HVAC Installation QualificationProtocol Protocol No. Installation Qualification Protocol Title: HVAC Company X Effective Date Revision # APPROVAL PAGE System HVAC Location Company X, Inc., Address Protocol Prepared By: Name/Title Signature Date Signature Date Protocol Reviewed By: Name/Title 1 Protocol Technical Reviewed By: Name/Title Signature Date Signature Date Protocol Approved By: Name/Title Table Of Contents 1.0 SYSTEM OVERVIEW 2.0 SYSTEM BOUNDARY 3.0 OBJECTIVE 4.0 SCOPE 5.0 QUALIFICATION STUDY OVERVIEW 6.0 RESPONSIBILITY 7.0 PREREQUSITES 8.0 ACRONYMS 9.0 DEFINITIONS 10.0 GENERAL DOCUMENTATION REQUIREMENTS 11.0 DATA COLLECTION AND DOCUMENTATION PROCEDURES 12.0 INSTALLATION QUALIFICATION TEST REQUIREMENTS 13.0 REFERENCES Index Of Attachments ATTACHMENT 1 – Personnel Identification List ATTACHMENT 2 – Test Equipment Identification/Calibration ATTACHMENT 3 – Test Equipment Operation ATTACHMENT 4 – Equipment / Component Verification ATTACHMENT 5 – Utilities Verification ATTACHMENT 6 – Support Documentation - Equipment/System Specifications ATTACHMENT 7 – Support Documentation - Submittals ATTACHMENT 8 – Support Documentation – Purchase Orders ATTACHMENT 9 – Support Documentation – Equipment Manuals ATTACHMENT 10 – Support Documentation - Equipment/System Drawings ATTACHMENT 11 – Support Documentation - Equipment/System Standard Operating Procedures ATTACHMENT 12 – Support Documentation - Equipment/System Calibration Procedures ATTACHMENT 13 – Support Documentation - Equipment/System Calibration Program ATTACHMENT 14 – Maintenance - Spare Parts List ATTACHMENT 15 – Maintenance - Lubricant Verification 1.0 SYSTEM OVERVIEW History The AHU-6 and MAU-1 HVAC system includes Air Handling Unit (AHU-6) and Make Up Air Unit (MAU-1). AHU-6 was purchased from York International in October 1994. AHU-6 was designed and installed to supply recirculating air to rooms: 123–125. MAU1 was purchased as part of the building and operated to supply make up air to the AHU6 and rooms 120-125, 111, 113, 114, 117, 118,and both service corridors. Description The major equipment / components of the AHU-6 and MAU-1 HVAC system include Air Handler Unit AHU-6, Make Up Air Unit MAU-1, Humidifier H-1, twelve (12) reheat coils RHC-1-RHC-9 and RHC-19 – RHC-21 and fourteen (14) exhaust fans EF-1 - EF-12, and EF-15 - EF-17. AHU–6 is a recirculating air handling unit, which provides a constant volume of airflow to rooms 123,124, and 125. It is equipped with a Pre Cooling coil, Preheat coil and 65% efficiency air filters. AHU-6 provides airflow using outside air from MAU-1 mixed with return air. MAU-1 provides conditioned air to rooms 111, 113, 114, 117, 118, and 120-125 utilizing 100% outside air. It is equipped with one (1) reheat coil and two (2) cooling coils. It has 35% efficiency pre-filters and 95% efficiency bag filters, it also utilizes eleven (11) Variable Air Volume controllers VAV-A, B, C, D, E, F, G, H and VAV-j, K and L. one (1) Steam Humidifier H-1 located in the supply air duct downstream from MAU-1 provides humidification The system is designed to provide personnel comfort. Performance criteria for the system are: Temperature: 70°F ± 5°F Humidity: 20-80% R.H. Rationale This protocol will be performed utilizing 21 CFR 210 & 211, ICH Q-7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients, August 2001,. Upon final approval of this IQ Protocol and Summary Report it will replace the previous IQ study and render it obsolete. The system will also be placed under formal change control in accordance with Company XChange Control Program summarized in Standard Operating Procedure DNAP/QM/012 entitled “Change Control System”. 2.0 SYSTEM BOUNDARY The system boundary is defined as the supply utility service first point of contact with the system/equipment being installation qualified. In most cases this is interpreted as the first inlet manual valve or motor control/electrical panel providing supply of said utility. Supplied Utilities ID Number Description Compressed Instrument Air Inlet at respective valve Supply air to all applicable pneumatic valves on the AHU-6 Compressed Instrument Air Inlet at respective valve Supply air to all applicable pneumatic valves on the MAU-1. Chilled Water InAHU-6 CHWS-18 Supply to Cooling Coil- Chilled Water OutAHU-6 CHWR-19 Return from Cooling Coil Hot Water In-AHU-6 HWS-2 Supply to hot water coil- Hot Water Out-AHU-6 HWR-2 Return from hot water coil Low Pressure Steam Out-MAU-1 To Be Field Verified Return from steam reheat coil Low Pressure Steam In-MAU-1 To Be Field