Environmental Monitoring Plan (EMP)
Factory: Paper Corrugation Box Manufacturing Facility
Standard: FSSC 22000 Version 6
Document No.: SOP/EMP/01
Revision No.: 01
Date: [Insert Date]
Prepared By: [Name/Dept.]
Approved By: [Management]
1. Purpose
To establish a systematic Environmental Monitoring Plan (EMP) for the identification, monitoring,
and control of environmental risks, ensuring compliance with FSSC 22000 v6.1 Additional
Requirement 2.5.7 and hygienic zoning principles.
2. Scope
Applicable to all manufacturing, storage, and support areas of the corrugated paper box
manufacturing factory. Covers environmental monitoring zones, sample types, testing frequency,
corrective actions, and review processes.
3. Zoning Assessment
3.1 Hygienic Zoning
• Zone H1 – Primary Pathogen Control Area (PPCA): Production lines where corrugated boards are
cut, glued, stitched, or printed.
• Zone H2 – Basic GMP Areas: Raw material storage, adhesive/glue preparation, printing ink storage.
• Zone H3 – Non-Production Areas: Offices, meeting rooms, canteens, toilets.
3.2 Environmental Monitoring Zones (1–4)
• Zone 1: Product Contact Surfaces (Direct) – Examples: Conveyor belts, stitching pins, glue
applicator nozzles, employee hands.
• Zone 2: Non-Product Contact Surfaces in Close Proximity (Indirect) – Examples: Machine frames,
control panels, glue tanks.
• Zone 3: Remote Non-Product Contact Surfaces (Near Processing) – Examples: Forklifts, trolley
wheels, drains, walls, hoses, air return covers.
• Zone 4: General Areas (Outside Processing) – Examples: Toilets, canteen, loading bays,
maintenance rooms, finished goods storage.
4. Sampling Protocols
• Sample Types: Air quality & dust monitoring, surface swabs (Zone 1–3), water samples (if glue
preparation or steam used).
• Sampling Techniques: Sterile swabs on defined surface areas; settle plates or air samplers for
airborne monitoring.
• Test Methods: Accredited laboratory methods (e.g., ISO 4833 for TVC, ISO 21528 for
Enterobacteriaceae); Rapid ATP swab kits.
• Frequency: Monthly routine sampling (minimum requirement); increased frequency during
renovation, new line setup, or customer complaint investigation.
5. Control Measures
• Define action limits and escalation steps for each zone.
• Link with Corrective Action & Nonconformity Procedure.
• Example:
- Zone 1: Immediate line stoppage + root cause analysis.
- Zone 2–3: Targeted cleaning + re-sampling.
- Zone 4: Increased housekeeping frequency.
6. Responsibilities
• Quality Assurance (QA): Plan, collect, and analyze samples.
• Production Supervisors: Support sampling, ensure corrective actions.
• Maintenance Team: Investigate contamination linked to utilities/equipment.
• Top Management: Approve EMP, review annual trends, allocate resources.
7. Trending & Review
• Maintain a trend analysis log of all results.
• Investigate consistent negative results to avoid false negatives.
• Conduct an annual review or earlier if: positive pathogen detection, process change, customer
complaint.
• Document updates in Management Review Meeting.
8. Training & Awareness
• All employees in Zones 1–2 trained on:
- Hygiene practices
- Importance of zoning & environmental monitoring
- Response actions for positive findings
9. Legal & Industry Compliance
• Complies with ISO 22000:2018 Clause 8.8.1, ISO/TS 22002-4, and FSSC 22000 v6 Additional
Requirements 2.5.7.
• Aligns with customer requirements and industry codes of practice.
10. Risk Assessment for Environmental Monitoring
A risk-based approach is applied to determine the extent and type of environmental monitoring
appropriate for a paper corrugation box manufacturing factory. Since this is a dry process with low
moisture, the potential for microbial growth and contamination is negligible. Therefore, swabbing of
product contact surfaces is not required. Alternative monitoring methods are applied.
Hazard/Aspect Zone(s) Affected Likelihood (L) Severity (S) Risk Rating (LxS)
& Control
Airborne dust Zones 1–3 2 2 Medium –
accumulation Controlled by
air/dust
monitoring,
housekeeping,
PPE
Water Zone 2 2 3 Medium –
contamination Controlled by
(used in glue periodic water
preparation) testing &
supplier COA
Pest activity Zones 3–4 2 3 Medium –
(rodents/insects) Controlled by
pest control
program &
monitoring logs
Poor Zones 2–4 3 2 Medium –
housekeeping Controlled by
cleaning
schedules &
supervisor
inspections
Cross- Zones 2–3 1 2 Low –
contamination Controlled by
from planned
maintenance maintenance &
activities cleaning post-
activity
Employee Zones 1–2 2 2 Medium –
hygiene lapses Controlled by
awareness
training & PPE
policies
Note: Risk Rating = Likelihood (1–3) × Severity (1–3). In this low-moisture environment, the highest
risks relate to dust, pest activity, and water used in glue preparation. Surface swabbing is excluded
with justification as microbial contamination risk is negligible.
