Standard Operating Procedure Measuring & Testing Equipment

Standard Operating Procedure Measuring & Testing Equipment

Purpose: 7.6 Responsibility: 7.6d Scope To have a procedure to ensure that all is controlled, maintained and calibrated to ensure that Product conforms to the specified company and regulatory standards. The overall responsibility is with the Technical Department Management and the Inspector, who will safeguard equipment from adjustments that would invalidate any measurement. All in-house Measuring and Testing Equipment used for product release. 1. General 1.1 7.6c,e 1.2 7.6c 1.3 7.6a 1.4 7.6a,b 1.5 7.6d 1.6 7.6a 1.7 7.6c All Measuring and Testing Equipment used throughout all processing activities will be identified. The description, serial number, location and the intervals for calibration will recorded and documented on the Calibration Record Card MLD 2.01. Details of all equipment will also be entered on the Calibration Records spreadsheet on the computer system. All calibration equipment will be adequately protected from damage and deterioration during handling, maintenance and storage. All the Measuring and Testing Equipment will be individually identified with a Serial Number and the valid status of calibration. All the Measuring and Testing Equipment will be calibrated on a scheduled basis or prior to use. Equipment may be calibrated prior to use only if there is adequate resources or where the use of Measuring and Testing Equipment is intermittent. The Calibration Record Card will specify if Measuring and Testing Equipment, is to be calibrated in-house by the Inspection Department or by a Sub- Contractor/Test House. Calibration activities will be performed in accordance to a recognised International Standard. It is the responsibility of the Technical Department Management to define the accuracy requirement for the calibration of in-house Testing & Inspection Equipment. The acceptance criteria will be recorded on the Calibration Record Card MLD 2.01. The Technical Department Management or a Deputy will ensure that all the Measuring and Testing Equipment used has a valid calibration status prior to use. The status of the Measuring and Testing, which includes the calibration validation dates, tolerances and the relative calibration certificate number (where applicable), will be recorded on the Calibration Record Card MLD 2.01. Calibration labels (from the testing house) will be attached to the equipment as appropriate. 1.8 Equipment that has Failed a calibration test will be placed into quarantine and the relevant details recorded on the Calibration Record spreadsheet. 1.9 7.6b If the equipment can be repaired and the costs not exceed a replacement, this will be sanctioned accordingly. An indication of the fault and corrective action will be requested from the repairer and the item will be recalibrated and certificated. 1.10 If a piece of equipment has Failed calibration and cannot or will not be repaired, it will be permanently withdrawn from use. This will be recorded both on the Calibration Records spreadsheet and on its Calibration Record Card MLD 2.01. 1.11 All calibration records and certificates (where applicable) will be retained and filed accordingly.

2. In-House Calibration 2.1 It is the responsibility of the Technical Department Management to define the accuracy requirement for the calibration of in-house Testing and Inspection Equipment. The acceptance criteria will be recorded on the Calibration Record Card MLD 2.01. 2.2 Measuring and Testing Equipment that requires in-house calibration will be performed recorded as stated in section 1.0. The identification of the person who performs calibration activities will be recorded. 2.3 Measuring and Testing Equipment that is calibrated In House and the calibrating methods are as follows: 2.3.1 Ring Type Thread Gauges. These are used for testing external threads on components. The gauge has a clearly marked GO side. Method: Apply GO side to thread. This side must fit fully into the thread with no play to give conformance. 2.3.2 Plug Type Thread Gauges. This gauge is used for testing internal threads of components. The gauge has two test positions clearly marked GO and NO GO. Method: Screw the GO position into the thread to be tested. The entry MUST be smooth and there MUST be no play. Secondly try to enter the NO GO position. For conformance the GO must go as above and the NO GO must not fit. 2.3.3 Six-Inch Digital Vernier. This gauge is used to measure internal and external diameters and distances across and inside faces. It can be used on certain types of components for measuring depths. Method: Firstly the gauge must be turned on, secondly the jaws must be closed and thirdly the readout indicator must be zeroed. Apply the gauge pointers to the component ensuring by observation of the digital readout that the plane of measurement goes through the centre of the component. Ensure that the measurement conforms to the stated tolerance. 2.3.4 Analogue/Digital Depth Gauge. This is used for measuring the depth of holes and recesses in components Method: Apply the gauge to the hole/recess ensuring that it reaches the base. Take the reading from the digital readout (or analogue scale if battery fails). Ensure that the measurement conforms to the stated tolerance. 2.3.5 Master High Pressure Gauge. This is a calibrated gauge used to calibrate the high-pressure testing gauge in the Inspection Department. This must have a current calibration certificate. Method: Firstly, ensure that the pressurised cylinder is turned off and the highpressure regulator Testing Rig has been drained. Fit the High Pressure Master Test Gauge into the valve adjacent the test gauge that is being calibrated. Turn on the cylinder valve and then turn on the valves under each gauge. Compare the readings on each gauge and record the results.

