Glossary / Lexicon

Deutsch: Datei / Español: Archivo / Português: Arquivo / Français: Fichier / Italiano: File /

A "file" refers to a document or record that contains information related to quality management activities. Files are an essential component of quality management systems as they provide a means of organizing, storing, and retrieving important information related to quality processes, standards, procedures, and documentation.

Here are some important aspects and examples related to files in the quality management context:

1. Quality Control Files: Quality control files contain information and records related to the inspection, testing, and verification of products or processes to ensure compliance with quality standards. These files may include test results, inspection reports, non-conformance reports, and corrective action records.

2. Quality Assurance Files: Quality assurance files document the processes and procedures implemented to ensure that products or services meet quality requirements. These files may include quality plans, audit reports, process documentation, and performance records.

3. Documentation Files: Documentation files are used to store various types of quality-related documents, including policies, procedures, work instructions, specifications, and guidelines. These files ensure that employees have access to the necessary information to perform their work according to established quality standards.

4. Training Files: Training files contain records of employee training and development activities related to quality management. These files may include training plans, training materials, attendance records, and competency assessments.

5. Corrective Action Files: Corrective action files document the steps taken to address and resolve quality issues or non-conformities. These files typically include details of the problem, root cause analysis, action plans, and verification of effectiveness.

6. Change Control Files: Change control files capture information related to changes in processes, procedures, or products to ensure proper management and control of modifications. These files may include change requests, change impact assessments, change control boards' decisions, and implementation records.

7. Calibration Files: Calibration files contain information related to the calibration of equipment and instruments used in quality control processes. These files include calibration certificates, calibration schedules, and records of calibration activities.

8. Supplier Files: Supplier files store information and records related to suppliers and vendors, including their qualifications, evaluations, and performance. These files may include supplier assessment reports, supplier audits, and records of supplier non-conformities.

9. Risk Management Files: Risk management files contain documentation related to the identification, assessment, and mitigation of risks within quality management processes. These files may include risk assessments, risk registers, and risk mitigation plans.

10. Change Request Files: Change request files store records of proposed changes to quality management systems or processes. These files include change requests, change impact assessments, and decisions regarding change implementation.

Similar to files in the quality management context, there are other related terms and concepts that play a role in organizing and managing information:

1. Records: Records are specific types of files that provide evidence of activities performed, decisions made, or results achieved. Records are typically retained for a specific period as evidence of compliance, traceability, or historical data.

2. Documents: Documents are written or printed pieces of information that provide instructions, guidelines, or specifications. In quality management, documents often serve as references for performing tasks, establishing standards, or ensuring consistency.

3. Data Management: Data management refers to the process of organizing, storing, and maintaining data to ensure its accuracy, integrity, and accessibility. Data management systems and practices are essential for managing quality-related data and facilitating data analysis.

4. Electronic Document Management Systems (EDMS): EDMS is a software solution used to store, organize, and manage electronic documents and files. EDMS systems provide features such as version control, document tracking, and access control, which enhance the efficiency and security of document management processes.

5. Document Control: Document control refers to the processes and procedures used to manage documents throughout their lifecycle. It includes activities such as document creation, revision control, distribution, and archiving.

6. Metadata: Metadata is descriptive information that provides context and attributes to files or documents. In the quality management context, metadata may include information such as document title, author, creation date, version number, and keywords.

7. Document Repository: A document repository is a centralized location or system where documents and files are stored and organized. It provides a structured and secure environment for accessing and managing documents.

Files and related concepts are fundamental to effective quality management systems. They ensure the availability of accurate and up-to-date information, facilitate compliance with quality standards, support decision-making processes, and enable traceability and accountability.

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