As a coating technician, what is the daily work besides doing experiments to do experiments to do experiments?
         That is report!
         In the past, I was also a technician, but the most painful thing is to write the report!
         But then there is a baby, it is no longer afraid of Oh!
         That is a complete and detailed experimental records.
 
         In the CNAS guidelines there are requirements for the original record, we look at.

       【4.13.1.2】 All records should be clear and easily accessible and stored and preserved in a facility with a suitable environment to prevent damage, deterioration, loss. Shall specify the retention period of the records.

       [4.13.1.3] All records shall be securely protected and confidential.

       [4.13.2.1] The records of each test or calibration shall contain sufficient information to identify the influences of uncertainty when possible and to ensure that the test or calibration is repeatable as close as possible to the original conditions. The records shall include identification of the person responsible for sampling, the operator of each test and/or calibration, and the person who verified the results.

        [4.13.2.2] Observations, data, and calculations shall be recorded at the time they are generated and can be categorized and identified according to the specific task.

        [4.13.2.3] When errors occur in the record, each error shall be crossed out and not erased so that the words are not blurred or disappear, and the correct value shall be filled in next to it. All changes to the records should be signed or initialed by the person making the changes.

         So in the daily work, how should we do a good job in the experimental process of the original record it?
 
1. Blank original record preparation and revision of the specifications
 
         The first is the preparation of the original record design, if the design of the original record within the design is not reasonable, contains a variety of incomplete, incomplete information, it will not be convenient to use. For the experimenter who needs to do a lot of experiments every day will instead add a lot of trouble. There will also be no use of the value.
 
         Then we need our laboratory technology and quality responsible for the format of the test records to make uniform provisions, and then organize a wealth of practical experience in accordance with the relevant standard specifications and methods and the actual situation of the test work to prepare a good variety of blank draft test records. (After all, the front-line use of people for the record of which data is the most clear ~)
 
         After that, the quality management department, together with the relevant departments in charge of the draft blank test records of the comprehensiveness, effectiveness, and coordination of a close audit, and according to the audit comments to make the corresponding changes to the technical responsible person for approval.
 
         After the actual use, if in the process of use feel that there are unreasonable places, the need to modify the blank test records how to do?
 
         Then you need to use the record of the section or personnel should apply for the preparation of a revised version of the draft to the quality management department. Then the quality management department will organize the person in charge of the relevant section to re-examine it, and after passing the examination, submit it to the technical manager for approval and implementation.
 
         Approval of the implementation of the revised draft by the quality management department to re-label the uniqueness of the logo (number with the original record, the edition should be different from the original record), replace the original record and organize the printing. Then also need to use the section or personnel to issue a notice of invalidation of the original record, retrieve the original record, issue the modified test records for the relevant personnel.

 
2. Original record writing and modification
 
         Talking about Tujun once saw a lab technician's experimental records, that simply 。。。。。。 I finally know why it took her so long to write a report! The handwriting was scribbled, and the content of the east piece and the west piece. For the experimenter with fewer experiments, it may be able to distinguish which data is a certain performance of which experiment. But for the experimenter doing several projects at the same time, may not be able to find the data, can not find the data how to do? Only in the test performance again!
 
         So a qualified original record since the most basic requirements are.

         1. writing handwriting should be neat and clear, the content should be accurate, and retain the appropriate line spacing, leaving a certain amount of room for change.

         2. When you encounter no fillable content, should be filled in "none" or "/", no empty items.

         3. the original records should use standardized terminology, try not to appear uncertainty (such as 1 to 2 drops, 5 to 10 ml), the unit of measurement should use international standard units of measurement, the rounding of valid numbers should be consistent with the experimental requirements.

         4. commonly used foreign language abbreviations (including foreign language abbreviations of experimental reagents) should comply with the norms, and must be annotated in Chinese when they first appear.

         5. All records shall be written with a blue or black handwriting pen or signature pen. Do not use pencil or other easily faded writing tools to write.
 
         The foregoing are the most basic requirements. In addition, the original records are not allowed to delete, modify or add or subtract data at will. If you must modify, should be modified in accordance with the requirements of the system documentation, the need to scratch, to ensure that the record before the modification can be identified, and should be signed by the modifier (changes are limited to the detection or preparation of personnel themselves, review and audit personnel shall not change the information or data related to the original record of the test); the testing process for some reason invalidated test records should also be retained to ensure that the original test records true, complete Accurate, clear and tidy, relevant data, information can be traced, traceable to the source of error-free.
 
         Emma, write an original record how so many requirements!
 
         And more! Let's move on to the next.
 
