Common questions

What is controlled copy and uncontrolled copy?

What is controlled copy and uncontrolled copy?

A Controlled copy is always at the correct/latest revision level. When a change is made, it is retreived and replaced. An Uncontrolled copy is a bit harder to get you hands around, and is where the variation comes in. Other than it is not replaced when a new rev is issued…..it could mean anything.

What is a controlled document?

A controlled document is a reference document which, through the course of its lifecycle may be reviewed, modified and distributed several times. Examples of a controlled document include: technical drawings, specifications, procedures, data-sheets, contracts, application forms and plans.

What is the difference between master copy and controlled copy?

The master copy must be readily identifiable as the master. Maintain a master document list which can be easily accessed as necessary. This list must show the document number, document name, latest revision letter, and origin date of the document. A control document is normally a copy of the master document.

What are controlled documents in quality assurance?

QA document control is an essential part of the quality assurance system for all aspects of GMP, GCP and GLP. It allows you to approve, review and update documents; make changes and identify revision status; control document distribution; and prevent use of obsolete documents, facilitating proper archiving.

What is control of documents in ISO?

ISO 9001:2015 requires that organizations control the documents required by the quality management system. Records are a special type of document and must be controlled as required by clause 7.5. Organizations must establish a documented procedure to: Approve documents for adequacy prior to issue.

What is quality QMS?

A quality management system (QMS) is defined as a formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives.

What are the 7 quality management principles?

  • 1 – Customer Focus. The primary focus of quality management is to meet customer requirements and to strive to exceed customer expectations.
  • 2 – Leadership.
  • 3 – Engagement of People.
  • 4 – Process Approach.
  • 5 – Improvement.
  • 6 – Evidence-based Decision Making.
  • 7 – Relationship Management.

What are the 7 tools of TQM?

7 Basic Quality Tool Templates

  • Cause-and-effect diagram template (Excel)
  • Check sheet template (Excel)
  • Control chart template (Excel)
  • Histogram template (Excel)
  • Pareto chart template (Excel)
  • Scatter diagram template (Excel)
  • Stratification template (Excel)

What are quality management strategies?

Quality management strategy is used to define the quality techniques and standards to be applied and the various responsibilities for achieving the required quality levels, during the project. It also confirms any quality standards, procedures, tools and techniques that will be used.

What are 4 strategies to improve quality management?

5 Strategies to Improve Your Approach to Quality Management

  • Build a company culture that emphasizes quality improvement.
  • Design a robust training program.
  • Develop a detailed quality inspection program.
  • Ensure that equipment is regularly maintained.
  • Schedule periodic internal audits.

What are the three levels of quality?

The levels of quality that the authors talk about are:

  • Acceptable quality.
  • Appropriate quality.
  • Aspirational quality.

What are the three main quality management activities?

Software quality management is split into three main activities:

  • Quality assurance. The development of a framework of organizational procedures and standards that lead to high quality software.
  • Quality planning.
  • Quality control.

What is the difference between QMS and TQM?

Total quality management focuses on waste reduction and improved efficiency to ensure that a quality product is produced right from the first time. It relies on continuous improvement to ensure a consistent product and process quality while resolving issues, which can be managed using a robust QMS.

Who is called as father of Six Sigma?

Bill Smith

Which is not a core step of Six Sigma?

Discussion Forum

Que. Which of the following is not a core step of Six Sigma?
b. Control
c. Measure
d. Analyse
Answer:Control

What is Six Sigma Mcq Sanfoundry?

This set of Total Quality Management Multiple Choice Questions & Answers (MCQs) focuses on “Basic Concepts of Six Sigma”. Explanation: Six Sigma allows only 3.4 defects per million opportunities.

What does QA and QC stand for?

Quality assurance/quality control

Is the 100 quality of a software is achievable?

If rigorous testing is done on software and no defects are detected , can we say the the software is 100% bug free? Comment: Testing reduces the probability of undiscovered defects remaining in software but, even if no defects are found , it is not a proof of correctness.

What is the example of load testing?

Some basic examples of load testing are: Testing a printer by transferring a large number of documents for printing. Testing a mail server with thousands of concurrent users. Testing a word processor by making a change in the large volume of data.

Which one is not an external failure cost?

Discussion Forum

Que. Which of the following is not included in External failure costs?
b. help line support
c. warranty work
d. complaint resolution
Answer:testing

What is an example of an external failure cost?

External failure costs when the defect is discovered after it has reached the customer. This is the most expensive category of quality costs. Examples include product returns, repairs, warranty claims, lost reputation, and lost business.

Why external failure is more expensive than internal failure?

External failure costs tend to be substantially higher than internal failure costs, so it makes sense for a manufacturer to expend more effort to ensure that all products leaving the factory adhere to its quality standards.

What are internal and external failure costs?

Internal failure costs are costs associated with defects found before the customer receives the product or service. External failure costs are costs associated with defects found after the customer receives the product or service.