Controll template in food testing laboratory
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"Control template" in a food testing laboratory refers to standardized documents or forms used
to manage, monitor, and document various critical activities and processes. These templates
are essential for ensuring consistency, traceability, quality control, and compliance with
regulatory standards like ISO 17025 and local requirements (such as those from the Saudi Food
and Drug Authority - SFDA).
Effectively designed control templates help laboratories:
● Standardize procedures: Ensuring tasks are performed consistently by different
personnel.
● Maintain accurate records: Providing evidence of activities performed, results
obtained, and any deviations.
● Facilitate traceability: Allowing for the tracking of samples, reagents, equipment, and
personnel involved in testing.
● Support quality control: Documenting QC checks and measures.
● Enable audits and reviews: Providing clear documentation for internal and external
assessments.
● Manage non-conformances: Documenting deviations and the corrective actions taken.
Here are some key types of control templates commonly used in food testing laboratories, along
with their typical components:
1. Quality Control (QC) Sample Log Template
● Purpose: To record the testing of quality control samples (e.g., blanks, spikes,
duplicates, reference materials) alongside routine test samples to validate the analytical
process.
● Key Elements:
○ General Information:
■ Template ID & Version
■ Date of Analysis
■ Test Method ID/Name
■ Analyst Name/Initials
■ Instrument ID (if applicable)
○ QC Sample Details:
■ QC Sample ID
■ Type of QC Sample (e.g., Method Blank, Lab Control Sample, Matrix
Spike, Duplicate)
■ Concentration/Expected Value (if applicable)
■ Source/Lot Number (for CRMs, LCS)
○ Results:
■ Measured Value(s)
■ Units
■ Recovery (%) (for spikes, LCS)
■ Relative Percent Difference (RPD) (for duplicates)
○ Acceptance Criteria:
■ Defined acceptable range/limits for each QC parameter
■ Pass/Fail Indication
○ Comments/Observations:
■ Any unusual observations during the test.
○ Review and Approval:
■ Reviewed by (Name/Signature/Date)
■ Approved by (Name/Signature/Date) (if required)
2. Equipment Calibration/Verification Record Template
● Purpose: To document the calibration and interim performance verification checks of
laboratory equipment (e.g., balances, pipettes, pH meters, thermometers, incubators,
ovens). This is crucial and directly relates to previous discussions on temperature
monitoring.
● Key Elements for a Thermometer/Temperature Monitoring Device:
○ Equipment Details:
■ Equipment ID (e.g., REF001, INC002, Thermometer ID T-05)
■ Equipment Name/Type (e.g., Refrigerator, Incubator, Reference
Thermometer)
■ Location
■ Serial Number
■ Manufacturer
○ Calibration/Verification Event:
■ Date of Calibration/Verification
■ Performed by (Name/Initials)
■ Type of Event (e.g., Annual Calibration, Monthly Verification, Daily Check)
■ Reference Standard Used (ID, traceability, calibration due date)
○ Procedure:
■ SOP Reference for Calibration/Verification
○ Readings:
■ Set Point(s) or Reference Point(s)
■ As Found Reading(s) from Device Under Test (DUT)
■ Reading(s) from Reference Standard
■ Correction/Error (Difference between DUT and Reference)
■ As Left Reading(s) (after adjustment, if any)
○ Acceptance Criteria:
■ Specified tolerance/acceptable error
■ Pass/Fail Status
○ Adjustments/Maintenance Performed (if any):
■ Details of any adjustments made.
○ Next Due Date:
■ Next Calibration/Verification Due Date
○ Review and Approval:
■ Reviewed by (Name/Signature/Date)
■ Approved by (Name/Signature/Date) (e.g., Quality Manager)
● (This template is directly applicable to the "Temperature Tracking Record System"
previously discussed. Manual temperature logs would be a simpler version
focusing on daily/routine checks, while this template is more for periodic
calibration/verification events.)
3. Corrective Action Report (CAR) Template
● Purpose: To document any non-conformance, deviation, or out-of-specification result,
investigate its root cause, implement corrective actions, and verify their effectiveness.
● Key Elements:
○ Identification:
■ CAR Number (Unique ID)
■ Date Issued
■ Issued by
■ Department/Area Affected
○ Description of Non-conformance:
■ Detailed description of the problem/deviation (What, Where, When, How)
■ Source of Identification (e.g., Internal Audit, QC Failure, Customer
Complaint, Routine Monitoring)
■ Reference to affected Test Method, SOP, Sample ID, Equipment ID
○ Immediate Action(s) Taken (Containment):
■ Actions taken to mitigate the immediate impact (e.g., stopping work,
quarantining samples).
