frequency
Comments
Assessment
Question #

Minimum Requirement Actual Condition Minimum Requirement Actual Condition (Pass / Fail /
N/A)

8.0 Quality Control

1.4 Start-up and once every 4

B8.1 2.11 Part weight Manual hours. For safety critical parts,
2.12 start-up and once every hour

1.4
Start-up and once every 4
B8.2 2.11 Wall thickness (if applicable) Manual
hours
2.12
1.4
Start-up and once every 4
B8.3 2.11 Dimensions Manual
hours
2.12
1.4
Start-up and once every 4
B8.4 2.11 Appearance Manual
hours
2.12
1.4
Start-up and once every 4
B8.5 2.11 Physical properties (if applicable) Manual
hours
2.12
Start-up and once every 24
1.4
hours. For safety critical parts,
B8.6 2.11 Layer thickness and thickness uniformity - (multi-layer only) Manual
start-up and once every 8
2.12
hours

Start-up and once every 24

1.4
hours. For safety critical parts,
B8.7 2.11 Pinch-off integrity Manual
start-up and once every 8
2.12
hours

PT B 29 of 47
 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 molder is conforming to customer requirements.

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

Related
Molding
Observation/
Item # System Category/Process Steps Type of Control Monitoring Frequency
Comments
Assessment
Question #

Minimum Requirement Actual Condition Minimum Requirement Actual Condition (Pass / Fail /
N/A)

1.0 Receiving Inspection

1.4 Incoming material assessment procedure, covering onsite testing or

C1.1 2.1 acceptance of supplier testing, with criteria (i.e., melt flow, specific Manual Once per lot
2.13 gravity).
1.4
Incoming components assessment procedure, covering onsite
C1.2 2.1 Manual Once per lot
testing or acceptance of supplier testing, with criteria (if applicable).
2.13

2.0 Storage & Handling

1.4
2.3 Stock rotation system in place for First in/First out (FIFO) and shelf- FIFO - per Lot
C2.1 Automatic/Manual
2.11 life. Shelf life - pull for use
2.12
1.4
Continuous by controller or
C2.2 2.11 Environment contamination (dust) controlled (if applicable) Automatic/Manual
manual verification daily
2.12

1.4
1.6
Continuous by controller or
C2.3 2.7 Environment humidity and temperature controlled (if applicable) Automatic
manual verification daily
2.11
2.12

1.4
1.6
Partial containers handling to ensure no contamination (closed
C2.4 2.7 Automatic/Manual Continuous
container, clean environment)
2.11
2.12

1.4
1.6
C2.5 2.7 Plastic Sheet Stacking Manual Continuous
2.11
2.12

3.0 Forming Process

1.4
1.15 There shall be a standardized startup procedure/checklist that Start-up and restart after long
C3.1 Manual
2.11 defines things to do at start-up down time event
2.12

PT C 30 of 47
 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 molder is conforming to customer requirements.

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

Related
Molding
Observation/
Item # System Category/Process Steps Type of Control Monitoring Frequency
Comments
Assessment
Question #

Minimum Requirement Actual Condition Minimum Requirement Actual Condition (Pass / Fail /
N/A)
1.4
1.15 At start-up, and after long
C3.2 Production plan (machine, mold, materials, part quantity) Manual
2.11 down time event
2.12

1.4
1.15 At start-up, and after long
C3.3 Startup check (verify process settings against setup sheet) Automatic / Manual
2.11 down time event
2.12

1.4
1.15
C3.4 Heating distance (between heater and sheet) Manual At start-up
2.11
2.12

1.4
1.15
C3.5 Sheet heating time and temperature (heating cycle, intensity) Manual At start-up
2.11
2.12

1.4
1.15 At start-up, and after long
C3.6 Startup check - Secondary Equipment (trimming, assembly) Manual
2.11 down time event
2.12

1.4
1.15 At start-up, and after long
C3.7 Sheet forming temperature per film supplier guidelines Automatic/Manual
2.11 down time event
2.12

1.4
1.15 At start-up, and after long
C3.8 Mold temperature per film supplier guidelines Automatic/Manual
2.11 down time event
2.12

1.4
1.15 At start-up, and after long
C3.9 Clamping frame closing pressure Automatic
2.11 down time event
2.12

1.4
1.15 At start-up, and after long
C3.10 Mold close speed Automatic
2.11 down time event
2.12

1.4
1.15 At start-up, and after long
C3.11 Plug temperature, start time and speed (if applicable) Automatic
2.11 down time event
2.12

1.4
1.15 At start-up, and after long
C3.12 Sheet pre-stretching sequence and time (if applicable) Automatic
2.11 down time event
2.12

PT C 31 of 47
 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 molder is conforming to customer requirements.

