cmqp assignment

Documentation Review

Intent Understand the performance of system document reviews and procedure reviews.

Time: 55 minutes

Instructions Conduct a documentation review of New Silicon’s quality manual and one procedure.

New Silicon is an organization that is focusing on leading edge technology in the chip-making industry. The industry is product-oriented and fast moving, with key strengths in engineering and design. Being first to market is a strength in this industry.

Review the list of customer expectations and determine what impact this should have on New Silicon’s QMS.

Attachments Use the attached materials for New Silicon:

Quality Manual Sections

• Customer Expectations

• Table of Contents

• 2.0 – Exclusions and Scope

• 4.0 – Management Responsibility

• 8.0 – Process Map

• SOP 14-0 – Management Review (not part of the quality manual)

Review the attached documentation and complete the Document Review Checklist. Record any nonconformities for 4.2.2 Quality Manual and 5.0 Management Responsibility.

• List any concerns you may have on the process map.

Amrita CMQP Assignment

of 10 Documentation Review

Customer Expectations Checklist Top Five Customer Expectations

• Reduce costs by 20% per year

• Provide the latest industry technology

• Provide PPM (parts per million) defect levels of 20 PPM or below

• Provide problem analysis/lab analysis in 24 hours

• Provide engineering support for new product development


Documentation Review of 10

Quality Manual Table of Contents

New Silicon

Contents

1.0

Introduction to New Silicon

2.0

Exclusions and Scope

3.0

Quality Management Systems

4.0

Management Responsibility

5.0

Resource Management

6.0

Product Realization

7.0

Measurement, Analysis and Improvement

8.0

Process Map



Quality Manual 2.0 – Exclusions and Scope New Silicon is applying for ISO 9001:2008 certification. No processes detailed in 7.0 –Product Realization are excluded. However, New Silicon has decided to exclude the Research and Development (R&D) Lab in Santa Barbara and the Subcontract Testing and Final Inspection Laboratory located in California.

Justification for excluding R&D:

ISO 9001:2008 processes and the standard do not apply to R&D facilities



Quality Manual 5.0 – Management Responsibility

5.0 Management Responsibility

Quality Manual5.0: Management Responsibility

Scope/Purpose The Quality Steering Committee is responsible for establishing, implementing, and maintaining the quality system. Specific responsibilities include defining the quality policy, defining organization, reviewing the quality system, and providing thepersonnel and resources necessary to maintain and improve the system.

Responsibility Quality Steering Committee

Policy5.1 Management Commitment

The Quality Steering Committee at New Silicon is composed of the Chairman, President and all ofthe other senior staff noted on the Corporate Organization Chart.

The Quality Steering Committee is committed to maintaining and improving the organization'sQuality Management System by:a) regularly communicating the importance of meeting client as well as regulatory and legalrequirements to the organization,b) updating and maintaining a mission statement and annually establishing quality objectives,c) conducting regular management reviews, andd) ensuring the availability of necessary resources.

5.2 Client Focus

The Quality Steering Committee evaluates client needs and expectations during its annualbusiness planning cycle, and converts them into requirements with the aim of achieving clientsatisfaction. Needs and expectations include those for products.

5.3 Mission

The Quality Steering Committee describes the purpose, vision and values of the organization in aMission statement. The Mission includes the Quality Policy.

5.4 Business Planning

The Quality Steering Committee establishes measurable objectives for key customer expectationcategories consistent with the Mission as part of the annual business planning cycle. TheseObjectives are communicated to the organization in an annual all staff meeting.

The Quality Steering Committee annually develops a business plan to achieve the organization'sbusiness objectives. The plan identifies the resources needed to accomplish the objectives andcontinually improve the business.

Rev 2:16 Sep 2000

ISO 9001:2008 Lead Auditor Training R5 09.09


Quality Manual 5.0 – Management Responsibility

5.0 Management Responsibility

Quality Manual5.0: Management Responsibility

Policy

5.5 Responsibility and Authority

Key personnel and their functional assignments are described on a Corporate Organization Chart. Functions andassignments relative to projects is outlined on the Project Organization Chart. Specific responsibilities and authoritiesare indicted on procedures and in job descriptions for each job category.

A member of the Quality Steering Committee acts as the Management Representative with the responsibility andauthority to:a) ensure that processes of the management system are established and maintained;b) report to Quality Steering Committee on the performance of the quality management system, including needs forimprovement;c) promote awareness of client requirements throughout the organization.

