SOP for Manufacturing Company

In this article

• Consequences of Noncompliance With Manufacturing SOPs
• How to Write a Manufacturing SOP
• Manufacturing SOP FAQs
• Mobile App for Conducting Manufacturing SOP Inspections
• Featured Manufacturing SOP Templates

Consequences of Noncompliance With Manufacturing SOPs

A good manufacturing SOP is designed to streamline the production process while minimizing the risk of errors. Noncompliance with manufacturing SOPs could result in the following consequences:

1. Lack of quality control
   Manufacturing SOPs help produce high-quality products consistently. Failure to comply with manufacturing SOPs may result in inconsistent quality outcomes and unsatisfied clients.
2. Low productivity
   Manufacturing SOPs are designed to improve efficiency. Noncompliance makes it difficult to achieve maximum productivity since operational time frames will vary for each worker.
3. Subjective performance evaluations
   SOPs clearly define worker tasks and responsibilities. Objective performance evaluations are done by measuring actual performance against the standard set by manufacturing SOPs. If management and workers don’t follow the same standard, expectations become unclear and evaluations may be influenced by personal biases.
4. Communication breakdown
   SOPs communicate process updates to workers. If workers fail to comply with SOPs, they risk making errors that could compromise the quality and efficiency of their work.
5. Increased risk of accidents
   Safe work practices are often integrated into manufacturing SOPs. Noncompliance may put workers at a higher risk of work-related accidents or injuries.

How to Write a Manufacturing SOP

Complying with regulations and producing consistent outputs don’t have to be an arduous journey. Preparing a well-written manufacturing SOP document can guide employees to perform routine tasks in the best and safest way possible. There is no official standard in writing an SOP document. However, some steps can help in writing an effective SOP.

Step 1: Determine the goal

Writing your manufacturing SOP begins with thinking of what you want to accomplish. Whether starting a new process or improving an existing one, determining the end game or the goal makes it easier to write the SOP document.

To give you an idea, we’ve written down the following examples:

Manufacturing SOP Compliance Template | Example 1:

Purpose: The purpose of this SOP is to ensure that the correct steps are taken to roast, freeze-dry, and process coffee beans to produce instant coffee.

Tablet Compression SOP Checklist | Example 2:

Purpose: The purpose of this SOP is to ensure that the correct steps are taken when using the tablet press to perform tablet compression.

Step 2: Define the scope

The scope defines the extent of your SOP document. It clarifies details such as limitations or exceptions of the SOP, and the people who will be engaging with it or will be impacted.

Manufacturing SOP Compliance Template | Example 1:
Scope:		– Where is the SOP to be used? Chemical Manufacturing Lab – Who is the SOP for? Lab Personnel and Tablet Press Operators – Are there any specific limitations or exceptions to this SOP? This only applies to the production of pharmaceutical tablets.

Tablet Compression SOP Checklist | Example 2:
Scope:		– Where is the SOP to be used? Chemical Manufacturing Lab – Who is the SOP for? Lab Personnel and Tablet Press Operators – Are there any specific limitations or exceptions to this SOP? This only applies to the production of pharmaceutical tablets.

Step 3: Choose a format

There are various formats you can write an SOP document. A manufacturing SOP commonly uses a step-by-step format, which is straightforward and easy to follow. There’s also the hierarchical format which is similar to the prior, the only difference is that it provides more detailed and specific instruction for each step. Lastly, the flowchart format where processes are illustrated. This is most suitable for processes that require decision-making. You can choose to use one or combine them, so long as it’s appropriate and can be easily understood by your audience.

Step 4: Write down the procedures

Depending on the format you chose, start writing down the procedures of your SOPs focus. A good principle to follow when writing is the 5 C’s: clear, concise, correct, courteous, and complete. Doing so will help eliminate the guesswork from the procedure and ensure that each step performed is consistent.

Manufacturing SOP Compliance Template | Example 1:
Procedure:		Step 1 – Wear PPE or sanitary clothing before entering the production floor Step 2 – Activate vents before turning on industrial machines Step 3 – Set oven to 200°C for initial roasting of coffee beans Step 4 – Set coffee freezing hall to -50°C Step 5 – Put on thermal clothing before entering coffee freezing hall Step 6 – Set low pressure vacuum at 60°C Step 7 – Check conformity to specs and for visual defects during assembly line production Step 8 – Perform final inspections before products are packed in boxes

Tablet Compression SOP Checklist | Example 2:
Procedure:		Remove “Cleaned” label prior to operating tablet press Affix label “[Product Name] and [Batch Details]” to tablet press Issue the punch set suitable for the compression as per separate SOP Set the machine as per tablet parameters given in BMR Destroy tablets from first few rotations before starting the machine for the 1st batch Collect tablets generated per batch then pack and label Stop compression as material in the hopper reaches the lowest level Clean all outside containers and store them with labels that show batch details Remove punch sets and clean as per separate SOP

Preview the full manufacturing standard operating procedure sample PDF report.

Step 5: Review and update where necessary

After writing your SOP document, review and test it with other team members before sending it to stakeholders for approval. Once it gets approved, it will then be implemented and shared across relevant employees. However, it doesn’t stop there. SOPs should be continuously reviewed and updated, preferably every 6-12 months or as necessary.