Glossary / Lexicon

Deutsch: Ablauf / Español: caducidad / Português: expiração / Français: expiration / Italian: scadenza

Expiration in the context of quality management refers to the date after which a product is no longer considered suitable for use. This is crucial for ensuring product safety, efficacy, and compliance with regulatory standards. Expiration dates are used to indicate the end of the product’s shelf life, beyond which the product may degrade, lose potency, or become unsafe.

Description

In quality management, expiration is a critical parameter for maintaining the integrity and safety of products, particularly in industries such as pharmaceuticals, food, and cosmetics. The concept encompasses:

1. Shelf Life: The period during which a product is expected to remain stable and effective when stored under recommended conditions. This is determined through stability testing and other quality assessments.

2. Regulatory Compliance: Adhering to regulations and guidelines set by authorities such as the FDA (Food and Drug Administration) or EMA (European Medicines Agency) that mandate the determination and labeling of expiration dates on products.

3. Product Safety and Efficacy: Ensuring that products are used within their intended time frame to avoid risks such as reduced effectiveness, potential toxicity, or spoilage.

4. Inventory Management: Implementing systems to manage stock rotation (e.g., First-In-First-Out or FIFO), preventing the use or sale of expired products.

Special Considerations

When addressing expiration in quality management, consider the following:

• Stability Testing: Conducting comprehensive stability tests to accurately determine the shelf life of a product under various environmental conditions.
• Packaging: Ensuring packaging materials and methods adequately protect the product throughout its shelf life.
• Storage Conditions: Maintaining proper storage conditions, such as temperature and humidity controls, to extend the product’s usability until the expiration date.

Application Areas

Expiration in quality management is applicable in various areas, including:

• Pharmaceuticals: Determining the expiration dates for drugs and vaccines to ensure they are effective and safe for use up to a specified date.
• Food and Beverage: Labeling expiration dates on perishable goods to prevent the sale and consumption of spoiled or unsafe food.
• Cosmetics: Ensuring the stability and safety of skincare and beauty products within their shelf life.
• Medical Devices: Establishing expiration dates for devices and materials that can degrade over time, such as sterile supplies and diagnostic reagents.

Well-Known Examples

1. Medication Expiry: Prescription and over-the-counter medications have expiration dates to ensure they remain effective and safe for patients.
2. Food Product Dating: Expiration dates on milk, meat, and other perishable foods to indicate when they should no longer be consumed.
3. Cosmetic Products: Expiration dates on products like sunscreen, mascara, and lotions to prevent skin irritation and other issues from degraded ingredients.

Treatment and Risks

Effectively managing expiration in quality management involves addressing potential risks such as:

• Health Hazards: Consuming or using expired products can lead to adverse health effects, such as food poisoning or ineffective medical treatment.
• Legal and Regulatory Consequences: Non-compliance with expiration date regulations can result in legal actions, fines, and damage to the organization’s reputation.
• Customer Satisfaction: Selling expired products can lead to customer dissatisfaction and loss of trust.

Similar Terms

• Best Before Date: Indicates the date until which the product is expected to remain at its best quality.
• Use By Date: Similar to expiration date, it specifies the last date recommended for the safe consumption or use of the product.
• Shelf Life: The length of time a product remains usable, stable, and effective.

Weblinks

• environment-database.eu: 'Expiration' in the glossary of the environment-database.eu
• architektur-lexikon.de: 'Ablauf' in the architektur-lexikon.de (German)

Summary

In quality management, expiration is a vital concept that ensures products are used within their safe and effective time frames. Proper management of expiration dates through stability testing, regulatory compliance, and inventory control is crucial for maintaining product quality, safety, and customer trust. Addressing expiration issues effectively helps prevent health hazards, legal consequences, and customer dissatisfaction.

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