Careers, University of Texas Medical Branch, UNITED STATES. However, consider the benefits. An official website of the United States government. CLSI also recommends document verification to ensure that by following the procedure the correct end result is obtained. All SOPs need to be stored in a manner that prevents loss, damage, or unauthorized access and should promote easy retrieval. Centre for Global Health, University of Oslo, Oslo, Norway, 9 It is only through adherence to SOPs that an organization sustains its quality of product and services and sustains its business growth. All researchers using a specified chemical or process must be trained on the relevant SOP, and this training must be recorded. In case of multinational organizations and multi location establishments SOPs ensure uniformity of products and services throughout the locations. To enhance its comprehensibility, each SOP should be pretested and adapted before finalization. Effective SOPs assist in training staff uniformly to optimize the quality of the product and/or study. SOP approval also allows coordinated and timely implementation of the SOP on-site. The key learning points about SOP writing and implementation during the NIDIAG study are summarized in Box 2. Pretesting of SOPs and staff training need to take place before distribution and implementation of SOPs. var domain = document.domain;document.write(unescape("%3Cscript src='https://seal.thawte.com/getthawteseal?host_name="+domain+"&size=S&lang=en' type='text/javascript'%3E%3C/script%3E")); Investigations of discrepancies, failures, Deficiencies in scientifically sound laboratory controls, Deficiencies in control procedures to monitor and validate performance, Written procedures not established / followed, Calibration/inspection / checking not done. Managers can use this as a tool to access each employees performance based on the work provided to them. Jacobs J, Barb B, Gillet P, Aidoo M, Serra-Casas E, Van Erps J, et al. Before Efforts should be made to ensure their legibility, readability, and comprehensibility. While SOP works differently for different industries, there are some common benefits that can be obtained by all. sharing sensitive information, make sure youre on a federal For example, the importance of SOP in pharmacy is high because even a little discrepancy can cause serious problems both for the manufacturer and for the consumer. Legibility is defined as the ease with which a reader can recognize the characters and words in a text. Clinical Research in Neglected Tropical Diseases: The Challenge of Implementing Good Clinical (Laboratory) Practices, Rapid Diagnostic Tests for Neglected Infectious Diseases: Case Study Highlights Need for Customer Awareness and Postmarket Surveillance, Diagnosis of Persistent Fever in the Tropics: Set of Standard Operating Procedures Used in the NIDIAG Febrile Syndrome Study, The Challenges of Conducting Clinical Research on Neglected Tropical Diseases in Remote Endemic Areas in Sudan, Experiences and Lessons from a Multicountry NIDIAG Study on Persistent Digestive Disorders in the Tropics, Clinical Research on Neglected Tropical Diseases: Challenges and Solutions, http://www.who.int/malaria/areas/diagnosis/rapid-diagnostic-tests/generic_PfPan_training_manual_web.pdf, http://apps.who.int/iris/bitstream/10665/44665/1/9789241548274_eng.pdf, http://www.who.int/tdr/publications/documents/gclp-web.pdf, http://www.ajlmonline.org/index.php/ajlm/article/view/3, https://www.nngroup.com/articles/legibility-readability-comprehension/, http://ec.europa.eu/health/files/eudralex/vol-2/c/2009_01_12_readability_guideline_final_en.pdf, http://www.fda.gov/downloads/MedicalDevices//ucm070771.pdf, http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm070801.pdf, http://link.springer.com/article/10.1007/BF02766547#page-1, https://www.usaidassist.org/sites/assist/files/using_quality_design_to_improve_malaria_rapid_diagnostic_tests_in_malawi_0.pdf, http://www.who.int/malaria/publications/atoz/9789241509978/en/, http://www.hablamosjuntos.org/signage/pdf/pt1evaluation.pdf, http://www.who.int/patientsafety/activities/technical/vincristine_learning-from-error.pdf, http://www.access.gpo.gov/nara/cfr/waisidx_04/42cfr493_04.html, General requirements for the competence of testing and calibration laboratories, Medical laboratoriesRequirements for quality and competence, QMS: Development and management of laboratory documents, Guideline on the readability of the labeling and package leaflet of medicinal products for human use, "Write it right"Recommendations for developing user instruction manuals for medical devices used in home health care, Guidance on medical device patient labeling; Final guidance for industry and FDA reviewers. Training records (e.g., sign-in sheets) must be kept either in the SOP master file or a group training file, but also in the individuals training file [2]. FOIA Clear job aids improved health workers performance during malaria rapid diagnostic tests (RDTs) [1719]. is that it helps in simplifying the overall performance management of the organization. Industrial establishments, laboratories, commercial business organizations and government agencies have their own set of standard operating procedures which are based on organizational requirements but all have one common goal which is to give best possible service to clients in terms of quality and, time commitments on deliveries. This guideline mentions document verification as part of the review process (see below), which can be considered as a form of pretesting [2]. Careers For clinical trials specifically, SOPs ensure that the research conducted within clinical sites adheres to the Federal regulations, ICH-GCP, and institutional policies to safeguard the human study participants' welfare and