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]. 3 Easy Simple Tests! These circumstances are based on the inherent hazards of the material being used, the hazards associated with the experimental process, the experience level of the worker, and the scale of the experiment. Acquadro, Conway K, Hareendran A, Aaronson N, European Regulatory Issues and Quality of Life Assessment (ERIQA) Group. SOPs are written step-by-step instructions on how to carry out procedures correctly. Strengthening Laboratory Management Toward Accreditation (SLMTA). Rennie W, Phetsouvanh R, Lupisan S, Vanisaveth V, Honganthong, Phompida S, et al. Location of use, including fume hood or other containment devices. Universit de Kinshasa, Kinshasa, Democratic Republic of the Congo, 10 is that it helps in simplifying the overall performance management of the organization. In low-resource settings, specific factors that may interfere with writing and understanding of SOPs should be anticipated and addressed. Copyright 2022 Auriga Research Private Limited, It is where SOP comes into the role. Waste collection, storage, and disposal requirements. Quality management system: Development and management of laboratory documents; Approved guidelineSixth edition. National Library of Medicine ", ICH-GCP 2.13: "systems with procedures that assure the quality of every aspect of the trial should be implemented. Apart from the QMS documents in Table 1, we aggregated additional guidelines for clarity of writing, mostly about writing for patients and health care workers (Table 3). Categories are clinical (in context of patient care) and nonclinical (laboratory work not related to patient care, clinical research). Careers It is where SOP comes into the role. The presence of documented step-by-step procedures will help in teaching staff how to carry out things effectively to get optimized results and enhance awareness and working knowledge. People from everywhere can follow the same processes and produce equally good products. One of the most crucial advantages of SOP is that it helps in simplifying the overall performance management of the organization. Rutgers, The State University of New Jersey. 1 IP&O Intranet, myRutgers For swift retrieval, consulting, and use, SOPs related to laboratory work must be visible and accessible close to the bench rather than in a cupboard in the quality managers office. 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. Before official website and that any information you provide is encrypted Readability can be assessed by formulas and is expressed as the grade level (years of formal education) needed to easily read the text [10]. 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. Readability measures the complexity of words and sentence structure (e.g., numbers of syllables in a word, difficulty of words, and sentence length). Rutgers is an equal access/equal opportunity institution. We will now see some basic benefits of SOP. Training can be documented by completing the signature page at the end of the SOP. They are designed for direct use at the testing site and are meant to supplement but not replace SOPs [1]. Bethesda, MD 20894, Web Policies Almost all owners plan to expand their businesses with time. The benchmarks of ethical research, A comprehensive review of the SLMTA literature part 1: Content analysis and future priorities. HHS Vulnerability Disclosure, Help The number, length, and complexity of SOPs can also be a barrier to writing and implementation, as well as the language issues. S2 Appendix gives the scope and content of the assessed documents. SOPs are written instructions that detail the steps to be performed during a given experimental procedure and include information about potential hazards and how these hazards will be mitigated. 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. SOPs contribute to the standardization of processes company-wide and help minimize errors. Most QMS documents (e.g., CLIA regulations 2011 and CLSI guideline QMS01-A4 2011 [31,8]) have been developed for high-resource settings, hence anticipating fast-track documentation and distribution systems (e.g., by using specific software systems). The users should be involved in SOP writing, and local development of SOPstogether with the site teamis encouraged. Also, on-site implementation of SOPs did not always happen in time. There is no agreement on font types (with or without serifs) or font sizes: a minimum type size of nine points (font Times New Roman, not narrowed) with space between the lines of at least 3 mm (for package leaflets) versus type sizes of 1014 points (for laboratory documents, user manuals, and medical device labeling) have been recommended [2,1113]. A controlled document master list should be kept by a dedicated document manager, specifying the SOP names and identification numbers, the versions in use, and the effective dates and locations of controlled copies. An SOP should be written by a person who knows the procedure [2] and, if possible, by the staff that will follow the instructions. Write it Right - Excellent SOPs for Improved Quality and Compliance, Writing and implementing a Standard Operating Procedure (SOP) in a Compliant Laboratory (US FDA, US EPA and OSHA Focus), SOP Development for Medical Device Firms: Utilizing ''lean compliance'' principles to meet your quality system documentation requirements, How to write SOP's that Avoid Human Error, Creating Effective SOPs for Regulatory Compliance, Implementation and Utilization of Standard Operating Procedures (SOPs) at the Clinical Research Site, How to Write SOPs: Tips on Writing the Perfect Document to Impress the FDA, Best Practices for Writing an Effective SOP to Lead to Successful FDA Inspections, Improving Sanitation Standard Operating Procedures In the Food Industry. SOPs provide an excellent source for training new employees. European Commission. So lets get started. When an SOP for a manufacturing company is defined beforehand, it wont be challenging to bring about the same quality from all branches. Of note, none of the QMS documents cites nor recommends pretesting, except for CLSI guideline QMS02-A6. Continuous support of local staff and regular site visits are needed to ensure SOP compliance and to allow timely revisions and implementation of SOPs. Table 2 describes the SOP template recommended by CLSI QMS02-A6. Clinical laboratory improvement amendments (CLIA)[homepage on the Internet]. Pretesting is the systematic and formal gathering of user reactions after reading a document and is a prerequisite to distribution, training, and implementation [1113]. 