Copia de CQI-23

CQI-23
Special Processes: Molding System Assessment
Version 1, 3/2014
Special Process: Molding System Assessment

Facility Name:
Address:
Phone Number:
Fax Number:
Number of Molding Employees at this Facility:
Type(s) of Molding Processes at this Facility:

Process Table A
Injection Molding
Captive Molder (Y/N):

Commercial Molder (Y/N):
Process Table B
Blow Molding
Date of Assessment:
Process Table C
Vacuum Forming
Date of Previous Assessment:

Process Table D
Compression Molding
Process Table E
Transfer Molding
Process Table F
Extrusion
Process Table G
Equipment
Process Table H
Part Inspection & Testing
Current Quality Certification(s):
Date of Re-assessment (if necessary):
Personnel Contacted:
Name:
Title:
Phone:
Email:
Auditors/Assessors:
Name:
Company:
Phone:
Email:
Number of "Not Satisfactory" Findings:
Number of "Needs Immediate Action" Findings:
Number of "Fail" Findings in the Job Audit(s):
Number of Process Table Items not meeting Minimum Requirements:
CQI-23
Version 1, 3/2014
Special Process: Molding System Assessment (General Facility Overview)
Assessment
Question
Number
Question
Requirements and Guidance
Objective Evidence
N/A
Section 1 - Management Responsibility and Quality Planning
1.1
1.2
To ensure readily available expertise, there shall be a

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

advanced quality planning?
The molder shall incorporate a documented advanced

quality planning procedure. A feasibility study shall be
performed and internally approved for each new part
or process. Similar parts can be grouped into part
families for this effort as defined by the molder. After
the part approval process is approved by the
customer, no process changes are allowed unless
approved by the customer. The molder shall contact
the customer when clarification of process changes is
required. This clarification of process changes shall
be documented.
Section 1-2, 2 of 79
Satisfactory
Not Satisfactory
Needs Immediate
Action
CQI-23
Version 1, 3/2014
Assessment
Question
Number
Question
Objective Evidence
1.3
The molder shall incorporate the use of a documented

Failure Mode and Effects Analysis (FMEA) procedure
and ensure the FMEAs are updated to reflect current
part quality status. The FMEA shall be written for each
part or part family or they may be process-specific and
Are the molder's FMEA's up to written for each process. In any case, they shall
date and reflecting current
address all process steps from part receipt to part
processing?
shipment and all key molding process parameters as
defined by the molder. A cross-functional team shall be
used in the development of the FMEA. All special
characteristics, as defined by the molder and its
customers, shall be identified, defined, and addressed
in the FMEA.
1.4
The molder shall incorporate the use of a documented

Control Plan procedure and ensure the Control Plans
are updated to reflect current controls. The Control
Plans shall be written for each part or part family or
they may be process-specific and written for each
process. In any case, they shall address all process
steps from part receipt to part shipment and identify all
equipment used and all key molding process
parameters as defined by the molder. A crossAre molding process Control
functional team, including a production operator, shall
Plans up to date and reflecting
be used in the development of Control Plans, which
current processing?
shall be consistent with all associated documentation
such as work instructions, shop travelers, and FMEAs.
All special characteristics, as defined by the molder
and its customers, shall be identified, defined, and
addressed in the Control Plans. Sample sizes and
frequencies for evaluation of process and product
characteristics shall also be addressed consistent with
the minimum requirements listed in the Process
Tables.
N/A
Satisfactory
Not Satisfactory
Needs Immediate
Action
CQI-23
Version 1, 3/2014
Assessment
Question
Number
Question
Objective Evidence
To ensure all customer requirements are both

understood and satisfied, the molder shall have all
related molding and customer referenced standards
and specifications available for use and a method to
ensure that they are current. Such standards and
specifications include, but are not limited to, those
relevant documents published by SAE, AIAG, ASTM,
General Motors, Ford, and Chrysler. The molder shall
have a process to ensure the timely review,
distribution, and implementation of all customer and
industry engineering standards and specifications and
changes based on customer-required schedule. This
process shall be executed as soon as possible and
shall not exceed two weeks. The molder shall
document this process of review and implementation,
and it shall address how customer and industry
documents are obtained, how they are maintained
within the molder, how the current status is
established, and how the relevant information is
cascaded to the shop floor within the two-week period.
The molder shall identify who is responsible for
performing these tasks.
1.5
Are all molding related and

referenced specifications
current and available? For
example: SAE, AIAG, ASTM,
General Motors, Ford, and
Chrysler.
1.6
Are all molding related internal The molder should have a documented process and
and external best practices
system for maintaining best practices obtained through
documented and maintained? lessons learned or from industry knowledge.
1.7
Is there a written process

specification for all active
processes?
The molder shall have written process specifications

for all active processes and identify all steps of the
process including relevant operating parameters.
Examples of operating parameters include process
temperatures, cycle times, etc. Such parameters shall
not only be defined, they shall have operating
tolerances as defined by the molder in order to
maintain process control. All active processes should
have a written process specification. These process
specifications may take the form of work instructions,
job card, start-up sheet, or other similar documents.
N/A
Satisfactory
Not Satisfactory
Needs Immediate
Action
CQI-23
Version 1, 3/2014
Assessment
Question
Number
Question
Objective Evidence
1.8
To demonstrate each process is capable of yielding

acceptable product, the molder shall perform product
capability studies for the initial validation of each
process, after relocation of any process equipment,
and after a major rebuild of any equipment. The
molder shall define what constitutes a major rebuild.
Initial product capability studies shall be conducted for
all molding processes per line as defined in scope of
Has a valid product capability
work and in accordance with customer requirements.
study been performed initially
Capability study techniques shall be appropriate for
and after process change?
the molding product characteristics, e.g., molding
thickness, part weight, etc. Any specific customer
requirements shall be met. In the absence of customer
requirements, the molder shall establish acceptable
ranges for measures of capability. An action plan shall
exist to address the steps to be followed in case
capability indices fall outside customer requirements or
established ranges.
1.9
The analysis of products and processes over time can

yield vital information for defect prevention efforts.
The molder shall have a system to collect, analyze,
and react to product or process data over time.
Does the molder collect and
Methods of analysis shall include ongoing trend or
analyze data over time, and
historical data analysis of special product or process
react to this data? Are records
parameters/characteristics. The molder shall
available?
determine which parameters/characteristics to include
in such analysis. All process control and testing
records must be retained for a minimum of one
calendar year after the year in which they were
created.
1.10
Are internal assessments

being completed on an annual
basis, at a minimum,
incorporating AIAG Molding
System Assessment?
The molder shall conduct internal assessments on an

annual basis, at a minimum, using the AIAG Molding
System Assessment. Concerns shall be addressed in
a timely manner.
N/A
Satisfactory
Not Satisfactory
Needs Immediate
Action
CQI-23
Version 1, 3/2014
Assessment
Question
Number
Question
Objective Evidence
1.11
The quality management system shall include a

documented process for reprocessing that shall
include authorization from a designated individual.
The reprocessing procedure shall describe product
characteristics for which reprocessing is allowed as
Is there a system in place to well as those characteristics for which reprocessing is
authorize reprocessing and is not permissible. All reprocessing activity shall require
it documented?
a new processing control sheet issued by qualified
technical personnel denoting the necessary molding
modifications. Records shall clearly indicate when and
how any material has been reprocessed. The Quality
Manager or a designee shall authorize the release of
reprocessed product.
1.12
Does the Quality Department

review, address, and
document customer and
internal concerns?
1.13
The molder shall define a process for continual