Verified Supply to steam reheat coil- Chilled Water OutMAU-1 To Be Field Verified Return from cooling coil Hot Water In-RHC-1 To Be Field Verified Supply to hot water coil .Low Pressure Steam Inlet at respective valve Supply to appropriate inlets of H-1 Compressed Instrument Air Inlet at respective valve Supply air to all applicable pneumatic valves on all VAV boxes: 19.19-21. Hot Water Out-RHC-1 To Be Field Verified Return from hot water coil Hot Water In-RHC-2 Supply to hot water coil To Be Field Verified Hot Water Out-RHC-2 To Be Field Verified Return from hot water coil Hot Water In-RHC-3 Supply to hot water coil To Be Field Verified Hot Water Out-RHC-3 To Be Field Verified Return from hot water coil Hot Water In-RHC-4 Supply to hot water coil To Be Field Verified Hot Water Out-RHC-4 To Be Field Verified Return from hot water coil Hot Water In-RHC-5 Supply to hot water coil To Be Field Verified Hot Water Out-RHC-5 To Be Field Verified Return from hot water coil Hot Water In-RHC-6 Supply to hot water coil To Be Field Verified Hot Water Out-RHC-6 To Be Field Verified Return from hot water coil . Hot Water In-RHC-7 To Be Field Verified Supply to hot water coil Hot Water Out-RHC-7 To Be Field Verified Return from hot water coil Hot Water In-RHC-8 Supply to hot water coil To Be Field Verified Hot Water Out-RHC-8 To Be Field Verified Return from hot water coil Hot Water In-RHC-9 Supply to hot water coil To Be Field Verified Hot Water Out-RHC-9 To Be Field Verified Return from hot water coil Hot Water In-RHC-19 To Be Field Verified Supply to hot water coil Hot Water Out-RHC19 Return from hot water coil To Be Field Verified Hot Water In-RHC-20 To Be Field Verified Supply to hot water coil Hot Water Out-RHC20 Return from hot water coil To Be Field Verified Hot Water In-RHC-21 To Be Field Verified Supply to hot water coil . 0 OBJECTIVE The intent of this Installation Qualification (IQ) is to provide a complete inventory of major equipment and/or components installed on the HVAC AHU-6 and MAU-1 system and to ensure that: Major components are those as specified in system manuals. original purchase orders or approved equivalents. These major components will be verified during execution of this protocol.Hot Water Out-RHC21 To Be Field Verified Return from hot water coil Chiller-1 To Be Field Verified Outlet to respective Valve Chiller-2 To Be Field Verified Outlet to respective Valve Chiller-3 To Be Field Verified Outlet to respective Valve Hot Water Boilers (7) To Be Field Verified Outlet to respective Valves Low pressure Steam Boilers (10) To Be Field Verified Outlet to respective Valves Electrical AHU-6 Main Breaker Supply to Unit Electrical MAU-1 Main Breaker Supply to Unit 3. . contractors’ submittals. All critical instruments are calibrated and placed within the calibration program as defined in MF/SOP/178. System or equipment cleaning procedures are established and current. and approved Standard Operating Procedures. Company X will calibrate all instrumentation requiring calibration with traceability to NIST and certificates of calibration provided to AAC for inclusion in the applicable section of this protocol.. regulatory requirements.0 RESPONSIBILITY 6. Inc. .0 QUALIFICATION STUDY OVERVIEW During the execution of this protocol. Required spare parts are identified System or equipment maintenance requirements are clearly defined and documented and are placed in the Preventative Maintenance Program as defined in MF/SOP/179. humidity and air/water pressure.0 SCOPE This protocol will be limited to the HVAC AHU-6 & MAU-1 System at Company X. Inc. Operation manuals for the system or equipment are identified and available. The operation is monitored through the use of the Metacomm system as a Building Management System (BMS).1. 4. determination of the calibration frequencies and formalized procedures will be provided to AAC Consulting Group. As-built drawings reflect the actual installation of the system or equipment installed on (HVAC AHU-6 and MAU-1 system). Inc. Metasys VAV Controllers are provided for the control of each VAV box. Lubricants will be identified and evaluated for acceptability during execution of this protocol.1 Validation Department: 6.1 Prepare and submit the protocol for approval in accordance with current industry standards. The Operational Qualifcation of this system will be performed in accordance with protocol # MF/VAL/OQ/013/PRO entitled “Operational Qualification of HVAC AHU-6 and MAU-1 System. Address 5. 