rights. The use of job aids is recommended (e.g., displayed on the wall), as they are often more practical than fully detailed SOPs. Meeting report. Make Sure That All Types of SOPs Are Included, If Deviations Are Allowed, Clearly Define the ConditionsDefine and document the conditions if they are allowed including who can provide permissions for this and what should be the complete procedure. Save my name, email, and website in this browser for the next time I comment. official website and that any information you provide is encrypted Federal government websites often end in .gov or .mil. Institut National de Recherche Biomdicale, Kinshasa, Democratic Republic of the Congo, 3 Quality management system: A model for laboratory services; Approved guidelineFourth edition, Review and comparison of quality standards, guidelines and regulations for laboratories. SOPs must be available where used [2]. SOPs should be written by laboratory personnel who are most knowledgeable and involved with the experimental process. The compilation of small changes could then be adapted at once during the planned periodic revisions of SOPs, resulting in official new versions only at specific time points, thereby facilitating distribution and implementation of these new versions. Write it rightRecommendations for developing user instruction manuals for medical devices used in home health care, Guidance on medical device patient labelling; Final guidance for industry and FDA reviewers, Cultural differences in the perception of image and color in pictures, Educational Technology Research and Development, Readability characteristics of consumer medical information for asthma inhalation devices. For instance, it could be allowed to adapt SOPs on-site, after discussion with the study quality manager and the sponsor, and the site quality managers sign-off. Institut de Recherche pour le Dveloppement, Montpellier, France, 4 A persons perception of a symbol varies across cultures [25] but also depends on training, educational level, and professional experience [26]. Harmonization of rapid diagnostic tests for malaria and implications for procurement. But when they will have proper documentation of things, there will be no room for confusion or misunderstandings. A simple way to understand and practice the clauses covered by ISO 17025:2005, Preparing For A Medical Laboratory Assistant Interview, On-line Certificate Program on High Performance Liquid Chromatography Join Now. 2009. International Organization for Standardization. The objective of writing this article is to make you realize your responsibilities and contributions towards your organisation and this is possible only if you are aware of your organizations activities, quality policies, ethics through a sound understanding of your organizations Standard Operating Procedures. Graphics are promoted if they are clear, simple, precise, and depicted at appropriate size and resolution. Due to the difficult internet and telephone communication with the remote site, some procedural changes could pass unnoticed. Geneva:WHO;2015. Fundamentals of Lab Safety Training Course, Course on Gas Chromatography - CPD Certified, Course on High Performance Liquid Chromatography - CPD Certified, Course on Atomic Absorption Spectroscopy - CPD Certified, Certificate Course on Atomic Absorption Spectroscopy, Fundamentals of Laboratory Safety Training Course, Certificate Course on High Performance Liquid Chromatography, Introduction to Pharmaceutical Preformulation, Free Course on High Performance Liquid Chromatography, Qualification of vendors for procurement of raw materials, Handling, storage and issue of raw materials to production departments, Maintenance schedules for manufacturing equipments and laboratory instruments, Pretreatment of industrial effluents and waste before disposal, Policies on withdrawal of supplies of defective items or products, Maintenance schedules and calibration of different test instruments and weighing balances, Laboratory environment control, i.e. Seidahmed OM, Mohamedein MM, Elsir AA, Ali FT, Malik el FM, Ahmed ES. Copyright 2022 Auriga Research Private Limited, It is where SOP comes into the role. The site is secure. Some of them include: Suppose you have the best working staff for your business. Barriers to the correct application of SOPs include misunderstandings because of language or jargon thats too technical, lack of familiarity with written guidelines, lack of belief that SOPs will improve practice, and lack of motivation to change practice [27]. Moreover, they help ensure compliance to the study protocol, regulations, and international standards. Copies of SOPs need to be clearly labelled as approved and current versions, while out-of-date versions must be removed from site. End-user errors in applying two malaria rapid diagnostic tests in a remote area of Sudan, Tavrow P, Knebel E, Cogswell L. Using quality design to improve malaria rapid diagnostic tests in Malawi. Some examples of circumstances that may require prior approval include working alone in a laboratory, unattended or overnight operations, the use of highly toxic gas of any amount, the use of large quantities of toxic or corrosive gases, the use of extremely reactive chemicals (e.g., pyrophorics, water reactive chemicals), or the use of carcinogens. By their nature and objective, SOPs connect to all other building blocks of the QMS, such as organization and personnel, equipment, procurement, process control, biosafety, and corrective and preventive actions. A training period should be foreseen [2], and continuous support should be available. It comprises 17 sections and is, therefore, comprehensive but long. The guidelines we assessed give different recommendations on legibility. is high because even a little discrepancy