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How long does the sample remain in the laboratory? Wait for 8 answers to laboratory accreditation questions

2022-01-07 14:55

Typical Question Answers

 

 

1

 

How long is the sample retained in the laboratory? Are there any specific regulations?

 

Answer:
There are no regulations, except for special industries, which are reserved according to their own requirements.
Sample retention time to consider:
1.     Meet the requirements of retest (can reach the time limit of retest)
2.Meet the requirements of industry sectors, such as judicial industry, food industry.
3.Taking into account the specific circumstances of the laboratory, preservation conditions, etc.
Sample handling:
1.If you can't handle it yourself, you can agree with the customer in advance or bear it yourself.
2.Return it to the customer. If the customer does not come to pick it up, we can set the basic retention time, with small fees for overtime, etc.

 

2

 

Whether the auditor on the original record must participate in the on-site experiment and whether the video remote supervision can sign the audit.
Answer:
Requirements for auditors
1.Work Experience Requirements
2.   G001Requirements, college related professional graduation, three years of industry work experience or ten years of work experience.
If the reviewer of the original record is not the reviewer, but the person ultimately responsible for the data, it is necessary to authorize the signatory.
Reviewers do not have to participate in the process of the experiment. They can supervise the audit remotely or sign the audit according to the experimental records. However, they cannot detect personnel witnessing the experiment to make a report.
3

 

Food safety testing unqualified data in the limit value of the range, to consider doing uncertainty assessment?
Answer:
Recommended Method: Measuring Ability IndexCm, is the limit value for judgmentTdivided by twice the expanded uncertaintyU.
Limit valueT: It can be understood as a tolerance, which is the range of technical indicators and also a limited range. For example, the diameter of a round rod is required to be10±1, thenTIt is2(positive1-Negative1
Cm3without considering the uncertainty,Cm3Consider the measurement uncertainty.
  
4

 

Does the laboratory need to cover all testing items for internal quality control?
Answer:
No, according to the actual situation, such as the risk of the experiment, personnel situation, past experimental results, external complaints, the difficulty of the experiment, whether the experiment is often operated, etc.
However, it is recommended to do every experiment for a period of time.

 

5

 

The customer has lost the test report sent to the customer, and the laboratory needs to supplement two copies. The authorized signatory of the original report has left the company. Should the laboratory reissue the report or print the previous report for the signature of the authorized signatory? (The customer does not agree to require the laboratory to keep a copy of the copy.)
Answer:
If the customer asks for a supplementary report, just give it a copy. If he doesn't want it, he doesn't understand what it means. The copy is a copy of the original sent to the customer, which has the same legal effect as the original. The content of the report is exactly the same. That's no problem.
Print it out and replace it with the signature of the authorized signatory, which is definitely not possible. It will become a number report with two authorized signatories. Isn't that a mess.
You can send out a copy of the original report, then give a new number, sign the new authorized signatory, and then declare in the report that it replaces the original, the original is invalid, and declare that the reason is that the customer is lost, so it is exempt from liability.
The best way is to give copies.
 
6

 

If the product test exceeds the standard, should the same person recheck or need to be rechecked by another person?
Answer:
Generally, it is a different person, for fear that the same mistake will be made by one person back and forth, and it is difficult to find the reason for the retest. But according to the guidelines, it can also be a person, which is a matter of work experience. If it is a customer request, it will be handled according to communication.

 

7

 

After the quality manual and procedure documents are changed, must the work instruction and record form be changed? If the quality manual and procedure documents are not changed, can the work instruction and record form be changed?
Answer:
Don't worry too much, it mainly depends on how to use it.
Changing the edition is a major revision. Generally, it may be more than 1/3 in length, changes in external documents, changes in content, and so on.

 

8

 

Quality manual, procedure documents, work instructions, record forms, they are the first level, the second level, the third level of documents, they must be the same version number?
Answer:
You can have a different version number, and you can specify it clearly in your own document. The point is whether to change or not, whether to change or not.
Of course, it is easier to manage if you change to one version.

Recommend a file:IS0/T 10013This document is devoted to the contents of the quality management system document. There is no mention of the word "change" here. It is mainly about revision.