Quality assurance document control is the process used in the management, coordination, control, delivery, or support of an item required for quality assurance purposes . QA document control is an essential part of the quality assurance system for all aspects of GMP, GCP and GLP.
What is the role of documentation in QA?
QA practices may be documented to enhance their repeatability . ... Specifications, designs, business rules, configurations, code changes, test plans, test cases, bug reports, user manuals, etc. may be documented in some form.
How do you document quality assure?
- Step 1: Identify Organizational Goals. ...
- Step 2: Identify Critical Success Factors. ...
- Step 3: Identify Internal and External Customers. ...
- Step 4: Customer Feedback. ...
- Step 5: Implement Continuous Improvements.
What type of documentation is used in QA?
Important types of Test Documents are Test policy, Test strategy, Test plan, Test case etc . The main reason behind creating test documentation is to either reduce or remove any uncertainties about the testing activities.
What is quality documentation?
Quality Documentation means the quality manuals, quality plans, quality procedures, inspection and test plans , work instructions or like documentation, as appropriate, which describe and define a Quality Management System.
What is an example of quality assurance?
Examples of quality assurance activities include process checklists, process standards, process documentation and project audit . Examples of quality control activities include inspection, deliverable peer reviews and the software testing process.
What are the three parts of quality assurance?
The three parts of quality assurance are determining use objectives, setting specifications, and assessment of results .
What is a QA checklist?
A quality control checklist is basically a written guide for your products’ contents, packaging, color, barcodes, appearance, possible defects, functions and special requirements . It’s also sometimes called an “inspection criteria sheet” or inspection checklist.
What is the role of documentation?
Documentation help ensure consent and expectations . It helps to tell the narrative for decisions made, and how yourself or the client responded to different situations. In this same manor, it is important to record information that can help support the proper treatment plan and the reasoning for such services.
What are the requirements for quality documentation?
- Monitoring and measuring equipment calibration records.
- Records of training, skills, experience and qualifications.
- Product/service requirements review records.
- Record about design and development outputs review.
- Record about design and development inputs.
How do you test documentation?
- Test scenarios.
- Test case.
- Test plan.
- Requirement traceability matrix(RTM)
- Test strategy.
- Test data.
- Bug report.
- Test execution report.
How do you write test cases for documentation?
- Keep things simple and transparent.
- Make test cases reusable.
- Keep test case IDs unique.
- Peer review is important.
- Test cases should have the end user or defined requirements in mind.
- Specify expected results and assumptions.
What is the main difference between a walkthrough and an inspection?
30 What is the main difference between a walkthrough and an inspection? a) An inspection is lead by the author , whilst a walkthrough is lead by a trained moderator.
What are the QMS documents?
- The organization’s quality policy and quality objectives.
- Quality manual.
- Procedures, instructions, and records.
- Data management.
- Internal processes.
- Customer satisfaction from product quality.
- Improvement opportunities.
- Quality analysis.
How do you maintain quality documentation?
- Approve documents for adequacy prior to issue.
- Review, update as necessary, and re-approve documents.
- Identify the changes and current document revision status.
- Make relevant documents available at points of use.
What are the benefits of good documentation?
- Leads to a smoother running operation, having complete information and knowing how to properly deal with issues.
- Reduces documentation errors by having the mechanisms to properly record data and correct errors.
