Special Processes: Molding System Asse

Vers

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:

Auditors/Assessors:
Name: Company: Phone:

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

lity:

Email:

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

Question
Number Question Requirements and Guidance

Section 1 - Management Responsibility and Quality Planni

To ensure readily available expertise, there shall be a dedicated

Is there a dedicated and qualified
1.1
molding professional on-site?
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 job description shall exist identifying the
qualifications for the position including chemical and molding
knowledge. The qualifications shall include a minimum of 5
years experience in molding operation or a combination of a
minimum of 5 years of formal technical education and molding
experience.

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
Does the molder perform advanced the customer. The molder shall contact the customer when
1.2 clarification of process changes is required. This clarification of
quality planning?
process changes shall be documented.

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 written for each process. In any case,
they shall address all process steps from part receipt to part
shipment and all key molding process parameters as defined by
the molder. A cross-functional team shall be used in the
Are the molder's FMEA's up to date development of the FMEA. All special characteristics, as
1.3
and reflecting current processing? 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- functional team, including a
production operator, shall be used in the development of
Control Plans, which shall be consistent with all associated
documentation such as work instructions, shop travelers, and
Are molding process Control Plans FMEAs. All special characteristics, as defined by the molder
1.4 up to date and reflecting current and its customers, shall be identified, defined, and addressed in
processing? 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.

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
Are all molding related and possible and shall not exceed two weeks. The molder shall
referenced specifications current document this process of review and implementation, and it
1.5 and available? For example: SAE, shall address how customer and industry documents are
AIAG, ASTM, General Motors, Ford, obtained, how they are maintained within the molder, how the
and Chrysler. 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.

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

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
Is there a written process
processes should have a written process specification. These
1.7 specification for all active
process specifications may take the form of work instructions,
processes?
job card, start-up sheet, or other similar documents.

Has a valid product capability study customer requirements, the molder shall establish acceptable
1.8 been performed initially and after
process change?
Does the molder collect and
1.9 analyze data over time, and react to parameters/characteristics to include in such analysis. All
this data? Are records available?
Are internal assessments being
completed on an annual basis, at a basis, at a minimum, using the AIAG Molding System
minimum, incorporating AIAG
1.10 Molding System Assessment?
Is there a system in place to
1.11 authorize reprocessing and is it
documented?
Does the Quality Department
review, address, and document
customer and internal concerns?
1.12
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 work and in
accordance with customer requirements. Capability study
techniques shall be appropriate for the molding product
characteristics, e.g., molding thickness, part weight, etc. Any
specific customer requirements shall be met. In the absence of
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.
Methods of analysis shall include ongoing trend or historical
data analysis of special product or process
parameters/characteristics. The molder shall determine which
process control and testing records must be retained for a
minimum of one calendar year after the year in which they were
created.
The molder shall conduct internal assessments on an annual
Assessment. Concerns shall be addressed in a timely manner.
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 well as those characteristics for which reprocessing
is not permissible. All reprocessing activity shall require 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 process for
documenting, reviewing, and addressing customer concerns
and any other concerns internal to the molder. A disciplined
problem solving approach shall be used.
 Is there a continual improvement
plan applicable to each process
defined in the scope of the
assessment?
1.13
The molder shall define a process for continual improvement for
each molding process identified in the scope of the Molding
System Assessment. The process shall be designed to bring
about continual improvement in quality and productivity.
Identified 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 The Quality Manager or designee is responsible for authorizing
designee authorize the disposition and documenting appropriate personnel to disposition
of material from quarantine status? quarantine material.

There shall be procedures or work instructions available to

Are there procedures or work
instructions available to molding
1.15
personnel that define the molding
process?
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
Is management providing employee the training. Management shall define the qualification
1.16 requirements for each function, and ongoing or follow- up
training for molding?
training shall also be addressed.

Is there a responsibility matrix to
ensure that all key management
and supervisory functions are
performed by qualified personnel?
1.17
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.

The molder shall have a documented preventive maintenance

Is there a preventive maintenance
program? Is maintenance data
1.18
being utilized to form a predictive
maintenance program?
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 critical The molder shall develop and maintain a critical spare parts list
spare parts list, and are the parts and shall ensure the availability of such parts to minimize
1.19 available to minimize production production disruptions.
disruptions?
 CQI-23
ocesses: Molding System Assessment
Version 1, 3/2014

Assessment
Needs Immediate
Objective Evidence N/A Satisfactory Not Satisfactory Action

ement Responsibility and Quality Planning


Question
Number Question
Does the facility ensure that the
data entered in the receiving system e.g., shop travelers, work orders, etc. The facility shall have a
matches the information on the
2.1 customer's shipping documents?
Is product clearly identified and
2.2 staged throughout the molding
process?
Is molder using adequate FIFO
system for material and product?
2.3
Is lot traceability and integrity
2.4 maintained throughout all
processes?
Are procedures adequate to prevent and tracking of material flow in and out of hold area. Non-
2.5 movement of non- conforming
product into the production system? segregation of such material.
Is there a system to identify trap
points in the entire process to
reduce risk of mixed parts
2.6 (inappropriate, unfinished or
improperly molded parts)?
CQI-23
Special Processes: Molding System Assessment
Version 1, 3/2014
Requirements and Guidance
Section 2 - Floor and Material Handling Responsibility
Documented processes and evidence of compliance shall exist,
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
conforming hold area shall be clearly designated to maintain
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.

