Type
Matching Worksheet
Description

Nonfulfillment of a specified requirement Nonconformannce
Combination of probability of occurrence and severity of harm Risk
Preplanned addition, exclusion from procedure Deviation
All employees are responsible for _______ Quality
Resposible for establishing PSI Quality Policy and Objectives Management
Allegation of product deficiency in written, electronic, or oral forms Complaint
Regulations apply to all PSI ___________ Employees
Supplies/Components must meet PSI Acceptance ________ Criteria
Compliance with this agency is required by law FDA
When to notify QA of a nonconformance Immediately

Good Manufacturing Practice (GMP) Crossword

Type
Crossword
Description

A system for ensuring that products are consistently produced and controlled according to quality standards, designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product Good Manufacturing Practice
The "c" in cGMP stands for "_____," reminding manufacturers that they must employ technologies and systems which are up-to-date in order to comply with the regulation Current
Planned and systematic activities implemented in a quality system so that quality requirements for a product will be fulfilled Quality Assurance
The FDA applies cGMP regulations on a _______ scale. Sliding
A document issued by QA that confirms that a product meets its specification. Certificate of Analysis
Version controlled templates or instructions for the manufacturing process MBR
A solution meant to reduce or eliminate the cause of a detected nonconformity or other undesirable situation Corrective Action
An action taken to remove or improve a process to prevent potential future occurences of a nonconformance Preventive
A specific quantity of a drug or other material that is intended to have uniform character and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of manufacture. (21 CFR 210.3) Batch
All operations involved in the preparation of a product, from receipt of materials, Production
an environment, typically used in manufacturing, that has a controlled level of contamination that is specified by the number of particles per cubic meter at a specified particle size Cleanroom
a set of step-by-step instructions compiled by an organization to help workers carry out complex routine operations SOPs
This group's mission is to ensure "quality and efficiancy, while supporting regulatory compliance, in the development and manufacture of clinical trial investigational products at MSK IPQA
One of the functions of this group is to accept or reject each batch or lot based on review of the completed manufacturing records Quality Control
A practice that ensures concision, legibility, accuracy, authenticity, and traceability of all development, production, and testing activity records GDP
A hierarchical set of MSK policies and procedures, documented in SOP format, describing institutional cGMP compliance Manufacturing Quality System
An inspection to check for GMP compliance Audit
A departure from standard procedures or specifications resulting in non-conforming material &/or processes, or where there have been unusual or unexplained events which have the potential to impact on product quality, system integrity or personal safety Deviation
The document used for each individual batch of API, based on the master production instruction BPR
A formal monitoring system by which qualified representatives of appropriate disciplines review proposed or actual changes that might affect the validation status of a system or process and cause corrective action, if any, to be taken that will ensure that the system or process retains, or is placed back into a validated state of control Change Control
All operations of purchase of materials and products, Production, Quality Control, release, storage, distribution of products and the related controls Manufacture
The non-fulfilment of a specified “material/product” requirement – (usually to a specification) that usually leads to rejection or reworking of the item Nonconformance
A finished product or raw material test result that falls outside approved, registered or official specifications or acceptance criteria. If validated it results in a Non-conforming product. OOS
The basic cause of a deviation, from which effective actions can be defined to prevent recurrence Root Cause
Action of proving, in accordance with the principles of GMP, that any procedure, process, equipment, material, activity or system actually leads to the expected results Validation
___________ validation is the process by which it is established, by laboratory studies, that the performance characteristics of the analytical methods meet the requirements for the intended application Method
A section in an Investigational New Drug (IND) application describing the composition, production, and controls of the drug substance and product (21 CFR 312.23(a)(7)) CMC
Any substance or mixture of substances intended to be used in the manufacture of a drug (medicinal) product and that, when used in the production of a drug, becomes an active ingredient of the drug product API
The suitability of either a drug substance or drug product for its intended use. This term includes such attributes as the identity, strength, and purity. Quality

HR TERMINOLOGY Crossword

Type
Crossword
Description

The process of taking control over another corporation by purchasing Acquisition
Acknowledgement of employees performance or achievements Recognition
The act of enlisting people for job Recruitment
the act of dismissing an employee redundancy
an unauthorized and illegal strike that occurs during the term of an existing contract wildcatstrike
The knowledge, skills and abilities required to perform a specific task or function competencies
The approach to managing people and their performance Appraisal
A complaint brought by one party to an employment contract against another party. grievance
The process of introducing a new employee into the organization induction
The favoring of one group of people to the detriment of others. Discrimination
A one-to-one process between an outside trainer and an employee mentoring
The process of discussion with a view to mutual settlement negotiation
The business practice of hiring a party outside a company outsourcing
Disciplinary action resulting in an employee being sent home without pay for a specified period of time Suspension

Introduction to Probability Crossword

Type
Crossword
Description

The likelihood of something occurring. Probability
A possible result of an experiment. Outcome
Probability based on analysis of all possible outcomes (______ Probability). Theoretical
A set of outcomes that have a common characteristic. Event
Events that have different attributes and cannot occur simultaneously (_____ Exclusive Events). Mutually
Different events that happen at the same time (___-____ Exclusive Events). Nonmutually
Situations in which the occurrence or non-occurrence of one event has no influence on the probability of the other event occurring (_____ Events). Independent
The occurrence or non-occurrence of one event influences the probability of the other event occurring (______ Events). Dependent
Multiple events in a probability experiment which may or may not affect each other (______ Events). Compound
Probability based on experimental trials (_____ Probability). Experimental

