Standard Operating Procedures (SOPs) Lecture 9

1. Standard Operating Procedures (SOPs)Lecture 9 Dr. Attya Bhatti HoD Health care Biotechnology ASAB-NUST

2. Standard Operating Procedures (SOPs) • ‘Detailed, written instructions to achieve uniformity of the performance of a specific function’. • Focus is always set on repeated application of unchanged processes and procedures.

3. 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: • job descriptions, • employee training • corrective action and discipline, and • performance review.

4. Help maximum safety and operational efficiency for organisations: • Pharmaceutical organizations • Government organizations • Emergency response operations • Clinical research organizations • Power producing organizations

5. Who is responsible? • Study director is mainly responsible for SOPs. • The Quality Assurance Unit are individuals who are responsible for monitoring whether the study report and tests are meeting the SOP.

6. How are SOP's developed? • The Four P's Model • Philosophy • Policies • Procedures • Practices

7. 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

8. 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 tense should be used. The term "you" should not be used, but implied. • 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 your organization, e.g., font size and margins

9. 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. • The level of detail provided in the SOP may differ based on, e.g., whether the process is critical, the frequency of that procedure being followed, the number of people who will use the SOP, and where training is not routinely available.

10. Title Page • The first page or cover page of each SOP should contain the following information: • A title that clearly identifies the activity or procedure, • An SOP identification (ID) number, • Date of issue and/or revision, • The name of the applicable agency, division, and/or branch to which this SOP applies, • The signatures and signature dates of those individuals who prepared and approved the SOP. • Electronic signatures are acceptable for SOPs maintained on a computerized database.

11. Table of Contents A Table of Contents may be needed for quick reference, especially if the SOP is long.

12. 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.

13. Text • 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.

14. SOPs Implementation • Have available for workers to review • 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

15. ALCOA Apply ALCOA to achieve data quality. 1. Attributable: is it obvious who wrote it? 2. Legible: can it be readable? 3. Contemporaneous: is the information current and in the correct time frame? 4. Original: is it a copy; has it been altered? 5. Accurate: are conflicting data recorded elsewhere? http://www.ofnisystems.com/growing-need-for-good-data-and-record-management/

16. The SOPs can be categorized

17. Instrument SOPs (S-SOP) • Procedures describing how to use our instruments  • e.g. Fume Hoods, Thermo cyclers, Gel Documentation System

18. Protocol SOPs (P-SOP) • Procedures describing methods • e.g. DNA isolation, RNA isolation, Agarose gel electrophoresis, Cell proliferation assay, ELISA etc.

19. Solution SOPs (S-SOP) • Procedures describing preparation of solutions • e.g. 1M TRIS, DNA extraction solution, MTT reagent, Bradford reagent, Cell lysis buffer, Loading dye etc.

20. Factors Affecting SOP Development • Factors that need to be considered for the SOP's to work in the real world environment. • Organizational Factors • Operational Factors

21. The pros of SOPs • Consistency • Must be consistent; • consistency in the performing of an operation, whether it is in manufacturing or department administration. The more consistent the process is from person to person, the less chance there will be quality problems.

22. The pros of SOPs • Reduction of Defects • Reduction of defects is another reason for operating procedures. • A written procedure is like a set of instructions for performing a task. As long as each person performs the task exactly as the process is written, there should not be any defects.

23. The pros of SOPs • Communication • Another reason for standard operating procedures is a method of communication. • As improvements are made to processes, the operating procedures are updated and each update requires new training. This provides a method to communicate the process changes to all employees.

24. 1. Scope: This procedure is applicable to Chemical Pathology Lab of PHLD when ALT estimation is performed. 2. Purpose: To streamline the quantitative in vitro determination of serum ALT level through appropriate verification & adequate documentation. To ensure and monitor the operational phases of ALT estimation in patients blood using standard protocol.