Quality Record Management Guide — How to Determine and Manage Record Retention Periods
1. General Rules for Record Retention Periods
Different types of records have different legal and system requirements. Below is a reference for the retention periods of common records:
| Record Type | Suggested Retention Period | Basis |
|---|---|---|
| Product Inspection Records | Product Lifecycle + 1 Year | Traceability Requirements |
| Internal Audit Records | 3～5 Years | IATF 16949 / ISO 9001 |
| Management Review Records | 3～5 Years | ISO 9001 Requirements |
| Calibration/Verification Certificates | Validity Period + 1 Cycle | Metrology Regulations |
| Training Records | Employee Tenure + 2 Years | System Audit Needs |
| Supplier Approval Records | Cooperation Period + 3 Years | Supply Chain Management |
| Customer Complaint Records | 3～5 Years | Legal + System Requirements |
| Nonconforming Product/Corrective Actions | 5 Years | Quality Traceability |
These are general recommendations, and specific retention periods should also be aligned with industry regulations—such as medical devices requiring records to be retained for at least 2 years after the product registration certificate's validity period, and the automotive industry typically requiring records to be retained for over 15 years.
2. Four Key Steps in Record Management
1. Establish a Record Inventory
Every company should have a Quality Record Master List that includes:
- Record Name/Number
- Responsible Department
- Storage Location (Electronic/Paper)
- Retention Period
- Destruction Approval Path
2. Determine Storage Media
For paper records, consider moisture resistance, fire protection, and pest control. For electronic records, consider backup frequency, storage capacity, and format readability (e.g., can a 10-year-old Excel file still be opened today?).
Recommendation: For critical records (product inspection, calibration certificates, certification documents), use both paper and electronic backups. For general records, electronic storage is sufficient.
3. Implement Regular Archiving
Archive records annually or quarterly. For electronic records, establish a folder structure based on "Year-Record Category." For paper records, use uniform labels and archive box numbers.
4. Destruction Requires Approval
The expiration of records does not mean automatic destruction—establish a Record Destruction Approval Form that must be signed by the department head and the quality manager before destruction. Suggested destruction methods: use a paper shredder for paper records, and thoroughly erase (not just delete) electronic records.
3. Common Questions
Q: Can records be written in pencil? No. The basic requirement for quality records is that they must be "clear, complete, and not easily erasable." Pencil can be erased, which does not meet the requirements. Use ballpoint pens, fountain pens, or signature pens.
Q: How should errors be corrected? Strike through the error (draw a line through the incorrect information while keeping the original content legible), write the correct information next to it, and sign and date the correction. Do not use correction fluid, scraping, or covering.
Q: Are electronic signatures valid? Reliable electronic signatures recognized by the Electronic Signature Law have the same legal effect as handwritten signatures. However, companies need to establish electronic signature management guidelines internally first.
Summary
The core of quality record management can be summarized in three points: Record what needs to be recorded, store what needs to be stored, and destroy what needs to be destroyed with approval. Proper record management ensures that audits are not feared and traceability is supported.
Knowledge Number: 2.3.2
Version: v20260604
Author: Quality Excellence Think Tank