Wiring Harness Quality Control

07.05.23 02:41 PM - By Biometric Cables

Wiring Harness Quality Control

wire harness quality control and its importance
The significance of wiring harness quality control should never be overlooked when it comes to medical device manufacturing !!! 
Wiring harness quality control is one of the most critical aspects of the medical device manufacturing processes. A wiring harness is a collection of bundled wires together which transmits power and electrical signals to the medical equipment components. The responsibility of ensuring the seamless working functionality of the components lies in the cable harness. 
Quality control generally involves a series of checks and inspections, tests conducted throughout every stage of harness manufacturing.

What is Quality in Wiring Harness ?

The significance of wire harness quality control can never be overstated. Wiring Harness quality in medical devices forms the integral basis for the proper functioning of the medical devices such as patient monitors, diagnostic medical equipment. Defective or damaged wiring harness causes severe safety hazards/problems such as electrical shocks and burns to the medical staff and patient. Alternatively, it poses malfunction issues to the medical devices, thus resulting in inaccurate readings. 

What is the standard for wiring harness wire ?

Several aspects such as reliability, patient safety and regulatory compliance are given importance when it comes to wiring harness processes.Effective implementation of rigorous quality control systems and processes in the medical device ensures that the harnesses are reliable and safe to use. It also aligns with the compliance and meeting with the regulations, particular standard requirements such as IPC WHMA-A-620D, IPC J-STD-001, ISO, IEC etc. An organized and quality wiring harness system brings about pros to both the manufacturer and as well customers.

On the manufacturing end, it can aid in eliminating downtime and costly medical equipment and accessories recalls. It ensures that accuracy is achieved throughout the processes and assembly of a wiring harness. Furthermore, the manufacturing firm can steer clear of reputational damage and any lawsuits due to strict quality controls in place.

Implementing the wiring harness quality control procedures helps not only in sustaining the low prices of the medical harnesses but also manufacturing reliable medical devices. These factors, in turn, promote customer satisfaction while delivering high-quality medical cable assemblies. 

Components of Wiring Harness Quality Control

Meticulous inspection of raw materials forms the first component of this control. It sets the foundation for the entire proper functioning and reliability of the entire assembly. Sourcing materials from the reputable suppliers and conduction of thorough inspections verifies the compliance with specifications. Secondly, for the proper connectivity of the wiring assembly, the integrity of the connectors and terminals are vital. Proper securing of the connector completely eliminates the wire failures or intermittent connections which possibly can compromise the functionality. A list of comprehensive testing methods and procedures such as environmental testing , insulation resistance testing , wire continuity testing etc is performed to identify the potential issues in each processes.


Continuous Improvement Process

Nowadays, The quality requirements of the medical wire harnesses in the manufacturing process are growing with a lot of complexity and marching towards the zero defect policy. Focusing on the continual improvement in the processes and services drive towards attaining quality medical cables and thereby, continually minimizing the production costs. Continuous improvement processes are incremental cyclical efforts that focus on enhancing the processes, systems and services.


Wiring harness manufacturers who implement continuous improvement processes aimed at driving the following 

  1. Improve Process Efficiency
  2. Waste Reduction 
  3. Improve the quality
  4. Minimizes the defects 
  5. Reduction of variations
  6. Enhance the value delivery
  7. Cost Savings
  8. Fosters Innovation

In recent years, Lean manufacturing strategies have gained traction in addressing conventional manufacturing practices. Kaizen is an effective approach that aims at creating perfection through waste elimination and exposes other new areas for improvement. Through establishing the Kaizen methodology, the employees are empowered to provide their own improvements on processes rather than the top-down changes that cause disruption.


Besides, the effectiveness of the lean tools namely 5S ( Sorting, Setting, Shining, Standardising and Sustaining) had engaged the employees in minimizing the waste throughout.

Additionally, the integration of Manufacturing Execution Systems ( MES) with the Kaizen process is instrumental for the success of the continual improvement process such as immediate problem/defect addressing and immediate corrective action.

Quality Assurance - Traceability

Traceability refers to the capability in the identification and tracing process of the location, history, application and distribution of materials and products. It is the prime key factor for ensuring the quality and reliability of the medical device. The faulty wire harnesses can be eliminated/minimised using the Traceability systems in place. 

For effective and agile production traceability,  the procedures namely product identification, and data capturing systems such as the assignment of barcodes / QR Codes to the materials are widely used at the supply chain level.

On the other hand, the implementation of continuous traceability procedures in the overall internal processes such as material handling, machines and equipment, production and assembly processes and the personnel responsible for each step can additionally aid in identifying the potential issues that can lead to timely corrective actions. 

As and when constant changes are happening in the wiring harness design, the changes are subsequently reflected in the processes, therefore posing difficulties to the standardization of the processes. Adopting the “First in First out” principle greatly minimizes the complexity and number of adjustments in the processes. 

Manufacturing Execution Systems serve as a crucial role in the control and management of the production environment. Via MES Systems, one can gain insights into the real-time monitoring data of the manufacturing operations such as resource status, inventory management, plant maintenance, wiring harness sampling and tests, KPIs, Staff tracking etc. 

1.The MES assigns unique batch numbers/barcodes for each incoming material and its history is recorded.

2.In the pre-assembly phase, the wires are cut, crimped, soldered and ultrasonically welded and the respective history record is updated accordingly.

3.In the wiring harness assembly phase, once the medical cable assembly is produced, a new barcode is generated, thus updating the history record.

Conversely, Organisational awareness forms a vital part when it comes to production traceability. For instance, staff scanning a product twice or scanning multiple wiring harnesses in advance can ultimately lead to inaccurate recordings.

A lot of challenges are being posed by Customized wire harness manufacturers while working with Original Equipment Manufacturers as the ultimate focus of OEM is on quality medical devices. For instance, the ISO 13845 Traceability program assures the original equipment manufacturers confidence in the quality and safety of medical cable assemblies. 
Documentation of the traceability procedures in alignment with the regulatory requirements and maintenance of those records helps in bringing safe medical products.


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