HR007: SOP FOR PERSONAL HYGINE

OBJECTIVE:

To define and implement personal hygiene standards for all employees and visitors entering or working within manufacturing, warehouse, laboratory, and support areas to prevent product contamination in accordance with regulatory requirements.

SCOPE:

This SOP applies to all employees, contract workers, and visitors involved in manufacturing, quality control, engineering, warehousing, and ancillary services at the facility.

RESPONSIBILITIES:

Human Resource Department (HR):

Conduct pre-employment & periodic medical check-ups; maintain health records.
Training of SOP for new employee and refreshment Training for existing employee.
To maintain training records of SOP training.
Ensure visitors follow hygiene and entry procedures.

Quality Assurance Department (QA):

Department Heads:

All Employee:

DEFINATIONS:

Clean Area: An area with controlled environmental conditions to minimize contamination.
Gowning: Procedure of wearing cleanroom garments before entry into production/QC areas.
PPE: Personal Protective Equipment such as gloves, masks, caps, and shoe covers.

PROCEDURE:

General Hygiene Requirements:

Personnel shall maintain a high degree of personal cleanliness and wear appropriate clothing.
Nails shall be kept short and clean; no nail polish or artificial nails permitted.
Beards are not allowed in cleanroom areas unless completely covered.
Hands shall be washed and sanitized before entering classified or product contact areas.
No eating, drinking, chewing, smoking, or storage of food, drink, or personal medicines in production, warehouse, or QC areas.
Jewelry, watches, cosmetics, and perfumes are prohibited in manufacturing, warehouses and laboratory.
Any open wounds, skin infections, or communicable diseases must be reported to HR/QA; such persons shall not enter manufacturing areas.

Entry Procedure to Controlled Areas

Only trained and authorized personnel shall enter manufacturing or QC areas.
Personnel shall pass through designated changing rooms, following entry sequence:

Street shoes removed → step over bench → wear factory slippers.

Change personal clothes → wear plant uniform.

Enter airlock → wear coverall, mask, cap, and shoe covers.

Wash and sanitize hands before final entry.

Garments shall be clean, free from loose fibers, and changed as per gown change frequency defined in area classification.

Gowning and Garment Control

Gown change frequency: Grade D/C areas: Daily or when visibly soiled and Unclassified areas: Every two days or when dirty.
All garments shall be laundered in designated laundry under controlled conditions.
Reusable garments shall be stored in closed, labeled cupboards to avoid mix-up.

Personal Health Requirements:

Pre-employment medical check-up to include fitness certificate, chest X-ray, and infection screening.
Periodic medical examinations every 12 months.
Any illness such as cold, cough, diarrhea, or skin disease must be immediately reported to HR/QA.

Visitors and Contractors:

All visitors shall sign the visitor register and free from health issues.
Visitors shall be briefed on hygiene and gowning requirements before entry.
Disposable gowns or regular gowns and PPE shall be provided to all visitors entering controlled areas.

Toilets and Washing Facilities

Toilets and washing facilities shall be easily accessible but separate from production areas.
Hand-washing facilities shall have non-hand operated taps, soap dispensers, and paper towels.
Personnel shall wash and sanitize hands after using toilets before returning to the working area.

Monitoring and Training:

QA shall monitor compliance through routine audits and inspections.
Hygiene training shall be conducted initially and every twelve months thereafter.
Records of training and audits shall be maintained.

REFERENCES: