Business Process Management

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Questions and Answers

What does the Quality Manual provide to the organisation?

A list of all employees and their roles

A detailed description of the organisation's history

A report on the organisation's financial performance

Evidence of specific controls implemented to ensure product/service quality (correct)

What is the main purpose of the Quality Manual?

To provide evidence of quality system elements (correct)

To list all the organisation's policies and procedures

To detail the organisation's management structure

To outline the organisation's mission and vision

What are the typical levels of information in quality documentation?

5 or 6 levels

2 or 3 levels

3 or 4 levels (correct)

1 or 2 levels

What is the purpose of controlling documents?

To ensure documents are approved prior to issue and remain legible Signup and view all the answers

What is the purpose of the Document Control Register?

To control and manage documents Signup and view all the answers

What is included in the Quality Manual?

All quality system elements Signup and view all the answers

What is the purpose of the External Document Register?

To monitor external documents received from suppliers or customers Signup and view all the answers

What is the purpose of the Document Creation, Revision, and Deletion Form?

To manage document creation, revision, and deletion Signup and view all the answers

What is the primary purpose of controlling records in a Quality Management System?

To provide evidence of implementation and conformity to requirements Signup and view all the answers

What is the primary focus of a management review in a Quality Management System?

Process of performance and product conformity Signup and view all the answers

What is included in the output of a management review?

Management decisions based on the review Signup and view all the answers

Who should be included in the management review process?

All departmental heads and top management Signup and view all the answers

What is the purpose of a management review report?

To submit to top management for review and approval Signup and view all the answers

What is the primary goal of a Quality Management System?

To improve QMS performance Signup and view all the answers

What is the primary goal of participation with suppliers and customers in a Quality Management System?

To understand and consistently meet mutually determined requirements Signup and view all the answers

Which of the following clauses is NOT a major clause in ISO 9001:2008?

Scope and application Signup and view all the answers

What is the total number of mandatory documented procedures in ISO 9001:2008?

6 Signup and view all the answers

What is the primary focus of the QMS approach in Clause 4 of ISO 9001:2008?

Establishing quality policy and objectives Signup and view all the answers

What is the main difference between the QMS approach and the process approach in ISO 9001:2008?

One focuses on products, the other on processes Signup and view all the answers

What is the purpose of maintaining control of documented procedures in a Quality Management System?

To describe methods for design, production, and delivery Signup and view all the answers

Which of the following is NOT a responsibility of management in a Quality Management System?

Conducting product design and development Signup and view all the answers

What is the main purpose of Clause 4 in ISO 9001:2008?

To outline the requirements for a quality management system Signup and view all the answers

Study Notes

The Process Approach

A process is a series of activities that add value to input, producing output for customers.
Customers can be internal or external to the organization.

Measuring a Process

Qualified people are essential for a process.
Efficient processes have no waste.
Effective processes achieve desired results.
Right equipment and materials are necessary for a process.
Proven methods ensure quality output.

Documentation Requirements

Quality documentation consists of 3-4 levels, including policies, procedures, and manuals.
The documentation pyramid has four levels: Quality Manual, Operational Procedures, Instruction to Operations, and Formats and Records.
Documentation requirements include control of documents, control of records, QMS manual, external document register, document control register, and work procedures register.

Quality Manual

The Quality Manual provides evidence of specific controls implemented to ensure product/service quality.
It benefits customers, suppliers, employees, and ISO.
It addresses all quality system elements.

Control of Documents

Documents are approved prior to issue.
Changes and current revision status of documents are identified.
Relevant versions of documents are available at the point of use.
Documents remain legible and readily identifiable.

Structure of ISO 9001:2008

The standard consists of 8 clauses, including scope, normative references, terms and definitions, QMS requirements, management responsibility, resource management, product realization, and measurement, analysis, and improvement.
There are 3 general/informative clauses and 5 major clauses.
6 mandatory documented procedures are required: control of documents, control of records, internal audit, control of non-conforming product/service, corrective action, and preventive action.

ISO 9001 Requirements

The standard requires a quality management system (QMS).
It does not establish requirements for product.
It uses two approaches: the QMS approach and the process approach.

Clause 4: QMS Approach

Determine the needs and expectations of customers.
Establish the quality policy and quality objectives.
Determine the processes and responsibilities necessary to attain quality objectives.
Determine and provide resources necessary to attain quality objectives.
Establish methods to measure the effectiveness and efficiency of each process.
Apply these measures to determine effectiveness and efficiency of each process.

Control of Records

Records provide evidence of implementation/conformity to the requirements specified in the process.
Records should not be tampered with.
Records should be legible, bear unique identification, and have proper storage locations, protection, and accessibility.
A disposable mechanism is required.

Clause 5: Management Responsibility

Management review includes results of the audit, customer feedback, process performance, and product conformity.
Customer complaints and feedback are considered.
The organization chart and individual responsibility authorities are established.
Quality policy and objectives are set.

Management Review

Results of the audit are reviewed.
Customer feedback is considered.
Process performance and product conformity are reviewed.
Status of preventive and corrective action is reviewed.
Follow-up actions from previous management reviews are reviewed.
Changes that could affect QMS are reviewed.
Recommendations for improvement are made.

Review Output

Management decisions are based on the review.
QMS improvement requirements are identified.
Customer requirements are identified.
Resource requirements are identified.
Product/process requirements are identified.

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Description

This quiz covers the process approach, including inputs, activities, and outputs. It also touches on measuring process efficiency and quality.