Quality Program Overview - Insulating Glass Manufacturers Alliance

QP-S100
Quality Program Review
Quality Program Overview
Provide a framework as a basis for an IG fabricator
specific program incorporating:
I. Process Control: detail best practice
procedures and work instructions for process
uniformity
II. Calibration: assure accuracy and uniformity of
quality inspection equipment
III. Inspection & Testing: procedures for
evaluation of incoming raw materials and
components and outgoing finished goods
IV. Non-Conforming Product & Corrective Action:
handling of non-conforming product and
materials and means to prevent reoccurrence.
Quality Program Overview
V.
VI.
VII.
VIII.
IX.
X.
Storage & Handling: procedures for proper
storage and handling of IG units
Field Service: gathering of customer information
useful for improving manufacturing procedures
(reports / visuals / audit forms, etc.)
Quality Audits: Ensure procedures in the quality
manual are followed and determine effectiveness
of the quality system.
Quality Control Forms: forms necessary to keep
proper records from each area of inspection.
Training: appropriate personnel and frequency
Statistical Techniques: how used to organize and
analyze information
Section 200 Process Control
1.0 Purpose
2.0 Procedure
• Unit Assembly
2.1 Unit Assembly
• Spacer assembly
• Glass Preparation
• Primary Sealant
Application
• Glass Spacer
Assembly
3.0 Unit Sealing
4.0 In Process Quality Checks
•
•
•
•
Sealant
Adhesion
Gunning vs. Toweling
Premature failure
prevention
• Glass breakage
prevention
• Material Parameters
• Application Rate
4.0 Process Quality Checks
•
•
•
•
•
•
•
Sealant bead shape
Sealant bead position
Pressing
Desiccant
Spacers
Glass
Visual Inspection
4.1 Sealant
• Visual Inspection
base & catalyst
• Ratio check for two
part
• Mixed Sealant
• Quality control checks
4.2 Adhesion
• Quality control checks
- Adhesion
4.3 Gunning vs. Troweling
4.4 Premature Failure Prevention
• Voids or skips in
sealant
• Corner fill
• Spacer / glass
Alignment
• Dirt / Contamination
• Desiccant
• Sealant Mix / Air
• PIB Placement
4.5 Glass Breakage
•
•
•
•
•
•
•
•
Edge quality
Spacer quality
Corner Keys
Muntin Bars
Spacer Profile
Lucor
Glass Deflection
Unit Separation
4.6 Material Parameters
• Amount of sealant
• Temperatures
• Pressures
4.7 Application Rates
• Spacer speed
• Variations
4.8 Shape of Sealant Bead
• Shape
• Cavities /
Depressions
4.9 Sealant Bead Position
4.10 Pressing
4.11 Desiccant
•
•
•
•
•
•
Desiccant testing
Spacer filling
Storage
Desiccant Types
Front Points
Record Keeping
4.12 Spacers
•
•
•
•
•
Accurate Cuts
Cleanlines
Handling
Coner Keys
Muntin Bars
4.13. Glass
•
•
•
•
•
•
Accuracy
Edge quality
Cleanliness
Handling
Stacking
Coated glass
4.14 visual Inspection
• Spacer / Glass
Alignment
• Corner Fill
• Sealant appearance
• Sealant depth
• Entrapped Air
• Sealant colorStacking
Units
5.0 Procedure
• Glass Washing Work
Instructions
• Hand Gunning Work
Instructions
• Additional Work
Instructions
5.1 Glass Washing Work
Instructions
•
•
•
•
•
•
Purpose
Responsibility
Definitions
Safety Equipment
Quality Checks
Work Instructions
5.2 Hand Gunning Work
Instructions
•
•
•
•
•
•
Purpose
Responsibilities
Definitions
Safety equipment
Quality checks
Work Instructions
QP-S201
Calibration
Purpose
The purpose of a calibration system is
to
assure
the
accuracy
and
maintenance of measuring and testing
devices used to determine the
acceptance
of
products
and/or
components. At it's core, a calibration
system is establishing traceability for
an instrument with unknown accuracy
to an instrument with a known
accuracy.
Responsibilities
A calibration system shall be implemented
to insure adequate accuracy of the
Measuring and Testing Devices (M&TD).