Are containers free of inappropriate inappropriate material shall be identified and addressed. This is
2.7
material?
Are operators trained in material
handling, containment action and
2.8 product segregation in the event of
an equipment emergency including
power failure?
Is the handling, storage and
packaging adequate to preserve
2.9 product quality?
Are plant cleanliness,
housekeeping, environmental and
working conditions conducive to
control and improved quality?
2.10
Are process control parameters
monitored per frequencies specified specified in Process Tables. Computer monitoring equipment
in Process Tables?
2.11
Are out of control/specification
parameters reviewed and reacted
2.12 to?
2.13 Are Test Frequencies performed as
specified in Process Tables?
2.14 Is product test equipment verified?
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
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 including power failure.
Training shall be documented. Work instructions specifically
addressing potential types of equipment emergencies and
failures shall be 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.
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.
Process control parameters shall be monitored per frequencies
with alarms and alarm logs satisfy the verification requirement.
A designated floor person shall verify the process parameters.
There are documented reaction plans to both out of control and
out of tolerance process parameters.
There is documented evidence that reaction plans are followed.
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.
 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
2.15 Lighting of inspection area evaluated.
 CQI-23
ocesses: Molding System Assessment
Version 1, 3/2014

Assessment
Needs Immediate
Objective Evidence N/A Satisfactory Not Satisfactory Action

or and Material Handling Responsibility

 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 Customer or Internal

System Assessment Requirement
Question #

Is contract review and advanced quality planning, 1.1

FMEA, Control Plans, etc., in place and performed 1.2
by qualified individuals? 1.3
3.1 1.4
1.6

Does the molder have the proper customer

3.2 specifications for the part? 1.5

3.3 Is there documented evidence of Receiving 2.1

Inspection?
3.4 Is material identification (part numbers, lot 2.2
numbers, contract numbers, etc.) maintained 2.3
throughout the molding process? 2.4

Is the proper procedure or process specification 1.5

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

Process #1:

Process #2:

What are the product inspection requirements? 1.5 Each part may have one or more requirements deter
3.6 2.13 requirement. List each requirement below and valida
2.14 (Listed below are some examples)

3.6.1 Requirement: Weight

 Test Method:
Test frequency or quantity:
Selection of samples:
Specification:
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:
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:
1.4
1.6
2.2
3.7 Were appropriate process steps signed off? 2.3
2.11
 Were all inspection steps, as documented in the 1.2
Control Plan performed? 1.4
3.8

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

If additional steps were performed, were they 1.2

authorized? 1.4
1.6
3.10 1.10
1.16

Does the governing specification allow 1.5

3.11 reprocessing or rework? 1.10

If the order was certified, did the certification 2.11

3.12 accurately reflect the process performed? 2.13

Was the certification signed by an authorized

3.13 individual? 1.16

Are the parts and containers free of inappropriate

3.14 objects or contamination? 2.6

Packaging Requirements

2.6
3.15 Are packaging requirements identified? 2.7
2.9

Are parts packaged to minimize mixed parts or 2.6

damaged (for example, work flow or over-pack of 2.7
3.16
container)? 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
 CQI-23
Special Processes: Molding System Assessment
Version 1, 3/2014

Job (Shop) Order or Reference Actual Condition (Objective Pass / Fail

Documentation Requirement Evidence) / N/A

N/A

N/A

or more requirements determined by the molding specification. Parts must meet each
equirement below and validate.
examples)
CQI-23
Special Processes: Molding System Assessment
Version 1, 3/2014

Related
Molding
Item # System Category/Process Steps Type of Control
Assessment
Question #

Minimum Requirement

PROCESS TABLE A - Injection Molding

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
2.13 gravity).
1.4 Incoming components assessment procedure, covering onsite testing or
A1.2 2.1 acceptance of supplier testing, with criteria (if applicable). Manual
2.13

2.0 Storage & Handling (If Applicable)

A2.1 1.4 Stock rotation system in place for First in/First out (FIFO) and shelf- life Automatic/Manual
2.3
2.11
2.12
1.4
A2.2 2.11 Environment temperature controlled Automatic
2.12
1.4 Handling of partial containers to ensure no contamination (closed
1.6 container, clean environment)
A2.3 2.7 Automatic/Manual
2.11
2.12
1.4
1.6
A2.4 2.7 Partial container quantity Automatic/Manual
2.11
2.12

3.0 Material Drying

1.4
A3.1 2.11 Dryer temperature per resin manufacturer guidelines (per material) Automatic
2.12
1.4
A3.2 2.11 Dryer time per resin manufacturer guidelines (per material) Manual
2.12
1.4
A3.3 2.11 Drying equipment (dryer dedicated or clean procedure in place) Manual
2.12
1.4
A3.4 2.11 Dew point Automatic
2.12
1.4
A3.5 2.11 Moisture analysis, if applicable, per Resin Manufacturer Guidelines Manual
2.12

4.0 Recycle (regrind) Material (If Applicable)

A4.1 1.4 Recycle ratio (per print, inspection standard or manufacturer Automatic
1.11 guidelines). Verified by feed pressure, weight or volume
2.11
2.13
A4.2 1.4 Dedicated regrind equipment or cleaning procedure in place Manual
1.11
2.11
2.12
A4.3 1.4 Fines management (de-dusting) Automatic/Manual
1.11
2.11
2.12
A4.4 1.4 Move regrind to IMM (contamination) Automatic/Manual
1.11
2.11
2.12

5.0 Color Management

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

6.0 Molding Process

A6.1 1.4 There shall be a standardized startup procedure/checklist that defines Manual
1.15 things to do at start-up
2.11
2.12
A6.2 1.4 Production plan (machine, mold, materials, part style) Manual
1.15
2.11
2.12
A6.3 1.4 Startup check (verify process settings against setup sheet) Manual
1.15
2.11
2.12
A6.4 1.4 Startup check - Secondary Equipment (De-gate, assembly equipment, Manual
1.15 welders, etc.)
2.11
2.12
A6.5 1.4 Mold surface temperature Automatic/Manual
1.15
2.11
2.12
A6.6 1.4 Plastication - Temperature (barrel, nozzle, hot manifold if applicable), Automatic
1.15 screw RPM, and back pressure
2.11
2.12
A6.7 1.4 Plastication - Melt temperature N/A
1.15
2.11
2.12
A6.8 1.4 Plastication - Screw recovery time N/A
1.15
2.11
2.12
A6.9 1.4 Fill - Screw velocity or velocity profile Automatic
1.15
2.11
2.12
A6.10 1.4 Fill - Fill time and peak pressure N/A
1.15
2.11
2.12
A6.11 1.4 Hold - Hold pressure and hold time Automatic
1.15
2.11
2.12
A6.12 1.4 Hold - Cushion N/A
1.15
2.11
2.12
A6.13 1.4 Hold - Cavity pressure (if applicable) N/A
1.15
2.11
2.12
A6.14 1.4 Temperature Control Cooling - Coolant inlet temperature and cooling Automatic
1.15 time
2.11
2.12
A6.15 1.4 Part weight (if applicable) Manual
1.15
2.11
2.12
A6.16 1.4 First piece approval Manual
1.15
2.11
2.12
A6.17 1.4 Material purge/evacuation of barrel - included in unplanned and Manual
1.15 downtime procedures
2.11
2.12
A6.18 1.4 Shut down procedures Manual
1.15
2.11
2.12

7.0 Quality Control

A7.1 1.4 Part weight Manual

2.11
2.12

1.4
A7.2 2.11 Dimensions Manual
2.12
1.4
A7.3 2.11 Appearance (vs. boundary sample or per instruction) Manual
2.12
1.4
A7.4 2.11 Physical properties (if applicable) Manual
2.12

PROCESS TABLE B - Blow Molding

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
2.13 gravity).
1.4 Incoming components assessment procedure, covering onsite testing or
B1.2 2.1 acceptance of supplier testing, with criteria (if applicable). Manual
2.13

2.0 Storage & Handling

B2.1 1.4 Stock rotation system in place for First in/First out (FIFO) and shelf- life Automatic/Manual
2.3
2.11
2.12
1.4
B2.2 2.11 Environment temperature and humidity controlled (if applicable) Automatic
2.12
1.4 Partial container handling to ensure no contamination (closed container,
1.6 clean environment)
B2.3 2.7 Automatic/Manual
2.11
2.12
1.4
1.6
B2.4 2.7 Partial container quantity Automatic/Manual
2.11
2.12
 3.0 Material Drying (If Applicable)

1.4
B3.1 2.11 Dryer temperature per resin manufacturer guidelines (per material) Automatic
2.12
1.4
B3.2 2.11 Drying time per resin manufacturer guidelines (per material) Manual
2.12
1.4
B3.3 2.11 Drying equipment (dryer dedicated or clean procedure in place) Manual
2.12
1.4
B3.4 2.11 Dew point Automatic
2.12
1.4
B3.5 2.11 Moisture content Manual
2.12

4.0 Recycle/Regrind Material (If Applicable)

B4.1 1.4 Recycle ratio (per print, inspection standard or manufacturer Automatic
1.11 guidelines). Verified by feed pressure, weight or volume. No regrind of
2.11 fluorine-treated parts.
2.13
B4.2 1.4 Regrind equipment (dedicated or cleaning procedure in place) Manual
1.11
2.11
2.12
B4.3 1.4 Ethylene Vinyl Alcohol (EVOH) particle size and distribution Manual
1.11
2.11
2.12
B4.4 1.4 Fines management (de-dusting) Automatic/Manual
1.11
2.11
2.12
B4.5 1.4 Prevention of contamination when transporting or feeding regrind to the Automatic/Manual
1.11 blow mold machine
2.11
2.12

