Standard Operating Procedure. The document detailed below is a sample format for a Standard Operating Procedure or SOP.

If you would benefit from a detailed understanding on a range of good manufacturing practices & procedures ...

1.0 Objective This procedure deals with the specific techniques needed to properly write standard operating procedures for all departments within xxxx (insert name of your organization, your department, etc).

2.0 Scope This procedure applies to all employees (who release or update standard operating procedures).

3.0 Equipment, Tools and Production Aids Detail any applicable equipment, tools, production aids, etc., necessary to completion of tasks referenced in the relevant SOPs.

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 organizations 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 Documentation Control Procedures 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 whom(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 MSDS reference. Materials are defined as items that may be used up or discarded after initial use.

Note: MSDS = 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 and/or external documents and/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 and/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.

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 doesnt 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 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 and/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 Device History Records 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 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 ECO process.