The hidden cost of incomplete projects

At Plyable, we understand the frustration of seeing promising projects stall. A high percentage of tooling projects are effectively removed before they ever reach execution.

Why does this happen? The reasons are numerous: incorrect material specifications, unmet tolerances, inadequate tooling systems, human error, or a myriad of other factors that must be considered during the initial design and process planning stages. It’s estimated that 50% of tooling jobs in the UK never make it to final production – a staggering waste of time and capital.

This is why having a rigorous quality framework is crucial.

What is process PFMEA (PFMEA)?

Process Failure Mode and Effects Analysis (PFMEA) is not just a regulatory hurdle; it’s a systematic, analytical method designed to eliminate potential failure before it happens.

Primarily used in production settings, a PFMEA reviews every single step of the design-to-manufacturing process to identify all the ways a process might fail to meet its functional requirements.

By implementing a PFMEA system, your team can proactively mitigate risks. The core function is to determine the individual consequence, or “effect,” of each potential failure on the product, the customer, and safety.

Analysing risk – A PFMEA example

Here is a classic manufacturing example demonstrating how a PFMEA identifies and quantifies risk:

Process Step	Potential Failure Mode	Potential Effect of Failure	Potential Cause(s) of Failure	Severity (S)	Occurrence (O)	Detection (D)	RPN
Apply Adhesive to Component A	Too little adhesive applied.	Component A separates prematurely, causing a product defect and customer complaint.	Operator error, clogged nozzle, low adhesive in dispenser.	9 (Major defect)	5 (Occasional failure)	8 (Visual check, easily missed)	360

Decoding the RPN Score

The PFMEA team assigns three key ratings for every failure mode:

• Process Step: Apply Adhesive to Component A – The required action
• Potential Failure Mode – How the action could fail
• Potential Effect of Failure – The consequence for the end customer/product
• Potential Cause(s) –The root reason the failure may occur
• Severity (S) – The rating of the seriousness of the effect on safety or function for customer
• Occurrence (O) – An approximation of the frequency this failure occurs.
• Detection (D) – How easily this failure can be detected before it reaches the customer

The most critical output is the Risk Priority Number (RPN) which is calculated as 

S X O X D = £X RPN 

In the example above, the high RPN of 360 flags this failure mode as a high-priority risk that requires immediate action to reduce one or more of the ratings.

Implementing corrective action

A high RPN dictates immediate corrective action. The team’s focus shifts to reducing the risk ratings:

• Reduce Occurrence (O) – Implement an automated, calibrated adhesive dispenser instead of relying on a manual process to eliminate human error.
• Improve Detection (D) – Add a camera or sensor system that verifies the adhesive bead’s volume/presence, making the failure instantly identifiable.

This process ensures that teams prioritise the most significant problems, allowing them to either eliminate the pitfall or consider the best strategy to mitigate its consequences.

The bottom line is cost savings and reliability

The ultimate goal of PFMEA is to boost process reliability, product quality, and safety by addressing potential problems before they occur. The cost benefits are significant:

• Avoided Rework and Scrappage: With the average cost for composite tooling production in the UK ranging from £10k to £50k, avoiding a single remake is essential. Proactive PFMEA can save hundreds, if not thousands, of pounds off the cost of each tool.
• Reduced Engineering Waste: Engineering and design costs, which often range between £400 and £600 per day, will skyrocket if multiple design iterations are needed due to preventable manufacturing failures.

While the Lead Process or Quality Engineer typically facilitates the PFMEA initiative and sets up the meetings, its success relies on every member of the engineering and manufacturing team being involved in the assessment.

By collaborating to identify, develop, and implement corrective actions (such as error-proofing and improved controls), teams can dramatically eliminate or reduce the chance of failure, securing huge cost savings for the client, the supplier, and all stakeholders.

How do we carry out a PFMEA:

Define the Scope and Objectives: Clearly identify the process to analyse and outline the objectives of the PFMEA. 

Assemble a Cross-Functional Team: Include members from engineering, quality assurance, production, and customer service to ensure a comprehensive understanding of the process. 

Create a Process Flow Diagram: Visualise each step in the process and identify potential failure points. 

Brainstorm Potential Failure Modes: Identify what could go wrong at each step and assess the severity, occurrence, and detection of these failures. 

Develop Corrective Actions: Create actionable steps to address high-priority risks and mitigate potential failure modes. 

By following these steps, organisations can proactively identify and mitigate risks in their processes, ensuring operational reliability and reducing the likelihood of failures.