Documents & Documentation
Written instructions designed to contain details on how to do a specific task correctly.
SOPs
18 inches
What is the distance of items stored away from the wall?
Completing sanitation audits and reviewing findings with Team for corrective action.
What are QFLs?
SQF
Safe Quality Food
RCA CAPA, FS&Q, Allergen, Infectious Disease, GMP, SQF, Food defense
Monthly Training Topics
Write-overs, scratch outs, black out, and scribbles.
Incorrect methods to correct a mistake on a record.
List 8 of the most common sanitation/GMP concerns you have seen during sanitation audits.
- hoses left on floor
- product contact hoses and tools touch floor
- nuts, bolts, screws, band clamps left out and unused
- dusty floors, walls, overheads, perimeters
-
QLFs must engaged who when a finding is repeat for the area, corrective action needed for long term resolution, or corrective action includes cross-function engagement.
Crew leader, team manager, and Kate Hudson.
Correction definition
Immediate action taken to eliminate a detected nonconformance
List the Safety Hallway Steps
- Don hairnet and beardnet (if applicable)
- Clean hard hat, safety glasses, and ear muffs with wipes (once a day or as needed) and don.
- Wash hands for 20 seconds and sanitize
- Use Smart step
- Don safety gloves and sanitize.
Finish the phrase: “If it isn’t documented,…”
it didn’t happen”
Describe steps to clean up a water leak or non-sterile product leak.
Stop line, if effected or leak is still active.
Quarantine the area from foot and forklift traffic.
Contact maintenance, CL/TM, and quality.
Maintenance to fix.
Quality to contact Aramark to clean and sanitize.
Quality to swab.
The 2021 SQF audit occurs when?
Unannounced. Could occur anytime during October to Novemeber.
Corrective Action definition
Action taken to eliminate the cause of a non-conformance and to prevent reoccurrence.
Actions to take when person is trying to enter an area without badge access.
Facility - direct them to front lobby to see Shirl during daylight hours. During non-business hours, contact CL to approve or deny individual.
Sensitive Area - Do not let them in without crew leader knowledge. Take necessary action required to be granted access.
.
Third Friday of the month and last day of the month
What is a sanitation audit due date. What is the corrective actions due date.
Describe visitor attire and requirements when on the GMP floor.
PPE - hard hat, closed-toed shoes, safety glasses
Visitor blue coat and safety vest
White hard hat
Accompanied by McCormick employee
The person/people who are responsible for product safety, quality and effectiveness.
Everyone
Preventative Action definition
Action taken to eliminate the cause of a potential non-conformance prior to one occurring or prior to one occurring in an area based on non-conformance in another area.
List production and storage requirements for allergens.
Red tools used during clean up.
Clean up spills as soon as they occur.
Stored on the bottom or segregated.
Allergen cleandown / validation of cleaning.
Ensure there is no contamination of adjacent lines.
These types of practices are used to ensure proper documentation is adhered to when documenting manufacturing related activities.
Bonus Question
GDPs- Good documentation practices
Name some:
correcting a mistake
completed as actions are completed
no empty spaces
no ditto marks or arrows
comment on abnormal information
no falsification or pencil-whip
Stop light program
Green - Food grade chemicals
Yellow - Non-Food grade chemicals that may be taken out of the maintenance area, but must be stored in the locked cabinet when not in use.
Red - Non-Food grade chemicals that must never leave maintenance and must be stored in locked cabinet when not is use.
List of Smart Step locations.
Bonus question
Smart steps: 1st floor safety hallway, second floor safety hallway, outside washroom, outside mechanical room, outside sterilizer room, outside QA lab, outside contractor/TIG room, outside Rotosol room, outside UPS drop-off cage, maintenance cage.
Badge access areas inside the production area: sterilizer room, QA lab, mechanical room, non-sterile, chemical cage, UPS cage. maintenance area.
HACCP
Bonus Question
Hazard Analysis Critical Control Point
SM: Metal detectors, magnets, sifters, screens, thermal screw
BIG 9 Allergens are???
Bonus question
Shell fish
Wheat
Soy
Milk
Egg
Fish
Tree nut
Peanut
Sesame
SM: Ginger