5.0 Color Management (If Applicable)

1.4
B5.1 2.11 Pigment blending - percent loading Automatic/Manual
2.12
1.4
B5.2 2.11 Color change procedure Manual
2.12

6.0 Molding Process

B6.1 1.4 There shall be a standardized startup procedure/checklist that defines Manual
1.15 things to do at start-up
2.11
2.12
B6.2 1.4 Production plan (machine, mold, materials, part quantity) Manual
1.15
2.11
2.12
B6.3 1.4 Environment temperature for parison Automatic
1.15
2.11
2.12
1.4 Verify molding machine settings including but not limited to barrel and
1.15 die/head temperature settings, parison thickness or thickness profile,
B6.4 2.11 pre-blow pressure and time, blow air pressure and time, mold close Manual
2.12 speed and clamp pressure
B6.5 1.4 Verify secondary equipment Manual
1.15
2.11
2.12
B6.6 1.4 Cooling water temperature and flow rate Automatic/Manual
1.15
2.11
2.12
B6.7 1.4 Verify post mold cooling temperature or pressure and time Manual
1.15
2.11
2.12
B6.8 1.4 First piece approval Manual
1.15
2.11
2.12
B6.9 1.4 Material purge/evacuation of barrel Manual
1.15
2.11
2.12
B6.10 1.4 Shut down procedures Manual
1.15
2.11
2.12

7.0 Fluorine/Sulfination Treatment (If Applicable)

B7.1 1.4 Start-up check Manual

1.15
2.11
2.12
B7.2 1.4 Carrier gas Automatic
1.15
2.11
2.12
B7.3 1.4 Volume Automatic
1.15
2.11
2.12
B7.4 1.4 Treatment time Automatic
1.15
2.11
2.12
B7.5 1.4 Neutralization and wash cycle Manual
1.15
2.11
2.12

8.0 Quality Control

B8.1 1.4 Part weight Manual

2.11
2.12

1.4
B8.2 2.11 Wall thickness (if applicable) Manual
2.12
1.4
B8.3 2.11 Dimensions Manual
2.12
1.4
B8.4 2.11 Appearance Manual
2.12
1.4
B8.5 2.11 Physical properties (if applicable) Manual
2.12
B8.6 1.4 Layer thickness and thickness uniformity - (multi-layer only) Manual
2.11
2.12
B8.7 1.4 Pinch-off integrity Manual
2.11
2.12

PROCESS TABLE C - Vacum Forming

1.0 Receiving Inspection

1.4 Incoming material assessment procedure, covering onsite testing or

2.1 acceptance of supplier testing, with criteria (i.e., melt flow, specific
C1.1 2.13 gravity). Manual

1.4 Incoming components assessment procedure, covering onsite testing or

2.1 acceptance of supplier testing, with criteria (if applicable).
C1.2 2.13 Manual

2.0 Storage & Handling

C2.1 1.4 Stock rotation system in place for First in/First out (FIFO) and shelf- life. Automatic/Manual
2.3
2.11
2.12

1.4
2.11
C2.2 2.12 Environment contamination (dust) controlled (if applicable) Automatic/Manual

1.4
1.6
2.7
C2.3 2.11 Environment humidity and temperature controlled (if applicable) Automatic
2.12

1.4 Partial containers handling to ensure no contamination (closed

1.6 container, clean environment)
2.7
C2.4 2.11 Automatic/Manual
2.12

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

3.0 Forming Process

C3.1 1.4 There shall be a standardized startup procedure/checklist that defines Manual
1.15 things to do at start-up
2.11
2.12
 C3.2 1.4 Production plan (machine, mold, materials, part quantity) Manual
1.15
2.11
2.12

C3.3 1.4 Startup check (verify process settings against setup sheet) Automatic / Manual
1.15
2.11
2.12

C3.4 1.4 Heating distance (between heater and sheet) Manual

1.15
2.11
2.12

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

C3.6 1.4 Startup check - Secondary Equipment (trimming, assembly) Manual

1.15
2.11
2.12

C3.7 1.4 Sheet forming temperature per film supplier guidelines Automatic/Manual
1.15
2.11
2.12

C3.8 1.4 Mold temperature per film supplier guidelines Automatic/Manual

1.15
2.11
2.12

C3.9 1.4 Clamping frame closing pressure Automatic

1.15
2.11
2.12

C3.10 1.4 Mold close speed Automatic

1.15
2.11
2.12

C3.11 1.4 Plug temperature, start time and speed (if applicable) Automatic
1.15
2.11
2.12

C3.12 1.4 Sheet pre-stretching sequence and time (if applicable) Automatic
1.15
2.11
2.12