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. The guidelines we assessed give different recommendations on legibility. 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. Obsolete versions should be clearly labeled as such, e.g., by means of a notation or stamp. We also searched for evidence about legibility, readability, and comprehensibility of other written documents (i.e., package leaflets of medicines and medical devices). Have the PI review it and then contact REHS for final approval. FDA, United States Food and Drug Administration. 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. This work is part of the NIDIAG European research network (Collaborative Project) supported by the European Unions Seventh Framework Programme for research, technological development and demonstration under grant agreement no 260260. Moreover, it is the ethical principle of collaborative partnership to engage local researchers and to share the responsibilities within a study [29]. For certain hazardous chemicals or specialized practices, consideration must be given to whether additional consultation with safety professionals is warranted or required. As these are not available in low-resource settings, one could reconsider some of the QMS requirements. In case of multinational organizations and multi location establishments SOPs ensure uniformity of products and services throughout the locations. While this may seem straightforward, it is actually a very complicated task, especially for the manufacturing companies that want to maintain their products qualities in all the branches. Circumstances requiring prior approval from the PI/Laboratory Supervisor must be addressed in laboratory-specific SOPs. Please feel free to offer your suggestions and comments. However, consider the benefits. ENTR/F/2/SF/jr(2009)D/869. An approval procedure should be established, specifying the individuals involved (by their positions or functions) and the order in which approvals are given. Deficiencies in training operations, GMPs, written procedures, Deficiencies in cleaning / sanitizing / maintenance, Operating instruments / apparatus / equipment SOPs. They simply have to follow the mentioned processes and rules. CLSI, Clinical and Laboratory Standards Institute; QMS, Quality Management System; SOP, Standard Operating Procedure. World Health Organization (WHO). The Clinical and Laboratory Standards Institute (CLSI) QMS02-A6 guideline, the World Health Organization (WHO) Laboratory QMS handbook, and the Strengthening Laboratory Management Toward Accreditation (SLMTA) provide the most extensive information [13]. Recommended grade levels are a maximum of 6th grade for patient education material [15,16]. SOPs harmonize laboratory practices, reduce user errors, and can be used as training tools. Regulatory bodies require organizations to have formal documentation describing their Business, Quality, and Compliance practices. Department of Microbiology and Immunology, KU Leuven, Leuven, Belgium. The NIDIAG SOP template includes a standardized header, title box, and five section headings: (i) Scope and application, (ii) Responsibilities, (iii) Procedures, (iv) Records and archives, and (v) Document history. Graphics are promoted if they are clear, simple, precise, and depicted at appropriate size and resolution. FOIA SOPs Help Train Staff Hanrahan D, Sexton P, Hui K, Teitcher J, Sugarman J, London AJ, et al. SOPs should be based on a template and kept simple and short, while still including the minimal essential information to perform the task correctly. Campus Health Safety Specialists, or call (848) 445-2550, About 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. In particular, a QMS cannot hinge solely on written instructions in an environment with a strong oral culture. temperature and humidity, Receipt and distribution of samples for testing, Time allocation for different activities including maximum response time to customers, Processing time for applications and appeals, Handling of disputes and client complaints. 33 Knightsbridge Road Piscataway, NJ 08854 SOP approval ensures that the content of the SOP is known to the managers and that they approve the use of the SOP by the staff. will also be available for a limited time. Some companies overlook the importance of writing SOPs or policies and procedures. Companies that pay attention to the importance of SOPs are likely to fulfill compliance obligations by incorporating regulations, best practices, and institutional requirements to the product and procedure. As for design and layout, emphasis is put on the proper use of white space, headers and templates, and bulleted or numbered lists. This is in line with the observations on QMS implementation in low-resource settings recently compiled by Luman and coworkers [30]. This is essential to maintain a competitive edge and keep their clients satisfied. Report Accessibility Barrier / Provide Feedback form. 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. Managers can use this as a tool to access each employees performance based on the work provided to them. 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]. 