QP-S100 Quality Program Review

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Presentation transcript:

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

S202a Inspection & Testing: Components & Raw Materials 1.0 Purpose: Define the major components in the assembly Outline means of inspection 2.0 Procedures address: List of acceptable/approved components Tolerance specifications and deviations Statement of material conformance Sampling of representative components for compliance evaluation

S202a 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

S202b 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

S202b Inspection & Testing: Finished Product Recommended sampling rate: Daily Production Number Inspected Up to 25 1 26-100 5 101-500 10 501-1000 15 Over 1000 20

S202a & b 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- 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 I think this needs to be expanded and include the terms from section 3.

QP-S205 Field Service

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-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 TM-4000 contain specific requirements.

2.0 List of Forms (a) Corrective Action Report QP-S203a (b) QC Inspection Form QP-207-1 (Two- Part Sealant) (c) QC Inspection Form QP-207-2 (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

Insulating Glass Manufacturing Quality Procedure Manual TM-4000-02(07) Section: QP-S204 STORAGE AND HANDLING 54

QP-S204: STORAGE AND HANDLING 1.0 PURPOSE 1.1 Control the handling of products and materials 1.2 Ensure material is moved or handled in a safe manner 1.3 Provide secure storage areas to prevent damage or deterioration 1.4 Preserve product integrity and product identification 1.5 Ensure product protection: after final inspection and test through delivery to the customer (where required) 55

QP-S204: STORAGE AND HANDLING 2.0 SCOPE Address all functional areas that have some responsibility for the movement, labeling or storage of materials 56

QP-S204: STORAGE AND HANDLING 3.0 GENERAL Establish documented procedures and work instructions for: Handling Labeling Storage Packaging Reservation Delivery of product To be in compliance with customer requirements or accepted commercial practice. 57

QP-S204: STORAGE AND HANDLING 4.0 PROCEDURES 4.1 Training Employees to know how to handle and transport products as part of their job introduction. 4.2 Handling Ensure against damage or degradation to: Incoming materials In-process materials Finished goods 4.3 Labeling Identity, source and date Use consistent label format Affix label securely 58

QP-S204: STORAGE AND HANDLING 4.0 PROCEDURES 4.4 Storage Store in a manner that ensures that material and product integrit Use designated storage areas (Bins, racks and shelves) protects product reduces damage improves identification and location of materials Document all procedures and work instructions Inspect stored product for damage/deterioration. (at least with each physical inventory) 4.5 Packaging Establish packaging procedures and work instructions in accordance with: contractual requirements internal requirements Use appropriate packaging materials to: prevent handling damage cushion normal transportation shock ensure the integrity of the product. 59

QP-S204: STORAGE AND HANDLING 4.0 PROCEDURES 4.6 Preservation Segregate and preserve materials/products against damage and deterioration Meet internal or customer requirements for preserving Control rotation of inventory to mantain appropriate shelf-life. 4.7 Delivery Select delivery methods and carriers to optimize: safe shipmen on-time delivery. Base transportation mode, carrier, and delivery instructions on: customer requirements other distribution requirements (requested delivery date, transportation lead-time, size and weight). select carriers who have proven records of on time delivery and damage free Protection is extended unti receipt by the customer. 60

QP-S204: STORAGE AND HANDLING 4.0 PROCEDURES 4.8 Work Instruction documents (examples) 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 61

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 thickness and durometer rubber pads are in place to receive and protect glass. 62

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?

What to Collect Verbal reports: QC department, managers, line supervisors and plant personnel…but anecdotal is not enough! Empirical evidence: Written reports, Inspection Forms, Statistical Analysis (variable control charts, spreadsheets, Pareto charts), Customer complaints.

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.

General Approach Establish target specifications. simply extract samples of a certain size from receiving, production, final inspection, shipping, in-field performance and customer feedback processes. 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 Verbal reports: QC department, managers, line supervisors and plant personnel…but anecdotal is not enough! Variable control charts, spreadsheets, visual observations derived from data gathered from processes, testing and inspection. Empirical evidence: Written reports, Inspection Forms, Statistical Analysis (variable control charts, spreadsheets, Pareto charts), Customer complaints.

Areas to Track Raw Material Receiving In-Process Inspections Final Product Inspection Field Performance Customer Complaints

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

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  IGCC-IGMA or 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