PQS Quality Assurance protocol. TITLE: Cold Room/Freezer Room:

Transcription

1 PQS Quality Assurance protocol WHO/XXX Original: English Distribution: General TITLE: Cold Room/Freezer Room: Note that this protocol is intended to form part of the contract documentation for a new cold room or freezer room installation in conjunction with E01/CR/FR-01. It should be read in conjunction with companion protocol E06/TR03-VP. It can only be fully completed when the details of the system are known. DRAFT D3 for preliminary comment Location of installation: <insert details> Name of Employer: <insert details> Product verification protocol: E01/CR/FR-VP1 Applies to specification ref(s): E01/CR/FR-01 Date of origin: Date of last revision: Contents: 1. Scope: This document sets out a Quality Assurance (QA) protocol for the installation of cold rooms and freezer rooms. Combination cold and/or freezer rooms are required to comply with all specifications for both cold room and freezer room. All Manufacturers or Resellers will be required to provide one satisfactory QA report for a successfully installed cold room or freezer room (in compliance with either E01/CR/FR 01). At a minimum, the QA report will consist of field survey reports to be provided by both the approved installer and the room user. At the discretion of the Employer, a full on-site inspection report may also be required. The QA report must be submitted within 45 days after the first installation following PQS implementation. 2. Normative references: 2.1 EMAS: European Union Eco-Management and Audit Scheme 2.2 ISO 9001: 2000 Quality Management Systems-Requirements 2.3 ISO 14001:2004 Environmental Management Systems-Requirements with guidance for use 2.4 PQS E06/TR03-VP2 Programmable electronic temperature and event logger 2.5 PQS E06/TRO5a Standalone temperature loggers 2.6 PQS E06/TR04 Wall mounted pen chart recorders 3. Terms and definitions: Terms and definitions: 3.1 Approved Installer: A person or organization approved by the Legal Manufacturer or Reseller as a competent installer of the system components and who has been appointed by the Employer to carry out the installation of the System.

2 3.2 Employer: The organization that contracts with the Installation Contractor to carry out the system installation and commissioning. 3.3 In writing: means communication by letter, fax or Legal Manufacturer: The natural or legal person with responsibility for the design, manufacture, packaging and labeling of a product or device before it is placed on the market under his own name, regardless of whether these operations are carried out by that person himself or on his behalf by a third party. 3.5 Montreal Protocol: Montreal Protocol on Substances that Deplete the Ozone Layer. 3.6 QA: Quality Assurance. 3.7 QA Assessor: the person or organization appointed by the Employer to assess the suitability of candidate Approved Installers, to evaluate their proposals and to monitor the installation and commissioning of the system on site. 3.8 Reseller: A commercial entity, licensed to act on behalf of a Legal Manufacturer, and which carries product liability and warranty responsibilities no less onerous than those carried by the Legal Manufacturer. 3.9 User: the person responsible for the day to day operation and temperature monitoring of the room. 4. Applicability: This assessment will be conducted by the Employer or by their designated QA Assessor. 5. Specification checklist 5.1 Criteria for qualification: A system offered by a Manufacturer will comply with these standards provided: Room complies with PQS E01/CR/FR-01. The system functions as designed. The Reseller meets the criteria defined in 3.8. The Reseller provides documentary evidence with his tender offer showing that he is the Legal Manufacturer or is a reseller licensed to act on behalf of the Legal Manufacturer. 6. Quality control checklist 6.1 Quality control standards: ISO 9001: 2000 is required of the Manufacturer. 6.2 Manufacturing quality control checklist: On-site inspection of the production facility is not required. 6.3 Site work quality control: The QA Assessor will carry out an Acceptance Test and submit the results to the Employer. For all cold rooms and all freezer rooms the Quality Assessor must conduct an on-site Quality Assurance Protocol to provide Employer/buyers with a method to determine compliance with PQS E01/CR/FR-01 through a successful installation and acceptance test. To prove compliance the test must utilize a stand-alone temperature data logger as defined in PQS E06/TR05a. This