improvement for each molding process identified in the
Is there a continual
scope of the Molding System Assessment. The
improvement plan applicable process shall be designed to bring about continual
to each process defined in the improvement in quality and productivity. Identified
scope of the assessment?
actions shall be prioritized and shall include timing
(estimated completion dates). The molder shall show
evidence of program effectiveness.
1.14
Does the Quality Manager or

designee authorize the
disposition of material from
quarantine status?
The quality management system shall include a

process for documenting, reviewing, and addressing
customer concerns and any other concerns internal to
the molder. A disciplined problem solving approach
shall be used.
The Quality Manager or designee is responsible for

authorizing and documenting appropriate personnel to
disposition quarantine material.
N/A
Satisfactory
Not Satisfactory
Needs Immediate
Action
CQI-23
Version 1, 3/2014
Assessment
Question
Number
Question
Objective Evidence
1.15
There shall be procedures or work instructions

available to molding personnel covering the molding
process. These procedures or work instructions shall
Are there procedures or work
include methods of addressing potential emergencies
instructions available to
(such as power failure), equipment start-up, equipment
molding personnel that define
shut-down, product segregation (See 2.8), product
the molding process?
inspection, and general operating procedures. These
procedures or work instructions shall be accessible to
shop floor personnel.
1.16
The molder shall provide employee training for

applicable molding operations. All employees,
including backup and temporary employees, shall be
trained. Documented evidence shall be maintained
Is management providing
showing the employees trained and the evidence shall
employee training for molding?
include an assessment of the effectiveness of the
training. Management shall define the qualification
requirements for each function, and ongoing or followup training shall also be addressed.
1.17
Is there a responsibility matrix

to ensure that all key
management and supervisory
functions are performed by
qualified personnel?
The molder shall maintain a responsibility matrix

identifying all key management and supervisory
functions and the qualified personnel who may
perform such functions. It shall identify both primary
and secondary (backup) personnel for the key
functions (as defined by the molder). This matrix shall
be readily available to management at all times.
N/A
Satisfactory
Not Satisfactory
Needs Immediate
Action
CQI-23
Version 1, 3/2014
Assessment
Question
Number
1.18
1.19
Question
Is there a preventive
maintenance program? Is
maintenance data being
utilized to form a predictive
maintenance program?
Objective Evidence
The molder shall have a documented preventive

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

The molder shall develop and maintain a critical spare
critical spare parts list, and are
parts list and shall ensure the availability of such parts
the parts available to minimize
to minimize production disruptions.
production disruptions?
N/A
Satisfactory
Not Satisfactory
Needs Immediate
Action
CQI-23
Version 1, 3/2014
Assessment
Question
Number
Question
Objective Evidence
Section 2 - Floor and Material Handling Responsibility

Does the facility ensure that
the data entered in the
receiving system matches the
information on the customer's
shipping documents?
Documented processes and evidence of compliance

shall exist, e.g., shop travelers, work orders, etc. The
facility shall have a detailed process in place to resolve
receiving discrepancies.
2.2
Is product clearly identified

and staged throughout the
molding process?
Procedures for part and container identification help to

avoid incorrect processing or mixing of lots.
Appropriate location and staging within the facility also
help to ensure that orders are not shipped until all
required operations are performed. Customer product
shall be clearly identified and staged throughout the
molding process. Non-molded, in-process, and
finished product shall be properly segregated and
identified. All material shall be staged in a dedicated
and clearly defined area.
2.3
Is molder using adequate

There shall be a procedure that ensures a FIFO
FIFO system for material and
system is utilized.
product?
2.4
Is lot traceability and integrity

maintained throughout all
processes?
2.1
Out-going lot(s) shall be traceable to the incoming

lot(s). The discipline of precisely identifying lots and
linking all pertinent information to them enhances the
ability to do root cause analysis and continual
improvement.
N/A
Satisfactory
Not Satisfactory
Needs Immediate
Action
CQI-23
Version 1, 3/2014
Assessment
Question
Number
2.5
Question
Are procedures adequate to

prevent movement of nonconforming product into the
production system?
Objective Evidence
The control of suspect or non-conforming product is

necessary to prevent inadvertent shipment or
contamination of other lots. Procedures shall be
adequate to prevent movement of non-conforming
product into the production system. Procedures shall
exist addressing proper disposition, product
identification and tracking of material flow in and out of
hold area. Non-conforming hold area shall be clearly
designated to maintain segregation of such material.
N/A
Satisfactory
Not Satisfactory
Needs Immediate
Action
CQI-23
Version 1, 3/2014
Assessment
Question
Number
Question
Objective Evidence
Is there a system to identify

trap points in the entire
process to reduce risk of
mixed parts (inappropriate,
unfinished or improperly
molded parts)?
The molder shall have documented procedures to

identify and monitor trap points for each
process/equipment. Monitoring of potential trap points
shall occur for every part changeover.
2.7
Are containers free of

inappropriate material?
Containers handling customer product shall be free of

inappropriate material. After emptying and before reusing containers, containers shall be inspected to
ensure that all parts and inappropriate material have
been removed. The source of inappropriate material
shall be identified and addressed. This is to ensure
that no nonconforming molded parts or inappropriate
material contaminate the finished lot.
2.8
Unplanned or emergency downtime greatly raises the

risk of improper processing. Operators shall be trained
in material handling, containment action, and product
Are operators trained in
segregation in the event of an equipment emergency
material handling, containment including power failure. Training shall be documented.
action and product
Work instructions specifically addressing potential
segregation in the event of an types of equipment emergencies and failures shall be
equipment emergency
accessible to and understood by equipment operators.
including power failure?
These instructions shall address containment/reaction
plans related to all elements of the process. Evidence
shall exist showing disposition and traceability of
affected product.
2.9
Is the handling, storage and

packaging adequate to
preserve product quality?
2.6
The molder's in-process handling and shipping

process shall be assessed for risk of part damage or
other quality concerns.
N/A
Satisfactory
Not Satisfactory
Needs Immediate
Action
CQI-23
Version 1, 3/2014
Assessment
Question
Number
Question
Objective Evidence
2.10
Are plant cleanliness,

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

working conditions shall be conducive to controlling
and improving quality. The molder should evaluate
such conditions and their affect on quality. A
housekeeping policy shall be clearly defined and
executed.
2.11
Are process control

parameters monitored per
frequencies specified in
Process Tables?
Process control parameters shall be monitored per

frequencies specified in Process Tables. Computer
monitoring equipment with alarms and alarm logs
satisfy the verification requirement. A designated floor
person shall verify the process parameters.
2.12
There are documented reaction plans to both out of

Are out of control/specification
control and out of tolerance process parameters.
parameters reviewed and
There is documented evidence that reaction plans are
reacted to?
followed.
2.13
Are Test Frequencies

performed as specified in
Process Tables?
2.14
Is product test equipment

verified?
Test Frequencies shall be performed as specified in

Process Tables. Refer to Process Tables
Test equipment shall be verified/calibrated per

applicable customer specific standard or per an
applicable consensus standard, e.g., ASTM, SAE,
ISO, NIST, etc. Verification/calibration results shall be
internally reviewed, approved and documented.
Refer to Process Tables for frequency of checks.
2.15
Lighting of inspection area
Lighting in the inspection area shall be sufficient to

allow the evaluation of all part surfaces. The lighting
shall be arranged to preclude spot lighting, glare or
shadows. There can be no moving or distracting
reflections on the surfaces to be evaluated.
N/A
Satisfactory
Not Satisfactory
Needs Immediate
Action
CQI-23
Version 1, 3/2014
Section 3 - Job Audit - Finished Product Review

Job Identity:
Customer:
Shop Order Number:
Part Number:
Part Description:
Molding Requirements:
Question #
Job Audit Question
Related
Molding System
Assessment
Question #
Customer or Internal
Requirement
Job (Shop) Order or Reference

