What is a Method Statement NEW. If you are looking for a specific method statement we have set up a sister site where we will be continually uploading pre written Method Statements, all fully editable. Click Here to visit our Pre written examples method statement site. A method statement is a sequence of steps taken to complete a work task in a safe manner. The method statement should be written by a person that is competent in the task. When a method statement is prepared, the risks are identified during the work sequence. Steps taken to reduce the risk are then determined. Next a series of steps are written down that are to be followed by the person or persons carrying out the works. Pat Testing Record Template' title='Pat Testing Record Template' />The worlds leading networking information sharing website for food safety practitioners. John Patrick Pat McInally born May 7, 1953 is a former punter and wide receiver for the National Football Leagues Cincinnati Bengals. McInally has been tapped. This sequence of steps should include all health and safety aspects, such as personal protective equipment requirements, tools and equipment, and importantly, safety related equipment such as scaffolding. All control measures that have been determined whilst preparing a method statement andor risk assessment should be used as a tool box talk prior to the works being carried out. By performing an overview of the method statement andor risk assessment during the tool box talk, everyone involved will have a clear understanding of the work to be carried out, as well as the safe work method sequences and safety equipment required. Here is a very simple example Scroll Down for a more advanced example method statement. Method Statement for Making a Cup of Coffee. Ingredients coffee powder, milk, sugar and boiling water. Equipment Needed kettle, spoon and mug. Potential hazards Burns from the kettle or contents, electrical shock from power cablesource. Method Ensure that the kettles electric cable and the kettle itself are in good condition and that there are no frayed cables or loose connections into the plug. In the UK this appliance would be PAT tested Portable Appliance Testing. The kettle will be filled with the required amount of water, the plug inserted into the power socket, and the kettle turned on. The desired amount of coffee granules will then be placed into the mug using a spoon. Once the kettle has boiled, it will be unplugged and the boiled water will be poured into the mug. Milk and sugar will be added to taste. If the coffee is made for other people, they will be informed that the drink is hot. The above example is obviously very basic, but even the simple task of making coffee carries some hazards and steps must be taken to reduce any risks. This Example Method Statement is for  Air Conditioning Maintenance and is  more advanced. Method StatementSafe System of WorkContract Name Address Ref Description of Works Main objectiveAir conditioning Maintenance Repairs. Pat Testing Record Template' title='Pat Testing Record Template' />Expected Start and End Dates Assessment Date Assessed By Approved By Associated Health, Safety and Environmental Assessments Risk Assessments, COSHH Assessments etcManual Handling. Slips Trips and Falls from Height Including Ladder Safety. COSHH     Pro Universal Universal Coil Cleaner. Reducing Risk. Note Steps that can be taken to reduce risks associated with this tasks. Only Trained and Certified Electricians and Air Conditioning Engineers will be permitted to disconnect and reconnect the appliances. Power tools will all have safety guards fitted as per manufacturers specification All tools 1. Power tools will be connected to a ground fault circuit interrupter. Protective eye, ear and foot protection will be worn at all times, by all workers. Gloves will be worn at all times where sharp hand tools or heat soldering are used and where coolant is used. When the Pro Universal Coil cleaner is used, wear full ppe in accordance with the COSHH assessment. Manual handling of the interior units and outdoor condensers units will be carried out by trained persons. Contract Supervision Training Supervisors and Current Certificationtraining Labour Number of personsIf Required List All Labour and their tradesThe maximum foreseen is 2 persons. Plant, Tools Equipment List allChemicals Ensure COSHH completed if reqd. Hand Tools. Steel capped boots. Pat Testing Record Template' title='Pat Testing Record Template' />Gloves and goggles. Step ladder. COSHH for Pro Universal Granular Coil Cleaner. Oxygen Free Nitrogen cylinder 1. Welfare Facilities Toilets, Washing Facilities Drinking WaterFirst Aid Facilities First Aider, Location of First Aid BoxClient facilities where possible. First Aid Box kept in works vehicle. MIMOSA is a notforprofit trade association dedicated to developing and encouraging the adoption of open information standards for Operations and Maintenance in. Pat McCrory 74th Governor of North Carolina In office January 1, 2013 January 1, 2017 Lieutenant Dan Forest Preceded by Bev Perdue Succeeded by Roy Cooper. What is a Method Statement NEW. If you are looking for a specific method statement we have set up a sister site where. Gift-Certificate-Template.jpg' alt='Pat Testing Record Template' title='Pat Testing Record Template' />Work MethodKey steps stages of the work required1. Arrival at site, report to required named person and sign in where required. Inspect the work area ensure safe area around required working space and that clients staff  are warned of works and if signage required set up. The electrical supply to the interior unit will be switched off and tagged if required, the supervisor will ensure that the supply is fully isolated. Using a safe and inspected step ladder placed on a non slip surface rubber mats if tiled floor etc the ceiling void will be entered, the filters removed and cleaned. The internal unit will be inspected for any damage to wiring, wear and tear and cleaned in full. Once cleaned and filters have been replaced the unit will be tested to ensure full working order. The 1. 5kg Oxygen free nitrogen bottle will then be taken to the bottom of the roof access ladder. A winch suitable to wind the 1. The external condenser unit will have its electrical power switched off and tagged if required. The condensers will be cleaned and the pipework tested for leaks, the fins will be checked for any damage. Once cleaned and maintained, the power will be switched on and the unit tested. The entire system will then be checked to ensure operation is at the optimal requirements. Any waste will be cleaned and removed, the staff will report back to the client. Briefing or Tool Box Talk recordThis method statement should be used to brief all persons involved in the works. They should add their name and signature to show they have received and understood this method statement. NAMESignature. Web portal for buildingrelated information with a whole building focus provided by the National Institute of Building Sciences. Areas include Design Guidance. Free Online Support Record Keeping PAT Testing Certificates, Records Results. There is no law which requires detailed records to be kept. Welcome to eAuditNet, a webbased system, developed and maintained by the Performance Review Institute PRI to support and improve efficiency in the Nadcap auditing. Pharmaceutical Quality Assurance Manuals