Natural Resources Canada CFS - GLFC STANDARD OPERATING PROCEDURE Maintenance, Calibration and Operation of Analytical Balances SOP Number: M52506/017/001/ Effective Date: TITLE: Maintenance, Calibration and Operation of Analytical Balances APPROVING OFFICIALS: DD / MM / YY Approved By: _________________ Concurred By: _________________ Prepared By: _________________ Management QAU Manager ___________ ___/___/___ ___/___/___ ___/___/___ 1.0 INTRODUCTION 1.1 Purpose To assure the proper maintenance, calibration, and operation of analytical balances for general use. 1.2 Scope This general-use technical SOP is a management directive for all projects/studies of Natural Resources Canada, CFS-GLFC, which utilize analytical balances for general use in relation to safety with respect to human health or the environment, for the purpose of supporting an application for registration or a research permit. 1.3 Definitions Analytical Balance – A balance that measures to 0.1mg precision, and is typically enclosed by sliding glass doors so as to minimize weight fluctuations caused by air currents. Calibration – Actions taken to correlate readings or output to expected values for known standards. Document Control Official (DCO) - The person specified by management who is responsible for controlling designated documents, including SOPs. Effective Date - The date from which the procedures given in a SOP are to be implemented by CFS-GLFC. The effective date is a date specified by management or the date of distribution. Good Laboratory Practices (GLPs) - Requirements set forth by the Organization for Economic Cooperation and Development (OECD) to assure the high quality and integrity of laboratory test data required to evaluate the health, environmental effects or fate of chemical substances and mixtures. Logbook – A detailed chronicle of all maintenance, repair and/or calibration conducted on a specific instrument used in generation, analysis or sample measurement to produce raw data. Page 1 of 7 Natural Resources Canada CFS - GLFC STANDARD OPERATING PROCEDURE Maintenance, Calibration and Operation of Analytical Balances SOP Number: M52506/017/001/ Maintenance – Routine actions taken on an instrument or piece of equipment to assure continuous performance according to accepted quality standards and specifications. MSDS – Material Safety Data Sheet, a summary description of a chemical, reagent or substance prepared by the manufacturer or supplier and required by WHMIS legislation to inform workers about procedures required to safely work with the material. NA - Not Applicable. Quality Assurance Unit (QAU) - Persons designated by management to ascertain that the study is in compliance with the OECD Principles of Good Laboratory Practice (OECD GLP, 1998), and who are completely independent from the conduct of the study for which they are performing quality assurance functions. Repair – Periodic replacement, change or renovation of parts of an instrument or piece of equipment to compensate for accidental breakage or wear and to assure good operating condition of the instrument or equipment. Standard Operating Procedures (SOPs) - Management directives which describe all administrative or technical routine procedures conducted in a laboratory or field operation that are not covered by a chemical specific or study specific protocol. Standard Weights – Weights that are traceable to a national standard, used for calibrating balances. Study Director - The individual responsible for the overall conduct of the nonclinical health and environmental safety study. Study Plan – A document that defines the objectives and experimental design for the conduct of the study, and includes any amendments. Test Facility Management – The individual who has the authority and formal responsibility for the organization and functioning of the test facility according to the Principles of Good Laboratory Practice (OECD GLP, 1998). WHMIS - Workplace Hazardous Materials Information System, a national information delivery system used to inform employees about hazardous materials in the workplace. 1.4 Safety 1.4.1 Persons using solvents or other hazardous materials must use minimum personal protective equipment as stipulated in SOP No. M52506/014, The Use of Personal Protective Equipment. Page 2 of 7 Natural Resources Canada CFS - GLFC 1.4.2 1.4.3 1.4.4 STANDARD OPERATING PROCEDURE Maintenance, Calibration and Operation of Analytical Balances SOP Number: M52506/017/001/ Persons using any solvents, chemicals, reagents or other hazardous materials must do so in accordance with the pertinent MSDS sheets and WHMIS labels which are stored on a shelf in the laboratory and in accordance with SOP No. M52506/015, The Safe Handling of Hazardous Materials. Decanting, transfer or other handling of large (>500 mL) containers of solvents must be conducted in an approved, operational fume hood. Fume hoods should be approved or certified annually. All persons must receive WHMIS training and be familiar with emergency procedures as described in the CFS-GLFC Emergency and Fire Safety Manual, prior to working in a laboratory using hazardous materials. WHMIS and emergency procedure training as well as records associated therewith are to be coordinated by the CFS-GLFC safety officer. 