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

Related
Molding
Observation/
Item # System Category/Process Steps Type of Control Monitoring Frequency
Comments
Assessment
Question #

Minimum Requirement Actual Condition Minimum Requirement Actual Condition (Pass / Fail /
N/A)
1.4
1.15
C3.13 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 Pressure level, start time and duration (if applicable) Automatic At start-up and every 8 hours
2.11
2.12

1.4
1.15 At start-up, and after long
C3.15 Cooling temperature and time Automatic
2.11 down time event
2.12

1.4
1.15 At start-up, and after long
C3.16 Ejection air (compressed) pressure and time Automatic
2.11 down time event
2.12

1.4
1.15 Start-up, and restart after
C3.17 First piece approval Manual
2.11 down time event
2.12

1.4
1.15
C3.18 Shut down procedures Manual End of production or run
2.11
2.12

4.0 Quality Control

1.4
Per cavity, start-up and once
C4.1 2.11 Dimensions Manual
every 8 hours
2.12
1.4
Per cavity, start-up and once
C4.2 2.11 Appearance (vs. boundary sample or per instruction) Manual
every 8 hours
2.12
1.4
Per cavity, start-up and once
C4.3 2.11 Physical properties (if applicable) Manual
every 8 hours
2.12

PT C 32 of 47
 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 molder is conforming to customer requirements.

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

Related
Molding
Observation/
Item # System Category/Process Steps Type of Control Monitoring Frequency
Comments
Assessment
Question #

Minimum Requirement Actual Condition Minimum Requirement Actual Condition (Pass / Fail /
N/A)

1.0 Receiving Inspection

1.4 Incoming material assessment procedure, covering onsite testing or

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

1.4
Incoming components assessment procedure, covering onsite
D1.2 2.1 Manual Once per lot
testing or acceptance of supplier testing, with criteria (if applicable).
2.13

2.0 Compounding (if applicable)

1.4
Purging all equipment and feeding system to avoid cross End of run or long downtime,
D2.1 2.1 Manual
contamination. material change
2.13
Process parameter verification:
1.4 At start-up, and after long
- For SMC, Doctor box blade height, glass chopper speed, additives,
D2.2 2.1 Manual down time event, material
carrier film speed, compaction pressure etc.
2.13 change
- For rubber, mixer RPM, temperature, additives etc.

1.4
D2.3 2.1 Glass fiber distribution and density verification(for SMC). Manual Hourly
2.13

Compound property verification when applicable:

1.4
- For SMC, viscosity, initial sheet thickness etc.
D2.4 2.1 Manual Per production lot
- For rubber preform, elongation, tensile strength, compression set,
2.13
pre-cure rate, or rheology etc.

3.0 Storage & Handling

1.4
Using a FIFO (First In - First Out) system for compound/preform,
D3.1 2.11 Manual Pull for use
shelf life storage.
2.12

1.4
Environment temperature and humidity for preform storage (if Continuous and manually
D3.2 2.11 Automatic
applicable). verify daily
2.12

1.4
Compound floor time (e.g.., sheet rolls in SMC and rubber
D3.3 2.11 Manual Pull for use
compound).
2.12

PT D 33 of 47
 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 molder is conforming to customer requirements.

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

Related
Molding
Observation/
Item # System Category/Process Steps Type of Control Monitoring Frequency
Comments
Assessment
Question #

Minimum Requirement Actual Condition Minimum Requirement Actual Condition (Pass / Fail /
N/A)

1.4 Prevention of contamination by lubricants such as silicone, mold

D3.4 2.11 release such as calcium carbonate or oil from the pressurization Manual Every eight hours
2.12 system.

1.4
1.6
Partial containers handling to ensure no contamination (closed
D3.5 2.7 Automatic/Manual Continuous
container, clean environment)
2.11
2.12

1.4
D3.6 2.11 Sheet shrinkage confirmation (for SMC) Manual Per lot (just before use)
2.12

4.0 Molding Process

1.4
1.15 There shall be a standardized startup procedure/checklist that Start-up and restart after long
D4.1 Manual
2.11 defines things to do at start-up down time event
2.12

1.4
1.15
D4.2 Production plan (machine, mold, materials, part style) Manual At start-up
2.11
2.12

1.4
1.15 At start-up, and after long
D4.3 Startup check (verify process settings against setup sheet) Manual
2.11 down time event
2.12

1.4
1.15
D4.4 Cavity surface temperature verification Automatic/Manual At startup and re-start
2.11
2.12

1.4
1.15
D4.5 Verification of preform size, or shape, or both Manual Each cycle
2.11
2.12

1.4
1.15
D4.6 Verification of charge pattern (for SMC) Manual Each cycle
2.11
2.12

1.4
1.15
D4.7 Cavity surface cleanliness (no debris) Manual Each cycle
2.11
2.12

PT D 34 of 47
 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 molder is conforming to customer requirements.

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

Related
Molding
Observation/
Item # System Category/Process Steps Type of Control Monitoring Frequency
Comments
Assessment
Question #

Minimum Requirement Actual Condition Minimum Requirement Actual Condition (Pass / Fail /
N/A)
1.4
1.15
D4.8 Mold closing speed Automatic Continuous
2.11
2.12

1.4
1.15
D4.9 Cavity temperature Automatic Continuous
2.11
2.12

1.4
1.15
D4.10 Post molding cooling (for SMC) - prevent deformation Manual Each cycle
2.11
2.12

1.4
1.15 Start-up, and restart after
D4.11 First piece approval Manual
2.11 down time event
2.12

1.4
1.15
D4.12 Shut down procedure Manual End of production or run
2.11
2.12

5.0 Quality Control

1.4 Start-up and once every 4

D5.1 2.11 Part weight Manual hours. For safety critical parts,
2.12 start-up and once every hour

1.4
Per cavity, start-up and once
D5.2 2.11 Dimensions Manual
every 8 hours
2.12
1.4
Per cavity, start-up and once
D5.3 2.11 Appearance Manual
every 8 hours
2.12
1.4
Per cavity, start-up and once
D5.4 2.11 Physical properties (if applicable) Manual
every 8 hours
2.12

PT D 35 of 47
 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 molder is conforming to customer requirements.

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

Related
Molding
Observation/
Item # System Category/Process Steps Type of Control Monitoring Frequency
Comments
Assessment
Question #

Minimum Requirement Actual Condition Minimum Requirement Actual Condition (Pass / Fail /
N/A)

1.0 Receiving Inspection

1.4 Incoming material assessment procedure, covering onsite testing or

E1.1 2.1 acceptance of supplier testing, with criteria (i.e., melt flow, specific Manual Once per lot
2.13 gravity, temperature recording).

1.4
Incoming components assessment procedure, covering onsite
E1.2 2.1 Manual Once per lot
testing or acceptance of supplier testing, with criteria (if applicable).
2.13

2.0 Compounding and Preforming (if applicable)

1.4
Purging all equipment and feeding system to avoid cross End of run or long downtime,
E2.1 2.1 Manual
contamination. material change
2.13

1.4 Compound property verification when applicable

E2.2 2.1 - For rubber and one part epoxy; preform, elongation, tensile Manual Per production lot
2.13 strength, compression set, pre-cure rate, or rheology etc.

3.0 Storage & Handling

1.4
Stock rotation system in place for First in/First out (FIFO) and shelf- FIFO - per Lot
E3.1 2.11 Automatic/Manual
life. Shelf life - pull for use
2.12

1.4 Continuous monitoring by

E3.2 2.11 Environment temperature and humidity for storage (if applicable). Automatic controller or manual
2.12 verification daily

1.4
Temperature control during shipment from material supplier to cold Continuous monitoring (i.e.,
E3.3 2.11 Automatic
storage area in plant (if applicable i.e.; one part epoxies). by chart recorder)
2.12

1.4 Time stamp on container from

Material container remains sealed during warm up to room
E3.4 2.11 Manual time out of cold storage to
temperature (supplier recommendation).
2.12 when container is opened

PT E 36 of 47
 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 molder is conforming to customer requirements.

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

Related
Molding
Observation/
Item # System Category/Process Steps Type of Control Monitoring Frequency
Comments
Assessment
Question #

Minimum Requirement Actual Condition Minimum Requirement Actual Condition (Pass / Fail /
N/A)

1.4 Time exposed to room temperature when removed from cold storage Continuous monitoring by
E3.5 2.11 area for production. Allowable usage time after room temperature is Automatic/Manual controller or manual
2.12 reached. verification

1.4
1.6 Partial container handling to ensure no contamination (closed
E3.6 Automatic/Manual Continuous
2.11 container, clean environment)
2.12

1.4
1.6
E3.7 Partial container quantity Automatic/Manual Per Container
2.11
2.12

4.0 Molding Process

1.4
1.15 There shall be a standardized startup procedure/checklist that Start-up and restart after long
E4.1 Manual
2.11 defines things to do at start-up down time event
2.12

1.4
1.15
E4.2 Production plan (machine, mold, materials, part style) Manual At start-up
2.11
2.12

1.4
1.15 At start-up, and after long
E4.3 Startup check (verify process settings against setup sheet) Manual
2.11 down time event
2.12

1.4
1.15 Mold cavity temperatures; variation between each cavity and set Continuous, at start-up and
E4.4 Automatic
2.11 temperatures after down time event.
2.12

1.4
1.15
E4.5 Verification of preform size, or shape, or both manual Continuous
2.11
2.12

1.4
1.15 Plasticization - Temperature (resin chamber), Transfer Speed, and
E4.6 Automatic Continuous
2.11 Transfer Pressure
2.12

1.4
1.15
E4.7 Fill - Fill time and peak pressure Automatic Continuous
2.11
2.12
PT E 37 of 47
 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 molder is conforming to customer requirements.

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

Related
Molding
Observation/
Item # System Category/Process Steps Type of Control Monitoring Frequency
Comments
Assessment
Question #

Minimum Requirement Actual Condition Minimum Requirement Actual Condition (Pass / Fail /
N/A)
1.4
1.15
E4.8 Hold - Hold pressure and hold time Automatic Continuous
2.11
2.12

1.4
1.15
E4.9 Cure Time Automatic Continuous
2.11
2.12

1.4
1.15
E4.10 Mold Closing speed Automatic Continuous
2.11
2.12

1.4
1.15
E4.11 Cavity surface cleanliness (no debris) manual Continuous
2.11
2.12

1.4
1.15
E4.12 Pre-heat of components - If Insert molding required Automatic Continuous
2.11
2.12

1.4
1.15 Pre-heat of resin pellets or compound - If applicable (per
E4.13 Automatic Continuous
2.11 manufacturers recommendations)
2.12

1.4
1.15
E4.14 Hold - Cavity pressure (if applicable) Automatic Continuous
2.11
2.12

1.4
1.15
E4.15 Part weight (if applicable) Manual Once every 8 hours*
2.11
2.12

1.4
1.15 Start-up, and restart after
E4.16 First piece approval Manual
2.11 down time event
2.12

1.4
1.15
E4.17 Shut down procedures Manual End of production or run
2.11
2.12

5.0 Quality Control

PT E 38 of 47
 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 molder is conforming to customer requirements.

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

Related
Molding
Observation/
Item # System Category/Process Steps Type of Control Monitoring Frequency
Comments
Assessment
Question #

Minimum Requirement Actual Condition Minimum Requirement Actual Condition (Pass / Fail /
N/A)

1.4 Start-up and once every 4

E5.1 2.11 Part weight Manual hours. For safety critical parts,
2.12 start-up and once every hour

1.4
Per cavity, start-up and once
E5.2 2.11 Dimensions Manual
every 8 hours
2.12

1.4
Per cavity, start-up and once
E5.3 2.11 Appearance (vs. boundary sample or per instruction) Manual
every 8 hours
2.12

1.4
Per cavity, start-up and once
E5.4 2.11 Physical properties (if applicable) Manual
every 8 hours
2.12

PT E 39 of 47
 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.

Related
Molding
Observation/
Item # System Category/Process Steps Type of Control Monitoring Frequency
Comments
Assessment
Question #

Minimum Requirement Actual Condition Minimum Requirement Actual Condition (Pass / Fail /
N/A)

1.0 Receiving Inspection

1.4 Incoming material assessment procedure, covering onsite testing or

F1.1 2.1 acceptance of supplier testing, with criteria (i.e., melt flow, specific Manual Once per lot
2.13 gravity).
1.4
Incoming components assessment procedure, covering onsite
F1.2 2.1 Manual Once per lot
testing or acceptance of supplier testing, with criteria (if applicable).
2.13

2.0 Storage & Handling

1.4
Stock rotation system in place for First in/First out (FIFO) and shelf- FIFO - per Lot
F2.1 2.11 Automatic/Manual
life Shelf life - pull for use
2.12
1.4 Continuous monitoring by
F2.2 2.11 Environment temperature and humidity controlled (if applicable) Automatic controller or manual
2.12 verification daily
1.4
1.6 Partial container handling to ensure no contamination (closed
F2.3 Automatic/Manual Continuous
2.11 container, clean environment)
2.12

1.4
1.6
F2.4 Partial container quantity Automatic/Manual Per Container
2.11
2.12

PT F 40 of 47
 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.

