Standard Operating Procedure for Gowning for raw material and primary packaging material sampling areas
1.0 Purpose:
To provide detailed procedure for gowning and de-gowning during entry and exit to raw material and primary packaging material sampling area.
2.0 Scope:
This procedure is applicable to all employees and visitors (both male and female) entering in the sampling area of raw material and primary packaging material at [Company Name].
3.0 Responsibility:
All authorized QC personnel entering the sampling area are responsible for following the proper gowning and de-growing procedure as per SOP.
4.0 Definitions:
Nil
5.0 Procedure:
5.1. Gowning procedure
5.1.1 Ensure that hands are washed, cleaned and dried in a washing area.
5.1.2 Enter in the First Change Room. Remove the street shoes, socks, sandals on the racks provided in the “Lockers for Street Shoes” and wear black colored shoes. Do not use black shoes in the wash area, canteen, reception or any other areas.
5.1.3 Take the clean linen from the factory linen room as per SOP for Linen Color Coding.
5.1.4 Enter in respective Gents or Ladies change room. Ensure that the lights are ON’, while entering into the change room.
5.1.5 Remove the black colored shoes and keep them in the cupboard provided in the change room.
5.1.6 Remove the street clothes (pant, shirt, skirt etc.), personal belongings (wristwatch, jewelry) and keep them in the lockers provided in the change room.
Note:
1. Do not carry any valuables/ eatables / personnel medication/ cosmetics/ ornaments in
manufacturing/ warehouse/ FD area.
2. Smoking/ sleeping / eating in the department is strictly prohibited.
3. Wearing damaged or soiled linen is strictly prohibited.
4. Wherever applicable, refer to the pictorial diagram step-wise (displayed in the change room) for gowning and de-gowning.
5. Persons involved in actual processing shall change their over gown while entering in the
processing area having different products.
6 Over gowns should be changed, when product campaign is over.
5.1.7 Cross over the bench.
5.1.8 Wear factory shoes (black colored) provided in the shelf below the cross over bench.
5.1.9 Wear a cap, shirt and pant. Check for correctness of clothing in the full-length mirror provided.
5.1.10 Disinfect the hands by using 70 % v/v IPA solution. [Spray disinfectant (dispense two pushes) on the hands from the dispenser provided in the area and rub the hands till it dry].
5.1.11 With this gowning enter the sampling area at the basement.
5.1.12 For entering into the sampling area, enter through respective man entries for the rooms by pressing the door release button of door interlock system.
5.1.13 Remove the black colored shoes and keep them on the shelf provided and cross over the partition. Wear the white colored shoes provided in the shelf.
5.1.14 Wear the snood and then over gown kept in the locker provided in the change room. Wear snood in such a manner that the nose, mouth & hair are completely covered and the skirt of snood should be completely inside the gown.
5.1.15 Check for correctness of over gowning clothing in full length mirror provided.
5.1.16 Disinfect the hands by using 70 % v/v IPA solution. [Spray disinfectant (dispense two pushes) on the hands from the dispenser provided in the area and rub the hands till it dry.] and then enter into the sampling area for sampling of materials.
5.2 De-gowning procedure:
5.2.1 Enter in the respective change room by pressing the door release button of door interlock system.
5.2.2 Remove the over gown and snood and put them in ‘Used linen’ plastic bin provided for keeping used over gowns and snood.
5.2.3 Remove the white colored shoes and keep them in the shelf provided and then cross over the partition. Wear black colored shoes on the shelf provided. Press the door release button provided on the door interlock system of the change room.
5.2.4 Enter into the respective factory change room through the corridor.
5.2.5 In the factory changing room, remove the cap, shirt, and pant and put them in the lockers for employee linen.
5.2.6 Remove the black colored shoes and keep them in the shelf below the cross over bench.
5.2.7 Cross over the bench and wear street cloths, personal belongings from locker and black colored slippers from lockers. Then come out of the factory change room.
5.2.8 Enter in the “shoe ware room”. Remove the black colored slippers, wear street shoes/ sandals, and proceed for washroom, dining or proceed for leaving the factory premises at the end of the day.
5.3 Gowning procedure for Visitors/ Auditors:
5.3.1. Enter the respective factory change room and make entry in the visitor’s register.
5.3.2 Remove the personal belongings (wristwatch, jewelry, etc.) and keep them in pocket or in the self-sealing polybag and put in the pockets.
5.3.3 Wear the shoe covers provided in locker for visitor over the street shoes while crossing over the bench.
5.3.4 Take visitor’s suit from locker ‘Clean Apron’. Wear the cap first and then the visitor’s suit (shirt and pant).
5.3.5 Disinfect the hands by using 70 % v/v IPA solution. Spray disinfectant (dispense two pushes) on the hands from the dispenser provided in the area and rub the hands as per provided pictorials for hand sanitization steps.
5.3.6 Enter into the controlled area.
5.3.7 For entering in sampling areas, enter through respective man entries for the rooms.
5.3.8 Get the new shoe cover provided in the area. Wear the new shoe cover over the old one and then cross over the partition.
5.3.9 Take over gown, nose mask, cap and beard cover (if applicable) from the locker provided in the area. Wear the overgrown cap, nose mask, and beard cover (if applicable).
5.3.10 Disinfect the hands by using 70 % v/v IPA solution. Spray disinfectant (dispense two pushes) on the hands from the dispenser provided in the area and rub the hands till it dry.
5.3.11 Enter in the sampling areas by pressing the door release button provided on the door interlock system of the area.
5.4 De-gowning procedure for Visitors/ Auditors:
5.4.1 Enter in the respective change room by pressing the door release button provided on the door interlock system.
5.4.2 Remove the over gown, nose mask, beard mask etc. put them in ‘Used linen’ plastic bin then cross over the partition.
5.4.3 Remove the outer shoe cover and put them in ‘Used shoe cover’ plastic bin.
5.4.4 Enter the respective factory change room. Remove the visitor’s suit and cap and then put them in the ‘Used Uniforms for Washing’ bin.
5.4.5 Cross over the bench and remove shoe cover and put them in ‘Used shoe cover bin’. Now I have come out of the factory change room.
6.0 Acceptance Criteria:
Not Applicable
7.0 Frequency:
As and when entering and exiting from the Sampling Areas
8.0 Format for recording:
Not applicable