C3.13 1.4 Vacuum level, start time, evacuation speed and duration Automatic
1.15
2.11
2.12
C3.14 1.4 Pressure level, start time and duration (if applicable) Automatic
1.15
2.11
2.12

C3.15 1.4 Cooling temperature and time Automatic

1.15
2.11
2.12

C3.16 1.4 Ejection air (compressed) pressure and time Automatic

1.15
2.11
2.12

C3.17 1.4 First piece approval Manual

1.15
2.11
2.12

C3.18 1.4 Shut down procedures Manual

1.15
2.11
2.12

4.0 Quality Control

1.4
2.11
C4.1 2.12 Dimensions Manual

1.4
2.11
C4.2 2.12 Appearance (vs. boundary sample or per instruction) Manual

1.4
2.11
C4.3 2.12 Physical properties (if applicable) Manual

PROCESS TABLE D - Compression Molding

1.0 Receiving Inspection

D1.1 1.4 Incoming material assessment procedure, covering onsite testing or Manual
2.1 acceptance of supplier testing, with criteria (i.e., melt flow, specific
2.13 gravity, temperature recording).

D1.2 1.4 Manual

2.1
2.13 Incoming components assessment procedure, covering onsite testing or
acceptance of supplier testing, with criteria (if applicable).

2.0 Compounding (if applicable)

 1.4 Purging all equipment and feeding system to avoid cross contamination.
2.1
D2.1 2.13 Manual

D2.2 1.4 Process parameter verification: Manual

2.1 - For SMC, Doctor box blade height, glass chopper speed, additives,
2.13 carrier film speed, compaction pressure etc.
- For rubber, mixer RPM, temperature, additives etc.

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

D2.4 1.4 Compound property verification when applicable: Manual

2.1 - For SMC, viscosity, initial sheet thickness etc.
2.13 - For rubber preform, elongation, tensile strength, compression set, pre-
cure rate, or rheology etc.

3.0 Storage & Handling

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

1.4 Environment temperature and humidity for preform storage (if

2.11 applicable).
D3.2 2.12 Automatic

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

D3.4 1.4 Prevention of contamination by lubricants such as silicone, mold release Manual
2.11 such as calcium carbonate or oil from the pressurization system.
2.12

1.4 Partial containers handling to ensure no contamination (closed

1.6 container, clean environment)
2.7
D3.5 2.11 Automatic/Manual
2.12

1.4
2.11
D3.6 2.12 Sheet shrinkage confirmation (for SMC) Manual

4.0 Molding Process

D4.1 1.4 There shall be a standardized startup procedure/checklist that defines Manual
1.15 things to do at start-up
2.11
2.12
D4.2 1.4 Production plan (machine, mold, materials, part style) Manual
1.15
2.11
2.12

D4.3 1.4 Startup check (verify process settings against setup sheet) Manual
1.15
2.11
2.12

D4.4 1.4 Cavity surface temperature verification Automatic/Manual

1.15
2.11
2.12

D4.5 1.4 Verification of preform size, or shape, or both Manual

1.15
2.11
2.12

D4.6 1.4 Verification of charge pattern (for SMC) Manual

1.15
2.11
2.12

D4.7 1.4 Cavity surface cleanliness (no debris) Manual

1.15
2.11
2.12

D4.8 1.4 Mold closing speed Automatic

1.15
2.11
2.12

D4.9 1.4 Cavity temperature Automatic

1.15
2.11
2.12

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

D4.11 1.4 First piece approval Manual

1.15
2.11
2.12

D4.12 1.4 Shut down procedure Manual

1.15
2.11
2.12

5.0 Quality Control

D5.1 1.4 Part weight Manual
2.11
2.12

1.4
2.11
D5.2 2.12 Dimensions Manual

1.4
2.11
D5.3 2.12 Appearance Manual

1.4
2.11
D5.4 2.12 Physical properties (if applicable) Manual

PROCESS TABLE E - Transfert Molding

1.0 Receiving Inspection

E1.1 1.4 Incoming material assessment procedure, covering onsite testing or Manual
2.1 acceptance of supplier testing, with criteria (i.e., melt flow, specific
2.13 gravity, temperature recording).

E1.2 1.4 Manual

2.1
2.13 Incoming components assessment procedure, covering onsite testing or
acceptance of supplier testing, with criteria (if applicable).

2.0 Compounding and Preforming (if applicable)

1.4 Purging all equipment and feeding system to avoid cross contamination.
2.1
E2.1 2.13 Manual

1.4 Compound property verification when applicable

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

3.0 Storage & Handling

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

1.4
2.11
E3.2 2.12 Environment temperature and humidity for storage (if applicable). Automatic
 1.4 Temperature control during shipment from material supplier to cold
2.11 storage area in plant (if applicable i.e.; one part epoxies).
E3.3 2.12 Automatic

1.4
2.11
2.12 Material container remains sealed during warm up to room temperature
E3.4 Manual
(supplier recommendation).

