Standard Operating Procedures: Standard Operating Procedures Prof. R. K. Dixit Pharmacology and Therapeutics C. S. M. Medical University Lucknow 226003 WHY SOPs?: WHY SOPs? To improve and maintain the quality of laboratory services To standardize laboratory working practices and performance To assure quality laboratory results To assure quality of public health care What is SOP?.......: What is SOP?....... A Standard Operating Procedure (SOP) is a set of written instructions that document a routine or repetitive activity followed by an organization. The development and use of SOPs are an integral part of a successful quality system as it provides individuals with the information to perform a job properly, and facilitates consistency in the quality and integrity of a product or end-result. The term “SOP” may not always be appropriate and terms such as protocols, instructions, worksheets, and laboratory operating procedures may also be used PowerPoint Presentation: SOPs describe both technical and fundamental programmatic operational elements of an organization that would be managed under a work plan or a Quality Assurance (QA) Purpose of SOP: Purpose of SOP SOPs detail the regularly recurring work processes that are to be conducted or followed within an organization. They document the way activities are to be performed to facilitate consistent conformance to technical and quality system requirements and to support data quality. They may describe, fundamental programmatic actions and technical actions such as analytical processes, and processes for maintaining, calibrating, and using equipment. SOPs are intended to be specific to the organization or facility whose activities are described and assist that organization to maintain their quality control and quality assurance processes and ensure compliance with governmental regulations. Purpose……: Purpose…… If not written correctly, SOPs are of limited value. In addition, the best written SOPs will fail if they are not followed. Therefore, the use of SOPs needs to be reviewed and re-enforced by management, preferably the direct supervisor. Current copies of the SOPs also need to be readily accessible for reference in the work areas of those individuals actually performing the activity, either in hard copy or electronic format, otherwise SOPs serve little purpose. Benefits………: Benefits……… The development and use of SOPs minimizes variation and promotes quality through consistent implementation of a process or procedure within the organization, even if there are temporary or permanent personnel changes. SOPs can indicate compliance with organizational and governmental requirements and can be used as a part of a personnel training program, since they should provide detailed work instructions Benefits…………: Benefits………… It minimizes opportunities for miscommunication and can address safety concerns. SOPs are frequently used as checklists by inspectors when auditing procedures. Ultimately, the benefits of a valid SOP are reduced work effort, along with improved comparability, credibility, and legal defensibility. PowerPoint Presentation: SOPs are needed even when published methods are being utilized. It also should detail how, if at all, the SOP differs from the standard method and any options that this organization follows. Using a correct well-written SOP can minimize such differences. Writing styles……….:
Writing styles………. SOPs should be written in a concise, step-by-step, easy-to-read format. The information presented should be unambiguous and not overly complicated. The active voice and present verb
should be used. The document should not be wordy, redundant, or overly lengthy. Keep it simple and short. Information should be conveyed clearly and explicitly to remove any doubt as to what is required. Also, use a flow chart to illustrate the process being described. In addition, follow the style guide used by organization, e.g., font size and margins.
What processes are involved ……..: What processes are involved …….. SOP Preparation SOP Review and Approval Checklists SOP Document Tracking and Archival SOP preparation: SOP preparation The organization should have a procedure in place for determining what procedures or processes need to be documented. Those SOPs should then be written by individuals knowledgeable with the activity and the organization's internal structure. These individuals are essentially subject-matter experts who actually perform the work or use the process. A team approach can be followed, especially for multi-tasked processes where the experiences of a number of individuals are critical, which also promotes “buy-in” from potential users of the SOP. SOP preparation………: SOP preparation……… SOPs should be written with sufficient detail so that someone with limited experience with or knowledge of the procedure, but with a basic understanding, can successfully reproduce the procedure when unsupervised. The experience requirement for performing an activity should be noted in the section on personnel qualifications. For example, if a basic chemistry or biological course experience or additional training is required that requirement should be indicated. SOP review and approval…….: SOP review and approval……. SOPs should be reviewed (that is, validated) by one or more individuals with appropriate training and experience with the process. It is especially helpful if draft SOPs are actually tested by individuals other than the original writer before the SOPs are finalized. SOP review and approval…….: SOP review and approval……. The finalized SOPs should be approved as described in the organization’s Quality Management Plan or its own SOP for preparation of SOPs. Generally the immediate