Quality Control

Products from Hamamatsu Photonics 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 Group.)

 


 

Quality Policy

Hamamatsu Photonics pursues customer satisfaction and contribution to social and human development with our quality policy.

 

We continuously improve our quality management system and providing customers with high quality and safe products and service, we contribute to the development of society and humankind with optical science and technology.

 

Quality Standardization

Each division employs the ISO 9001 Quality Management System to standardize quality. In this system, items that are basic requirements are formalized in a “Quality Manual” and rules for design, materials, manufacture, inspection, shipping, and equipment management are placed in document form as “Standards” to create a consistent quality assurance system.

 

Figure 1 shows the quality assurance system chart.

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

 

Status of Quality Management System Certification

Certificated unit Certificated in
Electron Tube Div. February 1997
Solid State Div. January 1998
System Div. June 1998
Laser Group March 2016

 

Design and development

After performing market research and drawing up plans to develop a new project, 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.

 

Reliabilty testing

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.

 

Process management

The production process is supervised based on 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.

 

The packing process also requires use of special packing materials and techniques to safeguard product quality.

 

Equipment and 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. 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 is given maintenance and also verified after modifications or expansions. Specific methods for making start-up and periodic equipment inspections are established to perform preventive maintenance, and constant efforts are made to prevent quality problems and keep stable production.

 

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, 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.

 

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

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 a final check made of all effects caused by the change.

 

Figure 2 shows a Changes Control Chart.

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

 

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.

 

At Hamamatsu Photonics, we have organized inside the company meeting "Guidelines for the management of chemical substances in products" by JAMP/JGPSSI, and promoted making products environmentally friendly 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.

 

green procurement

 

Response to Safety Standards of Product

At Hamamatsu Photonics, 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 EC directive.

 

Complaint handling

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.

 

Figure 3 shows a Complaint Action Chart.

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

 

Instruction and training

We provide worker instruction and training as an active promotion to maintain and improve product quality as well as upgrade employee skills. Employee skills are periodically reviewed, 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.

 


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