Preface

SOP is for the product manufacturing process, is to guide you how to do the product, it is based on the preparation of product drawings and process requirements. SIP is for the product inspection process, is to guide you how to inspect the product, it is based on product standards or specifications.

The difference between SIP and SOP will be illustrated from the following three points of difference between SIP and SOP:

SOP (Standard Operating Procedure) ------ standard operating instructions . This is the standard of operation for the operator to use. It is a guideline for operators to explain and standardize their work in order to achieve consistency and standardization of operation. Note: Some companies called (meaning work instruction); we said WI Work Instruction SOP is not (i.e., mass production) meaning.

Start of production SIP (Standard inspection Procedure) ------ Standard inspection (inspection) instruction. This is the inspection standard for QC personnel.

1

Department, Basis and Role

SOP is a standard operation book, i.e., a detailed standard operation guideline made by the engineering for each process of the product, which is used by the operators at the manufacturing site. Production department in accordance with this SOP operation.

SIP for the inspection standard inspection book, that is, the quality engineers do for the product feed, process, finished products made of standard inspection guidelines and standards. Quality department personnel in accordance with the SIP for production inspection.

SOP is for the product manufacturing process, is to guide you how to do the product, it is based on the preparation of product drawings and process requirements, and SIP is for the product inspection process, is to guide you how to test the product, it is based on product standards or specifications. SIP is based on customer specifications and their own standards to develop.

SIP in the production of SOP can be taken into account in the production process. For example, SIP in the inspection operation can refer to the operation of the SOP.

SOP IE staff production will reflect the operating methods & standards, the use of materials, tools & equipment, standard working hours; SIP QE staff production will reflect the operating methods & standards, the use of materials, tools & equipment, standard working hours.

SIP QE personnel will reflect the production of inspection methods, tools & equipment, sampling standards, defects in the definition of judgment.

2

Production Essentials

1. the production of SIP essentials

Should the SIP be labeled with key control dimensions or should it be labeled with key dimensions according to engineering drawings? Such as labeling key dimensions, some products have a lot of key dimensions, and some key dimensions are not good to describe in words, how do we test it?

Here we will talk about the key points of making SIP, SIP is for QC (IQC and OQC) to do, so SIP should be simple, easy to understand, easy to operate. For the size should pay attention to the following points.

1) Refer to the engineering development of this product, the list of key dimensions, SIP inspection dimensions should not be too much.

2) the size of the assembly involved, must be the focus of control (the process of product assembly needs to understand);; and

3) Client-specified dimensions.

4) As far as possible, drawings are attached to the SIP for easy reference during measurement.

5) The inspection equipment is commonly used as much as possible, avoiding the use of CMM; and

6) For the combination of dimensions or complex measurement of the size of the design as far as possible gage.

2. the production of SOP essentials

How to make SOP (standard operation procedure/standard operating instructions), SOP is the most basic and most important duties, a complete and the latest standard SOP can not only standardize the production process and affect the operation of the entire company.

Many senior managers summarize a company in this way: “a company has two manuals can be, a red book (quality manual), a blue book (SOP),” visible SOP extension and importance.

1) Preparation before production

A. Read the data provided by the customer or RD, summarize all the conditions and specifications, and make a “work notes”.

B. Analyze the structure of the samples, differentiate the engineering sections (SMT, AI, processing, insertion, repair, assembly), and check whether the BOM classification is correct.

C. Establish parts and components of the processing methods and specifications; safety parts of the distinction.

D. Formulate the production process, and workstation arrangements and prepare flow charts.

E. Confirm that the arrangement of workstations is reasonable, whether to achieve a balance of working hours, whether to repeat the confirmation and prevention of defective outflow function.

2) Preparation of SOP

The principle of making SOPs is to make them clear, easy to understand, and explicit, so that operators can easily read and understand the contents, sequence, and standards of operations. The SOP of the production line is divided into four sections: processing, insertion, repair, assembly, etc. The content of the SOP:

A. Machine name: the company's machine name, such as: S3359; if there is a customer's machine name should also be included, such as: MS-320. (emphasis) can not be a series of machine type way to indicate the name of the machine, each type of machine must have its own SOPs, can not be shared. Each machine type must have its own SOP and must not be shared. The machine type name specified by the company and the customer's machine type name must be distinguished by color.

