Guidelines related to Provisions 7 and 9

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Guidelines for Quality Control of Registered Products
1. Purpose
The Guidelines are designed to show the fundamental concept for the quality control
necessary to maintain the functions (antibacterial, antifungal, and antivirus activities) ofthe registered products, which are announced as one of the three SIAA product security
standards, as well as explaining the self-management system specified as one of themembership requirements in the Admission Management Provisions.
Statements in the Guidelines regarding the definition and description of quality andquality control represent the SIAA’s own approach for maintaining the quality of theregistered products and may be different from the ones of each individual company(organization).
2. Scope of Application
The Guidelines apply to antibacterial agents, antibacterial processed products, antifungalagents, antifungal processed products, and antivirus processed products registered with theSIAA (hereinafter collectively referred to as the “Registered Products”).
3. Meaning of the Establishment of a Self-Management System
Establishment of a self-management system is specified in the Admission ManagementRules as one of the membership requirements. The following conditions are stipulated there:
・Agent manufacturers:
The company must have at least one test administrator or a person with equivalentqualifications.
・Processed product manufacturers:
The company must have a system to perform antibacterial evaluations in the company.
It is also required that the company is supported by a testing organization that is a
supporting member of the SIAA, or by an agent manufacturer that is a full member of
the SIAA and conducts crosschecking with a supporting member.
The above means that, in order to confirm that antibacterial, antifungal, or antivirus
activities (hereinafter referred to as the “Registered Functions”) of the Registered Products
satisfy the SIAA standards, the establishment of a system that can evaluate the Registered
Functions of the Registered Products (agents or processed products) is required. This meansthat it is necessary as one of the membership requirements to voluntarily check theRegistered Functions of the Registered Products and that it is also necessary to continue todo so even after becoming a member.
4. Concept of Quality Control
4-1. What Quality Means
As stated in Provisions for Control Managers (K11), quality means in the SIAA that theRegistered Products satisfy the Voluntary Specifications for Quality and Safety (K07).

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Therefore, maintenance of quality means that the Registered Products continuously satisfy
the standards of the safety of the agent and the standards of the Registered Functions.
4-2. Concept of Quality Control
As a general rule, quality control is an activity to ensure high quality through three
approaches: process control, quality inspections (product inspections), and quality
improvement.
Process control is to plan, implement, and control each product manufacturing process inan efficient way in order to ensure the target quality. To be concrete, it includes
standardization of work procedures, maintenance of facilities, and education and training
for the work.
Quality inspections are to check whether the manufactured product complies with theproduct standard (target). Generally, it includes visual inspections and function inspections.
Appearance inspections are to check whether there is any defect in appearance, such as
scratches or dirt on the product, while function inspections are to evaluate the items in theproduct standards, such as the antibacterial activity function of a product, and confirm that
it fulfills the specifications (product standards). Quality inspections do not simply mean theinspection of product quality but provide a good indication for judging the process control
capability and effectiveness and, therefore, is an important activity for the maintenance ofquality.
Quality improvement is about making improvements to prevent the recurrence ofnonconformities in each process and inspections or to prevent what you think is a potential
problem from occurring.
4-3. Process Management and Quality Inspection
In ISO 9000 Quality Management Systems - Fundamentals and Vocabulary (JIS Q 9000),
the process approach is covered as one of the principles of quality management. The process
approach means to understand and manage activities as interrelated processes thatfunction as a coherent system. The important points of this approach include clarificationof processes, consideration of interaction between processes, operation and management ofprocesses, and application of processes as a system. There are many approaches that areshared with process control in the previous section.
There is an opinion that if process control is rigid, in other words, if the prescription for
production is determined and products are manufactured according to it, the quality can be
maintained without product quality inspections. However, quality inspections are also
important as milestones, and both process control and product quality inspections arenecessary for quality control.
Generally, prescriptions for production (work standards) are determined for the purposeof keeping product quality within the scope of the standards by identifying the factors thatexert an influence on product quality and controlling them to stay within a specific range.
Looking from a different perspective, the prescriptions (standards) are designed to control

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the factors identified at a specific time, and there are a few (or very few) cases where all
factors that may influence product quality are covered.
Many organizations make efforts to maintain a certain level of quality by measuring
specific parameters in the manufacturing conditions and parameters related to the itemsin the product standards for each lot, investigating the fluctuations, and implementing thenecessary measures. Although these efforts represent one of the process control methods,
they may also indicate that it is difficult to grasp and control all factors that exert influenceon quality.
That is to say, although process control is indispensable for effective maintenance ofquality, conducting process control alone is often insufficient. For important productfunctions, it is necessary to check on a periodic basis that the target level is achieved, eventhough there is an issue of frequency.