1.5 Materials The critical materials required to calibrate, operate and maintain analytical balances include: 1.5.1 Weighing vessels (weigh paper, plastic weigh boat). 1.5.2 Standard weights, traceable to a national standard. 1.5.3 Lint brush. 1.5.4 Analytical balance instruction manual. 1.5.5 Analytical balance log book. 2.0 PROCEDURES 2.1 Maintenance and Usage Recommendations 2.1.1 Balance must be leveled. 2.1.2 The use of a weighing vessel, such as a weigh boat, is recommended. 2.1.3 A constant temperature should be maintained within the weigh chamber so as to avoid thermal air currents that will affect weight accuracy. Samples to be weighed should be at room temperature, where practical. 2.1.4 After weighing samples that are powdery and dusty, the weigh chamber and balance pan should be swept free of any debris using a lint brush. 2.1.5 Any maintenance or repair made to the instrument must be recorded as set forth in the current version of SOP No. M52506/001, Preparation and Use of Logbooks for Repair, Maintenance and Calibration of Equipment. Additional information pertaining to maintenance or repair may be appended in this section of the logbook and cross-referenced to the Maintenance and Repair Log entry using a sequential hand-numbered code (e.g. REF-001) written in the upper right-hand corner of the appended sheet. 2.1.6 Maintain the instrument logbook, containing this SOP, calibration and maintenance repair logs, and associated instruction manuals in the immediate vicinity of the instrument. Page 3 of 7 Natural Resources Canada CFS - GLFC STANDARD OPERATING PROCEDURE Maintenance, Calibration and Operation of Analytical Balances SOP Number: M52506/017/001/ 2.1.7 Annual servicing by a Standards Council of Canada certified technician is required for calibration and certification. Such actions are to be recorded as set forth in the current version of M52506/001, Preparation and Use of Logbooks for Repair, Maintenance and Calibration of Equipment. Certification documentation shall be maintained with the logbook for the instrument. 2.2 General Operation The following describes the general procedure for using analytical balances. Please refer to instruction manuals for instrument-specific procedures. Prior to each weighing session, the balance’s sensitivity must be checked and adjusted if necessary. Refer to section 2.3 for instructions. 2.2.1 If balance is off, turn it on using the power switch. 2.2.2 Once the analytical balance has been stabilized (“g” or “o” lights up on the front display of some balances), press the tare button to zero the balance. 2.2.3 If using a weighing vessel, such as a weigh boat or a piece of paper, open the sliding door, place the vessel on the balance pan, close the sliding door, and press the tare button. 2.2.4 Once the balance has stabilized, open the sliding door and place the sample to be weighed on the balance pan (or the weighing vessel, if used). 2.2.5 Close the sliding door, and record the weight when the balance has stabilized. 2.2.6 To use the balance’s specific features, refer to the instruction manual. 2.3 Calibration and Sensitivity Adjustments 2.3.1 Using Standard Weights 2.3.1.1 Standard weights should be stored in a manner whereby contact with dust or debris is minimal (e.g. within the balance chamber or in a small box). If necessary the weight(s) should be cleaned with alcohol, wiped with a low-lint tissue, and air-dried prior to use. 2.3.1.2 Standard weights should be handled using clean forceps. 2.3.2 Checking the Balance’s Sensitivity 2.3.2.1 Prior to checking sensitivity, the balance must be on for a minimum amount of time, as specified in the instrument’s instruction manual. This is typically 30 minutes. 2.3.2.2 Clear the balance pan and close the sliding doors. 2.3.2.3 Once the balance has stabilized, zero the balance by pressing the tare button. Page 4 of 7 Natural Resources Canada CFS - GLFC STANDARD OPERATING PROCEDURE Maintenance, Calibration and Operation of Analytical Balances SOP Number: M52506/017/001/ 2.3.2.4 Once the balance has stabilized, open the sliding door, place standard weight(s) on the balance pan and close the sliding door. Standard weights should be of similar weight to the weights of samples being measured. 2.3.2.5 The test weights and the displayed weight must correspond to ±0.05% of the standard weight (i.e. 1.0g ± 0.0005g). If the deviation is larger, the balance’s sensitivity must be adjusted. 2.3.2.6 Record that the balance’s sensitivity was checked, and any calibrative adjustments in the instrument’s Calibration Log as set forth in the current version of SOP No. M52506/001, Preparation and Use of Logbooks for Repair, Maintenance and Calibration of Equipment. Include the standard weight(s) used, and the instrument’s reading before and after calibration. 2.3.3 To adjust the balance’s sensitivity, refer to the instrument’s instruction manual. 2.3.4 When initially installing the balance, or transporting the balance, certain procedures must be followed in order to minimize damage, and to adapt the balance to its new conditions (i.e. calibration, leveling). These procedures are detailed in the instruction manual. 