QA Flashcards
Define what is meant by quality
Quality means that a product should meet its specifications.
Fit for purpose
Continually meeting customer needs
Delivering the right product/service fit for purpose/ customer
Quality Control
A set of activities designed to evaluate a developed product.
Quality assurance
A set of activities designed to ensure that the development and or maintenance process is adequate to meet its objectives throughout the life cycle of a project.
Differentiate between conformance and non-conformance costs
Conformance Costs- Prevention + Appraisal
Documentation
Training
Auditing
Planning
Inspection
Non- Conformance Costs- Internal + External Failure
Rework
Scrap
Waiting
Downtime
Quality Management System
A formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives.
The hierarchy of documentation in a typical QMS
Quality Manual
Quality Procedures
Work Instructions
Quality Records
What are the key fey features of most Quality Assurance systems.
- Inspection
- Processes
- Quality circles
- Control of purchased goods
- Non-conformances
- Product recall
- Identification traceability
- QC
- Document control
- Auditing
Quality documentation
Describe the purpose of the quality policy in the Quality Manual
A quality policy is a brief statement that aligns with your organization’s purpose and strategic direction, provides a framework for quality objectives, and includes a commitment to meet applicable requirements (ISO 9001, customer, statutory or regulatory) as well as to continually improve.
What are the key aspects of a ‘controlled’ SOP
- Uniquely Identifiable
- Unique Name & Revision
- “X of Y” Format
- Revision History
- Controlled & Retrievable
- Kept Safe
Good Documentation Practice
Good documentation practices (GDocP) are key components of GMP compliance. Good record-keeping not only helps you during regulatory inspections (GMP audits), it is mandatory to ensure your documentation practices — and your products — meet industry standards and legal requirements for safety, efficacy and product quality.
Direct transcription onto document.
Legible writing
Initials to Authenticate
Justify overwriting
Date format DD/MM/YYYY
Time format 24.00hrs
Define what is meant by a quality audit
Quality Audit is the process of systematic examination of a quality management system (QMS) carried out by an internal or external quality auditor / team. QA
It is an important part of an organization’s QMS and is a key element in the ISO quality management system standard, ISO 9001.
- What is the purpose of a quality audit?
- assessing the strength of the quality culture.
- determining the commitment to continuous improvement.
- appraising the systems in place
- evaluating the systems in place to ensure that measures taken to maintain and enhance quality are appropriate and effective; and
- establishing whether the organisation is embracing the concept of fitness for purpose.
Outline the conduct of an audit
Planning the audit.
Executing the audit.
Reporting the audit results; and
Follow-up and evaluation of audit findings, conclusions, and recommendations.
Outline the role of the auditor
Evaluate the quality system.
Carry out assigned audit tasks.
Comply with audit requirements.
Respect all confidentiality requirements.
Collect evidence about the quality system.
Document audit observations and conclusions
Outline the role of the auditee
Explain the nature, purpose, and scope of the audit to employees.
Appoint employees to accompany and assist the auditors.
Ensure that all personnel cooperate fully with the audit team.
Provide the resources the audit team needs to do the audit.
Allow auditors to examine all documents, records, and facilities.
Correct and prevent problems that were identified by the audit