21 CFR 211.100 Written Procedures; Deviations Of note, none of the SOP templates recommended by the assessed QMS documents include a separate section about waste management. Federal government websites often end in .gov or .mil. 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. Some readability formulas are part of text processing programs such as Microsoft Office Word 2010. How a laboratory refrigerator is different, Paper Chromatography Principle, procedure, Applications, Partition Chromatography Principle, Procedure, Applications, Analysis Report A Reflection on Quality of your Laboratory Services. We reviewed QMS documents (identified through an unstructured internet search) that address SOP development. c2011 [cited 2011 Nov 11]. Font type Calibri, and type sizes of 18 and 24 points were used for table text and headers, respectively, allowing the text to be easily read when printed out and posted on a wall. [9]. 2009. International Organization for Standardization. Center for Medicare and Medicaid Services (US). 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). Careers, University of Texas Medical Branch, UNITED STATES. visit our Contact Page. Experimental procedures that include safety measures to reduce exposure. Quality management system: A model for laboratory services; Approved guidelineFourth edition, Review and comparison of quality standards, guidelines and regulations for laboratories. ", 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. In this symposium paper, we (i) review current standards and guidelines about writing and implementing laboratory SOPs, (ii) discuss best practices for writing and implementing laboratory SOPs in low-resource settings, and (iii) share some lessons learned in the NIDIAG study in the DRC. Hermans V, Monzote L, Van den Sande B, Mukadi P, Sopheak T, Gillet P, Jacobs J. In addition, producing a high-quality translation is labor intensive [21]. 15 November 2015. 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. Set of 50 SOPs used for the NIDIAG study on neurological disorders. SOPs should be written by laboratory personnel who are most knowledgeable and involved with the experimental process. When the potential toxicity is unknown, it must be assumed that the substance is "particularly hazardous.". 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? Some of them include: With all these benefits, the importance of SOP increases in all industries. 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. 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. Most laboratory staff have a good education level and are trained in understanding technical documents. Copies of SOPs need to be clearly labelled as approved and current versions, while out-of-date versions must be removed from site. By contrast, job aids were perceived to be very useful in day-to-day research practice. The European Commission guideline explains the concept of user testing, discusses the testing of multiple language versions, and describes a method for pretesting package leaflets [11]. 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]. Clear drawings, a flowchart, and a decision table are used. 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. SOP approval also allows coordinated and timely implementation of the SOP on-site. An official website of the United States government. Type, quantity, and nature of the chemical used. On the flip side, you can avoid this knowledge loss if you have everything written in the documents in the form of SOP. Linguistic and Cultural Challenges in Communication and Translation in US-Sponsored HIV Prevention Research in Emerging Economies. When relevant, safety precautions and waste management should be included as separate sections. Chemicals For Which Safe Work Practice Standard Operating Procedures Are Available(word docs). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Harmonization of malaria rapid diagnostic tests: best practices in labelling including instructions for use. For clarity and simplicity, we opted for these five sections only, rather than for the full list of 17 sections recommended by CLSI (Table 2); we also considered that these five sections were the most relevant at the time for all concerned SOPs (also for those SOPs outside the laboratory domain). To overcome these barriers, ownership by and dialogue with local users is crucial in SOP development and during periodic reviews. Comprehensibility (also referred to as comprehension) refers to whether or not a reader understands the intended meaning of a text and is able to draw the correct conclusions. Emanuel EJ, Wendler D, Killen K, Grady C. What makes clinical research in developing countries ethical? Revision 1, 12 January 2009. A few such benefits are: As stated earlier, quality management is the first and foremost goal of SOP. Regular exchange with the local users and supportive site visits are indispensable for guaranteeing correct use of SOPs. How to test a hand sanitizer at home? Job aids are instructions, lists, or quick reference materials derived from the main document and are used when the full procedure is not needed at the time the task is performed [2]. Apart from interlanguage differences, there is also the issue of terminology. 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). 