Quality Bingo

Type
Bingo Cards
Description

COMPLIANCE
GMP
DOCUMENTATION
REGULATION
CONTAMINATION
INDUCTION
BATCH RELEASE
RISK ASSESSMENT
EUDRALEX
CAPA
DEVIATION
VALIDATION
APPROVE
REVIEW
TRAINING
GDP
AUDIT
CALIBRATION
CHANGE CONTROL
EVALUATE
INSPECTION
Guidelines
SOP
POLICIES

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Probability Vocabulary Crossword

Type
Crossword
Description

A set of all outcomes in an experiment EVENT
The ratio of the number of times a specified event happens to the total number of trials or experiments performed Experimental Probability
An event that includes two or more independent events Compound Event
When there are M ways to do one thing, and N ways to do another, then there are M x N ways of doing both Counting Principle
All the possible results in a probability experiment Sample Space
An event that consists of exactly one outcome Simple Event
The number of possible ways an event can happen compared to all possible outcomes Theoretical Probability
All the OTHER possible outcomes of an experiment Complement
A chart that organizes possible outcomes for a process to make it easy to count Tree Diagram
All possible results of a trial or an experiment Outcome
Denoting two events that cannot occur at the same time Mutually Exclusive
The likelihood or chance of a given event happening Probability
An event whose outcome has nothing to do with the outcome of other event Independent Event
An event whose outcome is affected by the outcome of another event Dependent Event

Quality Crossword Word Search

Type
Word Search
Description

STRATEGY
REPORTS
PROCEDURES
DEFECTS
MANAGEMENT
WASTE
TRENDS
TEAM
SUPPLIERS
RISK
NONCONFORMITY
FEEDBACK
DEVIATION
CONTINUOUS IMPROVEMENT
CULTURE
AUDIT
ASSURANCE
CALIBRATION
JANKEL
DOCUMENTATION
TRACEABILITY
ENVIRONMENT
QUALITY
ISO STANDARDS

Compliance and Ethics Week Crossword

Type
Crossword
Description

Samaritan Daytop Village Privacy Officer Alan
Department in which Conflicts of Interest should be reported ________________ Compliance
Director of Compliance Jamie
Manager of Compliance Ia
Policy and _________________ Procedure
Employees are required to disclose potential _______________ Conflicts
Failure to report a Conflict will result in what action Disciplinary
Directors and Officers are required to annually submit a Disclosure Statement for_________ Gifts
VP of Compliance Alicia
Samaritan has a policy that ensures any outside activities of employees do not _______________. Conflict

Lockout Tagout Crossword

Type
Crossword
Description

The control of hazardous energy. LOTO
Title of the employee who locks or tags machines or equipment in order to perform servicing or maintenance. Authorized
Source of energy with suspended parts or springs. Mechanical
Source of energy by oil or water pressure. Hydraulic
Lockout tagout involves the use of a specific lock or locks to ____ equipment from all energy sources. Isolate
Locks, tags and isolating devices must not be used for other purposes. True
A completed tag should have a _____ and reason why the equipment is down. Name
____ by themselves, may only be used when locks cannot be used and when the employer can demonstrate that a tagout system will provide full employee protection. Tags
When implementing lockout tagout, ____ all affected employees in the work area. Notify
How do you insure that all the energy and hazard sources are off? Test
____ authorized employee must affix a personal lockout or tagout device to the machine or equipment when work begins and remove it when work is completed. Each
The municipality must ensure that the _____ employee knows when their lockout device has been removed before they resume work at the facility. Authorized
Never attempt a LOTO procedure unless you have been _____. Trained
____ remove a tagout device unless authorized. Never
Lockout tagout does not apply when a person has ____ control of the plug while doing the work. Exclusive

TOP QUALITY TERMS Word Search

Type
Word Search
Description

FDA
Food Safety
LIMS
Systems
Quality Culture
Analysis
Kosher Certification
Certificate of Analysis
GMP
Compliance
Monitoring
Controls
Continuous Improvement
Inspection
Temperature
FIFO
Communication
Training
Policies
Procedures
Testing
Microbiology
Environmentals
Data
Tracebility
Documentation
Audits
HACCP

Integrity and Ethics Crossword Puzzle

Type
Crossword
Description

Who We Are Month is a celebration of our ______, culture and values people
Ball employees are expected to behave as ______ of the business owners
______ has always been a key component to “Who We Are” at Ball Integrity
Our core purpose is to add ______ for all of our stakeholders value
Our core values are ______, integrity, respect, motivation, flexibility, innovation and teamwork honesty
Corporate compliance includes our legal and ethical responsibility to conform to all laws, rules, regulations, ______ and procedures policies
Every employee is responsible for maintaining personal ______ to ethics, laws and policies compliance
Ball Corporation has a formal Corporate Compliance ______ Program
The Corporation will not tolerate ______ in the workplace harassment
Conflicts of ______ interest
Never use the Corporation’s ______ information for personal benefit confidential
Ball’s Social ______ Activity policy is in effect whether you, as an employee, are at work or off duty Media
No ______ statements or entries may be made for any purpose in the records of the Corporation false
Ball has adopted ______ employment opportunity and affirmative action policies equal
Acts of discrimination and violence will not be ______ tolerated
Ball views health and ______ as one of its most important business priorities safety
All employees are expected to safeguard their own health and safety, as well as that of their fellow ______ employees
Our sustainability goal is focused on continuous improvement toward the ultimate goal of ______ accidents zero
EVA stands for Economic Value ______ Added
EVA dollars are the measurement of our long-term ______ success
Who We Are month reaffirms our ______ of ethical behavior and record of personal and corporate compliance culture
Which plant has the best employees? Conroe