Quality Systems
This document outlines the manufacturing steps for a batch and must be reviewed and submitted to Quality Systems within 24 hours.
What is a work order?
This process provides documented evidence that a system consistently produces a product meeting its specifications and quality attributes.
What is validation?
This type of hazard includes invisible organisms like E. coli, Salmonella, and Listeria that can cause illness or injury.
hat are biological hazards?
This form is used by employees to report pest sightings and helps track and trend pest issues.
What is the QVPEST form?
This document provides information about a chemical’s hazards, safe handling procedures, and emergency response.
What is a Safety Data Sheet (SDS)?
This checklist tool is used to document real-time facts and data when a quality event occurs.
What is a PIR (Product Incident Report)?
This systematic approach ensures that all changes are documented, necessary, and do not disrupt services or waste resources.
What is change control?
These practices are considered prerequisites for food safety and include gowning, pest control, and truck inspections.
What are Good Manufacturing Practices (GMPs)?
Keeping these closed unless actively in use is a key step in preventing pest entry into the facility.
What are exterior doors?
This acronym stands for the four key factors of effective cleaning: Time, Action, Concentration, and Temperature.
What is T.A.C.T.?
This term means reperforming a step or steps in the Batch Record to correct a defect.
What is rework?
These types of products, such as test packaging or clinical trial materials, are run on commercial lines and require strict controls to prevent mix-ups.
What are non-commercial products?
This type of audit is conducted by certified individuals at the site and may include unannounced visits to review paperwork and ask team members questions.
What is an internal audit?
If you observe these devices as damaged, missing, or inoperable, you must contact the Sanitation/Pest Control Manager.
What are pest control devices?
This program outlines routine cleaning schedules for production areas and excludes CIP systems and non-production zones.
What is the Master Sanitation Program?
This action confirms that a process was verified, a task was completed, and a document was understood—whether handwritten or electronic.
What does your signature mean?
This type of leak, including drips from condensation, is considered critical and must be addressed immediately in production areas.
What is a critical overhead leak?
Magnets, filters, and allergen handling procedures are examples of this type of control that significantly minimizes food safety hazards.
What are Preventive Controls (PCs)?
This is the first thing you should do if you see a pest or pest-related issue on site.
What is report it using the QVPEST form or contact the Sanitation Manager?
This cleaning method involves no moisture and is used in environments with low water activity foods.
What is dry cleaning?
This type of root cause explains why a change occurred and why it went undetected, leading to preventive measures.
What is a systemic root cause?
This type of consumable is not intended to contact the product but is part of the product pathway, such as lubricants or sanitizers.
What is indirect product contact?
This type of control is essential to eliminate or reduce a food safety hazard to an acceptable level and includes heat treatment and sterilization.
What are Critical Control Points (CCPs)?
This environmentally sensitive approach to pest management focuses on prevention, monitoring, and setting action thresholds.
What is Integrated Pest Management (IPM)?
When handling chemicals with a pH below 2 or above 12.5, this level of PPE is required, including a chemical splash hood and suit.
What is Level 3 PPE?