Documentation Requirement
3.1
Is contract review and advanced quality

planning, FMEA, Control Plans, etc., in
place and performed by qualified
individuals?
1.1
1.2
1.3
1.4
1.6
N/A
3.2
Does the molder have the proper

customer specifications for the part?
1.5
N/A
3.3
Is there documented evidence of

Receiving Inspection?
2.1
3.4
Is material identification (part numbers, lot

numbers, contract numbers, etc.)
maintained throughout the molding
process?
2.2
2.3
2.4
3.5
Is the proper procedure or process

specification used? Refer to Process
Tables for specific parameters. List
parameters that were verified in this audit
in the spaces provided below.
1.5
1.6
2.1
2.11
2.13
Job Audit 13 of 79
Actual Condition
(Objective Evidence)
Pass / Fail
/ N/A
CQI-23
Version 1, 3/2014

Job Identity:
Customer:
Shop Order Number:
Part Number:
Part Description:
Question #
Job Audit Question
Related
Molding System
Assessment
Question #
Requirement

Actual Condition
Process #1:
Process #2:
3.6
3.6.1
What are the product inspection

requirements?
1.5
2.13
2.14
Each part may have one or more requirements determined by the molding specification.
Parts must meet each requirement. List each requirement below and validate.
(Listed below are some examples)
Requirement: Weight
Test Method:
Test frequency or quantity:
Selection of samples:
Specification:
Job Audit 14 of 79
Pass / Fail
/ N/A
CQI-23
Version 1, 3/2014

Job Identity:
Customer:
Shop Order Number:
Part Number:
Part Description:
Question #
3.6.2
Job Audit Question
Related
Molding System
Assessment
Question #
Requirement
Requirement: Color
Test Method(s):
Specification:
3.6.3
Requirement: Gloss
Test Method:
Specification:
3.6.4
Requirement: Flash
Test Method(s):
Specification:
Job Audit 15 of 79

Actual Condition
Pass / Fail
/ N/A
CQI-23
Version 1, 3/2014

Job Identity:
Customer:
Shop Order Number:
Part Number:
Part Description:
Question #
3.6.5
Job Audit Question
Related
Molding System
Assessment
Question #
Requirement
Requirement: Dimension
Test Method:
Specification:
3.6.6
Requirement: Appearance
Test Method:
Specification:
3.6.7
Requirement: Customer Specific

Test Method(s):
Specification:
Job Audit 16 of 79

Actual Condition
Pass / Fail
/ N/A
CQI-23
Version 1, 3/2014

Job Identity:
Customer:
Shop Order Number:
Part Number:
Part Description:
Question #
Job Audit Question
Related
Molding System
Assessment
Question #
Requirement
Operator or Inspector Responsibilities

1.4
1.6
2.2
2.3
2.11
3.7
Were appropriate process steps signed

off?
3.8
Were all inspection steps, as documented

in the Control Plan performed?
3.9
Were steps/operations performed that

were not documented in the Control Plan?
1.2
1.4
1.6
3.10
If additional steps were performed, were

they authorized?
1.2
1.4
1.6
1.10
1.16
3.11
Does the governing specification allow

reprocessing or rework?
1.5
1.10
1.2
1.4
Job Audit 17 of 79

Actual Condition
Pass / Fail
/ N/A
CQI-23
Version 1, 3/2014

Job Identity:
Customer:
Shop Order Number:
Part Number:
Part Description:
Question #
Job Audit Question
Related
Molding System
Assessment
Question #
3.12
If the order was certified, did the

certification accurately reflect the process
performed?
2.11
2.13
3.13
Was the certification signed by an

authorized individual?
1.16
3.14
Are the parts and containers free of

inappropriate objects or contamination?
2.6
Requirement
Packaging Requirements
3.15
Are packaging requirements identified?
2.6
2.7
2.9
3.16
Are parts packaged to minimize mixed

parts or damaged (for example, work flow
or over-pack of container)?
2.6
2.7
2.9
Shipping Requirements
3.17
Were the parts properly identified?
2.3
2.9
3.18
Were the containers properly labeled?
2.3
2.9
Job Audit 18 of 79

Actual Condition
Pass / Fail
/ N/A
CQI-23
Version 1, 3/2014
PROCESS TABLE A - Injection Molding

All requirements given below are subordinate to customer specific requirements.
The customer may have additional requirements, e.g., inspection testing, greater frequencies, etc. When performing the job audit, the auditor shall verify molder is conforming to customer requirements.
*If minimum requirements are not met, provide supporting records to justify actual conditions.
Item #
Related
Molding
System
Assessment
Question #
Category/Process Steps
Type of Control
Minimum Requirement
1.0
Actual Condition
Monitoring Frequency
Minimum Requirement
Receiving Inspection
A1.1
1.4
2.1
2.13
Incoming material assessment procedure, covering onsite testing or

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

testing or acceptance of supplier testing, with criteria (if applicable).
Manual
Once per lot
2.0
Storage & Handling (If Applicable)
A2.1
1.4
2.3
2.11
2.12
Stock rotation system in place for First in/First out (FIFO) and shelflife
Automatic/Manual
FIFO - per Lot

Shelf life - pull for use
A2.2
1.4
2.11
2.12
Environment temperature controlled
Automatic
Continuous monitoring by
controller or manual
verification daily
A2.3
1.4
1.6
2.7
2.11
2.12
Handling of partial containers to ensure no contamination (closed

container, clean environment)
Automatic/Manual
Continuous
A2.4
1.4
1.6
2.7
2.11
2.12
Partial container quantity
Automatic/Manual
Per Container
PT A 19 of 79
Actual Condition
Observation/
Comments
(Pass / Fail /
N/A)
CQI-23
Version 1, 3/2014

Item #
Related
Molding
System
Assessment
Question #
Type of Control
Minimum Requirement
3.0
Actual Condition
Minimum Requirement
Material Drying
A3.1
1.4
2.11
2.12
Dryer temperature per resin manufacturer guidelines (per material)
Automatic
controller
A3.2
1.4
2.11
2.12
Dryer time per resin manufacturer guidelines (per material)
Manual
Per Resin Manufacturer

Guidelines
A3.3
1.4
2.11
2.12
Drying equipment (dryer dedicated or clean procedure in place)
Manual
Material change
A3.4
1.4
2.11
2.12
Dew point
Automatic
controller
A3.5
1.4
2.11
2.12
Moisture analysis, if applicable, per Resin Manufacturer Guidelines
Manual
At start-up and once per shift*
4.0
Recycle (regrind) Material (If Applicable)
A4.1
1.4
1.11
2.11
2.13
Recycle ratio (per print, inspection standard or manufacturer

guidelines). Verified by feed pressure, weight or volume
Automatic
Once every 8 hours and at

every part change over
A4.2
1.4
1.11
2.11
2.12
Dedicated regrind equipment or cleaning procedure in place
Manual
Material change
A4.3
1.4
1.11
2.11
2.12
Fines management (de-dusting)
Automatic/Manual
Material change
A4.4
1.4
1.11
2.11
2.12
Move regrind to IMM (contamination)
Automatic/Manual
Start-up and continuous
PT A 20 of 79
Actual Condition
Observation/
Comments
(Pass / Fail /
N/A)
CQI-23
Version 1, 3/2014

