Standard Operating Procedures: The Key to Repeatable Success
Creating Standard Operating Procedures
As a fellow executive in the manufacturing industry, three of my favorite words are Repeatable, Normalized, and Predictable. There is no better way to achieve these goals than through Standard Operating Procedures.
One of my passions is collaborating with leaders on effective ways to improve business operations. By the end of this article, you’ll have all the elements needed to create exceptional SOPs that will transform your environment the same way it has mine.
SOPs are high-level digital procedures that are strictly version controlled. They are an indispensable resource to your employees, providing them with step-by-step procedures, important safety information, process flowcharts, references, and instructional media. Reliable SOPs are the most effective method for ensuring that all employees follow the same procedures, resulting in accuracy, consistency, productivity and accountability.
Standardized Procedures encourage the distribution of knowledge, reducing the time it takes to onboard new employees. They can help to prevent otherwise informal knowledge from going undocumented or becoming lost, which has become increasingly important amidst record-breaking employee turnover in the 21st century.
Standard Operating Procedures are also critical for maintaining ISO 9001 compliance. It is essential to keep up-to-date SOPs in tandem with evolving regulatory requirements to maintain compliance. Every Company’s SOPs should be reviewed and updated regularly to include recent changes or new requirements, document improved processes, and to incorporate best practices.
If you aren’t sure where to begin, a great starting point for reviewing your SOP efficacy is to check when they were last updated. Have you hired new employees, incorporated new equipment, or made other significant changes since the last revision? If so, it is time to rework your standard operating procedures to incorporate these new workflows and policies.
You can also examine your output consistency. If there are areas that are falling short of their targets, these areas might present an opportunity for improving existing processes.
Use this checklist for reviewing or creating your company’s SOPs:
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The SOP should be appropriately Titled and include a Table of Contents.
The SOP should clearly note its purpose, such as what it is meant to accomplish or communicate, and the scope of what is covered.
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List of any prerequisites for training that must be completed prior to engaging in procedures covered in the SOP.
List of any mandatory Qualifications that must be held by the employee engaging in procedures covered in the SOP.
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Include information at the beginning of the document on what type of Safety Guidelines must be followed for the procedure.
Include a list of relevant PPE requirements such as hard hat, gloves, safety glasses, grounding info, anti slip footwear, etc. needed to perform the procedure, and who is responsible for supplying the relevant PPE.
Documentation should also specify what the waste disposal procedures are. This can include material scrapping, recycling requirements, and hazardous material handling procedures or contact information for the responsible party.
Waste disposal procedures should also include information on how often the station must be cleaned or sanitized, the responsible party, and what procedures must be followed to consider the action complete, such as a sign-off list or digital activity log entry.
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It is important to keep records of changes and reviews made to the documentation. The review process should consist of these checklist items, and also be documented in order to keep consistent records that identify that the SOP contains current and correct information.
Version control allows you to know when the procedure was last updated, how many revisions have taken place, and who performed the most recent update to the document. This is important in case there is an error in the contents, or additional context that has been added where a user might have further questions for the content writer.
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List of any related SOP’s, Previous Inspections, Batch Records, or Quality Control Documents.
Related Documentation may also include previous and relevant Records for completions or certifications, to provide further context for the reader on how the procedure is expected to be performed, or issues that have been previously troubleshooted and resolved.
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The resources included in your SOP should be tailored to the specific process being documented and designed to help users understand and follow the process accurately and efficiently.
If the procedure involves collecting or recording data, forms should be included for use to standardize the process and ensure that necessary information is collected.
If the process is complex or involves specialized knowledge, training materials such as presentations or videos may be included as references to help ensure that all readers understand the process.
References should include any relevant regulations, standards, or where to obtain other documents referenced in the SOP to provide additional context and ensure compliance.
Contact information should be included for key personnel involved in the process. This can include department leads, or machine operators that can assist users that encounter issues, have additional questions, or require support.
Contact information for repair personnel, equipment manufacturers or re-suppliers, and emergency contacts should be included as well.
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Further to the resources that you list, you should include file location references or information on where to obtain digital or additional copies of the documented procedures.
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Consistent layouts between procedure documents make it faster to find information. For instance, if in one of your SOP’s you first list the training requirements, and in a separate SOP the training requirements are only covered in a subsection of a procedure, these should be revised to be consistent and clear and contain the pertinent information and requirements prior to the procedures.
Clean and easy to read formatting allows workers to follow along and perform their work more efficiently. Documents should be clear of written notes, or scratched out lines. Edits to the document should always be officialized to avoid losing track of who revised the procedures and why they were revised.
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Step-by-step procedures should account for the bulk of your SOP content. The instructions should detail what steps must be followed and the correct order to complete them in.
If approvals are required, they should be included in the documentation. This would include details such as how to submit for approval and who needs to sign off on the approval, as well as what type of requirements must be fulfilled before submitting for approval to avoid requests being denied and requiring additional work.
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Sub-procedures should be detailed in a way that makes it clear at what point in the procedure the sub-procedure needs to be completed. Sub-procedures should not be separated into other documentation, but included as part of the standard procedures if those sub-procedures must be fulfilled as part of the overall process.
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Your step by step procedures should contain visual aides where relevant to assist the users, such as diagrams, flowcharts, or images of the expected process during, and the expected outcome.
Other Visual Aides may include checklists, templates, forms, references, contact information forms, and where to obtain training materials. Digital documentation should contain the Training Media alongside the procedure.
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Your SOP Content and step by step procedures should include information on the What, why, when, who and how. This includes ‘what is the process being completed’, ‘why is this procedure needed and what does it accomplish’ ‘what is the intended input and expected output’, ‘when the procedure should be followed, who is responsible for completing the steps of the procedure, and ‘how the procedure is performed’.
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Important callouts such as safety requirements, should always be highlighted in a way that draws attention to the importance of the step. This is critical in making sure that important information is not overlooked and is made very clear for the reader.
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Documentation should include information on common issues, and how to troubleshoot. If troubleshooting or maintenance is to be performed by a separate party, this should be noted.
Corrective actions should be included to address any issues that arise during the manufacturing process, and should be designed to identify and correct the root cause of the problem to prevent it from recurring in the future.
When a problem occurs, the details of the issue should be documented, including the date, time, location, and what was the potential cause, or what actions were being performed at the time of the incident. This can involve reviewing logs or data, conducting further tests, or discussing amongst personnel involved in the procedure.
Based on the results of the discussion, corrective actions may include changes to the manufacturing process, and an updated procedure, or additional training.
Information on Corrective Actions should specify what process should be monitored in the future to ensure the previous enacted action has addressed the issue.
I hope this checklist helps you get started on creating or updating your current SOPs. I would be happy to connect with you and your team if you have any questions, so please feel free to click the button below so we can set a time to chat further. Thank you for taking the time to read this and I hope to hear from you soon!
Wishing you continued success,
Scott Pierson
Chief Operating Officer