Related
Molding
Observation/
Item # System Category/Process Steps Type of Control Monitoring Frequency
Comments
Assessment
Question #

Minimum Requirement Actual Condition Minimum Requirement Actual Condition (Pass / Fail /
N/A)

3.0 Material Drying (If Applicable)

1.4
Start-up and continuous by
F3.1 2.11 Dryer temperature per resin manufacturer guidelines (per material) Automatic
controller.
2.12

1.4
Start-up and once every 8
F3.2 2.11 Dryer time per resin manufacturer guidelines (per material) Manual
hours
2.12

1.4
F3.3 2.11 Drying equipment (dryer dedicated or clean procedure in place) Manual Material change
2.12

1.4
F3.4 2.11 Dew point Automatic Continuous by controller
2.12

1.4
Start up and once every 8
F3.5 2.11 Moisture content Manual
hours
2.12

4.0 Recycle/Regrind Material (if Applicable)

1.4
1.11 Recycle ratio (per print, inspection standard or manufacturer Once every 8 hours and at
F4.1 Automatic
2.11 guidelines). Verified by feed pressure, weight or volume. every part change-over
2.13

1.4
1.11
F4.2 Regrind equipment (dedicated or cleaning procedure in place) Manual Material change
2.11
2.12

PT F 41 of 47
 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.

Related
Molding
Observation/
Item # System Category/Process Steps Type of Control Monitoring Frequency
Comments
Assessment
Question #

Minimum Requirement Actual Condition Minimum Requirement Actual Condition (Pass / Fail /
N/A)
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
F4.4 Automatic/Manual Start-up and continuous
2.11 the extrusion machine.
2.12

5.0 Color Management (If Applicable)

1.4
F5.1 2.11 Pigment blending - percent loading Automatic/Manual Start-up and continuous
2.12
1.4
F5.2 2.11 Color change procedure Manual At color change
2.12

6.0 Extrusion Process

1.4
1.15 There shall be a standardized startup procedure/checklist that Start-up and restart after long
F6.1 Manual
2.11 defines things to do at start-up down time event
2.12

1.4
1.15 Start-up and restart after long
F6.2 Production plan (machine, mold, materials, part quantity) Manual
2.11 down time event
2.12

1.4 Verify molding machine settings including but not limited to barrel
1.15 and head/die temperature settings, screw speed, screw cooling Start-up and restart after long
F6.3 Manual
2.11 temperature (if applicable), as well as settings for down stream down time event
2.12 processes

1.4
1.15 Start-up and restart after long
F6.4 Verify secondary equipment Manual
2.11 down time event
2.12

PT F 42 of 47
 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.

Related
Molding
Observation/
Item # System Category/Process Steps Type of Control Monitoring Frequency
Comments
Assessment
Question #

Minimum Requirement Actual Condition Minimum Requirement Actual Condition (Pass / Fail /
N/A)
1.4
Continuous if automatic, or at
1.15
F6.5 Mold surface temperature Automatic/Manual start-up and after down time
2.11
event.
2.12

1.4
1.15
F6.6 Extrusion Head Pressure 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 Coolant inlet temperature (if applicable) Automatic Start-up and continuous
2.11
2.12

1.4
1.15 Start-up, and restart after
F6.9 First piece approval Manual
2.11 down time event
2.12

1.4
1.15 Material purge/evacuation of barrel - included in unplanned and
F6.10 Manual End of run or long downtime
2.11 downtime procedures
2.12

1.4
1.15
F6.11 Shut down procedures Manual End of production or run
2.11
2.12

PT F 43 of 47
 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.

Related
Molding
Observation/
Item # System Category/Process Steps Type of Control Monitoring Frequency
Comments
Assessment
Question #

Minimum Requirement Actual Condition Minimum Requirement Actual Condition (Pass / Fail /
N/A)

7.0 Quality Control

Per cavity, start-up and once

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

Per cavity, start-up and once

1.4
every 8 hours. For safety
F7.2 2.11 Layer thickness/thickness uniformity (multi-layer only) Manual
critical parts, start-up and
2.12
once every 4 hours.

