Best Practices for Process Audits in Manufacturing

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Process Audits

The key to process audits in manufacturing is transparency. It’s essential to be able to have complete visibility into the entire production pathway. Manufacturers need to know where each part or build is at any time, what is being done to it, and what’s coming next. Every step needs to be documented for effective process audits in manufacturing operations.

What Are Process Audits in Manufacturing?

Processes generate results. Process audits show if the results meet performance standards and are being effectively managed. Process audits in manufacturing are a comprehensive evaluation of the process to verify that the process is producing the right results.

The Difference between Product Audits and Process Audits

Don’t confuse process audits in manufacturing with product audits.

Product audits typically take place after the manufacturing stage or process has been completed. Any nonconformance is identified and contained, while countermeasures are developed to prevent a recurrence. They are necessary to check on quality, but product audits are also reactive to problems.

Process audits are, by design, proactive to identify problems before they occur and finding ways to optimize the production pathway. They examine steps such as:

• How your team prepares and produces products

• Process tracking

• Safety and qualifications

• Machine calibration

Product and process audits go hand-in-hand for an efficient process to produce quality parts and products. Both need to be used in tandem for an effective quality control process.

Mistakes in Process Audits

In computer science, there’s an acronym that engineers use: GIGO, which stands for “garbage in, garbage out.” They know that if you put bad data into a computer, you’re going to get flawed results. The same standard is applied to process audits. Without accurate and up-to-date information, you can’t trust that the data will lead you to the right conclusions.

Mistake # 1: Information Silos

One of the keys to successful product audits is accurate real-time information. Too often, manufacturers live in a world of information silos. Manual recording of data can lead to human error, lost paperwork, or outdated information. The right information may be recorded and documented, but it may not be accessible to everyone who needs it or be easy to find when it’s needed.

Mistake #2: Infrequent Process Audit Scheduling

Another mistake that manufacturers make with process audits in manufacturing is waiting until something goes wrong before initiating an audit. By the time a systemic problem is uncovered, scrap, waste, rework, and costly labor have already occurred. Process audits should be conducted on a regular schedule. The goal is to make processes more efficient and uncover potential problems before they occur.

Mistake #3: Inefficient Documentation

When there isn’t one consistent way to document every step in the production process, it can be difficult to piece together everything. Inefficient documentation methods, such as paper, Excel spreadsheets, or manual entry, can lead to errors and information silos.

Bluestreak’s integrated quality management system (QMS) creates a complete audit trail for the entire production pathway. It avoids these mistakes by creating an efficient system to record everything in real-time with a paperless process.

Why You Need Process Audit Checklists

Besides committing to regularly scheduled process audits in manufacturing, you need to standardize your process audit checklists. This ensures that you are tracking the right things—and the same things over time—as you explore quality improvements.

Process audit checklists will:

• Formalize the process by creating a comprehensive checklist of what will be audited.

• Ensure audit consistency, even if different people conduct them.

• Make sure the right data is captured and reported every time.

• Provide evidence of the process audit (which may be a requirement for compliance).

• Help determine where to focus attention on the process for the next audit.

• Allow for tracking as changes or process improvements are made.

Your QMS can be configured to model this list so you will have the data you need.

The Importance of Statistical Process Control (SPC)

Part of the compliance process for manufacturing parts and products to rigid standards is using a statistical process control (SPC) process. This provides instant process feedback to inspection personnel, allowing for immediate response to detrimental process variation. It improves the repeatability and reproducibility of inspection equipment by using the SPC programs during the calibration and verification processes.

Your SPC standards and upper and lower control limits should be part of your process audit checklist. The right QMS, such as Bluestreak | SPC, can auto-calculate your control limits to help you determine if it’s time to tighten them.

Layered Process Audits

Many service-based manufacturers find great value in layered process audits (LPAs). Focusing on identifying process variations before they lead to defects, LPAs are frequent audits conducted by multiple layers of employees, from shop floor operators to quality engineers and plant managers.

LPAs benefit manufacturers by having multiple personnel looking at the data. Each will have a different viewpoint depending on their role in the organization and the production path.

The Benefits of Process Audits in Manufacturing

Manufacturers that avoid process audit mistakes, employ formal checklists and a regular schedule, and conduct layered process audits can generate significant results, including:

• Less scrap and lower rework costs

• Improved customer satisfaction metrics

• Increased number of conforming parts per shift

• Fewer warranty claims and safety issues

• Avoidance of recalls or litigation

It also lowers the overall cost of production by proactively identifying—and solving—roadblocks in the production pathway before they become problems. Optimizing the production process leads to better results at every level.

To be effective, process audits in manufacturing needs a robust integrated QMS to track every part, product, and process. Bluestreak’s QMS is an all-inclusive database that manages the entire production pathway and eliminates separate silos of disjointed and inaccurate data. To learn more about process audits in manufacturing or to test-drive Bluestreak QMS, contact the experts at Bluestreak.