Sample Standard Operating Procedure...
The following sample Standard Operating Procedure, provides guidance on expected information to be provided within a procedure to ensure best practice compliance with quality and regulatory expectations.1.0 Objective
Define the reason for the procedure, the objective to be achieved by writing and implementing this procedure. For example “this sample standard operating procedure will …. “.
2.0 Scope
The which areas, what aspects of the process, which departments, etc., does this procedure apply to? Are there areas where this SOP does not apply?
3.0 Equipment, Tools and Production Aids
Detail any applicable equipment, tools, production aids, etc., necessary to completion of tasks referenced in the relevant SOP’s.
4.0 Materials
As per equipment above, detail relevant materials necessary to complete tasks referenced in the SOP.
5.0 Safety
As per equipment above.
5.1 Safety Equipment
As per equipment above.
5.2 Safety Warning
As per equipment above.
6.0 Reference documents
Make referenced to all applicable documents which form part of the quality system, inspection documents, etc.
For example:
The organization’s Quality manual
ISO standards e.g. ISO 9001
Document Control Procedures
Documentation: Definitions & numbering
Engineering Change Procedures
Good Documentation Practices
Procedures
Procedure Format template forms
Standard Operating Procedure Guidelines
7.0 Responsibilities
7.1 All personnel are required to comply with this procedure.
7.2 Documentation personnel are responsible for updating this document.
8.0 Definitions
8.1 Objective
The Objective is a brief statement explaining the reason for the document.
Example:
The objective of this procedure is to detail the steps to be followed when performing test or process …
8.2 Scope
The scope describes where (e.g. facility), what (e.g. products, systems or activities affected) and to who (e.g. department, division or title) this document applies.
8.3 Equipment, Tools, Production Aids
8.3.1 Details any specific equipment, tools and or material requirements. Equipment is defined as any item that may be used repeatedly.
8.3.2 List any production aids required. Production aids include but are not limited to sample assemblies, sample finished devices, labeled photographs, video tapes and slide shows.
8.4 Materials
List the necessary materials, supplies and chemicals required to perform the procedure. Also include any pertinent details needed to clearly identify the material. Chemicals listed in this section will also include the appropriate MSS reference. Materials are defined as items that may be used up or discarded after initial use.
Note: MSS = Material Safety Sheets, Material Safety Documents, Material Safety Data Sheets.
8.5 Special Safety concerns
Because good manufacturing practice is safe manufacturing practice, special concerns should be noted for manufacturing, cleaning, testing or repair procedures where appropriate. This is not a substitute for general ‘safety practices’ manual or safety training but can help avoid injury to anyone who may not be aware of such special considerations for the task being identified.
8.5.1 Safety Equipment:
Specifies all safety equipment (e.g., gloves, goggles, etc.), required for safe operation of the process specified in the SOP.
8.5.2 Safety Warning:
Statements included where necessary in the document to warn personnel of specific safety HAZARDS, to remind them to use specified safety EQUIPMENT, to follow special safety METHODS/TECHNIQUES, and other miscellaneous safety-related NOTES.
8.6 Reference documents
List internal or external documents or databases used to determine the quality and accuracy of the SOP. These references will serve either as the original source or supporting rationale for the document. (e.g. List all SOPs, standards or regulations relevant in the document).
8.7 Responsibilities
Identify, by title or department, individuals responsible for the execution and/or compliance to the requirements of this document. These individuals must fall within the ‘Scope’.
8.8 Definitions
Clearly define all acronyms, abbreviations and technical or other significant terms.
Quality Assurance. Quality Management Systems.
CAPA – Corrective And Preventative Action
Calibration Certification
Change Management and Control
Quality Management Training
Product and Process Validation
Supplier Quality Assurance
Audits & Auditing
Ensuring the Quality Management System is Risk based
Etc. …. Etc. …. Etc. …
Information | Understanding | Best Practice >>>
9.0 Procedure
9.1 The template and content for the procedure shall follow the instructions of this procedure and the format of the Procedure Format Template form. Additional information may be included if needed for full clarification of procedural issues.
9.2 All standard procedures shall be typed.
9.3 The header is the identified information listed on every page at the top of the page and must include.
9.3.1 ‘Policy / Procedure’.
9.3.2 Procedure number, revision and page number. Ref SOP-AAAA
9.3.3 Title of the procedure.
9.4 The first page shall contain the following:
9.4.1 Department name to which the procedure applies.
9.4.2 The revision history of the procedure. Note this should not extend beyond one page. Early revision history shall be deleted to facilitate this.
9.5 The body of the procedure shall contain the following sections numbered as shown. Both the number and procedure section title are printed in bold letters. If the section doesn’t require any information then the preparer shall insert ‘N/A’.
1.0 Objective
2.0 Scope
3.0 Equipment, Tools and Production Aids
4.0 Materials
5.0 Safety
5.1 Safety Equipment
5.2 Safety Warning
6.0 Reference Documents
7.0 Responsibilities
8.0 Definitions
9.0 Procedure
9.6 Each subparagraph shall be numbered decimally e.g., 6.0, 6.1, 6.1.1, 6.1.1.1, etc.
9.7 Language used in procedures.
9.7.1 The use of certain verbs in procedures shall have the same meaning as their use in say the CFR (US FDA) regulations.
9.7.1.1 ‘Must’ or ‘Shall’ indicates a mandatory requirement.
9.7.1.2 ‘Should’ or ‘May’ indicates a desired practice, but is not mandatory.
9.7.2 The use of the words ‘he’, ‘she’ or ‘you’ should be avoided.
9.8 When writing a new procedure, it is useful to flow chart the process or procedure so it can be easily understood. Each procedure and each step of each procedure should include sufficient detail to enable any appropriately trained employee to perform the steps correctly. Attempt to find a balance between detail and conciseness. While it is possible to make reference to other documents, (manuals, instructions), one should determine that such references are available.
9.9 External standards listed in the SOP Reference Documents section must be available in Documentation either in hard copy or accessible online. It is the responsibility of the originator who references the external standards to request Document Control to source or order the standard. This is to ensure that the relevant department will be notified of any updates to the standard.
9.10 If the size of a diagram, form or label is too large to be attached then a reference document number should be furnished in the SOP.
9.11 Forms intended for use in (say) a Device History Record or Product Technical File shall be developed using the form template.
9.12 Forms intended for use as logbooks shall be developed using the form template.
9.13 The suggested font is (say) Arial, Size 10, Style: Body Text. Suggested Font for headings is Arial, Size 11, Style: Body Text, with text in Bold.
9.14 All procedures should end with ‘END OF DOCUMENT’
9.15 All procedures shall be reviewed and released by the Engineering Change process.
Quality Assurance. Quality Management Systems:
- The Principles of Quality Management
- The Quality Manual
- Quality Standards and Specifications
- The Quality Management System
- Revised requirements of ISO 9001: 2015
- Design Quality – Products & Processes
- Good Manufacturing Practice (GMP)
- Documentation
- CAPA – Corrective And Preventative Action
- Calibration Certification
- Change Management and Control
- Quality Management Training
- Product and Process Validation
- Supplier Quality Assurance
- Audits & Auditing
- Ensuring the Quality Management System is Risk based
- Etc. …. Etc. …. Etc. …
- Information | Understanding | Best Practice >>>