Glossary / Lexicon

Deutsch: Abweichung / Español: Desviación / Português: Desvio / Français: Déviation / Italiano: Deviazione /

Deviation in the quality management context refers to a departure or divergence from established standards, specifications, processes, or procedures within an organization. It is a term commonly used in various industries, including manufacturing, healthcare, pharmaceuticals, and many others, where maintaining consistent quality and adherence to predefined norms is crucial. Deviations can occur at any stage of a process or system and can have varying degrees of impact, ranging from minor issues to serious quality or safety concerns.

Application Areas:

1. Manufacturing and Production: In manufacturing industries, deviations may occur when a product is not produced according to its specified parameters, such as size, shape, or quality. This can lead to variations in product quality and performance.

2. Pharmaceutical and Healthcare: Deviations in pharmaceutical manufacturing can result in the production of medications that do not meet safety or efficacy standards. In healthcare, deviations may refer to variations from established medical procedures or protocols.

3. Information Technology (IT): In IT, deviations can occur during software development or system maintenance when a code change or update does not conform to the planned requirements, potentially leading to system failures or security vulnerabilities.

4. Quality Control: Deviations are closely monitored in quality control processes to ensure that products or services consistently meet established quality standards.

Examples:

• A deviation from the standard operating procedure led to the contamination of the product batch.

• The deviation's impact on product quality was assessed through thorough testing.

• Multiple deviations in the manufacturing process were identified and addressed during the quality audit.

• The team is currently deviating from the original project plan to accommodate the client's urgent requests.

Well-Known Examples:

1. Pharmaceutical Industry: In pharmaceutical manufacturing, any deviation from good manufacturing practices (GMP) can result in the recall of medications, regulatory penalties, or risks to patient safety. Companies must have robust deviation management systems in place to address and document any deviations that occur during production.

2. Aerospace Industry: In the aerospace sector, even a minor deviation in the construction of an aircraft can have catastrophic consequences. Strict quality control measures are implemented to prevent and address any deviations in the manufacturing process.

3. Food Safety: The food industry uses deviation management to track and correct any deviations in food processing that could compromise product safety. This is especially critical to prevent foodborne illnesses.

Risks:

• Quality and Safety Risks: Deviations can lead to compromised product quality or safety, potentially causing harm to end-users or consumers.

• Regulatory Compliance: Failure to address deviations appropriately can result in regulatory non-compliance, leading to fines, recalls, or legal consequences.

• Financial Impact: Deviations can be costly, leading to rework, waste, or the need for corrective actions, which can affect an organization's bottom line.

• Reputation Damage: Repeated deviations can harm an organization's reputation, eroding customer trust and confidence in its products or services.

Similar Terms and Synonyms:

• Non-conformance
• Aberration
• Anomaly
• Variation
• Departure
• Exception

In summary, in the context of quality management, a deviation represents any departure from established standards or processes. It is a critical aspect of maintaining quality and safety across various industries and requires careful monitoring, documentation, and corrective actions to mitigate associated risks.

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