Per cavity, start-up and once

1.4
every 8 hours. For safety
F7.3 2.11 Layer adhesion (multi-layer only) Manual
critical parts, start-up and
2.12
once every hour

1.4
Per cavity, start-up and once
F7.4 2.11 Dimensions Manual
every 8 hours
2.12
1.4
Per cavity, start-up and once
F7.5 2.11 Appearance (vs. boundary sample or per instruction) Manual
every 8 hours
2.12
1.4
Per cavity, start-up and once
F7.6 2.11 Physical properties (if applicable) Manual
every 8 hours
2.12

PT F 44 of 47
 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.

Related
Calibration /
Molding System Injection Blow Vacuum Compression Transfer Included in Preventative
Item # Equipment Type Extrusion Verification Frequency Certification Comment
Assessment Molding Molding Forming Molding Molding Maintenance Plan
Frequency *
Question #

1.0 PROCESS EQUIPMENT

G1.1 2.14 Mold Temperature Controller X X X X X X Once per shift N/A

Once per month or per

G1.2 2.14 Filters, if applicable X X X X X X N/A
preventive maintenance

G1.3 2.14 Thermocouple X X X X X X Per Preventive Maintenance Annual

G1.4 2.14 Injection Mold Machine X Per Preventive Maintenance Every 5 years

G1.5 2.14 Mold X X X X X X Per Preventive Maintenance N/A

G1.6 2.14 Blow mold machine X Per Preventive Maintenance Every 5 years

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

G1.8 2.14 Compression molding machine X X Per Preventive Maintenance N/A

G1.9 2.14 Extrusion machine X Per Preventive Maintenance Every 5 years

G1.10 2.14 Dryer X X X X Per Preventive Maintenance N/A

G1.11 2.14 Regrinder X X X Per Preventive Maintenance N/A

G1.12 2.14 Hot Runner Controller X Per Preventive Maintenance N/A

G1.13 2.14 Cavity Pressure Sensor X Per Preventive Maintenance N/A

G1.14 2.14 Hydraulic Pressure Transducer X X Per Preventive Maintenance N/A

Valve Gate Controller, if

G1.15 2.14 X X Per Preventive Maintenance N/A
applicable

PT G 45 of 47
 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.

Related
Calibration /
Molding System Injection Blow Vacuum Compression Transfer Included in Preventative
Item # Equipment Type Extrusion Verification Frequency Certification Comment
Assessment Molding Molding Forming Molding Molding Maintenance Plan
Frequency *
Question #

2.0 SECONDARY EQUIPMENT

Generic fixtures (cooling, heat

G2.1 2.14 X X X X Per Preventive Maintenance N/A
forming, if applicable)

G2.2 2.14 Conveyers X X X X X X Per Preventive Maintenance N/A

G2.3 2.14 Degater/Trim Operation X X X X X X Per Preventive Maintenance N/A

G2.4 2.14 Cutter X Per Preventive Maintenance N/A

G2.5 2.14 Robot X X X X X Per Preventive Maintenance At Installation

G2.6 2.14 Oven, if applicable X X X X Per Preventive Maintenance Annual

G2.7 2.14 Cooling Fan, if applicable X X Per Preventive Maintenance Annual

G2.8 2.14 End of arm tooling X X X X X Per Preventive Maintenance N/A

MINIMUM REQUIRED TESTING

3.0
CAPABILITY

G3.1 2.14 Cure Testing, if applicable X X Per lot Annual

G3.2 2.14 Leak Testing, if applicable X X X At start up and per shift Every 6 months

G3.3 2.14 Color X X Before each use Annual

G3.4 2.14 Gloss X X Before each use Annual

G3.5 2.14 Weight X X X At start up Annual

G3.6 2.14 Dimensions X X X X X X At start up Every 6 months

G3.7 2.14 Moisture X X X X X X Per Manufacturer Guidelines Every 6 months

G3.8 2.14 Performance, if applicable X X X X X X Per Manufacturer Guidelines Annual

PT G 46 of 47
 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.

Related
Molding
Item # System Category/Process Steps Monitoring Frequency Observation/Comments
Assessment
Question #

Dimension, Weight, Appearance, Minimum Requirement Actual Condition (Pass / Fail / N/A)

1.0 General

Dimensions

Appearance

Performance

1.4 Procedures are in place to prevent damage to the finish or part during the
H1.1 100%
2.9 inspection and packaging processes

Appearance (flash, color and gloss, short shots, splay/burns, blister, sink
First off by quality and 100%
H1.2 1.4 marks, gate vestige, and other molding defects) of the molding shall be
by operator
verified per specification and applications manual

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

Daily Production Meeting

H1.5 1.4 Manufacturing information
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 47 of 47