Such as system as a minimum shall include:
(a) Clearly identified personnel responsibility
(b) Procedures or work instructions
(c) Master report of all (M&TD) for identification and
status tracking
(d) Individual (M&TD) Identification labeling
Definition of Measurement
Standards
• New (M&TD) - Policies and procedures shall exist to
enter new devices into the calibration system prior to
use.
• Adequacy of Measurement Standards - Traceability
shall exist for each (M&TD) and the measurement
standards used in the calibration . This traceability
shall be to national or international standards, such
as National Bureau of Standards (NBS) now
National Institute of Standards And Technology
(NIST). Consideration shall be given to accuracy,
stability, range and resolution required for the
intended use.
Definition of Measurement
Standards
• Environmental Controls - Calibration equipment
should be located in an environment which assures
the equipment is not degraded by environmental
factors such as temperature, moisture, dust,
vibration.
Areas of Calibration
(a) Calipers
(b) Micrometer (Analog or Digital)
(c) Gauge Blocks (Shim)
(d) Scales - Weight (analog or digital)
(e) Pressure Gauges (Air-Hydraulic-Gas-Water;
Analog or Digital)
(f) Rulers and Tape Measures
(g) Vacuum Gauges (analog or Digital)
(h) Temperature Displays and Thermometers (Analog
or Digital)
(i) Test Equipment (Hardness tester, multi-meter, etc)
Interval of Calibration
The interval or frequency of calibration shall
be determined by appropriate responsible
parties in consideration of the calibration
standard used, instrument manufacturer's
recommendations, the intended use,
instrument history, and any regulatory or
contract requirement. In general calibration
frequencies of 6 or 12 months are frequently
used.
Work Instructions
Procedures or written instructions shall exist
for the calibration of (M&TD). These
procedures may be provided by equipment
manufacturers, government agencies,
published standard practices, outside
calibration vendors, or company personnel.
Work Instructions
Procedures shall include as a minimum:
(a) Manufacturer, model and ID number of the
(M&TD)
(b) Equipment necessary to perform the calibration
(c) Acceptable tolerance of the (M&TD)
(d) Acceptable accuracy of the measurement of
calibration standard
(e) Requirements of standards and equipment used
and dates for recalibration
(f) Written instruction of sufficient detail to assure a
calibration specialist can perform the function.
(g) Required data
Out-of-Tolerance Conditions
An operator or user of any (M&TD) shall
notify appropriate designated personnel of
any device suspected to be of unacceptable
accuracy. Action should then be taken to:
(a) Tag and isolate the device
(b) Forward the device to appropriate personnel for
corrective action
(c) Coordinate the acceptance, repair or destruction
of the device
(d) Assure the device remains clearly identified until
repaired, released or destroyed
Outside Calibration Source
(M&TD) may be calibrated by the company
or an outside source. An outside source
shall provide traceable calibrations to
national or international standards, such as
NIST. Certificates, reports and/or calibration
sheets must accompany the instrument and
be maintained on file by the company.
Calibration Status
All (M&TD) shall be labeled with a specific ID and
indicate the devices status. If a label on the device is
impractical alternate approaches may be used (label
the device container). Labels shall include:
(a) A distinct ID number
(b) Calibration date
(c) Calibration due date
(d) Any limitations of the (M&TD)
(e) Initials or signature of the person responsible for
the calibration
(M&TD) that are determined to be out-of-tolerance or
defective must be clearly identified as such.