2627 February 2015 Geneva, Switzerland. The three key procedural documentation types include policies, procedures (SOPs), and work instructions. Efforts should be made to ensure their legibility, readability, and comprehensibility. This is where SOP can help them out. Examples of NIDIAG SOPs are given as supporting information (S1 Appendix, S1 and S2 Figs). All SOPs need to be stored in a manner that prevents loss, damage, or unauthorized access and should promote easy retrieval. So lets get started. Every effort should be made to evaluate potential hazards based on analogy to similar compounds or expected structural features of the chemical. is high because even a little discrepancy can cause serious problems both for the manufacturer and for the consumer. Group training can be effective, if it allows time for discussion, questions, and answers. During the prestudy phase, the feedback of the study site team helped to refine and adapt the SOPs to the local setting. Legibility is defined as the ease with which a reader can recognize the characters and words in a text. Therefore, ensuring the best quality that you want. 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. Institute of Tropical Medicine, Antwerp, Belgium, 2 Consider the following information when developing an SOP: If a new chemical will be produced during the experiment, an SDS may not be available. The retention duration of SOPs is defined by regulations, accreditation requirements, study protocol requirements, and the sponsors quality system [2]. High Time to rate your Standard Operating Procedures? Clear job aids improved health workers performance during malaria rapid diagnostic tests (RDTs) [1719]. Once finalized, the SOPs were used for on-the-job training of all staff involved during the on-site pilot of the study. Learn more This must be done regularly in order to avoid accidents. Standard Operating Procedureshelp establish a benchmark for quality of products and services. As to accessibility and visibility, so-called job aids are a valuable adjunct. 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]. It should be noted that these recommendations are meant for documents written for patients and that the audience targeted by laboratory SOPs is different. Managers can use this as a tool to access each employees performance based on the work provided to them. With predefined processes and rules, it becomes extremely convenient to maintain the highest quality of your products. Using a home blood pressure monitor: do accompanying instruction materials meet low literacy guidelines? Graphics should be used to simplify the overall message, with preference for drawings [12,14]. offers various other advantages. For a clinical study in the European research network on better diagnosis for neglected infectious diseases (NIDIAG) project (Better Diagnosis of Neglected Infectious Diseases: www.nidiag.org), we developed Standard Operating Procedures (SOPs), which we implemented in a basically equipped laboratory in a 380-bed rural hospital (Hpital Gnral de Rfrence Mosango) in the Kwilu province in the Democratic Republic of the Congo (DRC). The new PMC design is here! They can follow it for proper results. For instance, the buffer used for RDTs is also called blood lysis buffer, clearing buffer, assay (or sample) diluent, or reagent, and the specimen transfer device may be named tube, straw, or pipette [2324]. For general or department specific inquiries, World Health Organization (WHO). Seidahmed OM, Mohamedein MM, Elsir AA, Ali FT, Malik el FM, Ahmed ES. This guideline mentions document verification as part of the review process (see below), which can be considered as a form of pretesting [2]. With hindsight, setting up and using this extensive SOP system in the NIDIAG project required more time and effort than anticipated. 21 CFR 11 requires organizations to have policies, procedures, and work instructions, including: System backup & recovery (21CFR 11.10(c)), Business continuity (disaster recovery) (21CFR 11.10(c)), Granting system access & computer system security (21CFR 11.10(d).100, .200, 300), Training & training documentation (21CFR 11.10(i)), Use of electronic signatures (21CFR 11.10(j)), System operation and maintenance (21CFR 11.10(k)(l)), 21 CFR 312.53: The investigator will "ensure that all associates, colleagues, and employees assisting in the conduct of the study (ies) are informed of their obligations in meeting the above commitment. I have been a part of an accredited laboratory for 10 years now and have successfully faced more than 12 audits based on the ISO, A lab assistant/ Technician is of utmost importance to any laboratory. 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. Timely review of SOPs proved to be challenging in our study because of unforeseen events (e.g., changed kit contents that had an effect on test procedures). Such procedures shall include all requirements in this subpart. Drawings are preferred over pictures [12,14]. Available safety equipment, including personal protective equipment. SOPs Help Maintain Operational Efficiencies When considering writing and implementing SOPs for a study in low-resource settings: Think about the language of the SOP (English, French, local language), Take extra care in adhering to requirements of legibility, readability, and comprehensibility, Take cultural differences into account: different meaning of words, terms, and symbols, the use of written documents in a setting with a strong oral culture, Think about possible impaired vision of the user and low light conditions (e.g., use larger print), Make sure SOPs are distributed in a timely fashion and are accessible to all staff involved, Provide training on SOPs for all users and other implicated staff, Plan periodic revisions and updating of SOPs in use, Provide continuous support and regular site visits, {"type":"clinical-trial","attrs":{"text":"NCT01589289","term_id":"NCT01589289"}}, Laboratory Quality Management System Handbook, Clinical and laboratory Standards Institute (CLSI). The SOP is based on the generic WHO job aid of a malaria RDT (http://www.who.int/malaria/areas/diagnosis/rapid-diagnostic-tests/generic_PfPan_training_manual_web.pdf). A controlled copy of the original SOPs can be displayed (marked as copy). They may receive some information from one person and exactly the opposite from the other. 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.