QP-S100 Quality Program Review

QP-S100 Quality Program Review

Quality Program Overview
Provide a framework as a basis for an IG fabricator specific program incorporating: Process Control: detail best practice procedures and work instructions for process uniformity Calibration: assure accuracy and uniformity of quality inspection equipment Inspection & Testing: procedures for evaluation of incoming raw materials and components and outgoing finished goods Non-Conforming Product & Corrective Action: handling of non-conforming product and materials and means to prevent reoccurrence.

Quality Program Overview
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

1.0 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.

2.0 Responsibilities A calibration system shall be implemented to insure adequate accuracy of the Measuring and Testing Devices (M&TD). Such a 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

3.0 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. 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. 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.

4.0 Areas of Calibration Calipers Micrometer (Analog or Digital)
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) Test Equipment (Hardness tester, multi-meter, etc) 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.

5.0 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. 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

6.0 Out-of-Tolerance Conditions
Any M&TD suspected to be of an unacceptable accuracy shall be Tag and isolate, forwarded to appropriate personnel for corrective action, and then accepted, repaired or destroyed. 7.0 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.

8.0 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.

9.0 Records (a) Description or ID of the device
Records shall be maintained for each M&TD and shall include: (a) Description or ID of the device (b) Calibration interval (c) Date Calibrated (d) Identification of the calibration source (e) Calibration Procedure used (f) Calibration results (report) (g) 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: List of acceptable/approved components Tolerance specifications and deviations Statement of material conformance Sampling of representative components for compliance evaluation

Inspection & Testing: Components & Raw Materials
Components & Materials include: Sealants: primary and secondary Desiccant Spacers and connectors Glass Insulating Gas Not necessarily everything that could be inspected. Ie. muntins and other airspace material

Inspection & Testing: Finished Product
Daily inspection for workmanship of: 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 Number Inspected Up to 25 1 26-100 5 10 15 Over 1000 20

Inspection & Testing: General
In consideration of regulatory requirements a policy shall be established for the retention of quality control records. All records to be made available to auditor upon request Use Quality Control Forms to manage inspection records of component and finished product Component Codes generic for IGCC/IGMA 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

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.

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.

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.

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, in-process 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.

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.

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.

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

4.0 PROCEDURES 4.9 Example document 4.9.1 Raw material receipt and storage Inspect for material conformance, quality, damage, etc. according to established Quality Control procedures. Label as required. Add material to inventory as required. Move to assigned storage area following established handling and safety procedures. 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.

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 2.0 Scope 4.0 Definition
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
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.

1.0 Purpose IGMA TM (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 TM-4000 contain specific requirements.

2.0 List of Forms (a) Corrective Action Report QP-S203a
(b) QC Inspection Form QP (Two- Part Sealant) (c) QC Inspection Form QP (Desiccant) (d) QC Inspection Form QP-207-3 (Gas Fill Inspection) (e) Customer Complaint Form

3.0 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 description (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 Water temperature, Cutting Wheels, Component Testing (ie sealant adhesion) Final product Skips and gaps in sealant Field Performance After Sales Service and QC Written Inspection Reports Verbal reports Seal failure, volatile fogging Customer Complaints Verbal and electronic correspondence Delivery delays, seal failures, volatile fogging, after sales service

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 limits on the chart. * *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: Production Number Inspected up to 25 1 over

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.

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.

Trend Exists on Control Chart?
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 Quality Systems – Model for Quality Assurance in Design, Development, Production and Installation And Servicing ISO Quality Systems – Model for Quality Assurance in Production, Installation and Servicing ISO Quality Systems – Model for Quality Assurance in Final Inspection and Test ANSI/ASQO Q 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 ASTM E2188 Standard Test Method for Insulating Glass Unit Performance ASTM E2189 Standard Test Method for Testing Resistance to Fogging in Insulating Glass Units ASTM E2190 Standard Specification for Insulating Glass Unit Performance and Evaluation AAMA documents: Glazing Sealants IGMA Sealant Siteline Survey

QP-S100 Quality Program Review

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