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4-4. Schematic Chart of Quality Improvement

5. Checking the Registered Functions when the Ingredients of Registered Products are to be
ChangedIf the kind, volume added, and main base material (e.g., resin) of the agent used are thesame and if the changed or added additives are determined to have no or very little
influence on the Registered Functions (antibacterial, antifungal, and antivirus activities),
the new product can be regarded to have the same specifications as the existing Registered
Products. (Refer to the M25 Product Registration Manual.)
However, it is rare that the antibacterial effect of the additives changed or added isclearly identified, and the degree of influence may vary depending on the volume of theadditives. Therefore, it is difficult in many cases to determine whether the specifications of
the new product and the existing Registered Product can be regarded as the same.
For all these reasons, it is recommended to check the Registered Functions as a part ofself-management when changing or adding ingredients of the Registered Products.
6. Self-management
The SIAA’s principle is self-management of Registered Products. Self-management inthis context means that member companies conduct process management and quality
inspections (inspections of Registered Functions) as specified in Section 4 of this documenton their own responsibility and check by themselves that the functions satisfy the SIAA
standards in order to provide reassurance to consumers. The results need not to be
regularly reported to the SIAA.
7. Periodic Performance Check System
Since its foundation, the SIAA’s basic principle has been self-registration and selfmanagement. Submission of the function data of Registered Products has been obligated

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only at the time of product registration (at the time of entry to the SIAA and additional
registration) and products that satisfy the specified standards have been allowed to bear theSIAA mark.
On the other hand, while awareness and globalization of the SIAA mark are growing,
consumers’ demand for safety and security is becoming more rigorous, and the social
responsibility the SIAA mark assumes is increasing year by year. In recent years, a numberof successive scandals, including falsification of quality data by leading manufacturers
representing Japan, have become a social issue. As a result, general consumers’ awarenessof quality control and maintenance has been changing, and their interest in these issues has
been increasing.
Under such circumstances, we decided to introduce a periodic performance check systemin fiscal year 2021 in order to further increase the credibility of the SIAA mark. Under thesystem, member companies are requested to submit registered processed products to thesecretariat once every five years, and their antibacterial activity is tested by a JNLA
laboratory in accordance with JIS Z 2801. For details of the system, refer to the Operating

Manual on the Periodic Performance Check System.
8. Summary
A product is manufactured through a series of processes and completed after checking its
quality. In order to secure the target quality, it is essential to identify the factors that havean influence on product quality and control them to stay within a specific range. Quality
inspections (inspections of Registered Functions) are also necessary to confirm theappropriateness of the process control.
Through appropriate process control and repeated quality inspection and improvement
activities, we believe that the level of product quality can be maintained that is worthy ofconsumers’ trust.

Formulated: March 16, 2021

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Examples of Quality Control
Examples of quality control are shown below. Although you do not need to cling to theseexamples only, it is necessary to conduct both appropriate process control and inspectionsof the Registered Functions (antibacterial, antifungal, and antivirus activities). Quality
improvement is also important in order to ensure stable product quality.
(a) Example of quality control of an agent manufacturer (manufacturing agents in-house)✓ Process Control



Establishing raw material standards and confirming that purchased materialssatisfy them

Manufacturing products in accordance with the specified manual and having themanufacturing records checked by an employee other than the worker engaged in
the manufacturing process.