Records
Records shall be maintained for each (M&TD) and shall
include:
(a) Description or ID of the device
(b)
(c)
(d)
(e)
(f)
(g)
Calibration interval
Date Calibrated
Identification of the calibration source
Calibration Procedure used
Calibration results (report)
Calibration action taken (returned to service, repaired,
destroyed)
(h) Certificate or report number
(i) Date to be recalibrated
QP-S202
Inspection and Testing
Inspection & Testing:
Components & Raw Materials
Purpose: to define the major components used in
the assembly of an IGU and to outline means of
inspection
Procedures address:
1. List of acceptable/approved components
2. Tolerance specifications and deviations
3. Statement of material conformance
4. Sampling of representative components for
compliance evaluation
Inspection & Testing:
Components & Raw Materials
Components & Materials include:
Sealants
Desiccant
Spacer
Glass
Insulating Gas
Inspection & Testing:
Finished Product
Daily inspection for workmanship of:
a)
b)
c)
d)
e)
f)
g)
h)
i)
Overall unit size & thickness
Alignment of glass lites
Cleanliness of airspace
Sealant bond to glass and at corners
Minimum vapor transmission path
Spacer position
Sealant uniformity
Sealant holes or underfills
Overall workmanship
Inspection & Testing:
Finished Product
Recommended sampling rate:
Daily Production
Up to 25
Number Inspected
1
26-100
5
101-500
10
501-1000
15
Over 1000
20
Inspection & Testing: General
 All inspection records to be maintained by
quality control designate for minimum 2 years
 All records to be made available to auditor upon
request
 Quality Control Forms used to manage
inspection records by component and finished
product
 Component Codes generic for IGMA/IGCC
Certification; manufacturer specific for IGMAC
QP-S205
Field Service
Insulating Glass Manufacturing
Quality Procedure Manual
TM-4000-02(07)
Section: QP-S204
STORAGE AND HANDLING
49
QP-S204: STORAGE AND HANDLING
• 1.0 PURPOSE
– 1.1 To control the handling of products and materials from the
point of receipt through storage, manufacturing and inventory,
until they are sent to their final destination.
– 1.2 To ensure material is moved or handled in a safe manner
that prevents damage or deterioration.
– 1.3 To provide secure storage areas to prevent damage or
deterioration of product pending use or delivery.
– 1.4 To preserve product integrity and product identification
during handling and storage.
– 1.5 To ensure that the product is protected after final inspection
and test and, where required, to protect the product through
delivery to the customer.
50
QP-S204: STORAGE AND HANDLING
• 2.0 SCOPE
– All functional areas that have some
responsibility for the movement, labeling or
storage of materials throughout the
manufacturing process should be addressed
in this procedure.
51
QP-S204: STORAGE AND HANDLING
• 3.0 GENERAL
– Documented procedures and work
instructions should be established and
maintained for handling, labeling, storage,
packaging, reservation and delivery of
product. These procedures and work
instructions should be developed to ensure
compliance with customer requirements or
accepted commercial practice.
52
QP-S204: STORAGE AND HANDLING
• 4.0 PROCEDURES
– 4.1 Training
• Employees are to be trained how to handle and transport
products as part of their job introduction by their supervisor.
– 4.2 Handling
• Materials are to be protected to prevent damage or
deterioration. Products including incoming materials, inprocess and finished goods are handled in a way that
ensures against damage or degradation of physical
characteristics. Materials and products are to be moved with
care to prevent damage that may result from handling.
– 4.3 Labeling
• Materials and finished products are to be properly labeled as
to identity, source and date. Labels are to be of a consistent
format to allow convenient use by all departments that may
handle the materials. They should be affixed in a manner
that will not come off during the expected storage time or in
normal transit.
53
QP-S204: STORAGE AND HANDLING
• 4.0 PROCEDURES
– 4.4 Storage
• Material and products should be stored in a manner that ensures that
material and product integrity will be maintained. Material and product
are held in designated storage areas. Bins, racks and shelves are
used to protect product, reduce damage and to improve identification
and location of materials. Procedures and work instructions should be
documented and maintained for documenting receipt and issue of
material or product from storage areas. Periodic inspections are
made on product held in storage areas to detect any damage or
deterioration. These inspections will be performed at a minimum with
each physical inventory.
– 4.5 Packaging
• Packaging procedures and work instructions should be established
and maintained in accordance with contractual and internal
requirements. Products should be packaged to protect against
physical damage during storage and shipment. Packaging materials
are used to protect products from handling damage and protect from
normal transportation shock and to ensure the integrity of the product.
54
QP-S204: STORAGE AND HANDLING
• 4.0 PROCEDURES
– 4.6 Preservation
• Materials and products should be segregated and
preserved against damage and deterioration as determined
by internal or customer requirements. Rotation of inventory
should be controlled to insure that materials are used within
the appropriate shelf-life.