supervisor, such as a section or branch chief, and the organization’s quality assurance officer review and approve each SOP. Signature approval indicates that an SOP has been both reviewed and approved by management. PowerPoint Presentation: SOPs need to remain current to be useful. Therefore, whenever procedures are changed, SOPs should be updated and re-approved. If desired, modify only the pertinent section of an SOP and indicate the change date/revision number for that section in the Table of Contents and the document control notation. SOPs should be also systematically reviewed on a periodic basis, e.g. every 1-2 years, to ensure that the policies and procedures remain current and appropriate, or to determine whether the SOPs are even needed. The review date should be added to each SOP that has been reviewed. If an SOP describes a process that is no longer followed, it should be withdrawn from the current file and archived. PowerPoint Presentation: The review process should not be overly cumbersome to encourage timely review. The frequency of review should be indicated by management in the organization’s Quality Management Plan. That plan should also indicate the individual (s) responsible for ensuring that SOPs are current. Checklists : Checklists Many activities use checklists to ensure that steps are followed in order. Checklists are also used to document completed actions. Any checklists or forms included as part of an activity should be referenced at the points in the procedure where they are to be used and then attached to the SOP. In some cases, detailed checklists are prepared specifically for a given activity. In those cases, the SOP should describe, at least generally, how the checklist is to be prepared, or on what it is to be based. Copies of specific checklists should be then maintained in the file with the activity results and/or with the SOP. Remember that the checklist is not the SOP, but a part of the SOP. SOP Document Tracking and Archival : SOP Document Tracking and Archival The organization should maintain a master list of all SOPs. This file or database should indicate the SOP number, version number, date of issuance, title, author, status, organizational division, branch, section, and any historical information regarding past versions. SOP GENERAL FORMAT : SOP GENERAL FORMAT SOPs should be organized to ensure ease and efficiency in use and to be specific to the organization which develops it. There is no one “correct” format; and internal formatting will vary with each organization and with the type of SOP being written. Where possible break the information into a series of logical steps to avoid a long list. Title Page : Title Page The first page or cover page of each SOP should contain the following information: Title that clearly identifies the activity or procedure, SOP identification (ID) number, Date of issue and/or revision, Name of the applicable agency, division, and/or branch to which this SOP applies, Signatures and signature dates of those individuals who prepared and approved the SOP. Table of Contents : Table of Contents A Table of Contents may be needed for quick reference, especially if the SOP is long, for locating information and to denote changes or revisions made only to certain sections of an SOP. Text : Text Well-written SOPs should first briefly describe the purpose of the work or process, including any regulatory information or standards that are appropriate to the SOP process, and the scope to indicate what is covered. Define any specialized or unusual terms either in a separate definition section or in the appropriate discussion section. Denote what sequential procedures should be followed, divided into significant sections; e.g., possible interferences, equipment needed, personnel qualifications, and safety considerations (preferably listed in bold to capture the attention of the user). Finally, describe next all appropriate QA and quality control (QC) activities for that procedure, and list any cited or significant references. PowerPoint Presentation: As noted above, SOPs should be clearly worded so as to be readily understandable by a person knowledgeable with the general concept of the procedure, and the procedures should be written in a format that clearly describes the steps in order. Use of diagrams and flow charts help to break up long sections of text and to briefly summarize a series of steps for the reader. Attach any appropriate information, e.g., an SOP may reference other SOPs. In such a case, the following should be included: 1. Cite the other SOP and attach a copy, or reference where it may be easily located. 2. If the referenced SOP is not to be followed exactly, the required modification should be specified in the SOP at the section where the other SOP is cited. TYPES OF SOPs : TYPES OF SOPs SOPs may be written for any repetitive technical activity, as well as for any administrative or functional programmatic procedure, that is being followed within an organization. General guidance for preparing both technical and administrative SOPs follows and examples of each are located in the Appendix. PowerPoint Presentation: In general, technical SOPs will consist of five elements: Title page, Table of Contents, Procedures, Quality Assurance/Quality Control, and References: 1. Title Page 2. Table of Contents 3. Procedures - The following are topics that may be appropriate for inclusion in technical SOPs. Not all will apply to every procedure or work process being detailed. a. Scope and Applicability (describing the purpose of the process or procedure and any organization or regulatory requirements, as well as any limits to the use of the procedure), b. Summary of Method (briefly summarizing the procedure), c. Definitions (identifying any acronyms, abbreviations, or specialized terms used), PowerPoint Presentation: d. Health & Safety Warnings (indicating operations that could result in personal injury or loss of life and explaining what will happen if the procedure is not followed or is followed incorrectly; listed here and at the critical steps in the procedure), e. Cautions (indicating activities that could result in equipment damage, degradation of sample, or possible invalidation of results; listed here and at the critical steps in the procedure), f. Interferences (describing any component of the process that may interfere with the accuracy of the final product), g. Personnel Qualifications/Responsibilities (denoting the minimal experience the user should have to complete the task satisfactorily, and citing any applicable requirements, like certification or “inherently governmental function”), h. Equipment and Supplies (listing and specifying, where necessary, equipment, materials, reagents, chemical standards, and biological specimens), PowerPoint Presentation: i. Procedure (identifying all pertinent steps, in order, and the materials needed to accomplish the procedure such as: • Instrument or Method Calibration and Standardization • Sample Collection • Sample Handling and Preservation • Sample Preparation and Analysis (such as extraction, digestion, analysis, identification, and counting procedures) • Troubleshooting • Data Acquisition, Calculations & Data Reduction Requirements (such as listing any mathematical steps to be followed) • Computer Hardware & Software (used to store field sampling records, manipulate analytical results, and/or report data), and j. Data and Records Management (e.g., identifying any calculations to be performed, forms to be used, reports to be written, and data and record storage information). PowerPoint Presentation: Purpose of SOP: • Serve as framework for organizational policy – provide direction and structure • Written documentation of best practice • Tells what, how, when, why, and who • Provide foundation for: o job descriptions, o employee training o corrective action and discipline, and o performance review. PowerPoint Presentation: Elements of an SOP: • Rationale for SOP • Detailed description of procedure – based on best practice/standards • Monitoring actions • Accountability • Corrective Actions • Date of last review or revision date PowerPoint Presentation: SOPs Implementation • Have available for employees to review • Conduct an employee in-service to present the information; post one set in a common area • Use to train new employees • Use them for corrective action/refresher training for all employees • Incorporate into written job descriptions and performance reviews so there is alignment • Review and update as needed (i.e new equipment item or employee job changes); at minimum review annually The 5M’s of Quality: The 5M’s of Quality Man Material Machinery Manuals/Methodology ( SOP) Motivation What should be covered under SOP: What should be covered under SOP General:Document Preparation (SOP for SOP) Preparation and maintenance of work area Washing and sterilization Decontamination Testing area Receipt of samples, Recording and labeling Storage and discarding ………cont ……What should be covered: ……What should be covered Laboratory operations Receipt of reagents, standards, etc – storage Preparation of reagents – labeling and storage Test procedures Reference material – identification,handling,storage and use Results – results, deviations, errors Reports – generation, distribution Archives maintenance Staff – Training, GLP, staffing pattern ………..cont ……What should be covered: ……What should be covered Equipments Indent, purchase, installation and validation Maintenance Daily checks and records Periodic calibration and validation Trouble shooting and action to be taken Annual maintenance In case of accidents – action to be taken ……cont ……What should be covered: ……What should be covered Deviations Planned deviations Unplanned deviations Variance Errors Record of all the above – Action taken Format of an SOP: Format of an SOP Title : descriptive Code : Number relating to procedure and revisions Objective : Aim of the procedure clearly described Scope : The operating unit and field of application Definitions : Meaning of principle terms used Description : Operating instructions clearly described without any ambiguity, understood by all staff with flow diagrams Safety : Measures to be kept in mind when executing the SOP Documentation : Protocol, Data sheets and measurements References : Used to draw up the SOP Format on each page of SOP: Format on each page of SOP Logo and name of the organization Department or unit issuing the SOP Title and date of issue Signature of person who drew up the SOP Signature of person who reviewed it Signature of person who authorized it Duration of validity Date of review Code Page number and total number of pages in the document “IF you have not documented it you have not done it” : “ IF you have not documented it you have not done it” Laboratory records Description and identification of sample received Description of method of testing Record of all data secured in the course of the test Record of test results and how they compare with standards of identity, strength and quality Record of all deviations and modification of test Record of standardization of reference standards Record of calibration of equipments Quality Assurance is responsibility of….: Quality Assurance is responsibility of…. All Staff Quality Assurance is a dynamic process: Quality Assurance is a dynamic process It is a journey towards the destination Thanks : Thanks