can cause serious problems both for the manufacturer and for the consumer. will also be available for a limited time. Most laboratory staff have a good education level and are trained in understanding technical documents. SOPs are subject to version control (e.g., version number and date), review and approval, distribution and implementation, update and revision, and archiving of superseded versions. The number, length, and complexity of SOPs can also be a barrier to writing and implementation, as well as the language issues. As these are not available in low-resource settings, one could reconsider some of the QMS requirements. Standard Operating Procedureshelp establish a benchmark for quality of products and services. HHS Vulnerability Disclosure, Help It secures the area and the quality of service. The United States Food and Drug Administration (FDA) guidelines recommend 6th or 7th grade [12] up to a maximum of 8th grade level [13] to reach most of the population of the United States. CLSI, Clinical and Laboratory Standards Institute; QMS, Quality Management System; SOP, Standard Operating Procedure. Furthermore, the reading level of a text does not reflect its comprehensibility as reading formulas do not take into account the content or the organization of a text. Institute of Tropical Medicine, Antwerp, Belgium, 2 Geneva: WHO; 2008. Because of the high number of SOPs, small errors slipped in, causing a series of (minor) revisions, which complicated document control and on-site SOP management. They simply have to follow the mentioned processes and rules. Chemicals For Which Safe Work Practice Standard Operating Procedures Are Available(word docs). Awareness of SOPs of your organization or at least your division is absolutely necessary as the overall output of your division and organization depends on the role played by each and every individual. They were provided as a supplement to a number of SOPs and were displayed on the walls in plastic covers (S3 Fig). In this context, extra care should be taken to adhere to the aforementioned requirements of legibility, readability, and comprehensibility of the SOP and to consistently use simple terms and words. CLSI, Clinical and Laboratory Standards Institute; ISO, International Organization for Standardization; JCI, Joint Commission International; (L)QMS, (Laboratory) Quality Management System; SLMTA, Strengthening Laboratory Management Toward Accreditation; SOP, Standard Operating Procedure; WHO, World Health Organization. Deficiencies in training operations, GMPs, written procedures, Deficiencies in cleaning / sanitizing / maintenance, Operating instruments / apparatus / equipment SOPs. This can be done, for example, by asking the laboratory staff who were not involved in writing and reviewing to perform the procedure exactly as is written in the SOP [2]. They highlight the importance of a logical and consistent structure and promote the use of a template in order to assure completeness and comprehension [12]. To overcome these barriers, ownership by and dialogue with local users is crucial in SOP development and during periodic reviews. offers various other advantages. Minimising human error in malaria rapid diagnosis: clarity of written instructions and health worker performance. [10]. visit our Contact Page. JD MacLean Centre for Tropical Diseases, McGill University Health Centre, Montreal, Canada, 7 We also searched for evidence about legibility, readability, and comprehensibility of other written documents (i.e., package leaflets of medicines and medical devices). Every effort should be made to evaluate potential hazards based on analogy to similar compounds or expected structural features of the chemical. SOPs should be based on a template and kept simple and short, while still including the minimal essential information to perform the task correctly. As all of them follow the standard processes and rules, it isnt much complicated to compare their performances. Have the PI review it and then contact REHS for final approval. Are SOPs really important - Not only to plan consistent manufacturing or testing operations repeatedly but also to ensure that your Quality Control (QC), Quality Assurance (QA), and production units use them to assure the accuracy of the original product development? News government site. Department of Neurology, Technical University of Munich, Munich, Germany, 8 Join Our Community Of 20000 Scientists & Get Instant Free Access To 5 Free Courses & A Weekly Newsletter. Such procedures shall include all requirements in this subpart. Web-based translation machines may be inaccurate: as an example, Google Translate only had an accuracy of 57.7% for the translation of common medical statements to 26 languages [22]. Categories are clinical (in context of patient care) and nonclinical (laboratory work not related to patient care, clinical research). People from everywhere can follow the same processes and produce equally good products. Copyright 2022. Waste collection, storage, and disposal requirements. When the potential toxicity is unknown, it must be assumed that the substance is "particularly hazardous.". Its strict adherence to standard processes and rules may become a problem for the creative industry. Of note, none of the QMS documents cites nor recommends pretesting, except for CLSI guideline QMS02-A6. ", The Rules Governing Medicinal Products in the European Union, Volume 4, Good Manufacturing Practice, Medicinal Products for Human and Veterinary Use, Chapter 4: Documentation: "Procedures: (Otherwise known as Standard Operating Procedures, or SOPs), give directions for performing certain operations. Apart from the review process during the SOP development, revisions are required on a regular basis (e.g., annual or biannual review), while updates