B. Job Name: Indicate the job name of this workstation. For example: Dispensing, Tin surface inspection”. (3). Operation section: indicate the operation is located in that section of the project. Such as: rotor section, stator section, assembly section....

C. Station: Label this workstation is located in the engineering section of the station, in order to facilitate the line.

D. Work content: indicate the work items and sequence of this workstation. (emphasis added)

- Identify the confirmation of the previous workstation's work (priority work).

- The order of work is scheduled.

- The order of work is scheduled. Safety parts must be labeled.

E. Notes: Indicate the contents and requirements of each work item. (Emphasis added)

- The sequence numbering of precautions must correspond to the job content.

- The customer's or design's requirements for the relative work shall be indicated, and if there are no requirements, the general standard of PH shall be used.

”, “front”, “back”), in order to prevent the identification of differences.

- If there is an extension of the machine, there is the use of similar parts, need to indicate the difference.

F. Illustration: Drawings or photographs to illustrate the work and notes. (Emphasis added)

- Use color boxes to differentiate the work and safety parts for inspection and confirmation of the station.

- Indicate the sequence of work.

- The direction of the drawing and the object on the icon must be the same as the actual work.

- For group work (e.g., heat sink processing, “....) For group work (e.g., heat sink processing, “...”), use exploded drawings or continuous pictures as much as possible.

- Marking of the relevant benchmarks must be clear and explicit.

G. Tools used: Label the tools, fixtures, instruments, and tool setting conditions to be used at this workstation. (Emphasis added)

- The setup conditions of the tools should be confirmed if there are any customer or design requirements, if not, then setup with PH general standards.

- Need to indicate the use of consumables, such as tin wire, paint pen.

H. Parts to be used: The parts to be used in this project station must be labeled with part number, specification, project location, and quantity. (emphasis added)

- Arrangement of parts need to be the same as the order of operations.

- If there is a substitute material also need to be put together, but must be added to the material number before the “S” to distinguish.

I. Changes: Record the changes in this operation and the reasons for the changes (emphasis added).

- The date of the change and the name of the person who made the change must be indicated.

- If there is an ECN, indicate the ECN number.

- The reason for the change must be indicated (e.g., operation improvement, design change, customer requirement, safety requirement).

- The reason for the change shall be indicated (e.g., operation improvement, design change, customer requirement, safety requirement). The change shall be marked in each field for easy comparison.

G. Versions: Guidance for controlling this work. (Emphasis added)

- Provisions for version coding shall be indicated by capital letters, e.g., “A”, “B”, “...”.

- If 26 letters are used up, two English words are used instead, e.g., “AA”, “AB”“...”.

H. Judgment: Indicate the criteria for the assignment. (emphasis added)

- The sequential numbering of the judgment labeling must correspond to the job content.

- The judgment specification should prioritize the customer's requirement, followed by the design requirement, and then the PH operation specification.

- The definition of OK and NG must be clear.

J. Standard working hours: Indicate the standard working hours of the workstation. (emphasis added)

- The “standard working hours” and “balanced working hours” of the workstation must be indicated.

3. Management of SOPs

(1). After the SOP is completed, it must be confirmed by quality assurance and then by the supervisor of biotechnology. (In addition to the producer, the signature part can not use the computer to print).

(2). Each type of SOP must have a version of the version of the LIST, to indicate the type of machine at the time of the latest version of the SOP of the workstation why.

(3). There shall be a change log for the SOP for that model, containing a LIST of all changes to all SOPs for that model.

(4). SOP issued by the manufacturing unit to use “A3” specification paper and quality assurance unit to use “A4” specification paper, and all must be signed.

(5). All SOP must be printed out and stored on disk, and electronic files must be backed up SOP is also the customer's information into the company's internal information to the production of personnel as a guide to make products that meet the customer's requirements, so that the company's costs can be better controlled as a principle.