3. The originality of the original record
 
         Since the original record, the emphasis is on the "originality".
 
         Each test project should be recorded before the start of the project's experimental purpose. After the end of the experiment should also be the results of the analysis, and come to a clear conclusion.
 
         Detectors can follow: "do have traces", "trace", "check the evidence" to fill out the original records of testing, once the experiment while making records.
  
         Missing, copy, after the fact to make up or transcription are not allowed.
 
         The original record should not only record the content of the experimental results described in the standard text, but also the complete record of the phenomena observed during the experiment, the treatment of abnormal phenomena, the possible causes of the abnormal phenomena and the analysis of the influencing factors.
 
         In addition to recording the phenomena, you should also keep the pictures of these phenomena, and promptly classify and comment on the photos! Especially the notes!

 
4. Traceability of the original records
 
         The content of the original records of the test includes solutions, instruments, reagents, controls, graphs, tables and many other contents, each of which must be traceable.

       (1) Solutions: Commonly used solutions include standard titrant, standard pH buffer, standard colorimetric solution, standard lead solution, standard arsenic solution and so on. When these solutions are used, their sources should be indicated in the original records, and should be able to be traced to the preparation, calibration and other records in a separate record book.  

       (2) Instruments: The use of instruments should be recorded during the experiment, and the original records should correspond to the registration of instrument use.  

       (3) reagents: some special test drugs (poison, anesthesia, essence, release) should be registered with the original records of the experiment.  

       (4) control: its source, lot number and treatment before use should be recorded; for content (or potency) determination, its content (or potency) and dry weight loss (or moisture) should be indicated.  

       (5) graphs, tables: with the progress of analytical instruments, data acquisition and processing software is becoming more and more powerful, each test, the system will record a lot of information, usually choose: sample number, collection time, storage path, printing time, method, operator and other information, print out, if necessary, pasted on the record paper, should not be pasted, can be separately organized and bound into a book and numbered, while in the The corresponding place in the record book is indicated.  

5. The tightness of the original records
 
         The original records should be reviewed at three levels to ensure that the relevant information and data are accurate.
 
         Any original records must be signed by the inspector, reviewed by the relevant inspectors, and audited by the higher-level inspectors or department heads.
 
         First-level audit.
         By the testing personnel are responsible for their own. Testing personnel in the completion of the original record of the test after filling out the record should be filled out whether the record is complete, whether there are errors in the numbers or symbols, whether the relevant arithmetic, sample markings and test numbers are correct and other content of the initial review to confirm that there are no errors signed by the testing personnel. If you find that there is a misprint of the content should be corrected, there are doubts should be retested.
 
         Second-level audit.
         By the same time involved in testing or other testing personnel in this post. Mainly on the testing process (steps) is in line with the requirements of the standard, whether the digital revision is appropriate, whether the calculation is correct, in the unqualified or marginal value of the test results for review, etc., to confirm that the reviewer's own name signed. If you find errors or have doubts should be returned to the original testing personnel to modify or re-test.
 
         Three-level audit.
         By a higher level of the relevant testing personnel or the person in charge of the section to complete. Mainly for the first and second level audit personnel whether to sign, whether the test is carried out within the validity of the sample, whether the test items are done in accordance with the requirements of the whole, from other original records, standard curves, drawings and information transmitted from the value of the error, whether the test is based on the commissioning unit or the requirements of the higher business sector to review, confirm that there are no errors signed by the auditor. If you find errors or questions should be returned to the original testing personnel to modify or retest.
 
6. Confidentiality of the original records
 
         Confidentiality of the original records

         The original records of the testing process is responsible for the custody of the testing personnel.

         After the end of the test, the relevant sections should be within the specified time limit will be reviewed by the three levels of the original records of various tests concentrated and delivered to the quality management department to organize and file.

         In order to avoid the original records have been filed testing is modified or leak customer confidentiality, the original test has been filed only the relevant unit of general access, access to the relevant procedures and approval by the department head signature, access to at least two people involved. Access only excerpts or copies of the content, not to change or mark the content; testing of original records shall not be lent, no one shall be taken away from the unit, if necessary, the borrower should go through the relevant lending procedures, approved by the laboratory leader, the archivist to provide a copy.
 
         Testing of original records shall not be less than 6 years (a recognized cycle), the state, the industry has relevant management regulations or important value of the original records can be appropriately extended or long-term preservation. To the storage period of the original records of the test, the archivist can apply for destruction, approved by the unit in charge, the archivist together with the relevant sections to implement the destruction and make the relevant registration.

Translated with www.DeepL.com/Translator (free version)