– 4.7 Delivery
• Delivery methods and carriers are selected to optimize for
safe shipment and on-time delivery. The transportation
mode is based on customer requirements or best way
based on other distribution requirements (requested
delivery date, transportation lead-time, size and weight).
The specific carriers and delivery instructions are in
accordance with the customer requirements or selected
from carriers who have proven they can deliver on time and
without damage due to mis-handling. Where specified, the
product protection is extended to receipt by the customer.
55
QP-S204: STORAGE AND HANDLING
• 4.0 PROCEDURES
– 4.8 Work Instruction documents (selected
examples or areas to be included)
•
•
•
•
4.8.1 Raw material receipt and storage
4.8.2 Finished product labeling and storage
4.8.3 Warehouse organization
4.8.4 In-plant handling and operation of fork-lift
equipment
• 4.8.5 Proper loading and unloading of trucks
• 4.8.6 Traffic planning and shipping
56
QP-S204: STORAGE AND HANDLING
• 4.0 PROCEDURES
– 4.9 Example document
• 4.9.1 Raw material receipt and storage
• 4.9.1.1 Inspect for material conformance, quality, damage,
etc. according to established Quality Control procedures.
• 4.9.1.2 Label as required.
• 4.9.1.3 Add material to inventory as required.
• 4.9.1.4 Move to assigned storage area following established
handling and safety procedures.
• 4.9.1.5 Assure that racks, shelving, etc. are in compliance to
receive materials to prevent damage. Example: Proper
durometer rubber pads are in place and have proper
thickness remaining to receive and protect glass.
57
QP-S206
Quality Audits
QP- 203
Non-Conforming Product and Corrective Action
1.0 Purpose
 Specify how non-conforming materials are identified, documented, controlled and disposed
 Corrective action is initiated to prevent recurrence
2.0 Scope
 Materials purchased, manufactured or returned by customer
4.0 Procedures
 Red-tagging for identification and disposition
 Recording, Reporting and Review of findings
5.0 Corrective action to prevent recurrence
QP 203a Forms
QP- 206
Quality Audits
1.0 Purpose
 To ensure the procedures in the Quality Manual are being followed and determine the adequacy of the Quality
System and Procedures
2.0 Scope
 All areas related to Quality, Procedures and Work Instructions
4.0 Definition
 Quality Audit – documented activity performed in accordance with written procedures or check lists to verify by
examination and evaluation of objective evidence that the program has been developed and implemented
5.0 Procedures
Selection of audit team
 Training of auditors
 Audit plan – Frequency and coverage
 Audit reports and audit reviews
5.9 Forms
QP-S207
Quality Control Forms
The core concept of a quality system is:
"Say what you do ... do what you say ...
and be able to prove it."
Quality Control Forms are the "and be able
to prove it" portion of a quality system.
Purpose
IGMA TM-4000-02(07) provides examples of
forms that can be used to document actions
taken in the quality system (i.e.
documentation of inspection and testing).
The information to be listed on QC forms will
vary with the application and specific details
of the quality system. Other sections of TM4000 contain specific requirements.
List of Forms
(a)
(b)
(c)
(d)
(e)
Corrective Action Report QP-S203a
QC Inspection Form QP-207-1 (TwoPart Sealant)
QC Inspection Form QP-207-2
(Desiccant)
QC Inspection Form QP-207-3
(Gas Fill Inspection)
Customer Complaint Form
Product and Component Inspection & Testing Forms
In general, the following information shall be included:
(a) Company and Plant identifier
(b) Production line (if applicable)
(c) Date of Inspection or test
(d) Initials or signature of responsible party
(e) Batch, serial, pallet or lot number or identifier
(f) Product or component discription
(g) Data to be taken (Temperature, pressure, force,
physical measurement, observation)
(h) Acceptance criteria (What is pass and what is fail)
(i) Conclusion and Disposition (pass/ fail and any
action taken)
(j) Comments and indication of supervisory review
Section 209 Training
1.0 Purpose
2.0 Scope
3.0 Responsibility
4.0 General
5.0 Procedure
• Training
Requirements
5.1Training Requirements
• Managers and
Supervisors
• New requirements
• Training Curriculum
5.2 Training
• Mangers and
Supervisor Role
• Work Experience
• Methods
• Frequency
• Qualification
6.0 Evaluation
• Managers and
Supervisor evaluation
• Training Records
7.0 Training Records
• Human Resources
• Record Contents
8.0 Reference Documents
• Department Forms
QP-S209 Statistical
Techniques
First Law of Statistics
Statistics Lie!
