Introduction of ISO 9000 in Printing Factory Management

Reference, research content

Since the beginning of 1980, China has introduced the ISO 9000 International Quality Assurance Certification System. There has been a big wave in all walks of life. Each company or factory door is marked with "Quality Policy, Objectives, and Commitments" to enable employees to implement In daily work, we also use this to gain the trust of our customers.

I. Application of ISO 9000 in Printing Factory Management

If the ISO 9000 series is introduced into a printing factory, what kind of changes and requirements should the printing factory make? First, start with the first requirement of ISO 9001:

(I) 4.1 Management responsibility

According to the original text, the following four items can be explained:

1. The high-level decision-making managers of the factory have their responsibilities ignoring the strategies for the growth and development of the planned factories and improving the constitution of the company's management, thereby improving the quality of products and services; since it is virtually impossible for every production or service process on weekdays. The matter must be intimate, so only through the various operating systems of the ISO 9000 series to understand the actual situation of the company's operations. Therefore, if this system is not recognized by the management decision-making class, this system will be useless in its own right, and it will not be able to generate strength and benefits in internal operations. The ISO 9000 series here proposes a management representative to help management decision-makers review the applicability of this system at all stages of growth. This is also a third-party certification unit. It can often be performed by the management representative in the internal operations of the company. The effectiveness of substantive monitoring and management is demonstrated, and management personnel review those quality records on a regular basis to effectively grasp the applicability of the company's quality system.

2. The management representative must be assigned from within the company's internal management rather than an external quality assurance consultant. At present, most domestic companies are mostly held by the highest executives of quality control units. In fact, the management representative can also concurrently perform other tasks such as “factory director”, “general manager’s room commissioner” or other senior managers. However, the most important thing is to have "full authority and responsibility" so that it can truly grasp the effective continuous operation of the company's quality assurance operating system and ensure that the conditions required by the customer are met.

3. The management class refers to the highest managers, such as supervisors and general managers above the department level, and even some factories refer to the management staff of the chairman (depending on the internal organization of the factory).

4. The management needs to require management representatives; the appropriateness of the company's quality assurance operating system, factual audits, or the convening of high-level management review meetings to truly operate the quality assurance system. As for the matter activity record and operation regulations, it must be formulated in writing.

(II) 4.2 Quality System

Vendors should establish, document, and maintain their quality systems to ensure that products meet regulatory requirements. It is also necessary to set a quality plan. As long as the factory is in operation, the quality plan has the work it needs to perform. Once the development of the quality plan is completed, these tasks are habitual and continuous. Apart from regular revisions, they can also be used to review the implementation of the work and its effectiveness so that the plan will always have its value. Since we must continue to implement the quality plan, we must also do a quality plan before we can formulate a project plan quality manual. Therefore, the project plan quality manual can list the detailed scope of work and is in the same format as the factory's quality manual. Its contents are as follows:

1. Policy Statement - Signed by a contract or program manager to reflect the project's quality strategy.

2. Powers and Responsibilities - Shows compliance with program or contract requirements.

3. Organization - The type of organization that meets the needs of the plan may include the representative of the owner.

4. The revision and republication must be in accordance with the spirit of the contract.

5. System Summary - Explains the standard items for a specific quality specification in the plan.

6. Operating Procedures - Index Determines the instructions for this program.

Just like the quality plan of the factory, the system summary is established, and the related operating program books can be determined. At this moment, the same program as the factory quality plan can be selected for use or be modified as necessary. Usually, there is no need to write a new program separately. The related operating procedures become the quality plan for this contract or project.

(c), 4.3 contract review

In accordance with the original content, contract or order review procedures, the factory shall provide:

1. Necessary coordination during the review and review (meaning internal: coordination of internal operations, external: coordination of buyers and sellers), contact (internal: internal links, external: external links) and understanding (inside : The understanding of all relevant personnel of the factory and external: understanding of the opinions of buyers and sellers) can all be implemented and achieved.

2. The contract (or order) review and review operations must be conducted in written records. The records of interpretation and review must be kept for a suitable period. In the common cases, the contract and order review and review of operational issues, examples are:

(1) Contract Scope: It is determined that all personnel involved in the contract review are fully aware of the scope of the contract.

(2) Demand for materials: The specifications and materials of the material management department of the design department shall determine the material quantity, schedule, etc., of the materials, whether the conditions meet the contractual requirements, and if the materials must be obtained through the purchase, the materials shall be provided. The appraisal, mode of transport, quality, delivery date, etc. of the supplier shall be included in the project for material needs assessment.