Item #
Related
Molding
System
Assessment
Question #
Type of Control
Minimum Requirement
5.0
Actual Condition
Minimum Requirement
Color Management
A5.1
1.4
2.11
2.12
Pigment blending - percent loading, if applicable
Automatic/Manual
A5.2
1.4
2.11
2.12
Color change procedure
Manual
Continuous
6.0
Molding Process
A6.1
1.4
1.15
2.11
2.12
There shall be a standardized startup procedure/checklist that

defines things to do at start-up
Manual
Start-up and restart after long

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

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

down time event
A6.4
1.4
1.15
2.11
2.12
Startup check - Secondary Equipment (De-gate, assembly

equipment, welders, etc.)
Manual

down time event
A6.5
1.4
1.15
2.11
2.12
Mold surface temperature
Automatic/Manual
Continuous if automatic, or at
start-up and after down time
event
A6.6
1.4
1.15
2.11
2.12
Plastication - Temperature (barrel, nozzle, hot manifold if applicable),

Automatic
screw RPM, and back pressure
PT A 21 of 79
Continuous
Actual Condition
Observation/
Comments
(Pass / Fail /
N/A)
CQI-23
Version 1, 3/2014

Item #
Related
Molding
System
Assessment
Question #
Type of Control
Minimum Requirement
Actual Condition
Minimum Requirement
A6.7
1.4
1.15
2.11
2.12
Plastication - Melt temperature
N/A
Start-up
A6.8
1.4
1.15
2.11
2.12
Plastication - Screw recovery time
N/A
Continuous
A6.9
1.4
1.15
2.11
2.12
Fill - Screw velocity or velocity profile
Automatic
Continuous
A6.10
1.4
1.15
2.11
2.12
Fill - Fill time and peak pressure
N/A
Continuous
A6.11
1.4
1.15
2.11
2.12
Hold - Hold pressure and hold time
Automatic
Continuous
A6.12
1.4
1.15
2.11
2.12
Hold - Cushion
N/A
Continuous
A6.13
1.4
1.15
2.11
2.12
Hold - Cavity pressure (if applicable)
N/A
Continuous
A6.14
1.4
1.15
2.11
2.12
Temperature Control Cooling - Coolant inlet temperature and cooling

Automatic
time
PT A 22 of 79
Continuous
Actual Condition
Observation/
Comments
(Pass / Fail /
N/A)
CQI-23
Version 1, 3/2014

Item #
Related
Molding
System
Assessment
Question #
Type of Control
Minimum Requirement
Actual Condition
Minimum Requirement
A6.15
1.4
1.15
2.11
2.12
Part weight (if applicable)
Manual
Once every 8 hours*
A6.16
1.4
1.15
2.11
2.12
First piece approval
Manual
Start-up, and restart after

down time event
A6.17
1.4
1.15
2.11
2.12
Material purge/evacuation of barrel - included in unplanned and

downtime procedures
Manual
End of run or long downtime
A6.18
1.4
1.15
2.11
2.12
Shut down procedures
Manual
End of production or run
7.0
Quality Control
A7.1
1.4
2.11
2.12
Part weight
Manual
Start-up and once every 4

hours. For safety critical parts,
start-up and once every hour
A7.2
1.4
2.11
2.12
Dimensions
Manual
Per cavity, start-up and once

every 8 hours
A7.3
1.4
2.11
2.12
Appearance (vs. boundary sample or per instruction)
Manual

every 8 hours
A7.4
1.4
2.11
2.12
Physical properties (if applicable)
Manual

every 8 hours
PT A 23 of 79
Actual Condition
Observation/
Comments
(Pass / Fail /
N/A)
CQI-23
Version 1, 3/2014
PROCESS TABLE B - Blow Molding

Item #
Related
Molding
System
Assessment
Question #
Type of Control
Minimum Requirement
1.0
Actual Condition
Minimum Requirement
B1.1
1.4
2.1
2.13

Manual
gravity).
Once per lot
B1.2
1.4
2.1
2.13

Manual
Once per lot
2.0
Storage & Handling
B2.1
1.4
2.3
2.11
2.12
Automatic/Manual
FIFO - per Lot

B2.2
1.4
2.11
2.12
Environment temperature and humidity controlled (if applicable)
Automatic
verification daily
B2.3
1.4
1.6
2.7
2.11
2.12
Partial container handling to ensure no contamination (closed

Automatic/Manual
Continuous
B2.4
1.4
1.6
2.7
2.11
2.12
Automatic/Manual
Per container
3.0
Material Drying (If Applicable)
B3.1
1.4
2.11
2.12
Automatic
Start-up and continuous by

controller
B3.2
1.4
2.11
2.12
Drying time per resin manufacturer guidelines (per material)
Manual

hours
PT B 24 of 79
Actual Condition
Observation/
Comments
(Pass / Fail /
N/A)
CQI-23
Version 1, 3/2014

Item #
Related
Molding
System
Assessment
Question #
Type of Control
Minimum Requirement
Actual Condition
Minimum Requirement
B3.3
1.4
2.11
2.12
Manual
Material change
B3.4
1.4
2.11
2.12
Dew point
Automatic
Continuous by controller
B3.5
1.4
2.11
2.12
Moisture content
Manual

hours
4.0
Recycle/Regrind Material (If Applicable)
B4.1
1.4
1.11
2.11
2.13
B4.2

guidelines). Verified by feed pressure, weight or volume. No regrind Automatic
of fluorine-treated parts.

every part change-over
1.4
1.11
2.11
2.12
Regrind equipment (dedicated or cleaning procedure in place)
Manual
Material change
B4.3
1.4
1.11
2.11
2.12
Ethylene Vinyl Alcohol (EVOH) particle size and distribution
Manual
Start-up
B4.4
1.4
1.11
2.11
2.12
Automatic/Manual
Material change
B4.5
1.4
1.11
2.11
2.12
Prevention of contamination when transporting or feeding regrind to

the blow mold machine
Automatic/Manual
PT B 25 of 79
Actual Condition
Observation/
Comments
(Pass / Fail /
N/A)
CQI-23
Version 1, 3/2014

Item #
Related
Molding
System
Assessment
Question #
Type of Control
Minimum Requirement
5.0
Actual Condition
Minimum Requirement
Color Management (If Applicable)
B5.1
1.4
2.11
2.12
Pigment blending - percent loading
Automatic/Manual
B5.2
1.4
2.11
2.12
Manual
At color change
6.0
Molding Process
B6.1
1.4
1.15
2.11
2.12

Manual

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

long down time event
B6.3
1.4
1.15
2.11
2.12
Environment temperature for parison
Automatic
Continuous by controller or
manual verification daily
B6.4
1.4
1.15
2.11
2.12
Verify molding machine settings including but not limited to barrel

and die/head temperature settings, parison thickness or thickness
profile, pre-blow pressure and time, blow air pressure and time,
mold close speed and clamp pressure
Manual

down time event
B6.5
1.4
1.15
2.11
2.12
Verify secondary equipment
Manual

down time event
B6.6
1.4
1.15
2.11
2.12
Cooling water temperature and flow rate
Automatic/Manual
event.
PT B 26 of 79
Actual Condition
Observation/
Comments
(Pass / Fail /
N/A)
CQI-23
Version 1, 3/2014

Item #
Related
Molding
System
Assessment
Question #
Type of Control
Minimum Requirement
Actual Condition
Minimum Requirement
B6.7
1.4
1.15
2.11
2.12
Verify post mold cooling temperature or pressure and time
Manual
Start-up
B6.8
1.4
1.15
2.11
2.12
Manual

down time event
B6.9
1.4
1.15
2.11
2.12
Material purge/evacuation of barrel
Manual
B6.10
1.4
1.15
2.11
2.12
Manual
7.0
Fluorine/Sulfination Treatment (If Applicable)
B7.1
1.4
1.15
2.11
2.12
Start-up check
Manual

down time event
B7.2
1.4
1.15
2.11
2.12
Carrier gas
Automatic
Continuous
B7.3
1.4
1.15
2.11
2.12
Volume
Automatic
Continuous
B7.4
1.4
1.15
2.11
2.12
Treatment time
Automatic
Continuous
PT B 27 of 79
Actual Condition
Observation/
Comments
(Pass / Fail /
N/A)
CQI-23
Version 1, 3/2014