2.3.6 Master Low Pressure Gauge. This is a calibrated pressure gauge and is used to calibrate pressure-testing gauges in the factory. This gauge MUST have a current calibration certificate. Method: The Master Pressure Gauge is coupled to an air cylinder via a T-piece gas tight connection. The gauge to be calibrated is similarly coupled to the opposite T-piece. The indicator on the gauge to be calibrated is adjusted to be the same as the Master Pressure Gauge. The date of calibration is attached to the face of the now calibrated gauge. 2.3.7 Master Vacuum Gauge. This is a calibrated vacuum gauge and is used to calibrate vacuum gauges within the factory area. This gauge MUST have a current calibration certificate. Method: The gauges are coupled up to a vacuum source and are proceeded with as in 2.3.5 above. 2.3.8 Digital Flowmeter. This is a calibrated Flowmeter used to calibrate Flowmeters in use within the Factory and Repair areas in the workshop. The Flowmeter may be used in absence or as an addition of other Flowmeters. This unit must have a current calibration certificate. Method: Using a standard Flowmeter for a supply, connect the calibrated Master Flowmeter to the supply Flowmeter with a 1mt length of Oxygen Delivery Tube. Open the Supply Flowmeter Valve (starting from the lowest calibration point) until the first full flow reads on the calibrated Flowmeter. Remove the tube from the Calibrated Flowmeter without disturbing the flow from the supply Flowmeter then connect it to the Flowmeter being calibrated. Observe the reading and compare with the Master Flowmeter. Continue throughout the scale of the Flowmeter. 2.4 All details of the calibrations performed will be recorded on the Calibration Record Card MLD 2.01. 3. Incorrectly Calibrated Products 3.1 Where it has been found that previous production has been produced using testing equipment that was out of calibration, the Technical Department Management will review the effects on the quality of the product. 3.2 Where it has been found that the effect of the product may be hazardous which may cause injury to the user, the patient and/or effect the environment, the Technical Department Management will refer to the Recall & Advisory Notices Procedure (SOP 25) for further action. 3.3 8.5.1 paragraph 2 The relevant competent authorities and the Notifying Bodies will be informed accordingly as stated in SOP 25 Recall & Advisory Notices.

Clause(sub) BS EN ISO 9001/13485 Details referenced 7.6 Control of monitoring and measuring devices 8.5.1 paragraph 2 The organization shall determine the monitoring and measurement to be undertaken and the monitoring and measuring equipment needed to provide evidence of conformity of product to determined requirements. The organization shall establish documented procedures (processes) to ensure that monitoring and measurement can be carried out and are carried out in a manner that is consistent with the monitoring and measurement requirements. Where necessary ensure valid results, measuring equipment shall a) be calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; where no such standards exist, the basis used for calibration or verification shall be recorded; b) be adjusted or re-adjusted as necessary; c) have identification in order to determine its calibration status; d) be safeguarded from adjustments that would invalidate the measurement result; e) be protected from damage and deterioration during handling, maintenance and storage. In addition, the organization shall assess and record the validity of the previous measuring results when the equipment is found not to conform to requirements. The organization shall take appropriate action on the equipment and any product affected. Records of the results of calibration and verification shall be maintained (see 4.2.4). NOTE: Conformation of the ability of computer software to satisfy the intended application would typically include its verification and configuration management to maintain its suitability for use. The organization shall establish documented procedures for the issue and implementation of advisory notices. These procedures shall be capable of being implemented at any time.

History Page DCN Author: Date: Details Red references ISO 9001 clauses; blue ISO 13485 clauses.