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

E3.6 1.4 Automatic/Manual

1.6
2.11 Partial container handling to ensure no contamination (closed container,
2.12 clean environment)

E3.7 1.4 Partial container quantity Automatic/Manual

1.6
2.11
2.12

4.0 Molding Process

E4.1 1.4 There shall be a standardized startup procedure/checklist that defines Manual
1.15 things to do at start-up
2.11
2.12

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

E4.3 1.4 Startup check (verify process settings against setup sheet) Manual
1.15
2.11
2.12

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

E4.5 1.4 Verification of preform size, or shape, or both manual

1.15
2.11
2.12

E4.6 1.4 Plasticization - Temperature (resin chamber), Transfer Speed, and Automatic
1.15 Transfer Pressure
2.11
2.12
E4.7 1.4 Fill - Fill time and peak pressure Automatic
1.15
2.11
2.12

E4.8 1.4 Hold - Hold pressure and hold time Automatic

1.15
2.11
2.12

E4.9 1.4 Cure Time Automatic

1.15
2.11
2.12

E4.10 1.4 Mold Closing speed Automatic

1.15
2.11
2.12

E4.11 1.4 Cavity surface cleanliness (no debris) manual

1.15
2.11
2.12

E4.12 1.4 Pre-heat of components - If Insert molding required Automatic

1.15
2.11
2.12

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

E4.14 1.4 Hold - Cavity pressure (if applicable) Automatic

1.15
2.11
2.12

E4.15 1.4 Part weight (if applicable) Manual

1.15
2.11
2.12

E4.16 1.4 First piece approval Manual

1.15
2.11
2.12

E4.17 1.4 Shut down procedures Manual

1.15
2.11
2.12

5.0 Quality Control

 E5.1 1.4 Part weight Manual
2.11
2.12

1.4
2.11
E5.2 2.12 Dimensions Manual

1.4
2.11
E5.3 2.12 Appearance (vs. boundary sample or per instruction) Manual

1.4
2.11
E5.4 2.12 Physical properties (if applicable) Manual

PROCESS TABLE F - Extrusion

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
2.13 gravity).
1.4 Incoming components assessment procedure, covering onsite testing or
F1.2 2.1 acceptance of supplier testing, with criteria (if applicable). Manual
2.13

2.0 Storage & Handling

1.4 Stock rotation system in place for First in/First out (FIFO) and shelf- life
F2.1 2.11 Automatic/Manual
2.12
1.4
F2.2 2.11 Environment temperature and humidity controlled (if applicable) Automatic
2.12
F2.3 1.4 Partial container handling to ensure no contamination (closed container, Automatic/Manual
1.6 clean environment)
2.11
2.12
F2.4 1.4 Partial container quantity Automatic/Manual
1.6
2.11
2.12

3.0 Material Drying (If Applicable)

1.4
F3.1 2.11 Dryer temperature per resin manufacturer guidelines (per material) Automatic
2.12

1.4
F3.2 2.11 Dryer time per resin manufacturer guidelines (per material) Manual
2.12
1.4
F3.3 2.11 Drying equipment (dryer dedicated or clean procedure in place) Manual
2.12

1.4
F3.4 2.11 Dew point Automatic
2.12

F3.5 1.4 Moisture content Manual

2.11
2.12
 4.0 Recycle/Regrind Material (if Applicable)

F4.1 1.4 Recycle ratio (per print, inspection standard or manufacturer Automatic
1.11 guidelines). Verified by feed pressure, weight or volume.
2.11
2.13
F4.2 1.4 Regrind equipment (dedicated or cleaning procedure in place) Manual
1.11
2.11
2.12
F4.3 1.4 Fines management (de-dusting) Automatic/Manual
1.11
2.11
2.12
F4.4 1.4 Prevention of contamination when transporting or feeding regrind to the Automatic/Manual
1.11 extrusion machine.
2.11
2.12

5.0 Color Management (If Applicable)

1.4
F5.1 2.11 Pigment blending - percent loading Automatic/Manual
2.12
1.4
F5.2 2.11 Color change procedure Manual
2.12

6.0 Extrusion Process

F6.1 1.4 There shall be a standardized startup procedure/checklist that defines Manual
1.15 things to do at start-up
2.11
2.12
F6.2 1.4 Production plan (machine, mold, materials, part quantity) Manual
1.15
2.11
2.12
F6.3 1.4 Verify molding machine settings including but not limited to barrel and Manual
1.15 head/die temperature settings, screw speed, screw cooling temperature
2.11 (if applicable), as well as settings for down stream processes
2.12
F6.4 1.4 Verify secondary equipment Manual
1.15
2.11
2.12
F6.5 1.4 Mold surface temperature Automatic/Manual
1.15
2.11
2.12
F6.6 1.4 Extrusion Head Pressure Automatic
1.15
2.11
2.12
F6.7 1.4 Vacuum level (if applicable) Automatic
1.15
2.11
2.12
F6.8 1.4 Coolant inlet temperature (if applicable) Automatic
1.15
2.11
2.12
F6.9 1.4 First piece approval Manual
1.15
2.11
2.12
F6.10 1.4 Material purge/evacuation of barrel - included in unplanned and Manual
1.15 downtime procedures
2.11
2.12
F6.11 1.4 Shut down procedures Manual
1.15
2.11
2.12

