Research & Best Practices

Standard Operating Procedures in Manufacturing

img

Standard Operating Procedures are the bedrock on which modern manufacturing rests. These step-by-step instructions for repetitive tasks eliminate variation and ensure consistency, enable continuous improvement and increase maintenance effectiveness. Without them, each employee is free to perform their tasks as they wish, which is usually slower and reduces product quality.

This blog takes the form of an introductory Standard Operating Procedures guide. It explains what they are, how to develop them and the benefits of using them. On completion, the reader will know enough to identify where they might be useful if they don’t already exist and how to initiate their development.

What are Standard Operating Procedures (SOPs) in manufacturing?

A manufacturing SOP is a set of instructions detailing how to perform a task. It can be set out as blocks of text, as a checklist or as a flowchart, depending on what best conveys the information needed. Including photos or drawings helps communicate important points. SOPs have long taken the form of paper documents, but manufacturers using connected worker technology are increasingly moving to digital versions.

SOPs are widely used for repetitive production processes, but they can also be used in maintenance and for administrative activities. A maintenance SOP could define the procedure for replacing a filter while an administrative activity covered by an SOP could be that of raising a purchase order.

SOPs are often included within the Quality Management System (QMS). This maintains them as controlled documents, so they cannot be changed without going through an approval process, and audits can be conducted to verify they are being followed.

Manufacturers use SOPs to ensure consistency between operators, shifts and even plants. Written to capture best practice or the optimal method, SOPs help improve operational efficiency by eliminating inefficient or wasteful ways of doing things.

In industries like pharmaceuticals and food and beverage, where it’s especially important that proven methods and techniques are used, SOPs are mandatory. Elsewhere, they are an accepted good practice, and for businesses on a lean journey they often overlap with the concept of “standard work.”

Benefits of implementing SOPs

Businesses use SOPs because they bring about consistent ways of working, providing audit mechanisms are in place to detect and correct noncompliance. This in turn helps to reduce waste and improve operational performance.

The main benefits of SOP adoption are:

  • Higher efficiency and productivity: Everyone who does a task goes about it the same way, so unnecessary or wasteful activities are avoided.
  • Improved quality and consistency: SOPs help prevent errors and reduce variation because every task is done the same way every time.
  • Compliance with industry regulations: Bodies like the FDA require that every manufacturing operation is performed in a manner that’s validated. SOPs are part of Good Manufacturing Practice (GMP) and Hazard Analysis and Critical Control Point (HACCP) planning.
  • Standardization: SOPs ensure the same best practices are applied wherever a particular job is done and regardless of who does it. A business can use the same SOPs at multiple sites and even at operations in different countries.
  • Safety improvements: SOPs discourage operators and technicians from taking shortcuts that could expose them to unnecessary risks. For example, the SOP for a production process will make reference to closing guards and possibly using PPE. A maintenance SOP will link to Lock-Out/Tag-Out (LOTO) procedures, ensuring equipment is safely de-energized before starting work.
  • Faster on-boarding and training: SOPs help new recruits get up to speed quickly and minimizes mistakes.

Core components of effective SOPs

While SOPs can take many formats, several common elements should always be included. These are:

  • Objective: Identify the task or activity covered by the SOP.
  • Scope: Set the boundaries. An SOP for changing a filter on a grinding machine will identify the type of machine it applies to. It may also identify what is excluded, such as coolant exchange in this example.
  • Instructions: Wording must describe the sequence of steps clearly and concisely. Use pictures to illustrate important points. Flowcharts can help when there are decisions to be made as part of the procedure. Video is especially powerful.
  • Tools, equipment and PPE: List items needed to perform the procedure. (This is especially important with maintenance SOPs where tools may need checking-out from a store.)
  • Roles and responsibilities: Detail who is responsible for each action or step within the SOP.
  • Revision history and version control: SOPs should be updated periodically to reflect new ways of working. Version control ensures everyone works to the latest issue. (Version control issues are easily avoided when SOPs are made available digitally.)

How to create an SOP

SOPs in manufacturing are usually drafted by engineering because this is the group with most process knowledge. However, in most organizations either quality or production will take ownership as they will be applying them and monitoring compliance.

It’s rare to create a manufacturing SOP from scratch. Usually, it’s an evolution of an existing SOP or can be based on one written previously. However, whether completely new or an update, the best approach is to follow these steps:

  • Identify the process and scope: Keep the SOP specific to the task and aspects directly affecting quality. Beware of making it too long or too broad as this makes it harder to verify compliance.
  • Gather input from stakeholders: The most important of these is the person or people who will be following the SOP in their daily duties. After that comes production or maintenance supervision (depending on whether it’s a production or maintenance SOP), and quality. Safety, and ideally someone with ergonomics expertise, (which may be the same person), should also be included.
  • Draft the SOP: Follow the KISS principle and keep it as simple as possible. This is a document that will only be used if it helps people do their jobs. Pictures are important, and if a simple checklist will do the job, use that. When a connected worker platform is used for digital delivery, there is also the opportunity to use short videos.
  • Review and test the SOP: Bring in someone unfamiliar with the task and have them attempt it with the help of the newly written SOP. This will flush out any assumptions or gray areas which should be addressed before the SOP goes live.
  • Implement and train employees: A manufacturing or maintenance SOP is only of value if it’s followed. This makes training an essential part of the roll-out. Training ensures production workers know what they’re expected to do. For the maintenance crew, technician training is an essential tool for maximizing effectiveness.

Tools and resources for developing SOPs

Developing SOPs, especially for new machinery or equipment, can seem like a daunting task. Fortunately, help is available. Three avenues are software and templates available for download, copying/adapting from others and taking advantage of training resources.

SOP creation software and templates are available from multiple sources, but the capabilities may also be available within the ERP system for manufacturing.

Another option is to build on SOPs developed by others for the same or similar equipment. Machine builders may be able to help and will at a minimum have maintenance and setup instructions that can be used.

Third, explore sending selected SOP writers for training in how to produce these documents effectively. This is available from several sources.

Common challenges and how to overcome them

As anyone who’s been through this process will affirm, writing SOPs is the easy part. Getting people to follow them is much harder. One reason is that people are naturally resistant to change. It can take time to win them over to new ways of working, which may be reduced by involving them in the SOP development process.

A second challenge is to keep SOPs current. Processes and equipment tend to evolve, and new product variants come out over time. (This is especially true in organizations committed to continuous improvement.) SOPs must be updated promptly otherwise they will lose credibility in the eyes of those who should be using them.

Third, there’s the challenge of ensuring comprehension and adherence. This is where audits come in. Making SOPs part of the QMS provides a way to measure compliance. Failure to follow an SOP, or working to outdated versions, will earn a demerit. The corrective action would be to ensure the SOPs are accurate and understood, and to provide training as needed.

Improve maintenance effectiveness with SOPs

Successful manufacturers strive to eliminate variation in the way jobs are done. Standardizing on a single set of steps ensures consistency, and when those steps represent best practice the result is to raise the overall competitiveness of the organization.

SOPs should be used for all repetitive tasks, in administration and maintenance as well as production. In maintenance they ensure no steps are overlooked or skipped and help minimize the time needed to carry out a task. Perhaps of greater importance though, checklists and clear instructions can also help keep technicians safe from harm.

ATS is a leader in outsourced maintenance and helps manufacturers across many industries to improve and optimize equipment performance. Our services range from short-term support and storeroom management to advising on and implementing machine health monitoring. Contact us to learn more.

Let’s Talk

Hidden
This field is for validation purposes and should be left unchanged.