Standard Operating Procedure
- 1. STANDARD OPERATING PROCEDURES BY- HEMLATA R. MORE ASSISTANT PROFESSOR QUALITY ASSURANCE
- 2. WHAT IS AN SOP ? • The term Standard Operating Procedure and Standing Operating Procedure, both abbreviated by the initialism, SOP, occur in a variety of different contexts, such as Healthcare, Education, Industry, Military, etc. 1
- 3. DEFINITION • An SOP is a written document or instruction detailing all steps and activities of a process or procedure. OR in other words- • A Standard Operating Procedure (SOP) is a set of written instructions that document a routine or repetitive activity followed by an organization. 2
- 4. BENEFITS OF SOP 1. To provide people with all the safety, health, environmental and operational information necessary to perform job properly. 2. To ensure that production operations are perform consistently to maintain quality control of processes and products. 3. To ensure that processes continue uninterrupted and are completed on a prescribed schedule. 4. To ensure that no failures occur in manufacturing and other processes that would harm anyone in the surrounding community. 5. To ensure that approved procedures are followed in compliance with government regulations. 3
- 5. CONTINUED… 6. To serve as a training document for teaching users about the process for which the SOP was written. 7. To serve as a checklist for co-workers who observe job performance to reinforce proper performance. 8. To serve as a checklist for auditors. 9. To serve as an historical record of the how, why and when of steps in an existing process so there is a factual basis for revising those steps when a process or equipment are changed. 10. To serve as an explanation of steps in a process so they can be reviewed in accident investigations. 4
- 6. SOPS: THE GOOD, THE BAD, AND THE UGLY 5
- 7. THE GOOD • Should provide all the information necessary to perform a task • Is usually specific to the equipment used for the procedure • Should be detailed • Should “stand alone” • Should provide Quality Control information • Should provide References 6
- 8. BAD “STUFF” IN AN SOP • DON’T generalize in a technical procedure. • DON’T assume that the reader knows the process. • DON’T refer to a method or analysis for most of the procedure steps. • DON’T ramble on about unnecessary things. Be concise 7
- 9. THE UGLY! • No Title Page • No Revision Numbers or Approval Signatures • No Table of Contents • No Page Numbers • No Quality Control (in a technical SOP) 8
- 10. TYPICAL STRUCTURE FOR SOPS Technical SOP • Title Page • Table of Contents • Procedures • Quality Control and Quality Assurance • Reference Section 9 Administrative SOP • Title Page • Table of Contents • Procedures • Quality Control and Quality Assurance • Reference Section
- 11. SOP WRITING STYLE • SOPs shall be written in a concise, step by step, easy-to-read format. • Information should not be complicated. The active voice and present verb tense should be used. • Should be simple and short. • Routine procedures that are short and require few decisions can be written using simple steps format. • Long procedures consisting of more than 10 steps, with few decisions should be written along with graphical format or hierarchical steps. • Procedures that require many decisions should be written along with flow chart. • Requirement for document identification and control, accountability and traceability responsibility must be included with every SOP; this can be achieved by providing consistent. 10
- 12. WHILE WRITING SOP • Write in the presence tense. • Don’t write in the past conditional or future tense unless you have good reason to do so. • Avoid ambiguity. • Be concise. • Keep the words short and get to point. • Move from one step to another step in logical manner. • Highlight exception. Use a symbol to flag that this is an exception and how to handle it. 11
- 13. CONTINUED… • Highlight warning. Again warn users that caution must be used in this scenario. Warning must stand out; use a larger font or a warning icon. • Reduce the word count where possible without altering the meaning of the text. • Introduce acronyms without explaining what it means. • Don’t use the word “may”, “if possible” as it implies that the user can do something under conditions. Instead be positive and tell them what to do. 12
- 14. INSIDE THE SOP • Company Name and Pagination. The company name and pagination (e.g. page 4 of 7) must appear on every page. • Title The title should be descriptive. The title should use directive language to declare what is being done to what. • Identification Procedures must be easily identified by giving unique number and version number. This identification number of the SOP supports accountability of the document throughout the facility and over time as it changes. 13
- 15. CONTINUED… • Review and Approval All SOPs shall have space for signature of Initiator (the person who has written the SOP) Reviewer (The persons who has reviewed the SOP) and Approver (Quality Assurance Head of the organization). • Purpose The purpose or objective of the procedure should restate and expand well written title. Expand or qualify the directive language used in the title (e.g. to describe the operation procedure of compression machine) 14
- 16. CONTINUED… • Scope The scope should provide limits to the use of procedure. • Responsibility Who is responsible for performing the work described? Who is responsible for implementing the procedure? • Procedure Describe the procedure in a step by step, chronological manner. Use active verbs and direct statements. 15
- 17. GENERAL FORMAT FOR SOP 16
- 18. STANDARD OPERATING PROCEDURES (SOP) FOR SHIMADZU UV-VIS IN RH385- • PPE required Gloves, lab glasses, lab coat • Turning on UV-VIS 1.Flip switch on the bottom left end of UV-VIS 2.Open UV Probe 2.21 program 3.On the bottom, click on connect A .UV-VIS will go through a checklist of items. B .Click OK after checklist is finished. 17
- 19. CONTINUED… • Taking Spectra 1.To take a background, fill 2 cuvettes with the same solution, place them in the reference slot (R) and sample slot (S), and click on Baseline 1.The program will ask for range of wavelength. Type in 700 to 200nm, then click ok 2.Replace the cuvette in the sample slot with your actual sample. Be sure that the cuvette is 2/3 full. 3.Click Start 4.After the scan is done, select where to save the data 5.To view data points, click on the icon that looks like a paper with writing on it. (to the right of the icon with an M in a circle) 18
- 20. CONTINUED… 6.To organize data, copy and paste data onto your own excel sheet 7.To save a single scan, go to file>save as • Turning Off UV-VIS 1.Click Disconnect 2.Flip switch on UV-VIS off 3.Always turn the system off when you do not plan to use it soon to conserve the lamp life 19
- 21. REFERENCES 1. United States Environmental Protection Agency. Guidance for Preparing Standard Operating Procedures (SOPs), EPA QA/G-6, April 2007. 2. Parikh K, Kataria M, Patel J, Manufacturing Documentation in Pharmaceutical Industry- Development and Implementation. PHARMATUTOR-ART-1525. 3. Guidance on the Documentation Requirements of ISO 9001:2008, October 15, 2011. 20
- 22. THANK YOU ! 22