• Is the sample size tested or inspected representative of
daily production?
• Is the data that is being collected relevant to your
processes?
• Collected data is not enough!
• What is the data telling you?
Quality…How Do You Know?
• Verbal reports: QC department, managers,
line supervisors and plant personnel…but
anectodal is not enough!
• Empirical evidence: Written reports,
Inspection Forms, Statistical Analysis
(variable control charts, spreadsheets,
Pareto charts), Customer complaints.
Quality is Everyone’s
Responsibility!
• Quality Control Department, Line
Managers, Supervisors, Plant Personnel.
Everyone can collect data!
• Raw Material Receiving
• In-Process Evaluations
• Final Product
Purpose
• To ensure consistent quality and
appropriate process control through the
use of statistical techniques.
• To collect, analyze and interpret data
relating to product and process
characteristics.
• To identify problem areas to reduce
returns and warranty claims.
• Assist in conducting root cause analysis
for problem areas.
Purpose
• The general approach to on-line quality
control is straightforward: simply extract
samples of a certain size from the ongoing receiving,
production, final inspection, shipping, in-field
performance and customer feedback processes. Line or
variable control charts of the variability in those samples
will identify product specification compliance, and
consider their closeness to target specifications. If a
trend emerges in those lines, or if samples fall outside
pre-specified limits, then the process is deemed to be
out of control and action is required to find the cause of
the problem.
Tools
• Variable control charts, spreadsheets,
visual observations derived from data
gathered from processes, testing and
inspection.
• Identification of special causes of variation
or deviation from the required
specification.
• Identify sources of product variation and
group into two major causes: common and
special causes.
Test of Inspection
Name
Responsibility
Data Type
Examples
Raw material
receiving
QC or designated
personnel
Test values
Visual
Components such
as connectors,
spacers, desiccant,
sealants etc.
Damaged
containers
In-Process
evaluations
QC or designated
personnel
Test values
Visual
Water
temperature,
Cutting Wheels,
Component
Testing (ie sealant
adhesion)
Final product
QC or designated
personnel
Visual
Skips and gaps in
sealant
Field Performance
After Sales Service
and QC
Written Inspection
Reports
Verbal reports
Seal failure,
volatile fogging
Customer
Complaints
After Sales Service
and QC
Verbal and
electronic
Delivery delays,
seal failures,
Raw Material Receiving
• Maintain Raw Material Log: date received,
component received, manufacturer identification, lot
tracking numbers (if applicable), condition of packaging
material, condition of material – conforming or
nonconforming to specifications
• Variable Control Charts: used to evaluate
variation in a product where the measurement is a
variable--i.e. the variable can be measured on a
continuous scale (e.g. height, weight, length,
concentration).
Variable Control Charts
• The general principle for
establishing control limits
applies to all control charts.
After deciding on the
characteristic you want to
control, for example, the
standard deviation
(acceptable upper and lower
limits within the
specification), you estimate
the expected variability of
the respective characteristic
in samples of the size.
Those estimates are then
used to establish the control
*
*Center line indicates product conforms to
required specifications. UCL and LCL
indicate upper and lower data points for
acceptable product.
Raw Material Receiving
• Sampling: Determine how much needs to be tested
which will be representative of the entire lot or batch.
• Nonconforming Product: Identify nonconforming
product, is the nonconforming product within tolerance or
acceptable levels?, isolate it so it will not be used if
outside of accepted specification, contact manufacturer
of product.
• Isolated or Repetitive Issue?: Variable control
chart will indicate if nonconforming product is an ongoing
or isolated issue.
In-process Inspections
• Designated plant personnel: collect data and
complete forms such as seal adhesion, desiccant
capacity, was spacer stored properly, cut glass sizes,
gas content verification, etc.
• Variable Control
Charts: monitor the
extent to which the
components that are used
to fabricate your products
meet specifications.