(3) Standards and specifications: Determine the specifications and standards specified in the contract, and at any time can be placed on the job site.

(4) Demand for special inspections and tests: When there are additional inspections, it is necessary to determine the acceptability of the factory products, and these requirements are included in the inspection and test standards of the factory.

(5) Production process: Determine the schedule of production and delivery.

(6) Assessment of participating staff: Determine the qualified experience and qualifications of the staff during the contract completion period.

(7) Organization work: whether the implementation of the staff organization type conforms to the requirements of the ISO 9000 series organization section.

(D), 4.4 Design Control This item is not required in ISO 9002, which is used in the printing industry.

(5) 4.5 Control of documents and data Due to the overall quality of the ISO 9000 series of work processes, the system is written to establish various quality assurance operating systems for the factory. Therefore, the preparation, review, modification, and change of the written system shall be reviewed and approved. Deletion of voids must be established through standardized management. The format to be formulated must have a unified way of expression. In the method of file numbering, there must also be a unified method of operation.

(VI), 4.6 Procurement

1. The factory shall determine the quality system of the contractor to implement effective controls to ensure that the quality on the supply meets the requirements of the quality plan.

2. For all approved contractors, the factory must establish documents and keep records.

3. In the procurement information, depending on the specifications of the products purchased by the factory, there are different management methods. The main purpose is to avoid delays in the purchase and sale of disputes and the agreed schedule.

4. The procurement information is also a control document in the quality assurance system. Prior to the issuance of the operation, the power and responsibility personnel must be designated to perform the review and approval beforehand to ensure the appropriateness of the procurement document before it is issued.

5. Verification of purchased products refers to the customer's requirements for the subcontractors of the factory. When there is a contract, the customer or other representative has the right to verify whether the products supplied by the factory meet the requirements specified in the contract at the source of supply or at the receiving office. .

(7), 4.7 Control of customer supply The written draft of the provisions of this set of operations is usually considered in general:

1. When receiving materials, specify the number of checkups and their correctness.

2. When storing, it should be stipulated that the correctness of the method of preservation should be determined, and regular inspections should be conducted; if necessary, proper positions or isolation must be made.

3. When transporting, it is required to establish various operational requirements such as appropriate transportation tools and methods.

4. When used, the correct method to use should be specified and understood, and the control of identifying and isolating such materials from other products should be prevented.

5. The above execution record should be saved.

6. In the event of any variation, damage or loss, the customer must be notified in writing.

(8) 4.8 Identification and traceability of products The main purpose of the product is to identify product quality and safety issues so as to effectively control product quality liability risks and reduce the number of accidents.

(IX), 4.9 Process Control Based on the conditions of personnel, methods, materials, machines, measurement, and on-site environment that the product must invest in, formulate various operating procedures, methods and standards to maintain the product in each stage of the process. , quality stability.

(X), 4.10 Inspection and Testing

1. Is there an agreement with the customer's order or contract for confirmation?

2. Confirm and record the shipping standard of the final product.

3. Confirm that the final inspection and other operations' operation (or inspection) regulations have been completed.

(XI), 4.11 Control of Inspection, Measuring and Testing Equipment

1. The factory shall make necessary controls on all measurement systems in the R&D, manufacturing, installation and maintenance of products to ensure the correctness of the measures or decisions made on the basis of the measured data.

2. Procedures should be established to monitor and maintain the measurement process, always under statistical control.

3.

(1) Maintain technical specifications and correctness of test instruments

(2) Before use for the first time

(3) draw up a regulatory operation, formulate a periodic checklist for the results of the last calibration, and regularly adjust the equipment

(4) The documented documents shall include the identification, recalibration, recovery, handling and storage, adjustment, maintenance, calibration and installation of the instrument.

Use and other items

(5) It is best to use national or international standards for reference standards that can be traced back to known accuracy and stability. f. Equipment for verification inspection, measurement and experimentation should have proper marking or record of approval to show its calibration situation.

4. If you find that the measurement process is out of control, or if the measurement equipment exceeds the required calibration limit, corrective actions must be taken.

(XII), 4.12 Inspection and Test Status The inspection and test status of the product shall be differentiated by an appropriate method and indicate whether the product is qualified.

(xiii) 4.13 Control of non-conforming products shall establish written management procedures to ensure that purchased materials, components, processed products, manufactured products, and finished products are judged unqualified during the prevention period, or when the customer returns the product. Improper use and installation. There are the following six ways of handling: