1.0 Objective
The purpose of this document is
to define a standardized procedure for the preparation, approval,
implementation, distribution, maintenance, and periodic review of Standard
Operating Procedures (SOPs) in the food testing laboratory. This ensures
uniformity, regulatory compliance, and operational efficiency across all
laboratory processes.
2.0 Scope
This SOP applies to all Standard
Operating Procedures developed and maintained within the food testing
laboratory. It encompasses administrative, operational, analytical, safety, and
quality assurance processes, ensuring all activities align with relevant
regulatory and accreditation requirements, including ISO 17025 and FSSAI
guidelines.
3.0 Responsibility
3.1 Preparation:
·
Designated
personnel within the specific department or functional area initiate the
drafting of SOPs relevant to their operations.
3.2 Review:
·
Department
Heads or Subject Matter Experts (SMEs) ensure the technical accuracy and
completeness of the drafted SOPs.
3.3 Approval:
·
The
Laboratory Director or a designated authority reviews and authorizes the
finalized SOP to ensure its compliance with organizational and regulatory
standards.
3.4 Control and Distribution:
·
The Quality
Assurance section (QA) oversees the issuance, distribution, and maintenance of
all SOPs.
3.5 Training and Implementation:
·
Training
coordinators ensure all relevant personnel are trained on new or revised SOPs
prior to their implementation.
3.6 Review and Revision:
·
Periodic
reviews are conducted by department heads and QA personnel to ensure SOP
relevance and compliance.
4.0 Definitions
·
SOP: A document providing detailed, step-by-step instructions to ensure
consistency in performing tasks or processes.
·
QA: Quality Assurance section, responsible for maintaining document
integrity, compliance, and accessibility.
·
Master
Copy: The original, approved version of an
SOP.
·
Controlled
Copy: Authorized duplicate of the master copy,
issued for departmental use.
·
Uncontrolled
Copy: Duplicate of the master copy, issued for
reference purposes without distribution tracking.
5.0 Procedure
5.1 SOP
Structure and Content
Each SOP must follow a standardized format for clarity and
consistency. The following components must be included:
1.
Header: Includes the organization’s name, SOP title, SOP number, issue
date, revision number, and review date.
2.
Objective: Brief statement outlining the purpose of the SOP, beginning with
"To ensure..."
3.
Scope: Specifies the applicability of the SOP, such as departments,
processes, or personnel.
4.
Responsibilities: Defines the roles and responsibilities of personnel involved in SOP
implementation.
5.
Introduction/General
Information: Provides background or rationale
for the SOP.
6.
Procedure: Details the step-by-step process to be followed, including
operational, safety, and quality checkpoints.
7.
Precautions: Lists specific warnings, risks, or safety measures.
8.
References: Documents, guidelines, or standards referenced during SOP
preparation.
9.
Abbreviations
and Definitions: Clarifies terms and acronyms
used within the SOP.
10. Annexures: Attachments such as forms, templates, or additional resources.
5.2 Format
and Layout Requirements
·
Page
Size: A4
·
Margins: 0.5-inch margins on all sides
·
Font: Arial, size 12 for body text, bold for headings
·
Line
Spacing: 1.5 lines
·
Numbering: SOPs are numbered uniquely as SOP/DeptCode/SerialNo (e.g., SOP/QA/001).
·
Footer: Includes page numbers and the document’s version status (e.g.,
Draft, Master Copy).
5.3 SOP
Development Process
5.3.1 Drafting:
·
The
initiating department drafts the SOP using the prescribed format. A watermark
indicating "DRAFT" must be included on each page.
5.3.2 Review:
·
The draft
SOP is reviewed by the department head for technical adequacy. Comments are
discussed with the Quality Assurance Unit (QAU) and resolved collaboratively.
5.3.3 Approval:
·
After
incorporating feedback, the SOP is submitted for final approval by the
Laboratory Director or their designee.
5.3.4 Training:
·
The
finalized SOP is shared with all relevant personnel, and training sessions are
conducted. Attendance records are maintained as evidence.
5.3.5 Implementation:
·
SOPs are
implemented only after training is completed. The implementation date is
recorded in the document.
5.4 SOP
Control and Distribution
1.
Master
Copies: Stamped "MASTER COPY" in red
ink, stored securely by QA.
2.
Controlled
Copies: Distributed to relevant departments
with a "CONTROLLED COPY" stamp in green ink. A record of distribution
is maintained.
3.
Uncontrolled
Copies: Marked "UNCONTROLLED COPY"
in black ink, issued for external reference. No distribution records are
required.
4.
Tracking: A Document Distribution, Retrieval & Destruction Record form is
used to track SOP dissemination and updates.
5.5 SOP
Review and Revision
1.
Review
Cycle: All SOPs must be reviewed every two
years or sooner if significant changes occur.
2.
Revision
History: Changes are documented in a history
table, including reasons for revision and authorizing personnel.
3.
Obsolete
Versions: Obsolete SOPs are archived and
marked "OBSOLETE COPY."
5.6
Training Requirements
·
All
personnel must be trained on SOPs relevant to their roles.
·
Training
records must include the SOP title, trainer name, trainees’ names, dates, and
signatures.
6.0 Precautions
1.
Only
authorized personnel may modify SOPs.
2.
Ensure
SOPs are accessible at workstations for reference.
3.
Periodically
check for outdated or missing SOPs.
7.0 References
1.
ISO 17025:
General requirements for the competence of testing and calibration
laboratories.
2.
FSSAI
Guidelines for Food Testing Laboratories.
3.
Internal
Quality Assurance Manuals.
8.0 Annexures
1.
SOP Draft
Template
2.
Training
Record Template
3.
Document
Distribution Record Form
4.
Revision
History Template
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