In-process Inspections
• Quality Control Forms: The following
information is required for each insulating
glass unit tested:
•
•
•
•
•
•
•
•
•
Length
Width
Position of spacer
Glass thickness
Airspace
Glass Edges
Primary and secondary sealant
Glass coatings
Percentage gas fill required and achieved
Final Product Inspection
• Data is collected from an appropriate
sample size based on your production; the
suggested number of finished units to be inspected shall
be randomly selected as determined from the following:
ProductionNumber Inspected
•
•
•
•
•
up to 25
26-100
101-500
501-1000
over 1000
1
5
10
15
20
Final Product Inspection
Each day representative samples shall be
inspected for workmanship for at least the
following characteristics:
•
•
•
•
•
•
•
•
•
Overall unit size and thickness.
Alignment of glass lites.
Cleanliness of airspace.
Sealant bond to glass and to itself at corners.
Sealant minimum vapor transmission path.
Spacer position (sight line) relative to the unit edge.
Uniformity of sealant application.
Possibility of holes or underfills.
Overall workmanship in finished units or windows.
Final Product Inspection
• Data is collected on a random basis:
representative samples are selected which
will represent the daily production.
• Pareto Charts: are useful for non-numeric data,
such as "cause", "type", or "classification". This tool
helps to prioritize where action and process changes
should be focused. If one is trying to take action based
upon causes of accidents or events, it is generally most
helpful to focus efforts on the most frequent causes.
Going after an "easy" yet infrequent cause will probably
not reap benefits.
Pareto Charts
• A Pareto Chart is generally shown as a vertical bar chart.
A Pareto Chart is a special form of a histogram where
the categories have been sorted from most frequent to
least frequent. One would not want to sort the categories
from most frequent to least frequent if there is a natural
order to the categories, such as a distribution by age or
cycle time.
Pareto Charts
Trend Exists on
Control Chart?
Data Points Used
Purpose
No
Use all data in the
applicable or relevant
statistical time period
To find common
causes(s) to apply to
process improvement
Yes
Use only the data for the
Point(s) which have
been identified as within
the significant trend,
such as a point outside
the control limits.
To find special cause(s)
for the determination of
corrective actions for
trends of decreased
compliance or identify
successful corrective
actions which have
resulted in increased
product compliance.
Final Inspection
• Data is prioritized based on company
quality control requirements and
specifications.
• Data is reviewed by all! (management, line
supervisors and plant personnel)
• Data which identifies that the level of
product rejection is above the established,
acceptable levels in sent to facility
management for review, discussion and
action.
Conclusion
• It’s not enough to collect data!
Data is
meaningless unless it is reviewed, analyzed (what is it
telling you) and acted upon.
• Collect the right data and the right amount
of data! One data point does not provide you with
enough information to determine if a component or
product conforms to specifications.
• Don’t assume you know the cause of a
problem!
• Statistical analysis can help you control
nonconforming components and products.
QP-S210
References
Quality Documents
•ISO 9001-1994 Quality Systems – Model for Quality
Assurance in Design, Development, Production and
Installation And Servicing
• ISO 9002-1994 Quality Systems – Model for Quality
Assurance in Production, Installation and Servicing
• ISO 9003-1994 Quality Systems – Model for Quality
Assurance in Final Inspection and Test
• ANSI/ASQO Q9003-1994 Quality Systems – Model for
Quality Assurance in Final Inspection and Test
• IGMAC Certification Program Manual
IGMA Test Methods
•Test Methods for IG Unit Sealants
•IGMA Recommended Voluntary In-Plant Test
Methods And Performance Criteria for Desiccants for
Sealed Insulating Glass Units
• IGMA Voluntary Test Methods and Voluntary
Performance Quality Assurance Criteria for Spacers
for Sealed Insulating Glass Units
• IGMA Voluntary Test Methods and Voluntary
Performance Quality Assurance Criteria for Two
Component Polysulfide Sealants Used in
Manufacturing Sealed Insulating Glass Units
Related Documents
• E2188 Standard Test Method for Insulating Glass
Unit Performance
• E2189 Standard Test Method for Testing
Resistance to Fogging in Insulating Glass Units
• E2190 Standard Specification for Insulating Glass
Unit Performance and Evaluation
• AAMA documents: Glazing Sealants
• IGMA Sealant Siteline Survey