7.0 Quality Control

1.4
2.11
F7.1 2.12 Thickness Manual

1.4
2.11
F7.2 2.12 Layer thickness/thickness uniformity (multi-layer only) Manual

1.4
2.11
F7.3 2.12 Layer adhesion (multi-layer only) Manual

1.4
F7.4 2.11 Dimensions Manual
2.12
1.4
F7.5 2.11 Appearance (vs. boundary sample or per instruction) Manual
2.12
1.4
F7.6 2.11 Physical properties (if applicable) Manual
2.12
 Observation/
Comments
Type of Control Monitoring Frequency

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

- Injection Molding

Once per lot

Once per lot

FIFO - per Lot

Shelf life - pull for use

Continuous monitoring by
controller or manual
verification daily

Continuous

Per Container

Continuous monitoring by
controller

Per Resin Manufacturer

Guidelines

Material change

Continuous monitoring by
controller

At start-up and once per shift*

Once every 8 hours and at

every part change over
Material change

Material change

Start-up and continuous

Start-up and continuous

Continuous

Start-up and restart after long

down time event

Start-up and restart and after

long down time event

At start-up, and after long

down time event

At start-up, and after long

down time event

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

Continuous

Start-up

Continuous

Continuous

Continuous

Continuous

Continuous
 Continuous

Continuous

Once every 8 hours*

Start-up, and restart after down

time event

End of run or long downtime

End of production or run

Start-up and once every 4

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

Per cavity, start-up and once

every 8 hours

Per cavity, start-up and once

every 8 hours

Per cavity, start-up and once

every 8 hours

B - Blow Molding

Once per lot

Once per lot

FIFO - per Lot

Shelf life - pull for use

Continuous monitoring by
controller or manual
verification daily

Continuous

Per container
Start-up and continuous by
controller

Start-up and once every 8

hours

Material change

Continuous by controller

Start-up and once every 8

hours

Once every 8 hours and at

every part change-over

Material change

Start-up

Material change

Start-up and continuous

Start-up and continuous

At color change

Start-up and restart after long

down time event

Start-up and restart and after

long down time event

Continuous by controller or
manual verification daily

Start-up and restart after long

down time event
Start-up and restart after long
down time event

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

Start-up

Start-up, and restart after down

time event

End of run or long downtime

End of production or run

Start-up and restart after long

down time event

Continuous

Continuous

Continuous

Start-up and once every 8

hours

Start-up and once every 4

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

Start-up and once every 4

hours

Start-up and once every 4

hours

Start-up and once every 4

hours

Start-up and once every 4

hours

Start-up and once every 24

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

C - Vacum Forming

Once per lot

Once per lot

FIFO - per Lot

Shelf life - pull for use

Continuous by controller or
manual verification daily

Continuous by controller or
manual verification daily

Continuous

Continuous

Start-up and restart after long

down time event
At start-up, and after long
down time event

At start-up, and after long

down time event

At start-up

At start-up

At start-up, and after long

down time event

At start-up, and after long

down time event

At start-up, and after long

down time event

At start-up, and after long

down time event

At start-up, and after long

down time event

At start-up, and after long

down time event

At start-up, and after long

down time event

At start-up and every 8 hours

 At start-up and every 8 hours

At start-up, and after long

down time event

At start-up, and after long

down time event

Start-up, and restart after down

time event

End of production or run

Per cavity, start-up and once

every 8 hours

Per cavity, start-up and once

every 8 hours

Per cavity, start-up and once

every 8 hours

Compression Molding

Once per lot

Once per lot

End of run or long downtime,
material change

At start-up, and after long

down time event, material
change

Hourly

Per production lot

Pull for use

Continuous and manually

verify daily

Pull for use

Every eight hours

Continuous

Per lot (just before use)

Start-up and restart after long

down time event
At start-up

At start-up, and after long

down time event

At startup and re-start

Each cycle

Each cycle

Each cycle

Continuous

Continuous

Each cycle

Start-up, and restart after down

time event

End of production or run

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

Per cavity, start-up and once

every 8 hours

Per cavity, start-up and once

every 8 hours

Per cavity, start-up and once

every 8 hours

- Transfert Molding

Once per lot

Once per lot

End of run or long downtime,

material change

Per production lot

FIFO - per Lot

Shelf life - pull for use

Continuous monitoring by
controller or manual
verification daily
Continuous monitoring (i.e., by
chart recorder)

Time stamp on container from

time out of cold storage to
when container is opened

Continuous monitoring by
controller or manual
verification

Continuous

Per Container

Start-up and restart after long

down time event

At start-up

At start-up, and after long

down time event

Continuous, at start-up and

after down time event.

