Quality control

Our products are used in a wide range of fields including medical diagnosis, measurement, industrial instrumentation, automobiles, information, general electronics, and academic research. As their product applications expand, demands for even higher product quality and reliability are increasing. To meet these marketplace demands, we are actively taking measures to improve product quality levels.

(The following statement is intended for Electron Tube Division, Solid State Division, System Division and Laser Promotion Division.)

Hamamatsu Photonics Group Quality Policy

The Hamamatsu Photonics Group pursues customer satisfaction, and the realization of the development of science and technology to contribute to a better society and a healthier planet through our Quality Policy.

Compliance with laws and regulations relevant to quality
We will abide by all relevant product laws and regulations, individual contracts and voluntary requirements.
Continuos improvement of quality management systems
We will continuously improve our quality management systems, and provide customers with high-quality, safe products, and levels of service that meet their expectations.

Established: November 1, 2013
Revised: April 1, 2024

Quality Headquarters Council

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Quality Headquarters Council System chart [72.3 KB/PDF］

The Quality Headquarters Council, a cross-sectional body within the company, has been established to share information on quality, standardize quality-related documents, and provide education to suppliers (supply chain). The committee also supports the quality management of our manufacturing subsidiaries, and strives to maintain and improve the quality of the Hamamatsu Group.

Quality management system

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[Figure 1] Quality assurance system chart [67 KB/PDF］

Each division has established and operates its own Quality Management System in compliance with the ISO 9001. In this system, items that are basic requirements are formalized in a “Quality Manual” and rules for design, development, purchasing, manufacture, inspection, shipping, and after-sales service are placed in document form to create a consistent quality assurance system.

Status of Quality Management System Certification

Certificated unit	Site	Certificated in
Electron Tube Div.	Toyooka Factory Tenno Glass Works	Feb-97
Solid State Div.	Main Factory Mitsue Factory Shingai Factory	Jan-98
System Div.	Joko Factory	Jun-98
Laser Promotion Div.	Miyakoda Factory	Mar-16

Design and development

After drawing up plans to develop a new product based on market research or requests from customers, we start investigating the possibility of production in terms of product functions, reliability, and costs, etc. Based on results obtained from judging design details, verifying the design from prototypes, trial mass production, and reliability tests, we make sure the design is valid and then authorize the product. We also identify risks and opportunities in the process of design and development and promote product designs with a high degree of perfection.

Process management

The production process is supervised based on manufacturing specifications, QC process charts, and work standards to ensure that quality and reliability are at levels planned in the product design.

To verify that the products meet the required specifications, HAMAMATSU performs process inspections and product inspections that check the product electrical/mechanical/optical characteristics and external appearance. The inspection items, methods, and test criteria are established in the product specifications. Destructive testing and lot evaluations are done by product sampling inspections.

We make continuous improvements on production processes based on the results from statistical process control and KPI (Key Performance Indicator) monitoring.

Traceability

The manufacturing history and material lot used for a product that has been shipped are traceable. This enables us to determine a retroactive range at an early stage when a problem occurs.

Packing

We use special packing techniques and materials which are also environmentally friendly in order to safeguard product quality and prevent shipping damage.

Reliability testing

When a product is authorized or a change is made to a product, we make reliability tests to verify that a product meets the specified reliability requirements. Reliability tests are performed by selecting typical products from among a group of structurally similar products. If needed, this testing is performed individually. Reliability test methods conform to JIS, JEITA, IEC, or MIL standards, and also some products are tested according to customers' requirement.

※Our reliability test equipment includes life test equipment, strength test equipment, transportation test equipment, radiation exposure test equipment, and others.

Work environment management

The work environment in the manufacturing process greatly affects product quality and reliability. Cleanliness, temperature, and humidity in particular must be strictly controlled. Some are produced in clean rooms where cleanliness is maintained at a high level. To maintain and control the cleanliness level in clean rooms, strict control standards are established for factors such as cleanliness, entry/exit methods, work clothing, carry-in items, and work procedures. Also, to maintain and control cleanliness, temperature, and humidity, we established the methods for managing factory equipment.

Damage caused by electro-static discharge (ESD) can be a serious problem as process geometry shrink and diverse packages become available, so electrostatic countermeasures are enforced. The department dealing with products requiring ESD countermeasures sets up special areas that must comply with ESD control standards and gives workers instructions in equipment and work site supervision, work clothing, and handling methods.

