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Standards at different levels define criteria and indicators that guarantee the quality of the business processes in the enterprise (including small ones), answering the question – what needs to be done correctly. However, the standards do not answer the second question of quality assurance – how to get it right when, where and by whom. These questions are answered in documents of different levels and different structures. Such documents are called Standard Operating Procedures (SOP).
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Standardisation does not allow quick results. The effect of its application is stretched over time and consists of a large number of different indicators. Reducing the number of defects, increasing safety at work and increasing productivity may be due to the actions of all management. They are developed and implemented within the undertaking itself.
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The Standard Operating Procedure (SOP) is an organizational document that translates the planning of the work to be performed. It is a detailed description of all the measures necessary to perform a task.
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What is Standard Operating Procedure (SOP)?
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Standard operating (working) procedures (SOP/SOP/Standard operating procedures) is a documented set of instructions or step-by-step steps that need to be performed to perform a particular work.
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If we go back to the 20th century, we have a clear example of a standardized procedure on Ford’s “T” model assembly lines, which was one of the first production lines to succeed and work with standardized tasks.
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The levels of standardization were so effective, for the time, that the cost of the product was reduced to the maximum, allowing “everyone could have a car, as long as it was black”. Later, it was noticed that only the black car was not enough to satisfy consumers, which led to the development of new standards of procedure.
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The Standard Operating Procedure (SOP) displays instructions of the sequences of operations and their frequency of execution, pointing out the following elements:
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The person responsible for the execution and listing of the equipment;
Parts and materials used in the accomplishment of the task;
Description of the procedures that must be performed in critical activities (the mode of operation and possible restrictions on execution, which may or may not be done);
Script of periodic inspections of production equipment.
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All these elements must be approved, signed, dated and reviewed annually or in accordance with the need of the process.
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Standard Operating Procedure (SOP) objectives
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The Standard Operating Procedure (SOP) aims to keep the process in operation through standardization and minimization deviations in the execution of the activity, that is, it seeks to ensure that the actions taken to ensure quality assurance are standardized and executed as planned.
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How to develop an SOP?
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To create a Standard Operating Procedure (SOP) document, simply describe the tasks that are part of the work routine, taking the following care:
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Do not copy procedures from books or other organizations, because each process has its particularities, and these procedures should be appropriate to its type of process;
The executor of the process must be an integral part of the elaboration of the procedures, because he is the connoisseur of the process and knows its characteristics and deficiencies;
The applicability of procedures should be constantly monitored to ensure that they are being followed correctly;
The language used in SOP must be simple, clear and objective, so that the document can be understood and applied by all.
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What should a Standard Operating Procedure (SOP) contain?
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It is important that the procedure has enough information for employees to use it as a guide, as well as, in case of doubt, know where to seek more information or who to turn to. Thus, it is interesting that POP contains the following items:
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Name;
Objective;
Reference documents (manuals, ITs, processes or other procedures);
Place of application;
Acronyms (if any);
Description of the steps of the task and its executors and guardians;
Flowchart;
Place where it can be found and the name of the person responsible for guarding and updating the POP;
Update frequency;
Form that will be generated (digital or physical);
Manager (who drew it up).
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Here is the checklist to follow to write an SOP.
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Information to insert on the first page:
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Title. The title includes one or two lines containing the subject of the SOP.
SOP Number( SOP Number): Each SOP should be numbered sequentially using 5-digit numbers. The first three digits identify the SOP and the last two indicate the progressive revision number.
Date: Indicates the date on which the SOP takes effect. This date is or is later than the approval date.
Superseded: Indicates the Number and date of the SOP preceding the current SOP.
Last and next review dates: The review date is the date on which the SOP was reviewed. If the SOP does not change after review, the details of the replacement will not change. The next revision date will coincide with the next date on which the SOP review was planned.
Approved by: Like any procedure, the SOP needs a person to approve it. In this field you must enter the date and signature of a manager of the department in which the SOP is applied. The approvals confirm that what is written in the SOP adequately describes the procedures developed and used by the Sponsor or the CRO.
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Sections to be inserted in the SOP text:
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Table of contents: The content table will include a list of what is included in the SOP, with the page number next to it.
Introduction: The introduction should briefly describe the rationale and purpose of the SOP.
Contents: The contents of the SOP should follow the order listed in the content table and generally follow the order in which the procedures are put into practice.
Appendixes: The appendixes of the SOP must be numbered and listed according to how they are discussed in the SOP. These are usually listed by roman numbering (e.g. Appendix I, Appendix II, etc.) and are placed at the end of the SOP. Every single page is also numbered.
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Importance of the Standard Operating Procedure (SOP)
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The Standard Operating Procedure (SOP) is an instrument aimed at those who perform the task and must be simple, complete and objective, so that it can be interpreted by all employees. As for its application, it represents the basis for ensuring the standardization of tasks and ensuring users a service or product free of variations (or non-conformities) that may interfere with their final quality.
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Keep your SOPs safe and ensure that only the latest version of documents is used in your company.
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As we have seen, the Standard Operating Procedure (SOP) is an important tool to guide the execution of processes. It helps ensure standardization of activities and can be very helpful in quality assurance. However, with the high flow of information within companies, it is common for outdated procedures to be used in processes. A process undergoes constant revisions to correct failures and improve its performance. By using an outdated procedure, the company continues to execute the flaws that were found by quality and fails to take advantage of standardized improvements, generating great losses for the organization.
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Here are the main topics on which you can write an SOP:
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General topics: quality assurance procedures and quality control; clinical development plans, clinical trial plans, staff qualifications, audits, regulatory inspections, fraud.
Ethical aspects: working procedures, informed consents, briefing notes, exceptions to normal informed consent procedures.
Designing a clinical trial: investigator brochures, protocols, protocol amendments, CRF, submission to regulatory authorities; (Responsibility Agreement, Financial Agreement; Insurance/Indemnity Agreement), centre selection, CRO selection, clinical laboratory selection, initiation visit, investigator meeting, start-up meeting.
Monitoring: monitoring visits, source data verification, CRF review, CRF tracking, query, development, database review and closure, statistical review.
Management of medical drugs/devices and clinical laboratory samples: labelling and packaging, shipping, receiving, control in centres, drug assignment, inventory, compliance assessment, final reconciliation, recall (recall), randomization procedures, clinical laboratory samples.
Safety Report: Definitions, logging and reporting of adverse events, reporting security information outside.
Closing of the study: closing visits, clinical study reports, premature term or suspension of the study, archiving.
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As your organization grows, you may want to create several locations where employees will replicate the work processes of the original location. Having SOP makes it easy to replicate processes within your organization. You can also monitor the productivity of each site based on the performance levels for each standard operating procedure, which is good information to have if you need to scale your organization.
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Large companies such as hospitals benefit greatly from SOPs as well as business models that need to be scaled up quickly. A Standard Operating Procedure (SOP) simplifies the replication of processes in the growth process.
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