■ Date and Responsibility
○ Root Cause Analysis (RCA):
■ Methodology used (e.g., 5 Whys, Fishbone diagram)
■ Detailed analysis of the underlying cause(s)
○ Corrective Action(s) Planned:
■ Specific actions to eliminate the root cause(s)
■ Responsible Person(s)
■ Target Completion Date
○ Implementation of Corrective Action(s):
■ Date Implemented
■ Evidence of Implementation
○ Verification of Effectiveness:
■ Method of Verification
■ Date of Verification
■ Results of Verification (Was the action effective in preventing
recurrence?)
■ Verified by
○ Preventive Action(s) (if applicable):
■ Actions to prevent similar potential non-conformances.
○ Closure:
■ Date Closed
■ Approved by (e.g., Quality Manager)
4. Standard Operating Procedure (SOP) Template
● Purpose: To provide a standardized structure for writing detailed instructions for
performing specific tasks or operations within the laboratory.
● Key Elements (Structure):
○ Header:
■ Laboratory Name/Logo
■ Title of SOP
■ SOP Number (Unique Identifier)
■ Version Number
■ Effective Date
■ Review Date/Next Review Date
■ Page Number (e.g., Page X of Y)
○ Approval Section:
■ Prepared by (Name/Title/Signature/Date)
■ Reviewed by (Name/Title/Signature/Date)
■ Approved by (Name/Title/Signature/Date - usually Lab Manager or
Quality Manager)
○ Table of Contents (for longer SOPs)
○ 1. Purpose: Brief statement of the SOP's objective.
○ 2. Scope: To whom and what processes/activities the SOP applies.
○ 3. Responsibilities: Who is responsible for performing the tasks and ensuring
compliance.
○ 4. Definitions/Abbreviations: Clarification of terms and acronyms used.
○ 5. Related Documents/References: List of other relevant SOPs, methods,
standards, manuals.
○ 6. Safety Precautions: Specific hazards and safety measures to be followed.
○ 7. Equipment and Materials/Reagents: List of necessary items.
○ 8. Procedure: Step-by-step instructions for carrying out the task. This is the core
of the SOP.
■ (Sub-sections for clarity: e.g., Preparation, Execution, Calculations, QC
Checks)
○ 9. Quality Control / Acceptance Criteria: Details of QC measures and
acceptable limits.
○ 10. Records/Data Handling: What records to keep and how to document them.
○ 11. Revision History: Log of changes made in previous versions.
○ Appendices (if any): Supporting information, forms, flowcharts.
5. Sample Receipt and Handling Log Template
● Purpose: To document the receipt of samples into the laboratory and their initial
condition, ensuring proper chain of custody and suitability for testing.
● Key Elements:
○ Log ID/Page Number
○ Date and Time of Receipt
○ Client Name/Source
○ Sample ID(s) (Client and/or Lab assigned)
○ Sample Description/Type
○ Number of Items/Quantity Received
○ Condition of Sample upon Receipt (e.g., temperature, intact seals, packaging)
○ Test(s) Requested
○ Received by (Name/Initials)
○ Storage Location Assigned
○ Comments/Discrepancies (e.g., insufficient sample, damaged packaging,
incorrect temperature)
○ Chain of Custody Form Number (if applicable)
General Tips for Creating and Using Control Templates:
● Keep it Clear and Simple: Templates should be easy to understand and fill out. Avoid
jargon where possible or provide definitions.
● Standardize: Use consistent formatting, terminology, and identification across all lab
templates.
● Version Control: Implement a system for version control (e.g., version number,
effective date) to ensure only current versions are in use. Maintain a master list of
current templates.
● Training: Train personnel on the correct use of each template.
● Accessibility: Make templates readily available to relevant personnel (e.g., hard copies
in designated locations, electronic copies on a shared drive or LIMS).
● Regular Review and Updates: Periodically review templates for continued suitability
and update them as processes change or improvements are identified.
● Completeness and Accuracy: Emphasize the importance of filling out templates
completely, accurately, and contemporaneously (at the time the activity occurs).
● Legibility (for manual records): Ensure handwriting is clear and legible. Use indelible
ink.
● Error Correction: Establish a proper procedure for correcting errors on manual records
(e.g., single line through the error, initialed and dated correction).
● Integration with LIMS: If a Laboratory Information Management System (LIMS) is used,
many of these templates may be incorporated as electronic forms within the system,
which can automate many aspects of data capture, validation, and record keeping.
By implementing and diligently using well-designed control templates, a food testing laboratory
can significantly enhance its operational efficiency, data quality, and ability to demonstrate
compliance with stringent quality standards.
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