PDA Technical Glossary
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PDA Technical Glossary

PDA Technical Reports are highly valued membership benefits because they offer expert guidance and opinions on important scientific and regulatory topics and are used as essential references by industry and regulatory authorities around the world. These reports include terms which explain the material and enhance the reader’s understanding.

The database presented here includes the glossary terms from all current technical reports. The database is searchable by keyword, topic, or by technical report. Each definition provided includes a link to the source technical report within the  PDA Technical Report Portal.

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TR 54: QRM:Manufacturing Operations TR 44: QRM: Aseptic Processes TR 54-2: QRM: Packaging Labeling
Failure Mode and Effects Analysis (FMEA)
A method of assessing and evaluating risk. (TR44) A systematic method for identifying, analyzing, prioritizing and documenting potential failure modes, their effects on system, product and process performance, and the possible causes of failure in order to prevent defects from occurring. (TR54) (TR54-2) (TR54-3) (TR54-4) (TR74) (TR54-5) A tool for analyzing processes or systems to evaluate all operating steps in order to identify and assess the risk associated with any potential failures. (TR65) An analytical technique that results in a rankordered list of concerns to take action on. (TR72)
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Harm
Damage to health, including damage occurring from loss of product quality or availability. (TR44) (TR54) (TR54-2) (TR54-4) (TR68)
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Hazard
The potential source of harm. (TR44) (TR54) (TR54-2) (TR58) (TR61)
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Residual Risk
Risk remaining after risk control measures have been taken. (TR44) (TR58) Risk remaining after risk control measures have been implemented (derived from ISO 14971:2007). (TR54) (TR54-2) Risk remaining after risk control measures has been implemented. (TR54-5)
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Risk
The combination of the probability of occurrence of harm and the severity of that harm.(TR30) (TR44) (TR54) (TR54-2) (TR54-4) (TR58) (TR67) (TR68) (TR88)
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Risk Management
The systematic application of quality management policies, procedures and practices to the tasks of assessing, controlling, communicating and reviewing risk. (TR44) (TR54) (TR54-2) (TR55) (TR67) (TR54-5)
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Severity (S)
A measure of the possible consequences of a hazard. (TR44) (TR54) (TR54-2) (TR54-3)(TR54-4) (TR54-5)
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