If your organization follows ISO manufacturing standards (e.g., ISO 9000) or plans to, your Engineering department will need Standard Operating Procedures (SOPs) for key tasks. These aren’t about how to ‘Engineer’ but focus on managing documentation and design processes more effectively. SOPs ensure consistency, improve efficiency, and help your team meet compliance requirements without extra headaches. This article builds on my SOLIDWORKS World 2011 presentation and offers updated information to help your team navigate these needs.
The following are examples of procedures that will likely be necessary for your organization.
- Drawing Standards SOP – preparing mechanical drawings per Engineering Standards (e.g., ISO 128, ASME Y14.5, BS 8888). This should include instructions on selecting templates, naming conventions, part numbering, filling out title blocks and even preferred drawing view layouts. Model-based Definition may require its own SOP too.
- CAD Document Management SOP – processes for organizing, naming, storing, accessing and distributing CAD documents, including guidelines for 3D CAD models and cloud-based tools. This may include instructions on file and model formats, such as creating PDFs of drawings or distributing models as STEP to outside vendors.
- Drawing Review and Approval SOP – steps for peer reviews, quality checks and approvals of drawings.
- Revision Notation and Control SOP – marking and controlling revisions of drawings.
- Template and Symbol Libraries SOP – maintenance and use of standardized templates, symbols, blocks and CAD customizations such as macros and data tables .
- Design Review SOP – formal process for review of design and drawings
- Engineering Change SOP – steps for initiating and documenting proposed changes to designs and drawings (Engineering Change Request; ECR), then their approval and implementation (Engineering Change Order; ECO), including notification and effectivity for full traceability (Engineering Change Notification; ECN).
For Engineering departments, these procedures should be tailored around their CAD application(s), PDM and PLM systems.
Structure of SOPs
Organizations that have well-documented processes should establish a template for their procedures. There are several elements that most standard operating procedures should include. Each SOP should be use a number-base layout that employs functionality of the chosen wordprocessor. This list of elements should be tailored for the Engineering department. The following is an example of the required (as applicable) elements with a brief explanation.
- Title and Document Information
- Title – descriptive and specific to the task or process.
- Document Number – unique identifier for tracking.
- Version or Revision Number – indicates current version.
- Effective Date – the date upon which the document becomes valid.
- Approval Signatures – for validation and compliance.
- Purpose – the reason the procedure exists.
- Scope – extent to which the procedure applies (the processes and roles are controlled by this document).
- Responsibilities – define roles and responsibilities of personnel involved.
- Definitions – list and define specialized terms and abbreviations.
- Materials, Tools, and Equipment – list of required resources to complete the procedure. Include software applications that are utilized within the process described within this document.
- Procedure – actual procedural instructions, often in step-by-step format with clear statements with explanatory diagrams and images. Typically, this will be the bulk of the document.
- Troubleshooting – guidance for handling common issues or errors.
- References -links to related documents, manuals, or regulations.
- Revision History – a table that tracks changes over time with notes on updates.
Once the types of SOPs are established and a structure for the SOPs is agreed upon within your organization, the task of actually writing the procedures comes next. This could mean completely rewriting old procedures or writing new ones. Future articles in this series will address good writing practices for SOPs and specific considerations that cover CAD related needs and an organization’s processes.