SRM-QM

Safery Risk Management - Quality Management

0.0 (0)

Kartei Details

Karten	48
Sprache	English
Kategorie	Technik
Stufe	Universität
Erstellt / Aktualisiert	19.02.2020 / 23.12.2020
Weblink	https://card2brain.ch/box/20200219_srmqm
Einbinden	<iframe src="https://card2brain.ch/box/20200219_srmqm/embed" width="780" height="150" scrolling="no" frameborder="0"></iframe>

What are the components of a compliance monitoring program?

Schedule of the monitoring program
Audit procedures including an audit plan
Audit reporting
Follow up and corrective action monitoring (wie wird mit Befunden der Audits umgegangen?)
Recording system

Worin liegt der Unterscheid zwischen Inspektionen und Audits?

Inspektionen betrachten Ergebisse, Audits betrachten Prozesse

Weshalb sind Checklisten für Audits sehr wichtig?

Da Audits sehr umfangreich sein können, helfen Checklisten dabei nichts zu vergessen.

Weiter hat man so gerade Aufzeichnungen zu den durchgeführten Audits welche archiviert werden können.

What are the two types of Audit Findings?

Non Conformity (not documented):
Manual provisions do not satisfy/reflect applicable regulations/standards
Non Conformity (not implemented):
Performed activities do not comply with applicable manual provisions and/or regulations/standards

What are some of the main Auditing Methods to collect information?

Interview

Review of documents

Examination of documents

Witnessing of activities

What should an Audit Report contain?

Checked requirements and items
Description of findings (non compliances and non conformities)
- Finding = non-conformity
  - non-conformity -> non-fulfillment of a requirement
    - requirement -> Need or expectation that is stated, generally implied or obligatory.
- Requirement reference
- Observed facts
- Source of the information on facts
- Objective evidence (documents, records, photographs, audio recordings, etc.)
Level of findings
- 1 - safety affected (
  - Gegenmassnahmen zwingend nötig
  - Operation kann nicht fortgesetzt werden
- 2 - safety may be affected
  - Gegenmassnahmen zwingend nötig
  - Operation kann fortgesetzt werden
- 3 - observation / recommendation
  - Keine zwingenden Gegenmassnahmen nötig
Due date (DD) for corrective action plan (CAP)
- To be set taking into consideration the safety impact of the finding
- Consider to use standard DD periods for CAPs
Due dates for corrective actions
- To be set taking into consideration the safety impact of the finding
- Consider temporary procedure
- Consider available resources
Allocation of responsibility for corrective action
- Consider responsibility for affected activity
- Consider capability/qualification