3 logger will normally be a permanently installed component of the system. If the system uses a wall mounted pen recorder as defined in PQS E01/TR04 then the approved installer must utilize a temporary stand-alone temperature data logger as defined in PQS E06/TR05a for the acceptance test. Temperature control and compliance must be demonstrated with a zero failure rate on all tests as defined in PQS E06/TR03-VP2. A minimum of eight separate sensors are required for test purposes. A minimum of five temperature sensors must be used inside the cold room or freezer room. One temperature sensor is to be placed directly in the discharge air stream at the closest point where vaccine will be stored. The other four temperature sensors are to be placed as one in each corner with two sensors located in opposite upper corners and two sensors located in the adjacent opposite lower corners. A sixth sensor is to be used for the immediate area external ambient air temperature outside of the cold room (or freezer room). The remaining two sensors are used for door open sensing and voltage sensing. Note that the buyer must specify certain parameters (e.g. high alarm setting temperature and lag interval) as noted in Section 5. Specification Checklist (PQS E06/TR03-VP2) and that these parameters are included in the acceptance test criteria. Note that no external ambient air temperature can be specified for on-site tests and test results may not be indicative of true compliance under all temperature conditions the system may experience. In addition to tests required by E06/TR03 the following tests must conducted with a zero failure rate. Cool-down time: This test can be conducted simultaneously with the Run Test (see E06/TR03-VP2). The Run Test and Cool-down time test is started when the room is empty and when the temperature is the same inside and outside the room. Close the door and start the refrigeration or freezing equipment. During the test the cold room (or freezer room) door must be kept closed. The test period is at least 48 hours. The time needed for the internal temperature to drop below +8 C for cold rooms (or 15 C for freezer rooms) is recorded. Compliance is proven by reaching the specified temperature. No standard is set for the time period required to reach the specified temperature. Operation test: The number of hours for which the compressor runs is recorded with the doors closed and the room empty. The internal and external temperatures, the evaporator and condenser temperatures and the pressures of the system are monitored. The maximum temperature difference in the room is measured and the location of any cold or warm spots are recorded. Compliance is proven after if all temperatures remain within the range of +2 C to +8 C for cold rooms (or 15 to 25 C for freezer rooms). Holdover test: The electricity supply is cut off and the period required for the

4 internal temperature to rise to +10 C for cold rooms (or 10 C for freezer rooms) from normal operating temperature is recorded. Note: In order to calculate the minimum holdover time, the electricity supply should be switched off at the start of a new compressor cycle. The door must remain closed throughout the test. External ambient air temperature is recorded throughout the test period. Compliance is proven if the time period is equal to or greater than 8 hours. Optional low temperature protection system test: For cold rooms only. Trigger a low temperature condition in one temperature sensor and demonstrate proper heating system operation. Allow sensor to return to specified temperature range (i.e. +2 C to +8 C) and demonstrate proper heating system shut down. Compliance is accepted if the system starts and stops automatically within specified temperature range. Optional Stand-by generator operation test: The power output of the standby generator is checked, together with the operation of the automatic mains failure control system. The generator is run continuously for 48 hours. Acceptance is granted if the system starts automatically on time and runs properly for 48 hours. 6.4 QA Assessor/approved installer checklist (to be completed immediately following installation with a copy of the Acceptance Test as required in 6.3): Name, address, phone, address (if used) of approved installer and employer. Did the system shipment arrive with no damage? Note any damage. Were all system components provided per the Bill of Materials supplied with system? Note all missing parts. Is the room marked with vaccine storage and freeze protection information? Is the refrigeration system marked with refrigerant identification? Was an installation instruction manual provided in the correct language? Did the instructions note safety considerations? Did the installation match the wiring schematic drawings and mechanical drawings? If the system installation deviates from drawings then submit any as-installed drawings. The as-installed drawings can be notes written over a copy of the original drawing prepared by the approved installer. Was the electrical cable and hardware adequate for this installation? If no, explain. Are all system components positioned so that they can be routinely maintained? Is there proper protection for all system components exposed to the weather or to other environmental conditions? Are all system electrical connections concealed and properly protected? Were commissioning instruction provided? Did the system installation finish with an acceptable commissioning test? Send a copy of the acceptance test results. Are all system components functioning properly?

5 Are indicator lights or other feedback systems labelled? Note any observations. Acceptance criteria: All questions answered yes. 6.5 User checklist (User to record room temperatures and return a copy of the first 30 day record. Checklist to be completed after the system has been in operation for 30 days): Were User Instructions in correct language supplied with the room? Was user training provided? Do User Instructions include maintenance requirements? Does the system operate correctly? If no, please explain. Are cold room temperatures within +2 C and + 8 C or are freezer room temperatures equal to or less than -15 C? Please provide a 30 day temperature record log for the cold room or freezer room. Are indicator lights or other feedback systems labelled? Does the room operate correctly? Note any observations, please. Acceptance criteria: All recorded temperatures are within range and all questions answered yes. 6.6 Training: Was training provided per E01/CR/FR-01? 6.7 Handover dossier: After installation a handover dossier must be sent to the Employer (and also end-user, if different) by the Manufacturer or Reseller. The dossier must be presented in a lever arch folder and must contain the following: System sizing rationale. One copy of the system manual with as-built drawings. One complete set of user documentation and maintenance instructions. Acceptance Test. Any observations by the approved installers, user and/or QA Assessor. 7. Customer reference checklist: Not applicable 8. Pre-qualification evaluation: Not applicable. 9. Modified products: Not applicable. Annexes: None Revision history: Date Change summary Reason for change Approved ddmmyy < change item> < etc.> < reason for change> < etc.> <name>