2.4 Calculations NA 2.5 Documentation and Reporting 2.5.1 The balance’s sensitivity shall be checked and, if required, adjusted prior to each weighing session. These checks and adjustments are to be as set forth in the current version of SOP No. M52506/001, Preparation and Use of Logbooks for Repair, Maintenance and Calibration of Equipment. 2.5.2 Any maintenance or repair actions taken on this instrument must be recorded as set forth in the current version of SOP No. M52506/001, Preparation and Use of Logbooks for Repair, Maintenance and Calibration of Equipment on the day that the action was taken and initialed by the person performing the maintenance or repair action. 2.5.3 Any additional information pertinent to calibration, maintenance or repair activities (e.g. calibration sample data, quality control check sample data, certification report etc.) should be incorporated into the logbook in the appropriate section in chronological order. Sequentially number additional information sheets in the upper right hand corner for easy reference. 2.5.4 All weight readings specified in the study plan, shall be documented as specified in the study plan and maintained with the raw data for the study. Page 5 of 7 Natural Resources Canada CFS - GLFC STANDARD OPERATING PROCEDURE Maintenance, Calibration and Operation of Analytical Balances SOP Number: M52506/017/001/ 3.0 DISTRIBUTION AND ARCHIVING 3.1 Distribution 3.1.1 3.1.2 3.1.3 Official copies of this SOP shall be made by the DCO and distributed as follows: (a) The original SOP and an exact copy shall be retained in the CFSGLFC archive (copies 001 and 002). (b) One copy shall be kept by the DCO in the DCO SOP manual (copy 003). (c) One copy shall be kept by the QAU manager in the QAU manager SOP manual (copy 004). The DCO may distribute additional copies of this SOP to personnel engaged in the conduct of, or responsible for, the supervision of GLP compliant studies. The DCO shall announce the availability of new versions of this SOP within one week of the effective date, and shall distribute new versions by requiring that old versions be exchanged for the new ones. The DCO shall not release a revised SOP to recipients of prior versions unless it is exchanged for the previous version. 3.2 Archiving 3.2.1 It is the responsibility of the DCO to assure that the signed original SOP (copy number 001), an exact copy (copy number 002) and an electronic copy of the final version, be archived according to the current version of SOP No. M02004/004, Archiving Data and Test Materials. 3.2.2 It is the responsibility of the study director (or PI, if applicable) to ensure that instruction manuals for the instrument and peripherals are archived upon retirement/disposal of the equipment. 3.2.3 It is the responsibility of the Study director (or PI, if applicable) to ensure that all original equipment, maintenance, repair and calibration log forms are transferred annually to the archive. 3.3 Destruction of Outdated SOPs With the exception of the original archived SOPs (copies 001 and 002) which are retained in the CFS-GLFC archive, the DCO shall assure that all other retired versions of SOPs are destroyed by shredding. 4.0 ASSURING SOP VALIDATION AND COMPLIANCE 4.1 Responsible Individual 4.1.1 4.1.2 The QAU is responsible for assuring that this SOP is valid. The Study Director is responsible for assuring that this SOP is followed by persons using such equipment and that these persons have been appropriately trained in the use of this SOP. Page 6 of 7 Natural Resources Canada CFS - GLFC STANDARD OPERATING PROCEDURE Maintenance, Calibration and Operation of Analytical Balances SOP Number: M52506/017/001/ 5.0 REVISION OF THE SOP 5.1 Responsible Individual The QAU is responsible for assuring that this SOP is current. If necessary, the QAU manager shall initiate the revision process. 5.2 Revision Schedule 5.2.1 5.2.2 This SOP shall be revised when its provisions no longer agree with current practices or applicable regulations. If this SOP requires revision, it shall be revised according to the procedures set forth in the current version of SOP No. M02004/001 Writing Standard Operating Procedures and approved within 45 calendar days of initiation of the revision process. 6.0 CONTINGENCIES When personnel find circumstances that do not permit compliance with this SOP, they shall consult the study director or the QAU manager within 24 hours. 7.0 CONFIDENTIALITY All SOPs are considered confidential and shall be handled accordingly. They are not to be copied or made available to outside parties without proper safeguards and the approval of management. 8.0 REFERENCES (a) OECD Principles of Good Laboratory Practices, 1998. (b) CFS-GLFC Emergency and Fire Safety Manual. (c) SOP No. M52506/001, Preparation and Use of Logbooks for Repair, Maintenance and Calibration of Equipment. (d) SOP No. M52506/014, The Use of Personal Protective Equipment (e) SOP No. M52506/015, The Safe Handling of Hazardous Materials. (f) SOP No. M02004/004, Archiving Data and Test Materials. (g) SOP No. M02004/001, Writing Standard Operating Procedures (h) Analytical Balance Instruction Manual (specific to the instrument). 9.0 APPENDICES NA Page 7 of 7