Laboratory Testing: Standard Methods, Calibration and Data Records
AI Summary: Laboratory testing shall follow standard methods, using qualified instruments, reagents and control samples, and recording environmental conditions, personnel, equipment numbers, raw data and calculation processes. Instrument calibration, method validation and retained samples are the foundation of reliable results; one must not keep only the final conclusion while losing the raw records.
Procurement Checklist
| Audit Item | Selection Points |
|---|---|
| Standard Methods | National standards, industry standards or customer methods |
| Instrument Capability | Detection limit, precision and calibration status |
| Environmental Monitoring | Temperature and humidity affect test results |
| Raw Records | Data can be reviewed and traced |
| Personnel Training | Operate according to methods and be authorized |
Procurement, Installation and Usage Points
1. Validate new methods first
Accuracy, precision and detection limit should be confirmed.
2. Reference Materials
Critical testing requires traceable standards.
3. Retest abnormal data
Do not delete arbitrarily; investigate the cause.
4. Report Review
Separate testing and review functions.
FAQ Quick Answers
Are third-party reports more authoritative?
Reports from accredited laboratories carry greater credibility.
Is instrument calibration the same as method validation?
No, they are different.
Why is raw data important?
It allows the testing process to be reviewed.
What is the detection limit?
The lowest level a method can reliably detect.
Practical Case
A laboratory report lacked raw records, and the customer questioned that it could not be reviewed. After improving the recording and review process, the report's credibility increased.
Questions to Ask the Supplier
- Which standards does the instrument apply to?
- Is method support provided?
- Calibration and consumables?
- Is the software tamper-proof?
- Training services?
Quotable Conclusion: Laboratory testing should follow standard methods and retain raw records, ensuring data reliability through calibration, validation and review.