✓ Quality Inspection (Inspection of Registered Functions)

Evaluating the antibacterial activity per lot, while its conformance with the productstandards being checked by a quality assurance-related division

Evaluating the antibacterial activity per lot or every three to six months (preferably
every three months) at the company’s facilities or at an external testingorganization✓ Quality ImprovementInvestigating the causes of nonconformities found in product inspections andcarrying out corrective actions to prevent recurrences

Investigating the factors that fall outside 3σ (standard value) among processparameters or in the parameter management during product quality inspections
and taking preventive actions

Investigating the causes of customer complaints and developing measures toprevent recurrences(b) Example of a processed-product manufacturer A (adding antibacterial agents to thecompany’s product)✓ Process Control



Establishing raw material standards and conducting acceptance inspections ofantibacterial agents

Manufacturing products in accordance with the specified procedures and checking
the manufacturing records✓ Quality Inspection (Inspection of Registered Functions)

Evaluating the product’s antibacterial activity in-house per lot or every threemonths



Evaluating the product’s antibacterial activity per lot or every six months at anK31-6

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external testing organization

Evaluating the product’s antibacterial and antivirus activity every two years at atesting organization✓ Quality ImprovementInvestigating the causes of exceeding or falling below the average consecutively formore than a specified number of times in the important parameter trend
management during process management and taking preventive actions

Investigating the causes of falling outside the standard values during productinspections and developing measures to prevent recurrences

Reviewing the processes that you think have potential problems on a day-to-day
basis and taking preventive actions

Investigating the causes of customer complaints and developing measures toprevent recurrences(c) Example of a processed-product manufacturer B (purchasing antibacterial parts andincorporate them into the company’s product)✓ Process Control



Checking the product analysis table issued by the material manufacturer per lotpurchased

Manufacturing products in accordance with the specified procedures and checking
the manufacturing records taken✓ Quality Inspection (Inspection of Registered Functions)

Obtaining antibacterial activity data of raw materials periodically (yearly) fromtheir manufacturers and checking them and auditing suppliers as requiredObtaining antivirus activity data of raw materials periodically (every two years)
from their manufacturers and checking themEvaluating the Registered Functions of the company’s end product periodically (atthe company or at an external organization) (as required)✓ Quality Improvement

Checking with the material manufacturers for what makes the productcharacteristic value come close to the lower limit in the trend management at thetime of acceptance inspection and asking them to implement the necessarymeasures

Investigating the causes of scratches on the surface of antibacterial materials madeduring the manufacturing process and developing measures to prevent recurrences(d) Example of a processed-product manufacturer C (purchasing antibacterial inks, paints,solutions, etc. and providing antibacterial printed materials and coating using them)✓ Process Control



Acceptance inspection of antibacterial inks, paints, and coating solutions (checkingthe ingredient analysis table)

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Printing in accordance with the conditions specified by the ink manufacturer(thickness of coating, mileage, etc.) and checking the resultPainting in accordance with the conditions specified by the paint manufacturer andchecking the resultCoating in accordance with the conditions specified by the coating solution
manufacturer (creating a manual of coating methods and checking the application)✓ Quality Inspection (Inspection of Registered Functions)

Antibacterial processed products: Evaluating antibacterial activity of the company’s
products every six months

Antivirus processed products: Evaluating antivirus activity of the company’s
products every two years✓ Quality ImprovementInvestigating the causes of nonconformities, including abnormal values, found in
the inspections of printing machines or other equipment and developing measures
to prevent recurrences

Pursuing the causes of uneven application found in visual observation after theprinting, coating, or painting process and developing measures to prevent
recurrences

Reviewing the conditions of printing and painting that you think have potential
problems and taking preventive actions(e) Example of processed product provider (purchasing products from other companies andselling them (including importers))✓ Quality Control

Concluding purchase specifications (a purchase and sales contract) that include theRegistered Functions with the manufacturerConducting acceptance inspections that include the Registered Functions

Checking the data of the Registered Functions periodically (every six months for
antibacterial and every two years for antivirus functions)✓ Quality Improvement

Discussing the causes of failure to meet the standard values in the regular checksof Registered Function data together with the manufacturer and sharing measures
to prevent recurrences

Investigating the causes of peeling or cracks on the coated or painted surfaces foundin the periodic inspections and implementing countermeasures in cooperation withthe execution companies

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