A QA/QC manual must be developed for each installed CEM system. The QA/QC manual must describe a complete program of activities to be implemented to ensure that the data generated by the CEM system will be complete, accurate, and precise. The manual must include the QA/QC procedures specified in Table B-1.
Table B-1 Table of Contents for the Quality Assurance/Quality Control Manual
| Subsection | Contents |
|---|---|
| Quality assurance policies and system descriptions | |
| 1 Quality Assurance Goals and Objectives | Specific system goals relating to precision, accuracy, and completeness. Emission standards and emission reporting requirements. |
| 2 CEM System Description and Design Considerations | Detailed system description, including principles of operation, sample location layout, flow and temperature measurement, sample conditioning system, analyzer layout, CEM shelter, and data handling system. Design considerations and engineering evaluation of CEM system options, including sample location, extractive vs. in situ, flow monitoring, and supplier. Includes a detailed list of CEM system component serial and model numbers. |
| 3 Exceptions/Clarifications/ Alternative Methods | Any exceptions/clarifications or alternative methods relating to this document or reference test methods. |
| 4 Organization and Responsibilities | Description of the organization of personnel involved with the CEM system and its quality system. Defines the roles and responsibilities of the personnel involved as related to CEM system operation and maintenance, control of documents/records, and control of data. |
| 5 Calibration and Quality Control Checks | Description of the calibrations and QC checks that are performed on a routine basis, generally daily, to determine whether the system is functioning properly. Includes daily zero and calibration checks and visual checks of system operating indicators, such as vacuum and pressure gauges, rotameters, analyzer displays, LEDs, and so on. |
| 6 Data Acquisition and Analysis | Description of the data acquisition system and analysis program. Includes references to data completeness, validation, reporting, storage, and revision management. Includes roles and responsibilities of the personnel involved in the data handling. |
| 7 Preventative Maintenance Policy | Description of the CEM system preventative maintenance program, including how preventative maintenance scheduling is determined and maintained along with roles and responsibilities of the personnel involved. |
| 8 Corrective Action Program | Description of the policies for correcting any CEM system non-conformance. Parameters such as CEM system downtime/reliability should be addressed. Roles and responsibilities of the personnel involved in the corrective action program. |
| 9 Performance Evaluations/Audits | Description of the policies and specifications for performance evaluations/audits (i.e., stack quarterly audits and RATAs). Describe the action necessary to ensure that the appropriate evaluations are carried out on the appropriate schedule. |
| 10 Document Control System | Description of the policies and systems used to control all the documents that form part of the CEM system's quality system. Lists how and where the related documents are located, how they are reviewed and revised, and how they are approved for use by authorized personnel prior to issue. |
| 11 Reports and Records | Description of all reports and records collected including method of collection, person responsible, data storage location, data security, data distribution, and length of data storage. |
| 12 Modifications and Upgrades | Description of the policies regarding modifications and upgrades to the CEM system. |
| 13 Training and Qualification Policy | Training and qualification policy for CEM system maintainers, CEM system coordinators, computer and programming technicians, data validators, quarterly audit and RATA testers. Includes educational and experience requirements, on-the-job training, job shadowing, and classroom training requirements. |
| 14 References | References for QA/QC plan. |
| Quality control (standard operating) procedures | |
| 1 Startup and Operation | Lists in detail complete, step-by-step procedures for the startup and operation of the CEM system. |
| 2 Daily CEM System Operation and Inspection | Detailed description of daily routine operation and inspection of the CEM system. Includes descriptions of equipment and data validation procedures and examples of daily equipment checks and/or logbook entries. |
| 3 Daily and Manual Calibration Procedures | Lists in detail complete, step-by-step procedures for daily and manual calibrations. References to specific OEM documentation/manuals are acceptable. Includes schedule for manual (midpoint) calibration, if done. |
| 4 Gas Bottle Check Procedures | Description of procedure to cross-reference cylinder gases. Gases can be cross-referenced to previous gas bottles and quarterly bottles. Specifications for rejection of gas bottle to be stated. |
| 5 Preventative Maintenance Procedures | Detailed description of the CEM system preventative maintenance procedures along with the preventative maintenance schedule. |
| 6 Spare Parts List and Inventory Procedures | Detailed descriptions of the spare parts inventory available for the CEM system, along with a description of the procedures for obtaining spare parts from inventory and ensuring that the spare parts inventory is maintained. |
| 7 Corrective Maintenance Procedures | Detailed descriptions of the non-routine maintenance that is performed when the system or part of the system fails. References to specific OEM documentation/manuals are acceptable. |
| 8 Data Backfilling Procedures | Procedures for data backfilling when a CEM system is not available. Data backfilling algorithms to be based on process variables. |
| 9 Data Backup Procedures | Procedures for regular backup of data in hard or soft copy. |
| 10 Data Quality Assessment Procedures | Procedures to identify suspected data. Includes automatic flagging of a) out-of-range concentrations and flows, b) abnormal system calibration response times, c) abnormal flow-to-input or flow-to-output levels, and d) abnormal concentrations during periods when the EGU burned no fuel. |
| 11 CEM System Security | Includes security actions for CEM equipment software and data. |
| 12 Data Approval and Reporting Procedures | Procedure for approval and reporting of CEM data. Includes any systems for review, modifications, approval, summary, and release of data. |
| 13 Quarterly Audit Procedures | Detailed procedures on conducting quarterly audit procedures. Includes roles and responsibilities, gas bottle requirements, scheduling, and test methods. |
| 14 Semiannual Relative Accuracy Test Audit Procedures | Detailed pretest sampling plan for executing RATAs. Pretest plan to include organization plan, sampling points, scheduling, test methods, calibration requirements, reporting schedule, reporting format, and site safety plan. |
| 15 Bias Procedures | Describes process of assessing and correcting for bias. Includes roles and responsibilities for assessing and approving bias factors. |
| 16 Annual System Audit Procedures | Describes procedure for annual system audit. Includes selection of auditor, scheduling, audit plan, and reporting. |
| 17 Managing Change | Procedure for managing change when upgrades are required due to failure of equipment, changes in regulation, changes in system management. Includes approval process for accepting changes with roles and responsibilities. Addresses replacement of CEM systems. |
| Appendices 1 CEM System Specifications 2 Reference Method Procedures 3 Blank Forms |
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