6. (AAC) by Company X. as part of the Computer System Validation (CSV). The operation of AHU-6 and MAU-1 are controlled by Johnson Controls’ Metasys Air Handling Unit Controllers with sensors monitoring air/water temperature. The BMS control system will be qualified in a separate protocol. 6.2 Assist in the performance of the execution of the test protocol and recording/analysis of the test results.4 Assist in the preparation of a final report and provide input as to the conclusions summarizing the study and submit to Company Xmanagement for review and approval. 6.4.3 Review deviations and support the preparation of all corrective action reports that may be required to resolve discrepant situations.4 Review and approve the final report. 6.6.2.4 Engineering and/or Facilities Department: 6.3.1 Review and approve the test protocol.4 Prepare and/or coordinate the preparation of a final test report analyzing and summarizing the data and submit for review and approval. 6.3. USFDA standards and guidelines.3 Assist in the preparation of deviation reports and recommend corrective actions to resolve discrepant situations that may arise during execution of the test protocol.1.2. 6.3.2 AAC Consulting Group: 6. 6.2.5 Quality Assurance: . 6.3 Provide equipment that has been commissioned and functional as specified by Site Acceptance Test Report.3. 6. industry. 6.2. and Company Xapproved Standard Operating Procedures.3 Assist in preparation of deviation reports and recommend corrective action to resolve discrepant situations that may arise during execution of the protocol. Provide expert review of the finished protocol and procedures. 6. 6.4.4 Provide assistance in evaluating and resolving equipment malfunctions that may be encountered during execution of the protocol. 6.1. 6.4.2 Provide documentation required for the generation and execution of the protocol.1 Review and approve the test protocol.2 Provide qualified personnel to assist with the execution of the protocol and the collection of samples.4. 6.2 Perform and coordinate the execution of the protocol and recording of all raw data.1 Provide technical input into the preparation of the test protocol in accordance with cGMPs.1. 6.3 Manufacturing: 6. 3 Review and approve the final report.5. 7. 6.6. cGMPs. 8. Ventilating.0 PREREQUSITES All Standard Operating Procedures required for the execution of this IQ such as maintenance and calibration of the equipment undergoing IQ must be approved before the IQ Final Report can be approved.2 Review deviations and support preparation of corrective action reports that may be required to resolve discrepant situations.1 Review and approve the test protocol in accordance with the approved SOPs. 6.0 ACRONYMS AHU Air Handling Unit AL Airlock CGMP current Good Manufacturing Practice CPH Changes per hour CAV Control Air Volume Boxes EWT Entering Water Temperature GPM Gallons Per Minute HEPA High Efficiency Particulate Air HVAC Heating.5. and current industry guidelines. and Air Conditioning IWG Inches of Water Gage LAT Leaving Air Temperature .5. and Balancing VAV Variable Air Volume (Dampers or Boxes) 5.LWT Leaving Water Temperature MAU Make-Up Air Unit NEBB National Environmental Balancing Bureau NLT Not Less Than NMT Not More Than IQ Installation Qualification PSI Pound per Square Inch PM Preventive Maintenance P&ID Piping and Instrumentation Diagram RPM Revolutions Per Minute SOPs Standard operating Procedures RHC Re Heat Coils TAB Testing. Adjusting. .0 DEFINITIONS Acceptance Criteria The system specifications and accept/reject criteria that are necessary for making a decision to accept or reject the system and/or component being qualified. 1 All personnel involved in the execution of the protocol must review and complete Attachment 1. that when working together perform a function considered critical to the manufacturing of a product intended for medicinal use.2 Curriculum Vitae for all contract personnel have been submitted to the Validation Department.1 Protocol corrections must be documented by the issuance of a protocol amendment providing the correct information. and results that may include graphs and tables to support conclusions and final acceptance. Inc. services.3 Test Equipment Operation 10. documented in the approved Test Instrument List maintained by the Document Control Department at Company X. measuring or control devices and/or equipment.1.. 10.2 Test Equipment Identification/Calibration 10. Copies of all calibration certificates for the test equipment must be included in this attachment.0 GENERAL DOCUMENTATION REQUIREMENTS 10.Summary of Results A written summary of the qualification policies.2. utilities. 