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Batch Manufacturing Records: What You Need to Know

Lean manufacturing requires strong process control and organization. Whether making industrial product solutions or consumer goods, manufacturers benefit from master records that track batch production and the key elements required for the process. One manufacturing resource planning method that is critical for this organization is the batch manufacturing record.

A batch manufacturing record is the document used for tracking batch production throughout the manufacturing lifecycle. Batch manufacturing records typically include the inputs needed for producing the batch, detailed instructions on how to make the product, quality control procedures including tests that should be run on the given batch, and other relevant data necessary for managing it end-to-end during the production lifecycle.

Here's what you need to know about batch manufacturing records.

What you need to know about batch manufacturing records


Batch Records: A Key Manufacturing Resource Planning Method

Batch manufacturing records play an important role in safely and consistently producing products. With all of a batch’s specifications, requirements, and processes housed in a single master document, process control, and standardization become much easier. A batch manufacturing record is the roadmap and logs for a given batch.

Beyond centralizing the details of a batch in a single document, batch manufacturing records also benefit manufacturers in other ways.

1. Establishes quality standards. Batch records define each step necessary for producing a product. This clear process control can be used for setting quality standards that should be met during production so each product is produced according to the required standard. For manufacturers of industrial product solutions and life sciences manufacturing that must get FDA approval, the quality control standards that come from batch records are essential.

2. Enables traceability and reproducibility. Batch manufacturing records serve as an audit trail for each product that is produced. Through a batch record, manufacturers can trace a given product back to its raw materials and replicate or review the manufacturing process of a given product as needed.

3. Improves efficiency. With detailed records of how each batch is manufactured, it becomes easier to spot inefficiencies and tighten production workflows. Manufacturers can re-use master records for future batches as a starting template, and iterate on the process with each batch.

4. Ensures safety and compliance. When a defect or contamination is identified, batch manufacturing records make it possible to quickly identify and recall all the products that may contain the defect or contamination. Batch records also are a manufacturing resource planning method for demonstrating that quality standards and safety protocols are being met.

5. Facilitates communication. As an end-to-end master record for a given batch, batch records help departments such as production and quality control better coordinate and communicate throughout the lifecycle of a product. Batch manufacturing records enable different departments within the company to work from the same page.

 

What’s Typically Included on a Batch Manufacturing Record

While each manufacturer defines what goes on a batch record, there are several common elements that most manufacturers include.

Batch Details. Basic details of the batch should be included, specifically the batch name, the unique identification number for the batch, and the amount produced.

Bill of Materials. The BOM should include all the raw materials required for the batch, including packaging components and finished products incorporated into the products being produced.

Key Dates. The batch record should include the start and finish dates for the batch, along with any milestones that are a part of the batch manufacturing process.

Manufacturing process. The batch record should include a step-by-step summary of each action that will be taken to manufacture the product, including the mixing of ingredients, assembly of components, and the molding of materials. Deviations from the established process used for previous batches also should be included.

Hazards. Safety concerns such as dangerous processes and hazardous materials or byproducts should be listed in the batch manufacturing record, along with how to properly handle these materials and processes.

Quality control specifications. The tests that will be performed on the products to ensure adequate quality control typically are included on a batch manufacturing record. This section should also include guidance on how the test should be carried out, and what equipment will be used for testing. Anomalies during testing also will be listed on the batch record.

Equipment. The batch record should include all the tools and equipment needed for manufacturing the given batch, as well as any equipment calibration that is required for the batch.

Maintenance guidelines. Equipment and tool maintenance activities performed during the batch process should be included in the batch manufacturing record, including the recording of unforeseen maintenance tasks. The date performed and people involved in the maintenance also should be listed.

Compliance Record. The batch record also should include the documents related to GMP or other compliance requirements of the batch. This documentation should include approval signatures and any third-party testing that is performed on the batch.

 

The Importance of Centrality and Automation

While batch manufacturing records can be created and maintained in Word documents or spreadsheets, the manufacturing resource planning method most used for batch records is an enterprise resource planning solution (ERP).

ERP solutions are end-to-end backend systems that house all aspects of company operations and enable both systems automation and real-time visibility.

With ERP, manufacturers of consumer products or  industrial product solutions can easily access and update batch records in real time during the manufacturing process. Manufacturers also can reduce the logging and chance of data entry errors by automating many of the steps in batch record creation and maintenance.

For instance, the ERP can replicate previous batch records and automatically update them for the current availability of inputs or availability of equipment. Enforced workflows and compliance sign-offs also can be performed within the system.

To learn more about batch manufacturing records or how an ERP can help, call one of our experienced ERP consultants at (801) 642-0123 or write us at info@nbs-us.com.

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