Item #
Related
Molding
System
Assessment
Question #
Type of Control
Minimum Requirement
B7.5
1.4
1.15
2.11
2.12
Neutralization and wash cycle
Actual Condition
Minimum Requirement

hours
Manual
PT B 28 of 79
Actual Condition
Observation/
Comments
(Pass / Fail /
N/A)
CQI-23
Version 1, 3/2014

Item #
Related
Molding
System
Assessment
Question #
Type of Control
Minimum Requirement
8.0
Actual Condition
Minimum Requirement
Quality Control
B8.1
1.4
2.11
2.12
Part weight
Manual

B8.2
1.4
2.11
2.12
Wall thickness (if applicable)
Manual

hours
B8.3
1.4
2.11
2.12
Dimensions
Manual

hours
B8.4
1.4
2.11
2.12
Appearance
Manual

hours
B8.5
1.4
2.11
2.12
Manual

hours
B8.6
1.4
2.11
2.12
Layer thickness and thickness uniformity - (multi-layer only)
Manual

start-up and once every 8
hours
B8.7
1.4
2.11
2.12
Pinch-off integrity
Manual

start-up and once every 8
hours
PT B 29 of 79
Actual Condition
Observation/
Comments
(Pass / Fail /
N/A)
CQI-23

Version 1, 3/2014
PROCESS TABLE C - Vacuum Forming

The customer may have additional requirements, e.g., inspection testing, greater frequencies, etc. When performing the job audit, the auditor shall verify mo
Item #
Related
Molding
System
Assessment
Question #
Type of Control
Minimum Requirement
1.0
C1.1
1.4
2.1
2.13

Manual
gravity).
C1.2
1.4
2.1
2.13

2.0
Manual
Storage & Handling
C2.1
1.4
2.3
2.11
2.12
Stock rotation system in place for First in/First out (FIFO) and shelflife.
Automatic/Manual
C2.2
1.4
2.11
2.12
Environment contamination (dust) controlled (if applicable)
Automatic/Manual
PT C 30 of 79
Actual Condition
CQI-23

Version 1, 3/2014

Item #
Related
Molding
System
Assessment
Question #
Type of Control
Minimum Requirement
C2.3
1.4
1.6
2.7
2.11
2.12
Environment humidity and temperature controlled (if applicable)
Automatic
C2.4
1.4
1.6
2.7
2.11
2.12
Partial containers handling to ensure no contamination (closed

Automatic/Manual
C2.5
1.4
1.6
2.7
2.11
2.12
Plastic Sheet Stacking
Manual
3.0
C3.1
Forming Process
1.4
1.15
2.11
2.12

PT C 31 of 79
Manual
Actual Condition
CQI-23

Version 1, 3/2014

Item #
Related
Molding
System
Assessment
Question #
Type of Control
Minimum Requirement
C3.2
1.4
1.15
2.11
2.12
Manual
C3.3
1.4
1.15
2.11
2.12
Automatic / Manual
C3.4
1.4
1.15
2.11
2.12
Heating distance (between heater and sheet)
Manual
C3.5
1.4
1.15
2.11
2.12
Sheet heating time and temperature (heating cycle, intensity)
Manual
C3.6
1.4
1.15
2.11
2.12
Startup check - Secondary Equipment (trimming, assembly)
Manual
PT C 32 of 79
Actual Condition
CQI-23

Version 1, 3/2014

Item #
Related
Molding
System
Assessment
Question #
Type of Control
Minimum Requirement
C3.7
1.4
1.15
2.11
2.12
Sheet forming temperature per film supplier guidelines
Automatic/Manual
C3.8
1.4
1.15
2.11
2.12
Mold temperature per film supplier guidelines
Automatic/Manual
C3.9
1.4
1.15
2.11
2.12
Clamping frame closing pressure
Automatic
C3.10
1.4
1.15
2.11
2.12
Mold close speed
Automatic
C3.11
1.4
1.15
2.11
2.12
Plug temperature, start time and speed (if applicable)
Automatic
PT C 33 of 79
Actual Condition
CQI-23

Version 1, 3/2014

Item #
Related
Molding
System
Assessment
Question #
Type of Control
Minimum Requirement
C3.12
1.4
1.15
2.11
2.12
Sheet pre-stretching sequence and time (if applicable)
Automatic
C3.13
1.4
1.15
2.11
2.12
Vacuum level, start time, evacuation speed and duration
Automatic
C3.14
1.4
1.15
2.11
2.12
Pressure level, start time and duration (if applicable)
Automatic
C3.15
1.4
1.15
2.11
2.12
Cooling temperature and time
Automatic
C3.16
1.4
1.15
2.11
2.12
Ejection air (compressed) pressure and time
Automatic
PT C 34 of 79
Actual Condition
CQI-23

Version 1, 3/2014

Item #
Related
Molding
System
Assessment
Question #
Type of Control
Minimum Requirement
C3.17
1.4
1.15
2.11
2.12
Manual
C3.18
1.4
1.15
2.11
2.12
Manual
4.0
Quality Control
C4.1
1.4
2.11
2.12
Dimensions
Manual
C4.2
1.4
2.11
2.12
Manual
C4.3
1.4
2.11
2.12
Manual
PT C 35 of 79
Actual Condition
CQI-23

Version 1, 3/2014
TABLE C - Vacuum Forming
etc. When performing the job audit, the auditor shall verify molder is conforming to customer requirements.
Minimum Requirement
Actual Condition
Once per lot
Once per lot
FIFO - per Lot

PT C 36 of 79
Observation/
Comments
(Pass / Fail /
N/A)
CQI-23

Version 1, 3/2014
Minimum Requirement
Actual Condition
Continuous
Continuous

down time event
PT C 37 of 79
Observation/
Comments
(Pass / Fail /
N/A)
CQI-23

Version 1, 3/2014
Minimum Requirement
Actual Condition

down time event

down time event
At start-up
At start-up

down time event
PT C 38 of 79
Observation/
Comments
(Pass / Fail /
N/A)
CQI-23

Version 1, 3/2014
Minimum Requirement
Actual Condition

down time event

down time event

down time event

down time event

down time event
PT C 39 of 79
Observation/
Comments
(Pass / Fail /
N/A)
CQI-23

Version 1, 3/2014
Minimum Requirement
Actual Condition

down time event
At start-up and every 8 hours
At start-up and every 8 hours

down time event

down time event
PT C 40 of 79
Observation/
Comments
(Pass / Fail /
N/A)
CQI-23

Version 1, 3/2014
Minimum Requirement
Actual Condition

down time event

every 8 hours
every 8 hours
every 8 hours
PT C 41 of 79
Observation/
Comments
(Pass / Fail /
N/A)
CQI-23

Version 1, 3/2014
PROCESS TABLE D - Compression Molding

Item #
Related
Molding
System
Assessment
Question #
Type of Control
Minimum Requirement
1.0
D1.1
1.4
2.1
2.13

Manual
gravity, temperature recording).
D1.2
1.4
2.1
2.13

2.0
Manual
Compounding (if applicable)
D2.1
1.4
2.1
2.13
Purging all equipment and feeding system to avoid cross

contamination.
D2.2
1.4
2.1
2.13
Process parameter verification:

- For SMC, Doctor box blade height, glass chopper speed, additives,
Manual
carrier film speed, compaction pressure etc.
- For rubber, mixer RPM, temperature, additives etc.
PT D 42 of 79
Manual
Actual Condition
CQI-23

Version 1, 3/2014

Item #
Related
Molding
System
Assessment
Question #
Type of Control
Minimum Requirement
D2.3
1.4
2.1
2.13
Glass fiber distribution and density verification(for SMC).
Manual
D2.4
1.4
2.1
2.13
Compound property verification when applicable:

- For SMC, viscosity, initial sheet thickness etc.
- For rubber preform, elongation, tensile strength, compression set,
pre-cure rate, or rheology etc.
Manual
3.0
Storage & Handling
D3.1
1.4
2.11
2.12
Using a FIFO (First In - First Out) system for compound/preform,

shelf life storage.
Manual
D3.2
1.4
2.11
2.12
Environment temperature and humidity for preform storage (if

applicable).
Automatic
D3.3
1.4
2.11
2.12
Compound floor time (e.g.., sheet rolls in SMC and rubber

compound).
Manual
PT D 43 of 79
Actual Condition
CQI-23

Version 1, 3/2014

Item #
Related
Molding
System
Assessment
Question #
Type of Control
Minimum Requirement
D3.4
1.4
2.11
2.12
Prevention of contamination by lubricants such as silicone, mold

release such as calcium carbonate or oil from the pressurization
system.
Manual
D3.5
1.4
1.6
2.7
2.11
2.12
Partial containers handling to ensure no contamination (closed

Automatic/Manual
D3.6
1.4
2.11
2.12
Sheet shrinkage confirmation (for SMC)
Manual
4.0
D4.1
Molding Process
1.4
1.15
2.11
2.12

PT D 44 of 79
Manual
Actual Condition
CQI-23

Version 1, 3/2014

Item #
Related
Molding
System
Assessment
Question #
Type of Control
Minimum Requirement
D4.2
1.4
1.15
2.11
2.12
Manual
D4.3
1.4
1.15
2.11
2.12
Manual
D4.4
1.4
1.15
2.11
2.12
Cavity surface temperature verification
Automatic/Manual
D4.5
1.4
1.15
2.11
2.12
Verification of preform size, or shape, or both
Manual
D4.6
1.4
1.15
2.11
2.12
Verification of charge pattern (for SMC)
Manual
PT D 45 of 79
Actual Condition
CQI-23

Version 1, 3/2014

Item #
Related
Molding
System
Assessment
Question #
Type of Control
Minimum Requirement
D4.7
1.4
1.15
2.11
2.12
Cavity surface cleanliness (no debris)
Manual
D4.8
1.4
1.15
2.11
2.12
Mold closing speed
Automatic
D4.9
1.4
1.15
2.11
2.12
Cavity temperature
Automatic
D4.10
1.4
1.15
2.11
2.12
Post molding cooling (for SMC) - prevent deformation
Manual
D4.11
1.4
1.15
2.11
2.12
Manual
PT D 46 of 79
Actual Condition
CQI-23

Version 1, 3/2014

Item #
Related
Molding
System
Assessment
Question #
Type of Control
Minimum Requirement
D4.12
1.4
1.15
2.11
2.12
5.0
Shut down procedure
Manual
Quality Control
D5.1
1.4
2.11
2.12
Part weight
Manual
D5.2
1.4
2.11
2.12
Dimensions
Manual
D5.3
1.4
2.11
2.12
Appearance
Manual
D5.4
1.4
2.11
2.12
Manual
PT D 47 of 79
Actual Condition
CQI-23

Version 1, 3/2014

Item #
Related
Molding
System
Assessment
Question #
Type of Control
Minimum Requirement
PT D 48 of 79
Actual Condition
CQI-23

Version 1, 3/2014
BLE D - Compression Molding
tc. When performing the job audit, the auditor shall verify molder is conforming to customer requirements.
Minimum Requirement
Actual Condition
Once per lot
Once per lot
End of run or long downtime,

material change
down time event, material
change
PT D 49 of 79
Observation/
Comments
(Pass / Fail /
N/A)
CQI-23

Version 1, 3/2014
Minimum Requirement
Actual Condition
Hourly
Per production lot
Pull for use
Continuous and manually

verify daily
Pull for use

PT D 50 of 79
Observation/
Comments
(Pass / Fail /
N/A)
CQI-23

Version 1, 3/2014
Minimum Requirement
Actual Condition
Every eight hours
Continuous
Per lot (just before use)

down time event
PT D 51 of 79
Observation/
Comments
(Pass / Fail /
N/A)
CQI-23

Version 1, 3/2014
Minimum Requirement
Actual Condition
At start-up

down time event
At startup and re-start
Each cycle
Each cycle
PT D 52 of 79
Observation/
Comments
(Pass / Fail /
N/A)
CQI-23

Version 1, 3/2014
Minimum Requirement
Actual Condition
Each cycle
Continuous
Continuous
Each cycle

down time event
PT D 53 of 79
Observation/
Comments
(Pass / Fail /
N/A)
CQI-23

Version 1, 3/2014
Minimum Requirement
Actual Condition

every 8 hours
every 8 hours
every 8 hours
PT D 54 of 79
Observation/
Comments
(Pass / Fail /
N/A)
CQI-23

Version 1, 3/2014
Minimum Requirement
Actual Condition
PT D 55 of 79
Observation/
Comments
(Pass / Fail /
N/A)
CQI-23

Version 1, 3/2014
PROCESS TABLE E - Transfer Molding

Item #
Related
Molding
System
Assessment
Question #
Type of Control
Minimum Requirement
1.0
E1.1
1.4
2.1
2.13

Manual
gravity, temperature recording).
E1.2
1.4
2.1
2.13

2.0
E2.1
Manual
Compounding and Preforming (if applicable)

1.4
2.1
2.13
Purging all equipment and feeding system to avoid cross

contamination.
PT E 56 of 79
Manual
Actual Condition
CQI-23

Version 1, 3/2014

Item #
Related
Molding
System
Assessment
Question #
Type of Control
Minimum Requirement
E2.2
1.4
2.1
2.13
3.0
Compound property verification when applicable

- For rubber and one part epoxy; preform, elongation, tensile
strength, compression set, pre-cure rate, or rheology etc.
Manual
Storage & Handling
E3.1
1.4
2.11
2.12
Stock rotation system in place for First in/First out (FIFO) and shelflife.
Automatic/Manual
E3.2
1.4
2.11
2.12
Environment temperature and humidity for storage (if applicable).
Automatic
E3.3
1.4
2.11
2.12
Temperature control during shipment from material supplier to cold

storage area in plant (if applicable i.e.; one part epoxies).
Automatic
PT E 57 of 79
Actual Condition
CQI-23

Version 1, 3/2014

Item #
Related
Molding
System
Assessment
Question #
Type of Control
Minimum Requirement
E3.4
1.4
2.11
2.12
Material container remains sealed during warm up to room

temperature (supplier recommendation).
E3.5
1.4
2.11
2.12
Time exposed to room temperature when removed from cold storage

area for production. Allowable usage time after room temperature is Automatic/Manual
reached.
E3.6
1.4
1.6
2.11
2.12

Automatic/Manual
E3.7
1.4
1.6
2.11
2.12
Automatic/Manual
4.0
Molding Process
PT E 58 of 79
Manual
Actual Condition
CQI-23

Version 1, 3/2014

Item #
Related
Molding
System
Assessment
Question #
Type of Control
Minimum Requirement
E4.1
1.4
1.15
2.11
2.12

Manual
E4.2
1.4
1.15
2.11
2.12
Manual
E4.3
1.4
1.15
2.11
2.12
Manual
E4.4
1.4
1.15
2.11
2.12
Mold cavity temperatures; variation between each cavity and set

temperatures
Automatic
E4.5
1.4
1.15
2.11
2.12
Verification of preform size, or shape, or both
manual
PT E 59 of 79
Actual Condition
CQI-23