and Validation Procedures. Cleaning Validation. The Maximum Allowable Residue for Therapeutics MART and Residue Acceptability Limit for Therapeutic Dose RALT should be calculated based on each product that is to be processed in a specific equipment train and determined by the formulas and equations provided in Appendix A. A common default MART is not more than ten 1. This document provides guidance in selecting the type of routine verification sampling method to use for particular types of API equipment and recommends locations for where to perform swab and or visual inspection conducted during cleaning validation and during subsequent routine verification. The ability to group products or equipment for the purpose of reducing the amount of sampling and testing during cleaning validation is dependent on scientific, documented rationale. Program Pentru Bluetooth Pc. Similarly, scientific, documented rationale is also required when determining a worst case product for the purposes of cleaning validation of API and DP manufacturing equipment. The area to be swabbed must be defined, typical areas range from 5cm x 5cm to 4 x 4. It shall include special requirements andor calculations for specific areas or equipment. It should be constant and well defined at each site to ensure consistency. If visual inspection is the only verification of a changeover cleaning process on minor equipment, the limit of detection using visual inspection techniques should be quantified in the laboratory or referenced from recognized literature. Comparison of an unknown peak to the RAL determines if an investigation is initiated. There are multiple Safety Factors typically applied in the RAL calculations. Therefore, the risk of having an unknown peak present that is significant to toxicity or dose limits is relatively low considering the conservative approach chosen to calculate the RAL. The cleaning program requires that cleaning is conducted and the cleaning activities documented following written instruction records, or SOPs with attached checklists. An understanding of the concept and relationship between normal operating range and proven acceptable range is necessary in establishing the range for a critical process parameter. Rationale for the determination of a parameter as critical must be documented. Other Validation. Critical process parameters should be determined by a review of available historical data generated during development andor manufacturing, or by experimentation. Each critical step is evaluated by observing the effect that potential critical process parameters have on quality attributes. A Cleaning Evaluation should be conducted, documented, and approved by the Site Quality and Production Team. This evaluation may be a single report or several reports and may be equipment centric or process centric and document or reference the required information. Demonstrating equivalence is needed in all API validations, but this guidance is applicable to APIs prepared by chemical synthesis. Additional analysis not described here may be needed to evaluate physical attributes of the API, where requirements are defined for the corresponding Drug Product. A new or modified drug products should be demonstrated to be equivalent to previously produced product. Comparisons must be done as part of process validation studies for new product and significantly modified processes that require validation. This guidance describes considerations and risks for determining if the establishment of clean equipment hold times for equipment producing drug product and Active Pharmaceutical Ingredients API are required. This guidance outlines considerations and risks associated with hold times between equipment use and cleaning. The recommendations to evaluate if the time between equipment use and cleaning needs to be established and controlled are described for Active Pharmaceutical Ingredients APIs and Drug Products. When they are determined to be critical, recommendations on how to establish and extend existing hold times are also described. This guidance provides recommendations and examples for evaluating the process validation impact of changes to manufacturing processes used for manufacture of API, Drug Products and packaging processes. This guidance addresses recommendations for good sampling practices. Validation sampling plans must be specified or referenced in the protocol. This guidance provides recommendations related to the selection and application of swab sampling and visual inspection for various types of Drug Product equipment. This Guidance sets out guidelines for the determination and validation of in process and bulk product holding times. This guidance provides information on demonstrating batch homogeneity of final APIs small and large molecules and critical intermediates. This procedure provides guidance for performing a homogeneity evaluation in support of API process validation. The following components of the evaluation are described Materials to be tested, Selection of test methods for examining homogeneity, Sampling plan when to collect samples, from what locations, and the number of samples, Selecting acceptance criteria for evaluating homogeneity test results. This guidance provides an example of documentation to support the use of Continuous Quality Verification for demonstrating that a manufacturing process is in a validated state. This guidance describes the documentation needed to support the use of Continuous Quality Verification to demonstrate that a drug product or active pharmaceutical ingredient process is in a validated state. It also describes some similarities and differences between Continuous Quality Verification and traditional process validation using three discrete lots. This guidance provides points to consider when selecting Dosage and Toxicity data for use in the Cleaning Limits calculations. This procedure provides examples and guidance on classification of defects for packaged non sterile drug products. This procedure provides guidance in the qualification of simple, moderate, and complex laboratory equipment that is used in an analytical laboratory in a Good Manufacturing Practices GMP environment associated with products in or intended for the market place. Bracketing and matrixing allow a most appropriate challenge condition to be defined for a process or drug product family the same drug product with different dosage strengths. This risk based approach can allow the validation to be focused on the most challenging circumstances, or worst cases. Use of this approach can provide a significant benefit to reduce the overall validation effort. Examples of primary and secondary packaging validation, both manual and automated operations are provided in this guidance. This also provides guidance on aspects to consider for packaging validation. Explanations of factors to consider for acceptable packaging validation and lot size are provided with various practical examples. This guidance is to address environmental control for existing, new, and modified non sterile API processing areas used for the manufacture of commercial materials. This includes non sterile API manufacturing areas where the API will subsequently be used to produce sterile Drug Product. This Guidance provides a tabulation of potential critical process parameters and quality attributes of typical steps of primary solid drug product i.