1.0 Objective
To establish standardized
procedures for documenting, maintaining, and reviewing records in the food
testing laboratory to ensure data integrity, traceability, and compliance with
regulatory requirements specific to food safety and testing.
2.0 Scope
This SOP applies to all
laboratory personnel involved in data recording, document preparation,
maintenance, and review in compliance with Good laboratory Practices (GLP), ISO
17025, and FSSAI mannula for food testing.
3.0 Responsibility
3.1 Laboratory Personnel:
·
Ensure
compliance with Good Documentation Practices while recording and handling food
testing data.
3.2 Department Heads:
·
Oversee
adherence to GDP guidelines and perform periodic audits of food testing
records.
3.3 Quality Assurance (QA):
·
Maintain
master copies of documents and review controlled document compliance for food
testing processes.
4.0 Definitions and Abbreviations
4.1 Definitions:
·
Good
Documentation Practices (GDP): Guidelines for
creating and maintaining accurate, clear, and complete records specific to food
testing procedures.
4.2 Abbreviations:
·
SOP: Standard Operating Procedure.
·
GDP: Good Documentation Practices.
·
QA: Quality Assurance.
·
FSSAI: Food Safety and Standards Authority of India.
5.0 Procedure
5.1
General Guidelines
1.
Use
of Ink:
Always use indelible blue or
black ink for manual entries. Entries must be legible, clear, and without
ambiguity.
2.
Date
Format:
Record dates as DD/MM/YYYY
3.
Error
Correction:
Do not overwrite or erase
errors. Draw a single line through the incorrect entry, write the correct
information nearby, and initial with the date of correction.
4.
Completeness:
All fields in documents must be
filled. If not applicable, write "N/A" or "Not Applicable."
5.
Page
numbaer:
Number pages as “Page X of Y” to
ensure completeness.
6.
Avoid
Blank Spaces:
Cross out any unused space with
a diagonal line and note "Cancelled" or "Not Applicable"
with initials and date.
5.2
Documentation Standards
1.
Headers
and Footers:
Include document title, SOP
number, version, and effective date on each page.
2.
Signatures
and Initials:
Every document must have
signatures, initials, and dates of preparation, review, and approval.
3.
Instrument
Records:
Record the name, identification
number, and calibration status of instruments used in food testing or analysis.
4.
Analytical
Data:
Maintain detailed records of
reference standards, lot numbers, and method descriptions for food samples.
5.
Sample
Identification:
Each food sample must have a
unique identification number to ensure traceability.
5.3
Handling and Storage
1.
Control
Copies:
Use "Controlled Copy"
stamps for distributed documents and maintain a log of issued copies.
2.
Master
Copies:
Store original documents
securely in the Quality Assurance archive.
3.
Document
Retention:
Retain documents for the
duration specified by regulatory requirements (e.g., FSSAI guidelines).
4.
Access
Control:
Restrict access to sensitive
documents to authorized personnel only.
5.4
Training
1.
Awareness
Training:
Conduct regular training for all
personnel on GDP principles specific to food testing.
2.
Documentation
Updates:
Train employees on changes to
documentation formats or requirements related to food safety standards.
6.0 Precautions
1.
Do not use
correction fluid, tape, or pencil entries in records.
2.
Ensure
records are clean, safe, and stored to prevent damage or loss.
3.
Verify
data accuracy during entry to minimize errors.
4.
Maintain
confidentiality of food testing records.
7.0 References
1.
ISO 17025:
General requirements for the competence of testing and calibration
laboratories.
2.
FSSAI
Guidelines for Food Testing Laboratories.
8.0 Annexures
1.
Annexure 1: Format for Document Correction Log.
2.
Annexure
2: Training Record Template.
3.
Annexure
3: Document Issuance and Retrieval Log.
4.
Annexure 4: Sample Identification Log Template.
9.0 Revision History
|
Version |
Effective Date |
Description of Changes |
Prepared By |
Approved By |
|
1.0 |
DD/MM/YYYY |
Initial Release |
QA Officer |
Lab Director |
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