Continuous

Continuous
Continuous

Continuous

Continuous

Continuous

Continuous

Continuous

Continuous

Continuous

Once every 8 hours*

Start-up, and restart after down

time event

End of production or run

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

Per cavity, start-up and once

every 8 hours

Per cavity, start-up and once

every 8 hours

Per cavity, start-up and once

every 8 hours

LE F - Extrusion

Once per lot

Once per lot

FIFO - per Lot

Shelf life - pull for use

Continuous monitoring by
controller or manual
verification daily
Continuous

Per Container

Start-up and continuous by

controller.

Start-up and once every 8

hours

Material change

Continuous by controller

Start up and once every 8

hours
Once every 8 hours and at
every part change-over

Material change

Material change

Start-up and continuous

Start-up and continuous

At color change

Start-up and restart after long

down time event

Start-up and restart after long

down time event

Start-up and restart after long

down time event

Start-up and restart after long

down time event

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

Start-up and continuous

Start-up and continuous

Start-up and continuous

Start-up, and restart after down

time event

End of run or long downtime

End of production or run

Per cavity, start-up and once

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

Per cavity, start-up and once

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

Per cavity, start-up and once

every 8 hours

Per cavity, start-up and once

every 8 hours
 CQI-23
Special Processes: Molding System Assessment
Version 1, 3/2014

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.

PROCESS TABLE G - Equipment- Process Control and Testing Equipment

Related Molding
System
Assessment Injection Blow Vacuum Compression Transfer
Item # Equipment Type Extrusion
Question # Molding Molding Forming Molding Molding

1.0 PROCESS EQUIPMENT

G1.1 2.14 Mold Temperature Controller X X X X X X

G1.2 2.14 Filters, if applicable X X X X X X

G1.3 2.14 Thermocouple X X X X X X

G1.4 2.14 Injection Mold Machine X

G1.5 2.14 Mold X X X X X X

G1.6 2.14 Blow mold machine X

G1.7 2.14 Vacuum molding machine X

G1.8 2.14 Compression molding machine X X

G1.9 2.14 Extrusion machine X

G1.10 2.14 Dryer X X X X

G1.11 2.14 Regrinder X X X

G1.12 2.14 Hot Runner Controller X

G1.13 2.14 Cavity Pressure Sensor X

G1.14 2.14 Hydraulic Pressure Transducer X X

Valve Gate Controller, if applicable

G1.15 2.14 X X

2.0 SECONDARY EQUIPMENT

Generic fixtures (cooling, heat forming,

G2.1 2.14 if applicable) X X X X

G2.2 2.14 Conveyers X X X X X X

G2.3 2.14 Degater/Trim Operation X X X X X X

G2.4 2.14 Cutter X

G2.5 2.14 Robot X X X X X

G2.6 2.14 Oven, if applicable X X X X

G2.7 2.14 Cooling Fan, if applicable X X

G2.8 2.14 End of arm tooling X X X X X

MINIMUM REQUIRED TESTING

3.0 CAPABILITY

G3.1 2.14 Cure Testing, if applicable X X

G3.2 2.14 Leak Testing, if applicable X X X

G3.3 2.14 Color X X

G3.4 2.14 Gloss X X

G3.5 2.14 Weight X X X

G3.6 2.14 Dimensions X X X X X X

G3.7 2.14 Moisture X X X X X X

G3.8 2.14 Performance, if applicable X X X X X X

 CQI-23
s: Molding System Assessment
Version 1, 3/2014

y molder is conforming to customer requirements.

Calibration /
Certification
Frequency * Included in Preventative
Verification Frequency Comment
Maintenance Plan

Once per shift N/A

Once per month or per preventive

maintenance N/A

Per Preventive Maintenance Annual

Per Preventive Maintenance Every 5 years

Per Preventive Maintenance N/A

Per Preventive Maintenance Every 5 years

Per Preventive Maintenance N/A

Per Preventive Maintenance N/A

Per Preventive Maintenance Every 5 years

Per Preventive Maintenance N/A

Per Preventive Maintenance N/A

Per Preventive Maintenance N/A

Per Preventive Maintenance N/A

Per Preventive Maintenance N/A

Per Preventive Maintenance N/A

Per Preventive Maintenance N/A

Per Preventive Maintenance N/A

Per Preventive Maintenance N/A

Per Preventive Maintenance N/A

Per Preventive Maintenance At Installation

Per Preventive Maintenance Annual

Per Preventive Maintenance Annual

Per Preventive Maintenance 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

At start up Every 6 months

Per Manufacturer Guidelines Every 6 months

Per Manufacturer Guidelines Annual

 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 confor
Note that not all tests are applicable to all molding processes.

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

Dimension, Weight, Appearance, Minimum Requirement

1.0 General

Dimensions

Appearance

Performance

1.4 Procedures are in place to prevent damage to the finish or part during the inspection
H1.1 2.9 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 First off by quality and 100% by
applications manual 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

Daily Production Meeting Review

H1.5 1.4 Manufacturing information

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

nspection and Testing

e auditor shall verify molder is conforming to specifications or other requirements.

onitoring Frequency Observation/Comments

Actual Condition (Pass / Fail / N/A)

79