may occur at any time, when needed. All organizations irrespective of their functional areas strive to give their best in terms of quality of products and services. Box 1 lists the basic principles of SOP writing. SOPs are written step-by-step instructions on how to carry out procedures correctly. Hermans V, Monzote L, Van den Sande B, Mukadi P, Sopheak T, Gillet P, Jacobs J. One of the most crucial advantages of SOP is that it helps in simplifying the overall performance management of the organization. Place the original SOPs in a secure place and authenticate the working copies with stamps and/or signatures of authorized persons. Job aids are also subject to document control and can be included or referred to in the related documents section of the SOP template [2]. Some companies overlook the importance of writing SOPs or policies and procedures. The authors have declared that no competing interests exist. The SOP master file contains the current and previous versions of the SOP and serves as the source for generating working copies of current SOPs as well as a historic record, which is useful for audit and inspection purposes. They are designed for direct use at the testing site and are meant to supplement but not replace SOPs [1]. Readability measures the complexity of words and sentence structure (e.g., numbers of syllables in a word, difficulty of words, and sentence length). The study aimed to improve the early diagnosis of severe and treatable infections among patients with neurological disorders and took place over a 20-month period (14/09/201224/05/2014) (ClinicalTrials.gov Identifier: {"type":"clinical-trial","attrs":{"text":"NCT01589289","term_id":"NCT01589289"}}NCT01589289). Concepts and symbols can be interpreted differently in different cultures [20,25]. Individual hands-on training is recommended for more challenging or unfamiliar techniques and for new laboratory staff. Why is it necessary to validate the Analyst? We reviewed QMS documents (identified through an unstructured internet search) that address SOP development. Apart from these three primary benefits, the function of SOP offers various other advantages. In this article, we will explore all the details about the topic and find the importance of SOP in different industries. Finally, the SOP is approved by the laboratory management, e.g., by circulating a signature page together with the SOP or by an electronic sign-off. Training of staff on SOPs (with competence assessment) is an essential QMS requirement and connects the SOPs to the organization and personnel building block [2]. Nielsen J. Legibility, Readability and comprehension: Making users read your words. The review process should also involve people outside of the writing process, to ensure that the SOP can be used by persons that are not familiar with the topic. The set of 50 SOPs (S1 Appendix), all in French, include procedures related to the inclusion and clinical management of patients with neurological disorders (n = 4), diagnostic testing (n = 33), data collection and management (n = 5), and quality assurance (n = 8). Ensure the Three Main Classes of Procedural Documentation The compilation and version management of the SOPs were handled by the NIDIAG Good Clinical Practice (GCP) focal point, who ensured availability of the most recent versions on the NIDIAG website, allowing for timely distribution to all concerned individuals. Circumstances requiring prior approval from the PI/Laboratory Supervisor must be addressed in laboratory-specific SOPs. Training can be documented by completing the signature page at the end of the SOP. Examples are the Simple Measure of Gobbledygook grading (McLaughlin 1969) and the FleschKincaid grade level. Adequate budget and staff should be allocated to pretest the draft SOPs and to implement them once finalized. Graphics should be used to simplify the overall message, with preference for drawings [12,14]. Of note, none of the SOP templates recommended by the assessed QMS documents include a separate section about waste management. This is essential to maintain a competitive edge and keep their clients satisfied. and transmitted securely. The development of a set of SOPs is essential for the good conduct of a clinical study, such as the NIDIAG study on neurological disorders. An approval procedure should be established, specifying the individuals involved (by their positions or functions) and the order in which approvals are given. Required fields are marked *. Using a home blood pressure monitor: do accompanying instruction materials meet low literacy guidelines? ", ICH-GCP 2.13: "systems with procedures that assure the quality of every aspect of the trial should be implemented. These standard procedures serve as a guide for the employees that provide them with the details on what has to be done at each step of production. In particular, a QMS cannot hinge solely on written instructions in an environment with a strong oral culture. Table 2 describes the SOP template recommended by CLSI QMS02-A6. They may receive some information from one person and exactly the opposite from the other. Bethesda, MD 20894, Web Policies Center for Medicare and Medicaid Services (US). They can follow it for proper results. The new PMC design is here! Rutgers Connect Acquadro, Conway K, Hareendran A, Aaronson N, European Regulatory Issues and Quality of Life Assessment (ERIQA) Group. We will now see some basic benefits of SOP. The quality manual specifies standard operating procedures (SOPs) which are a set of documents which define practices which need to be followed in word and spirit by all employees strictly and without deviation. Obsolete versions should be clearly labeled as such, e.g., by means of a notation or stamp.
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