The organization holds regular all staff meetings to communicate information about business progress andeffectiveness. In addition, a newsletter is published on a regular basis.

5.6 Management Review

The Quality Steering Committee reviews the Quality Management System to evaluate its continuing effectivenessand to assess opportunities for continuous improvement. These reviews are held at regularly planned intervalsaccording to a SOP 14-0.

Rev 2:16 Sep 2000



Quality Manual 8.0 – Process Map

Contract Review

SOP 3.0

Contract Review

SOP 3.0

New ProductDevelopment

SOP 4.0

New ProductDevelopment

SOP 4.0

Technology andProcess

SOP 5.0

Technology andProcess

SOP 5.0

Qualifications

SOP 6.0

Qualifications

SOP 6.0

Receiving Inspection

SOP 7.0

Receiving Inspection

SOP 7.0

Product Identification

SOP 8.0

Product Identification

SOP 8.0Process Control

SOP 9.0

Process Control

SOP 9.0

Final Inspectionand Shipping

SOP 10.0

Final Inspectionand Shipping

SOP 10.0

Training

SOP 11.0

Training

SOP 11.0

Business Planning

SOP 13.0

Business Planning

SOP 13.0

Measurement andImprovement

SOP 15.0

Measurement andImprovement

SOP 15.0

Purchasing

SOP 12.0

Purchasing

SOP 12.0

Management Review

SOP 14.0

Management Review

SOP 14.0

Product Realization

Support Processes



New Silicon SOP 14-0

TITLE: Quality Operating SystemSample Company

Number: Revision DateSOP 14-0

Department: Approval:

Revision: Page:

SampleCompany

Purpose:

Scope:

To define procedures contributing to the Management Review Meetings

As it applies to all Management Review Meetings of the Sample Company

Responsibility Inputs Flow Outputs Remarks

QAManager

QualitySteering

Committee

QSC

QSC

QSC

QA Manager(QAM)

maintains alldocumentation

Meets at leastmonthly

Each function willhave supporting

metrics

Tracking andreporting by QAM.

ManagementReview meetings

once/month

MeetingCalendar

Agenda

ActionPlans

Minutes

QMS

QSC

SelectedQuantifiers

EstablishedFrequency for

Trashing &Reporting

Set attainablegoals for each

indicator

1

Quality levels

OperationalPerformance

Key product/Service features

Internal Auditor

CustomerComplaints

Open CAR's

TrendsBusiness Plans



New Silicon SOP 14-0

Includes corrective/preventive action

TITLE: Management Review

Number: Revision DateSOP 14-0

Department: Approval:

Revision: Page:

SampleCompany

Purpose:

Scope:

QSC

QAM

QSC&

QAM

Metrics

PARETO

1

Report toChampion forManagement

Review

Action Plan Status

ConductManagement

Review

Action PlanUpdate

QAM ManagerHolds

Documentation

Responsibility Inputs Flow Outputs Remarks

Establish Teamsto work on

Improvement

DocumentImprovements



ISO 9001:2008 Document Review Checklist

ISO 9001:2008Level I Level II Question NC C COMMENTS

4 QUALITY MANAGEMENT SYSTEM4.2 Documentation Requirements4.2.2 Quality Manual

Has the organization established and maintained a quality manual that includesa) the scope of the quality management system, including details of and justification for any exclusion (see 1.2),

b) the documented procedures established for the quality management system, or reference to them, andc) a description of the interaction between the processes of the quality management system?

5 MANAGEMENT RESPONSIBILITY5.1 Management Commitment

Has Top Management provided evidence of its commitment to the development and implementation of the quality management system and continual improvement of its effectiveness bya) communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements,b) establishing as quality policy,c) ensuring that quality objectives are established,d) conducting management reviews,e) ensuring the availability of resources?

5.2 Customer FocusHas Top Management ensured that customer requirements are determined and fulfilled with the aim of enhancing customer satisfaction ? (see 7.2.1 and 8.2.1)

4.1 General RequirementsHas the organization established, documented, implemented and maintained QMS per the current ISO standarda) identifing the processes needed for QMS and their application throughout the orgainzation b) determining sequence and interaction of processesc) determining criteria and methods needed to ensure operation and control of these processes are effectived) ensuring the availability of resources and information supporting operation and monitoring of processese) monitoring, measuring and analyzing these processes

f) implementing actions necessary to achieve planned results and continual improvement of these processes?

Omnex, Inc.


cmqp assignment

Documents