Production equipment management

When production equipment is implemented and authorized, it is given maintenance and verified for modifications or expansions. Specific methods for making start-up and periodic equipment inspections are established to perform preventive maintenance. Thus quality problems are prevented and stable production is maintained.

Procurement management

Procurement management of parts and materials has a large effect on product quality, so we use a system that judges and then registers both the suppliers and the parts and materials for purchasing.

We carry out an inspection of the suppliers to check compliance with quality environment system, green procurement policy, regulations regarding the chemical substances contained in products, and other factors. We then register those suppliers who meet our standards and also make new and periodic supplier audits mainly by the purchasing, quality control, and design departments. We strive to improve the quality of parts and materials for purchasing by giving proper guidance to the suppliers based on the audit results.

Purchased items undergo strict individual testing and are then registered before they can be used in our products.
An incoming inspection of those purchased items is then made based on the required specifications to verify their quality. After acceptance, these purchased items are stored in properly controlled locations that meet storage conditions specified in the design standards, and a high level of purchased item quality is maintained.

Measurement management

The quality control department periodically calibrates the test and measuring equipment. Calibration equipment is traceable to the national standards through the manufacturers and public organizations. Besides calibration, start-up inspections and periodic inspections are made to prevent and detect a drop in accuracy or a malfunction in the measuring equipment.

Dealing with process errors

When a problem occurs in the production process, which might cause defects that exceed preset process standards or might adversely affect the product quality, then the problematic lot is immediately identified and separated from other semi-finished parts. At the same time, the cause of the problem is investigated, and the corrective action that should be taken is decided. Along with confirming the corrective action was effective, we take measures to prevent the problem from reoccurring.

Change control

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[Figure 2] Changes Control Chart [12 KB/PDF]

Changes such as in designs, purchased items, and production methods and equipment are made in order to improve product quality, function, reliability, and productivity. Change planning is first of all drawn up, the job schedule from change setup to completion is clarified, and the planning then finalized at a change conference attended by all related departments including quality control. Finally, the change is decided after evaluating effects on quality, reliability, and productivity, etc.

Changes requiring the customer’s approval in advance are implemented after obtaining the customer’s consent. Initial production control is performed as needed and all effects caused by the change are checked.

Management of chemical substances in products

Environmental regulations, such as EU RoHS, REACH and China RoHS, have become stricter than ever in worldwide, thereby requiring companies to properly manage the chemicals contained in their products throughout their supply chains.

We have organized a system inside the company in compliance with "Guidelines for the management of chemical substances in products" by JAMP/JGPSSI. We make sure to register and use materials complying with the guidelines by implementing green procurement and its survey to our suppliers based on our "Green Procurement Guidelines" and "Green Procurement Management Standard for Chemical Substances". The survey results are stored in centralized information system for chemical substances in products, and used for actions to environmental regulations.

Management of chemicals in products

Green procurement activities

Request for survey on chemical substances in products

Response to safety standards of product

We design products meeting with related standards of EMC and product safety in its development, then make shipments after confirming the conformity with such standards by model testing.　For example, we affix CE marking on regulated products after implementing tests based on the harmonized standards of the target EU directive.

Complaint handling

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Figure 3] Complaint Action Chart [64 KB/PDF］

At Hamamatsu Photonics, we work to speedily resolve customer complaints by way of our complaint handling system.

The contents of the complaint are first checked and an investigation made to find the cause. Besides notifying the customer of these results, we also use them as feedback in the design and production processes to prevent a recurrence of the trouble. If we decide, based on those investigation results, that the quality control system must be overhauled, then corrective action is taken and results from that action are verified.

Failure analysis

We possess numerous failure analysis systems in the company in order to respond promptly to the needs of in-process defect analysis, complaint analysis and other analysis at any time.

※Our failure analysis systems are available for electron, optical, and acoustic microscopy, surface roughness analysis, atomic analysis, semiconductor failure analysis, and strength test, etc.

Instruction and training

We provide worker instruction and training to maintain and improve product quality as well as upgrade employee skills. Employee skills are periodically evaluated, and instruction/training plans are then drawn up and performed as needed. When a particular job requires obtaining qualifications, then those are clearly specified, and a system is then set up to certify employees who meet the requirements of the job.

The types of instruction span many areas including new employee education, on-the-job training, and safety and health instruction. Positive efforts are also made to collect information outside our company in order to upgrade employee knowledge and skills.