Confirmation of special printing process of ISO quality management system

1 Several basic related concepts

1) Process

Process is a set of interrelated or interactive activities that transforms input into output.

2) Special process

Under the definition of the term process, there are three notes, of which note 3 is a note on "special process", that is, "a process that is not easy or economical to verify whether the formed product is qualified". The standard requires companies to "confirm the implementation of any such process."

3) Confirm

The determination that the specific intended use or application requirements have been met by providing objective evidence.

4) Product

The product is the result of the process. Products are generally classified into four categories: services (eg transportation); software (eg computer programs, dictionaries); hardware (eg engine mechanical parts); process materials (eg lubricants). Many products are composed of different categories of products, so the difference in product categories depends on their dominant ingredients. In addition, one should also pay special attention to the quality assurance mainly focused on the expected product, for example, such as the book cutting process, its products are finished books and paper wool, the establishment of a quality management system, the focus is on the cutting quality of finished books , Not the quality of paper wool.

5) Procedure

The path specified for carrying out an activity or process is a procedure.

6) qualified

fulfil requirements.

7) failed

The requirements are not met.

8) Record

Documents that clarify the results achieved or provide evidence of completed activities. Records can be used to provide documentation for traceability and provide a basis for verification, preventive measures, and corrective actions. Although the record is also a type of file, it usually does not require version control.

9) Continuous improvement

Cyclic activities that enhance the ability to meet requirements.

10) PDCA cycle

Also known as the Deming Cycle, it is a method applied to total quality management proposed by the American quality management scientist Deming and reinterpreted after being adopted by the 2000 edition of the ISO9001 standard. It applies to all processes. In the standard, the interpretation of the PDCA cycle is:

P is planning: According to objective requirements and organizational policies, establish the necessary goals and processes for providing results.

D is implementation: implementation process.

C for inspection: monitor and measure processes and products according to policies, objectives and product requirements, and report the results.

A for disposal: take measures to continuously improve process performance.

The PDCA cycle is embodied in the general requirements of Standard 4.1 (Quality Management System):

(1) Identify the process required by the quality management system and its application in the organization;

(2) Determine the sequence and interaction of these processes;

(3) Determine the criteria and methods required to ensure the effective operation and control of these processes;

(4) Ensure that the necessary resources and information are available to support the operation and monitoring of these processes;

(5) Monitor, measure and analyze these processes;

(6) Implement the necessary measures to achieve the results of these process planning and continuous improvement of these processes.

The correspondence between the above items and the PDCA cycle is as follows: P → 4.1 a, b, c; D → 4.1 d; C-4.1e; A → 4.1 f

11) Preventive measures and corrective measures

They are all measures taken to eliminate the causes of unqualified or undesirable situations. The difference is that preventive measures are to prevent occurrences, and the objects to be prevented are potential; corrective measures are to prevent recurrences, and the objects to be prevented are discovered. There is also a difference between corrective actions and corrective actions. Correction is a measure taken against the unqualified or undesirable situation itself, and corrective action is a measure taken against the cause of the unqualified or undesirable situation. Correction can be implemented together with corrective actions. For example, if the upper cover of the bound book is skewed, it leads to failure. The product needs to be reworked, and rework is a type of correction. To prevent this from happening again, it is necessary to find the cause of the skew, for example, whether the rules of the upper seal are inappropriate, the rules of the cover itself are different, or there are two reasons. If you find the reason, take measures to make this happen. No longer happening, this is a corrective measure. Before the deflection of the upper seal occurs, carefully inspect the cover, carefully adjust the rules of the upper seal, and eliminate the unsuitable and inconsistent rules. The potential causes of unqualified deflection of the upper seal have been eliminated, so that the deflection of the upper seal did not occur. These measures are called preventive measures. [next]

2 Basis for determining special process

For a production and service provision process, whether it needs to be determined as a special process, from the above special process and its related concepts, we can already find the basis, that is, whether the product formed is qualified or not easy or economical to verify. That is "cannot be verified by subsequent monitoring or measurement". For example, the firmness of the glued products, the fastness of the laminating of the laminated product film and whether it will blister, the adhesion of the packaging products, etc. according to the above standards. The process, laminating process and paste box process are "special processes". At the same time, special attention should be paid to its scope in determining the special process, which only "includes the process where the problem appears only after the product has been used or the service has been delivered".

In printing enterprises, the quality of printing, printing quality, and baking quality have a great influence on printing quality, and even play a decisive role to a certain extent. Should these processes also be included in the special process for confirmation? We also argued in the early stages of the implementation of the standard. Later, we repeatedly studied the standards together and thought that although there are some difficulties in determining the quality of these intermediate products, they need to be strictly implemented Standards are tested according to prescribed standard methods and instruments, and their quality can still be identified. Therefore, it is not a special process. In view of the importance of printing quality and the particularity of its process control, you can refer to special processes to confirm the control of these processes, starting from strengthening equipment recognition and personnel qualification, standardizing operating procedures and records, to improve quality and ensure product qualification .

Identify and confirm special processes, the purpose of which is to "prove the ability of these processes to achieve planned results".

3 Preparation of content and documents

1) Confirm included content

The standard proposes that, when applicable, it includes:

(1) Guidelines established for process review and approval;

(2) Approval of equipment and identification of personnel qualifications;

(3) Use specific methods and procedures;

(4) Record requirements;

(5) Confirm again.

The problems to be solved in the confirmation mainly include:

What are the characteristics of the expected and undesired process results? Based on which characteristics are the documents for special process validation reviewed and approved? What data needs to be collected and what records should be kept? What are the appropriate methods for collecting data? What are the requirements for measurement frequency and method? How to effectively analyze the collected information (that is, how to use statistical techniques)? Under what circumstances should re-confirmation? Generally, how long is the re-confirmation period? Process? What corrective and / or preventive measures are required? Are these corrective and / or preventive measures implemented in time? Are they effective?

2) Preparation of special process confirmation documents

Special process documents shall be prepared, reviewed, approved, released, issued and controlled in accordance with the requirements of the documents in the standard. The structure of its reference format is as follows:

(1) Purpose: Specify the purpose to be achieved by preparing this special process confirmation document.

(2) Scope: Which production processes this special process document applies to.

(3) Responsibilities: Who will make this document, and who will review, approve and release it.

(4) Criteria for special process review and approval, including meeting product quality standard requirements, continuous improvement process capability and related requirements.

(5) Approval of equipment: including the name and model of the applicable equipment, equipment status requirements, testing instruments and usage requirements, of which the control of the testing device should be calibrated or calibrated in accordance with the requirements of the section "Control of Monitoring and Measuring Devices" Identify and mark the words "calibrated" or "identified" and time on the appliance, and save the calibration or identification records.

(6) Appraisal of personnel qualifications: including technical, training and assessment requirements for various personnel (such as captains and assistants) in this special process.

(7) The quality requirements and printing storage time of products entering this process are special, such as the binding requirements for book stickers of bound products; the requirements for entering the binding room in advance in winter; the ink curing requirements for film products; printing Medium spray powder, paper powder, and dust should be handled cleanly; the requirements for the selection and use of raw materials in this process; the requirements of ambient temperature; the process requirements and operating regulations.

(8) Who, when, and which records should be filled out.

(9) How to use records according to the requirements of the PKCA cycle to continuously improve process capabilities.

(10) Under what circumstances (such as equipment update, process update) should be re-evaluated and confirmed, usually how often should be re-evaluated and confirmed once.

According to the requirements of the standard, the conditions used for special process confirmation can be actual or simulated.

For the special process that has been confirmed, "confirmed" is used to indicate its confirmation status. In actual operation, the words "confirmed" and time can be pasted on the device. In order to confirm the execution of the file.