10. process control systems. .2. the term “system” equally applies to computerized systems.4 Protocol Corrections 10. 10. Inc. their investigation.2. a reactorcondenser-motor-agitator set-up).1 Personnel Identification List 10.g. Within the scope of this procedure. System The term “system” as used in this protocol refers to the series of components. and equipment set-ups (e. documented in the Approved Personnel List maintained by the Document Control Department at Company X. Also included in this summary would be documentation of deviations.1 Document on Attachment 3 the SOPs and/or Operation Manuals that are required for the test equipment used in the execution of this protocol. 10. 10. procedures.3 All test equipment must be calibrated against standards that are NIST traceable.1 Document on Attachment 2 the test equipment that is used during execution of this protocol.2 All test equipment descriptions have been submitted to the Validation Department. and final corrective action implemented to provide final closure.3.1. 10.4. 10. 6. methods. 11. 11.2 The executed IQ worksheet raw data should be compared against the acceptance criteria.3 All protocol deviations.7.1. may be customized for additional data collection or clarification. 10. 10.1 Installation Qualification Worksheets 11.3 The General Data Worksheet provided in the attachments. provided in the attachments.1 Corrections to the raw data must be performed using a single line cross out and explanation with the person’s initials and date.10. 11. evaluated.7.6.1. and incidents must be documented in accordance with the current Company X Standard Operating Procedure # MF/SOP/097.7 Worksheets 10.1 A protocol deviation indicates the discovery of discrepant results. 10. In the event the acceptance criteria are not met. . and initialed/dated.2 A discrepancy indicates the discovery of discrepant results. information. reviewed and approved.7.6 Protocol Deviations 10. other than laboratory data. discrepancies.3 All data and results are to be recorded on approved copies of IQ worksheets.1.4 Copies of raw data from notebook pages or laboratory test results may be attached to this summary package.7. 11.2 Protocol specific data worksheets. 11.5. a deviation report must be prepared.4 Initial and date each entry and sign and date each worksheet.6.1. Discrepancies and Deviations”. 10.1 Data. are to be used to record data as required.5 Raw Data Corrections 10.1. 10. 10.1 Each IQ worksheet must be completed as directed on the individual worksheet. or procedures resulting from the execution of this protocol. entitled “SOP for the Reporting and Investigation of Investigation on Incidents. and recorded on the deviation report log for each occurrence. and must be initialed and dated.5 Each page of any attachments to the protocol must reference the protocol #. must be documented on one of the following types of worksheets during the execution of the protocol: 10. section and page #. DATA COLLECTION AND DOCUMENTATION PROCEDURES 11. 13. 13. 11. 12. The source of each specified value entered should be referenced in the comment section of each IQ worksheet.1 ISO-14644-1. REFERENCES 13.1 The acceptance criteria as indicated on each protocol attachment must be met or written explanation providing resolution must be documented. INSTALLATION QUALIFICATION TEST REQUIREMENTS 12. 2000-09-15.7 The acceptance criteria as indicated for each IQ worksheet must be met.3 ISO-14644-4. and Start-up .1 Review all completed attachments and compare against the acceptance criteria to assure that all criteria have been met. Construction. initialed.8 All specified data available at the time of protocol generation should be entered on each worksheet prior to approval of the protocol.2. 12. First Edition.3 Procedure 12. First Edition.4 Methods of Data Analysis 12. 12.2 ISO-14644-2. Cleanrooms and Associated Controlled Environments. In the event a specified cannot be field verified a reason should be entered in the comment section of the form. . Part 2: Specifications for Testing and Monitoring to Prove Compliance with ISO 14644-1. 11. Part 4: Design.2 Acceptance Criteria 11.1.1.1.6 A summary of results reflecting conclusions for all verifications should be prepared and this document inserted at the beginning of the data package. and dated. Part 1: Classification of Air Cleanliness.1 Objective 11.1 To verify that the HVAC system and its components have been installed in accordance with the requirements as indicated in the engineering specifications and system drawings. 12. 2000-04-01. Cleanrooms and Associated Controlled Environments.4.11. Cleanrooms and Associated Controlled Environments. First Edition.3.1. 1999-05-01.1 Complete each protocol attachment as directed on the individual attachment making sure all required data is properly recorded. All specified data that cannot be determined at the time of protocol generation will be recorded as “Not specified” and the actual value from field verification will be recorded. 13. Part 7: Separative Enclosures (Clean Air Hoods. Code of Federal Regulations. Change Control System”. General Data Worksheet Attachment #__ Use this worksheet for additional data gathering or data clarification. 13. 13.6 ICH. Gloveboxes. Mini-Environments. Parts 210 and 211 13.4 ISO-14644-7. NOTE: Make copies of this worksheet as necessary. Draft. Preventive Maintenance. Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients. August 2001. Include in applicable section of summary package. . Isolators.5 Title 21.13. Metrology Services. Cleanrooms and Associated Controlled Environments.7 Standard Operating Procedures for Reporting and Investigation of Deviations. Name Title Signatures Initials Date . Signatures signify that they have been trained in the protocol and understand the protocol requirements.Completed by: Reviewed by: QA Approval: Date: Date: Date: ATTACHMENT #1 – Personnel Identification List Each person who will be executing the protocol must complete an entry on this page. NOTE: Make copies of this attachment as necessary. Reviewed by: Date : . NOTE: Make copies of this attachment as necessary.QA Approval: Date : ATTACHMENT 2 – Test Equipment Identification/Calibration Document test equipment not installed on the equipment/system being qualified that are required for execution of this protocol. Test Equipment Calibration Description Model Serial # Tag # # Last Cal Initials Cal Due Date Date Date . The calibration standards are traceable to NIST. . NOTE: Make copies of this attachment as necessary.Criteria Met? Initials (Yes/No/NA) Date Acceptance Criteria The test equipment is calibrated and the calibration is current. Comments: Completed by: Reviewed by: QA Approval: Date: Date: Date: ATTACHMENT 3 – Test Equipment Operation Document SOPs and/or Operation Manuals that are required for operation of the test equipment used in the execution of this protocol and verify they are current. A copy of the calibration certification(s) for the test equipment used is attached. Documen t# Title Current and Effectiv Documented Initial/Dat e Date ? e (Yes/No) . Completed by: Reviewed by: QA Approval: Date: Date: Date: ATTACHMENT 4 – Equipment / Component Verification (one per each main component including instrumentation/Controls) Description AIR HANDLING UNIT AHU-6 Specified1 Type A-Series Location Mezzanine above Room 124 ID # AHU-6 Manufacture York International r Model # AP80FSFCV12X1 2 Serial # CADM-005952 Capacity Rating 3400 CFM Actual Initial/Dat e . York International I/O/M Manual.09-nom1. Comments PO # 30563-05. 100.Dimensions 126”x 53”x 43” (L*W*H) Acceptance Criteria Criteria Met? Initial/ (Yes/No/NA) Date Actual values conform to specified values. Justifications are provided for actual values that cannot be field verified. Specified values taken from Dwg # H-04-rev 2. 1 . should be measured where possible. Also document specific connections to the facility steam supply. NOTE: Actual information. All information recorded as actual is from field verification unless recorded as otherwise in comments. List sources for any specified information recorded on this page in comments.Completed by: Reviewed by: QA Approval: Date: Date: Date: ATTACHMENT 5 – Utilities Verification Document Hot Water requirements for the applicable equipment/system undergoing IQ. such as pressure. Description / Type ( X ) Plant ( ) Clean Purpose Item Source Specified1 Boiler (7) HydroTherm- Actual Initial/Date . Justifications are provided for actual values that cannot be field verified. Comments Criteria Met? Initial/ (Yes/No/NA) Date . Dielectric Unions are present between piping of dissimilar metals.MultiTemp Regulated Pressure 18 PSI Temp 173 °F Method of Joining To be field verified Acceptance Criteria Actual values conform to specified values. manufacturing specifications. NOTE: Make copies of this attachment as necessary. and inspection reports for the equipment/system undergoing IQ. vendor audits. document the equipment/system logbook established for the equipment/system undergoing IQ. functional requirements. Also. document associated specifications including computer system validation plan. Location Initial/Date # . process description (user requirements). NOTE: For computer related systems.Equipment/System Specifications Document associated equipment/system specifications including.Completed by: Reviewed by: QA Approval: Date: Date: Date: ATTACHMENT 6 – Support Documentation . Type Title/Description Doc. Factory Acceptance Testing. software description and change control history. design specification. Equipment/system logbook established. Computer related systems have specifications available.Acceptance Criteria Copies of the manufacturing specifications for the equipment/system are attached. Filter specifications and manufacturing validation guides are available. HEPA filter specifications are available. Criteria Met? (Yes/No/NA) Initial / Date . Installed conditions have been verified to reflect functional specifications. Submittals List the approved submittals as supplied by the contractor or manufacturer supporting the system and system components.Comments Completed by: Reviewed by: QA Approval: Date: Date: Date: ATTACHMENT 7 – Support Documentation . Description: Initials Date . Include a copy of each submittal with this protocol. Copies of the approved submittals for the system and components are attached. Criteria Met? (Yes/No/NA) Initials Date .Acceptance Criteria The submittals have been verified to accurately describe and document the system being qualified. Include a copy of each purchase order with this protocol.Comments Completed by: Reviewed by: QA Approval: Date: Date: Date: ATTACHMENT 8 – Support Documentation . Description Purchase Order Number Initials Date .Purchase Orders List the purchase orders supporting the system and system components. Copies of the purchase orders for the system and system components are attached.Air Handler AHU-6 30563-05 Variable Air Volume Box 30563-12 Heating/Cooling Coils 30563-05 Exhaust Fans 30563-12 Humidifier H-1 30563-07 Acceptance Criteria The system being qualified conforms to the PO requirements. Comments Criteria Met? Initials (Yes/No/NA) Date . Completed by: Reviewed by: QA Approval: Date: Date: Date: ATTACHMENT 9 – Support Documentation . Title Location Initials/Date .Equipment Manuals Verify that pertinent equipment documentation exists and reference the location where the document is kept. Comments Criteria Met? Initials/Date (Yes/No/NA) .Acceptance Criteria The manufacturers equipment manuals are described above and the location of each manual is documented. and utility drawings for the equipment/system undergoing IQ. verified drawings. Verify that the drawings are accurate and sufficient to characterize the equipment/system. Highlight the verified portions of the drawings and redline changes as necessary. P&IDs. Verify that components are physically labeled in accordance with drawings.Equipment/System Drawings Document associated process flow drawings.Completed by: Reviewed by: QA Approval: Date: Date: Date: ATTACHMENT 10 – Support Documentation . Submit any redlined drawings to the Document Control Group for revision. including all associated equipment. All drawings must be verified. shop drawings. facility. and any other pertinent drawings. redlined copies. layout drawings. Include copies of the highlighted. Initial/Date Date . NOTE: Controller diagrams and wiring diagrams will be documented on separate attachments. signed. and dated. Rev. and applicable Document Control Forms with this summary package. Drawing # Title Rev. NOTE: Make copies of this attachment as necessary. Drawings. Components including equipment. with redlines if applicable. valves. Equipment/system installation corresponds to drawings. facility. Copies of verified drawings and redline copies are included with this summary package. and dated. Drawings have been verified. Redlined drawings submitted for Criteria Met? Initial/ (Yes/No/NA) Date . and utility drawings. with redlines if applicable.Acceptance Criteria Drawing list includes associated equipment. are sufficient to characterize equipment/system. and instruments are physically labeled and labels correspond to drawings. signed. with redlines if applicable. Comments Completed by: Reviewed by: Date: Date: .revision to the Document Control Group and copy of Document Control form included with this summary package. The Document Control Group controls original drawing files. undergoing IQ. NOTE: Make copies of this attachment as