Version 1, 3/2014

Item #
Related
Molding
System
Assessment
Question #
Type of Control
Minimum Requirement
E4.6
1.4
1.15
2.11
2.12
Plasticization - Temperature (resin chamber), Transfer Speed, and

Transfer Pressure
Automatic
E4.7
1.4
1.15
2.11
2.12
Fill - Fill time and peak pressure
Automatic
E4.8
1.4
1.15
2.11
2.12
Hold - Hold pressure and hold time
Automatic
E4.9
1.4
1.15
2.11
2.12
Cure Time
Automatic
E4.10
1.4
1.15
2.11
2.12
Mold Closing speed
Automatic
PT E 60 of 79
Actual Condition
CQI-23

Version 1, 3/2014

Item #
Related
Molding
System
Assessment
Question #
Type of Control
Minimum Requirement
E4.11
1.4
1.15
2.11
2.12
Cavity surface cleanliness (no debris)
manual
E4.12
1.4
1.15
2.11
2.12
Pre-heat of components - If Insert molding required
Automatic
E4.13
1.4
1.15
2.11
2.12
Pre-heat of resin pellets or compound - If applicable (per

manufacturers recommendations)
Automatic
E4.14
1.4
1.15
2.11
2.12
Hold - Cavity pressure (if applicable)
Automatic
E4.15
1.4
1.15
2.11
2.12
Part weight (if applicable)
Manual
PT E 61 of 79
Actual Condition
CQI-23

Version 1, 3/2014

Item #
Related
Molding
System
Assessment
Question #
Type of Control
Minimum Requirement
E4.16
1.4
1.15
2.11
2.12
Manual
E4.17
1.4
1.15
2.11
2.12
Manual
5.0
Quality Control
E5.1
1.4
2.11
2.12
Part weight
Manual
E5.2
1.4
2.11
2.12
Dimensions
Manual
PT E 62 of 79
Actual Condition
CQI-23

Version 1, 3/2014

Item #
Related
Molding
System
Assessment
Question #
Type of Control
Minimum Requirement
E5.3
1.4
2.11
2.12
Manual
E5.4
1.4
2.11
2.12
Manual
PT E 63 of 79
Actual Condition
CQI-23

Version 1, 3/2014
TABLE E - Transfer Molding
c. When performing the job audit, the auditor shall verify molder is conforming to customer requirements.
Minimum Requirement
Actual Condition
Once per lot
Once per lot
End of run or long downtime,

material change
PT E 64 of 79
Observation/
Comments
(Pass / Fail /
N/A)
CQI-23

Version 1, 3/2014
Minimum Requirement
Actual Condition
Per production lot
FIFO - per Lot

verification daily
Continuous monitoring (i.e.,
by chart recorder)
PT E 65 of 79
Observation/
Comments
(Pass / Fail /
N/A)
CQI-23

Version 1, 3/2014
Minimum Requirement
Actual Condition
Time stamp on container from

time out of cold storage to
when container is opened
verification
Continuous
Per Container
PT E 66 of 79
Observation/
Comments
(Pass / Fail /
N/A)
CQI-23

Version 1, 3/2014
Minimum Requirement
Actual Condition

down time event
At start-up

down time event
Continuous, at start-up and

after down time event.
Continuous
PT E 67 of 79
Observation/
Comments
(Pass / Fail /
N/A)
CQI-23

Version 1, 3/2014
Minimum Requirement
Actual Condition
Continuous
Continuous
Continuous
Continuous
Continuous
PT E 68 of 79
Observation/
Comments
(Pass / Fail /
N/A)
CQI-23

Version 1, 3/2014
Minimum Requirement
Actual Condition
Continuous
Continuous
Continuous
Continuous
Once every 8 hours*
PT E 69 of 79
Observation/
Comments
(Pass / Fail /
N/A)
CQI-23

Version 1, 3/2014
Minimum Requirement
Actual Condition

down time event

every 8 hours
PT E 70 of 79
Observation/
Comments
(Pass / Fail /
N/A)
CQI-23

Version 1, 3/2014
Minimum Requirement
Actual Condition

every 8 hours
every 8 hours
PT E 71 of 79
Observation/
Comments
(Pass / Fail /
N/A)
CQI-23

Version 1, 3/2014
PROCESS TABLE F - Extrusion

Item #
Related
Molding
System
Assessment
Question #
Type of Control
Minimum Requirement
1.0
Actual Condition
Minimum Requirement
F1.1
1.4
2.1
2.13

Manual
gravity).
Once per lot
F1.2
1.4
2.1
2.13

Manual
Once per lot
2.0
Storage & Handling
F2.1
1.4
2.11
2.12
Automatic/Manual
FIFO - per Lot

F2.2
1.4
2.11
2.12
Environment temperature and humidity controlled (if applicable)
Automatic
verification daily
F2.3
1.4
1.6
2.11
2.12

Automatic/Manual
Continuous
F2.4
1.4
1.6
2.11
2.12
Automatic/Manual
Per Container
PT F 72 of 79
Actual Condition
Observation/
Comments
(Pass / Fail /
N/A)
CQI-23

Version 1, 3/2014

Item #
Related
Molding
System
Assessment
Question #
Type of Control
Minimum Requirement
3.0
Actual Condition
Minimum Requirement
Material Drying (If Applicable)
F3.1
1.4
2.11
2.12
Automatic
Start-up and continuous by

controller.
F3.2
1.4
2.11
2.12
Dryer time per resin manufacturer guidelines (per material)
Manual

hours
F3.3
1.4
2.11
2.12
Manual
Material change
F3.4
1.4
2.11
2.12
Dew point
Automatic
Continuous by controller
F3.5
1.4
2.11
2.12
Moisture content
Manual
Start up and once every 8

hours

guidelines). Verified by feed pressure, weight or volume.
Automatic

every part change-over
Regrind equipment (dedicated or cleaning procedure in place)
Manual
Material change
4.0
Recycle/Regrind Material (if Applicable)
F4.1
1.4
1.11
2.11
2.13
F4.2
1.4
1.11
2.11
2.12
PT F 73 of 79
Actual Condition
Observation/
Comments
(Pass / Fail /
N/A)
CQI-23

Version 1, 3/2014

Item #
Related
Molding
System
Assessment
Question #
Type of Control
Minimum Requirement
Actual Condition
Minimum Requirement
F4.3
1.4
1.11
2.11
2.12
Automatic/Manual
Material change
F4.4
1.4
1.11
2.11
2.12
Prevention of contamination when transporting or feeding regrind to

the extrusion machine.
Automatic/Manual
5.0
Color Management (If Applicable)
F5.1
1.4
2.11
2.12
Pigment blending - percent loading
Automatic/Manual
F5.2
1.4
2.11
2.12
Manual
At color change
6.0
Extrusion Process
F6.1
1.4
1.15
2.11
2.12

Manual

down time event
F6.2
1.4
1.15
2.11
2.12
Manual

down time event
F6.3
1.4
1.15
2.11
2.12
Verify molding machine settings including but not limited to barrel

and head/die temperature settings, screw speed, screw cooling
temperature (if applicable), as well as settings for down stream
processes
Manual

down time event
F6.4
1.4
1.15
2.11
2.12
Verify secondary equipment
Manual

down time event
PT F 74 of 79
Actual Condition
Observation/
Comments
(Pass / Fail /
N/A)
CQI-23

