Key Safe Operating Instructions
Yury Morris
A safe operating procedure (SOP) is a set of step-by-step instructions compiled by an organisation to help workers carry out complex routine operations. SOP's aim to achieve efficiency, quality output and uniformity of performance, while reducing miscommunication and failure to comply with industry regulations.
SOP's should be written with sufficient detail to ensure that someone with limited experience or knowledge of the procedure, but with a basic understanding, can successfully carry out the procedure in a safe manner when unsupervised. They should be written in concise, logical, step-by-step, easy-to-read format.
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The U.S. Food and Drug Administration (FDA) is raising awareness among health care providers and facilities about the safe use of electrical operating room tables. The FDA has received reports of adverse events associated with electrical operating room tables and is providing recommendations for health care providers to help protect patients.
The FDA has received reports of adverse events associated with electrical operating room tables, including problems with positioning or unintended movement of the table which may result in serious patient injury, or extended or delayed surgical procedures which can lead to potentially life-threatening complications. While the FDA believes that serious adverse events associated with electrical operating room tables are rare, health care providers and users should be aware that these can and do occur.
Although medical device reports (MDRs) are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to under-reporting of events, inaccuracies in reports, lack of verification that the device caused the reported event, and lack of information about frequency of device use. Because of this, MDRs comprise only one of the FDA's several important postmarket surveillance data sources.
The FDA routinely monitors postmarket performance of marketed devices. We will continue to collect and analyze all available information related to operating room tables to better understand the potential risks.
(2) Self-propelled units shall be equipped with electrical or other interlock means which will prevent driving them with the platform height greater than the Maximum Travel Height or at speeds greater than permitted at Maximum Travel Height.
(j) In operations involving production of small debris, chips, etc., and the use of small tools and materials, and where persons are required to work or pass under the equipment, screens shall be required between toeboards and guardrails. The screen shall extend along the entire opening, shall consist of No. 18 gage U.S. Standard Wire 1/2 inch mesh, or equivalent.
(l) Employees shall be instructed by a qualified person in the safe use of the work platform in accordance with the manufacturer's operating instructions, and Section 3203, Injury and Illness Prevention Program.
Operating instructions are instructions issued by the company to its employees on the operation or use of equipment, technical products, work processes, substances or mixtures with the aim of preventing accidents and health risks. The preparation of operating instructions is mandatory in many areas and is required by numerous regulations.
It is possible to create operating instructions for hazardous products as individual operating instructions or group operating instructions for certain product groups with the same hazard characteristics. The operating instructions must be written in a form and language that is understandable for the employees.
SOPs describe in detail how hazardous equipment should be used and processes conducted to perform the work safely. Safe operating procedures help reinforce safety protocols to prevent unforeseen accidents and fatalities. Documented, step-by-step procedures can save lives.
Differences in work processes can compromise work quality and efficiency. By referring to the SOP for a particular procedure, your new workers will know exactly how to perform an assigned task. SOPs can help assist in standardising critical processes to reduce variations in completed work. SOPs can also greatly assist with improving a Quality Management System (QMS) and can help prepare an organisation for ISO certification.
SOPs can complement your existing training materials to educate new workers and provide training on new equipment or processes. SOP procedures and steps should be drafted by experienced senior personnel and checked they are suitable for use by all staff. Remember, some workers may not have English as a first language or may have different literacy levels. Using images in a SOP not only makes it easier to comprehend but helps to ensure it is understood when needed.
Digital documents are great for many uses, and some SOPs work great in a digital format; however, paper-based documents still play a key role in making sure that workers can readily access and use the SOP in their daily duties. An effective SOP is one that is easy for staff to use and be available at all times regardless of the type.
At SafetyDocs by SafetyCulture, we acknowledge the Traditional Custodians of country throughout Australia and their connection to land, sea and community. We pay our respect to their Elders past and present and extend that respect to all Aboriginal and Torres Strait Islander peoples today.
Tire flatproofing is a precision process and should only be performed by an Carlisle TyrFil Certified Technician. Below are resources to help you promote safety in your tire fill processing rooms. Also, we have a knowledgeable Global Technical Support Team who can assist you with questions relating to safe operating procedures and can provide flatproofing technician training.
Flatproofed tires must be processed correctly to provide the customer with the maximum benefits of no flat tires, full tire life, consistent internal pressure, no rim slippage, improved safety, proper tire flex, cost savings, and retreadability.
There have been numerous recorded incidents where failings by operators have been the major contributing cause of major accidents. Provision of clear, concise and accurate operating procedures is the most effective measure to prevent, control and mitigate such events.
Operating procedures should clearly lay down instructions for operation of process plant that take into consideration COSHH, manual handling, permit to work, PPE Regulations, quality, HAZOP, and SHE requirements. The procedure should represent a definition of good or best practice that should be adhered to at all times. Process operatives should be provided with guidance concerning the required operating philosophy to ensure that they comply with procedural requirements.
Operating procedures should be controlled documents, generally covered under the company's quality system and thus kept fully up to date. Any changes should be fully controlled and documented and should be subject to company change procedures (see Technical Measures Document on Plant Modification / Change Procedures). Standard operating procedures may be revised for the following reasons:
Clear demarcation of where limits of intervention cease and reliance upon the control systems interface begins is a critical step in defining the operating procedures for a given plant or process. During the hazard and operability stage, the justification of reliance upon human intervention rather than automated systems should be established. This should be assessed in more depth in a subsequent risk assessment.
Commissioning of process plant is the practical test of the adequacy of prior preparations, including training of operating personnel and provision of adequate operating instructions. Since the possibility of unforeseen eventualities cannot be eliminated during this period when operating experience is being gained, the need for safety precautions should be reviewed. This should form part of the HAZOP / Risk Assessment processes applied to the installation. Full written operating instructions should be provided for all commissioning activities.
Commissioning Procedures document a logical progression of steps necessary to verify that installed plant is fully functional and fit for purpose. A general sequence of steps in commissioning may typically include:
Each section should be read in detail to gain understanding about the particular requirements of the activity prior to undertaking the activity itself and completing the associated check list. The checklist will serve as a permanent record of the activity, and can be reviewed if future modifications are undertaken.
Many potential hazards can be realised during start-up or shut-down of plant or process. Specific operating procedures should be provided which take account of all eventualities. For some specific plant items, start-up is know to present particular additional hazards; some examples of these are:
Any potential deviations to normal operation that cannot be addressed by design or control identified in the Hazard and Operability studies should be covered by emergency procedures. These should detail how to make plant and process safe, minimising risks to operators at all stages. They should cover PPE, the level of intervention which is safe and when to evacuate. The procedures will need to tie in closely with the on and off-site emergency plans provided under COMAH.
A clear management structure should be in place that defines competent responsible person(s) for generation of operating procedures and supervision of plant and personnel. The role of the supervisor in terms of training of operators, overseeing certain critical operations and checking of logs and other activities to ensure compliance with operating procedures. This should fulfil the requirements of the company's health and safety policy.
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