necessary. including controls.QA Approval: Date: ATTACHMENT 11 – Support Documentation . SOPs should include failure/backup/recovery. operation. maintenance. Initial/Date Date Criteria Met? Initial/ (Yes/No/NA) Date . system monitoring and maintenance. Rev. NOTE: For computer related systems. security. Document # Title Acceptance Criteria Rev.Equipment/System Standard Operating Procedures Document operating SOPs (e.g. cleaning and sanitization) associated with the equipment/system. Document # Title Rev. and sanitization procedures as applicable that are approved and current. Initial/Date Date . Comments Completed by: Reviewed by: QA Approval: Date: Date: Date: ATTACHMENT 12 – Support Documentation . undergoing IQ. Rev. maintenance.Equipment/System Calibration Procedures Page ______ of _______ Document the calibration SOPs associated with the critical instruments on equipment/system. NOTE: Make copies of this attachment as necessary.List above includes operation. including controls. cleaning. Acceptance Criteria All calibration procedures associated with the critical instruments on the equipment/system undergoing are approved and current. Comments Criteria Met? Initial/ (Yes/No/NA) Date . Dat Descripti cy Dat Date e# e Title e on e . controlling/monitoring switches) undergoing IQ that require calibration. verify that all calibrated instruments have a calibration tag. Additionally.Equipment/System Calibration Program Page ______ of _______ Document the equipment/system components (e. NOTE: Make copies of this attachment as necessary. NOTE: Instrument verification.. Include copies of the calibration reports with this summary package. and Frequen Cal l/ Procedur Procedur v. process instrument materials of construction verification. Verify that these components are entered into calibration program by reviewing copies of the calibration reports obtained from the Metrology Department. instruments. Ensure that all components requiring calibration have been calibrated and are traceable to National Institute of Standards and Technology (NIST). or other applicable standard. and digital sensors and controlling/monitoring switches list will be documented on separate attachments. Compone Las Associat Associat Re nt Asset # Cal t Initia ed Cal ed Cal Re v.Completed by: Reviewed by: QA Approval: Date: Date: Date: ATTACHMENT 13 – Support Documentation . the American Society of Testing and Materials (ASTM).g. Components are traceable to applicable standard. Components have a tag indicating last cal date and cal due date. Components are calibrated by the conclusion of protocol execution. Copies of the calibration reports are included with this summary package.Acceptance Criteria Components that require calibration are entered into the calibration program. Comments Criteria Met? (Yes/No/NA) Initial / Date . 09-MOM1 York International O/M Manual MAU-1 4/5/95 Mammoth O/M Manual Initial/ Date .g.. Equipment/ System Name Spare Parts List Location AHU-6 Form 100. NOTE: Make copies of this attachment as necessary. installation manual).Spare Parts List Page ______ of _______ Document spare parts lists for the applicable equipment/system and associated controls undergoing IQ. Document the location of the manufacturer’s recommended list (e.Completed by: Reviewed by: QA Approval: Date: Date: Date: ATTACHMENT 14 – Maintenance . Acceptance Criteria Criteria Met? Initial/ (Yes/No/NA) Date Locations of manufacturer’s recommended spare parts lists are documented. Comments Completed by: Reviewed by: Date: Date: . QA Approval: Date: ATTACHMENT 15 – Maintenance . the manufacturer. Using information obtained from the Quality Assurance or Maintenance Departments. and/or the supplier. used with equipment/system undergoing IQ. List sources for any information recorded on this page in comments. Lubricant Type and Manufacturer Purpose Acceptance Criteria Acceptable? Initial/ (Yes/No) Date Criteria Met? Initial/ (Yes/No/NA) Date .Lubricant Verification Page ______ of _______ Document lubricants. Include documentation supporting the acceptability of the lubricants with this summary package. NOTE: Make copies of this attachment as necessary. verify the lubricants are acceptable for their intended use. Comments Completed by: Reviewed by: QA Approval: Date: Date: Date: Download the accompanying presentation. "Effective Qualification of Critical Utilities.All lubricants are acceptable for intended use." presented at IVT's Validation . Documentation supporting the acceptability of the lubricants is included with this summary package.