Version 1, 3/2014

Item #
Related
Molding
System
Assessment
Question #
Type of Control
Minimum Requirement
Actual Condition
Minimum Requirement
F6.5
1.4
1.15
2.11
2.12
Mold surface temperature
Automatic/Manual
event.
F6.6
1.4
1.15
2.11
2.12
Extrusion Head Pressure
Automatic
F6.7
1.4
1.15
2.11
2.12
Vacuum level (if applicable)
Automatic
F6.8
1.4
1.15
2.11
2.12
Coolant inlet temperature (if applicable)
Automatic
F6.9
1.4
1.15
2.11
2.12
Manual

down time event
F6.10
1.4
1.15
2.11
2.12
Material purge/evacuation of barrel - included in unplanned and

downtime procedures
Manual
F6.11
1.4
1.15
2.11
2.12
Manual
PT F 75 of 79
Actual Condition
Observation/
Comments
(Pass / Fail /
N/A)
CQI-23

Version 1, 3/2014

Item #
Related
Molding
System
Assessment
Question #
Type of Control
Minimum Requirement
7.0
Actual Condition
Minimum Requirement
Quality Control
F7.1
1.4
2.11
2.12
Thickness
Manual

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

once every 4 hours.
F7.3
1.4
2.11
2.12
Layer adhesion (multi-layer only)
Manual

once every hour
F7.4
1.4
2.11
2.12
Dimensions
Manual

every 8 hours
F7.5
1.4
2.11
2.12
Manual

every 8 hours
F7.6
1.4
2.11
2.12
Manual

every 8 hours
PT F 76 of 79
Actual Condition
Observation/
Comments
(Pass / Fail /
N/A)
CQI-23

Version 1, 3/2014
PROCESS TABLE G - Equipment

* When historical results show capability, test frequency may be reduced.
Item #
Related
Molding System
Assessment
Question #
1.0
Equipment Type
Injection
Molding
Blow
Molding
Vacuum
Forming
Compression
Molding
Transfer
Molding
Extrusion
Verification Frequency
Calibration /
Certification
Frequency *
PROCESS EQUIPMENT
G1.1
2.14
Mold Temperature Controller
Once per shift
N/A
G1.2
2.14
Filters, if applicable
Once per month or per

preventive maintenance
N/A
G1.3
2.14
Thermocouple
G1.4
2.14
Injection Mold Machine
G1.5
2.14
Mold
G1.6
2.14
Blow mold machine
G1.7
2.14
Vacuum molding machine
G1.8
2.14
Compression molding machine
G1.9
2.14
Extrusion machine
G1.10
2.14
Dryer
G1.11
2.14
Regrinder
G1.12
2.14
Hot Runner Controller
G1.13
2.14
G1.14
G1.15
Per Preventive Maintenance
Annual
Every 5 years
N/A
Every 5 years
N/A
N/A
Every 5 years
N/A
N/A
N/A
Cavity Pressure Sensor
N/A
2.14
Hydraulic Pressure Transducer
N/A
2.14
Valve Gate Controller, if

applicable
N/A
X
X
X
X
X
PT G 77 of 79
Included in Preventative
Maintenance Plan
Comment
CQI-23

Version 1, 3/2014
PROCESS TABLE G - Equipment

* When historical results show capability, test frequency may be reduced.
Item #
Related
Molding System
Assessment
Question #
2.0
Equipment Type
Injection
Molding
Blow
Molding
Vacuum
Forming
Compression
Molding
Transfer
Molding
Extrusion
Verification Frequency
Calibration /
Certification
Frequency *
N/A
SECONDARY EQUIPMENT
G2.1
2.14
Generic fixtures (cooling, heat

forming, if applicable)
G2.2
2.14
Conveyers
N/A
G2.3
2.14
Degater/Trim Operation
N/A
G2.4
2.14
Cutter
N/A
G2.5
2.14
Robot
At Installation
G2.6
2.14
Oven, if applicable
Annual
G2.7
2.14
Cooling Fan, if applicable
Annual
G2.8
2.14
End of arm tooling
N/A
Per lot
Annual
At start up and per shift
Every 6 months
Before each use
Annual
Before each use
Annual
At start up
Annual
MINIMUM REQUIRED TESTING

CAPABILITY
3.0
G3.1
2.14
Cure Testing, if applicable
G3.2
2.14
Leak Testing, if applicable
G3.3
2.14
Color
G3.4
2.14
Gloss
G3.5
2.14
Weight
G3.6
2.14
Dimensions
At start up
Every 6 months
G3.7
2.14
Moisture
Per Manufacturer Guidelines
Every 6 months
G3.8
2.14
Performance, if applicable
Per Manufacturer Guidelines
Annual
X
X
X
X
PT G 78 of 79
Included in Preventative
Maintenance Plan
Comment
CQI-23

Version 1, 3/2014
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.
Item #
Related
Molding
System
Assessment
Question #
Dimension, Weight, Appearance,

1.0
Minimum Requirement
General
Dimensions
Appearance
Performance
H1.1
1.4
2.9
Procedures are in place to prevent damage to the finish or part during the
inspection and packaging processes
100%
H1.2
1.4
Appearance (flash, color and gloss, short shots, splay/burns, blister, sink
marks, gate vestige, and other molding defects) of the molding shall be
verified per specification and applications manual
First off by quality and 100%

by operator
H1.3
1.4
Cracks, Weld line/Knit lines, and Whitening/ stress mark
First off and last off
H1.4
1.4
Part identification
First off
H1.5
1.4
Manufacturing information
Daily Production Meeting

Review
H1.6
1.4
Dimensional check (e.g., Go-no go, Plug and Ring gage)
First off and once per shift
H1.7
1.4
Wall thickness
Per process table
H1.8
1.4
General - Weight, Resin, Components, Porosity/Voids (if applicable)
First off
H1.9
1.4
Performance
Per customer specifications
H1.10
1.4
Environmental
Per customer specifications
PT H 79 of 79
Actual Condition
Observation/Comments
(Pass / Fail / N/A)

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CQI-23

Special Processes: Molding System Assessment

Special Process: Molding System Assessment

Type(s) of Molding Processes at this Facility:

Captive Molder (Y/N):

Date of Previous Assessment:

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:

Special Processes: Molding System Assessment

Special Process: Molding System Assessment (General Facility Overview)

Requirements and Guidance

Section 1 - Management Responsibility and Quality Planning

To ensure readily available expertise, there shall be a

Does the molder perform

The molder shall incorporate a documented advanced

Special Processes: Molding System Assessment

Special Process: Molding System Assessment (General Facility Overview)

Requirements and Guidance

The molder shall incorporate the use of a documented

The molder shall incorporate the use of a documented

Special Processes: Molding System Assessment

Special Process: Molding System Assessment (General Facility Overview)

Requirements and Guidance

To ensure all customer requirements are both

Are all molding related and

Is there a written process

The molder shall have written process specifications

Special Processes: Molding System Assessment

Special Process: Molding System Assessment (General Facility Overview)

Requirements and Guidance

To demonstrate each process is capable of yielding

The analysis of products and processes over time can

Are internal assessments

The molder shall conduct internal assessments on an

Special Processes: Molding System Assessment

Special Process: Molding System Assessment (General Facility Overview)

Requirements and Guidance

The quality management system shall include a

Does the Quality Department

The molder shall define a process for continual

Does the Quality Manager or

The quality management system shall include a

The Quality Manager or designee is responsible for

Special Processes: Molding System Assessment

Special Process: Molding System Assessment (General Facility Overview)

Requirements and Guidance

There shall be procedures or work instructions

The molder shall provide employee training for

Is there a responsibility matrix

The molder shall maintain a responsibility matrix

Special Processes: Molding System Assessment

Special Process: Molding System Assessment (General Facility Overview)

Requirements and Guidance

The molder shall have a documented preventive

Has the molder developed a

Special Processes: Molding System Assessment

Special Process: Molding System Assessment (General Facility Overview)

Requirements and Guidance

Section 2 - Floor and Material Handling Responsibility

Documented processes and evidence of compliance

Is product clearly identified

Procedures for part and container identification help to