EXAMPLE

Results International

RI Procedure

Quality Management System

Issue Date: 02/15/04

Purpose:

For the effective functioning of a Quality Management System it is important that the requirements and content of the operational systems be structured and documented according to the standard(s) that they are intended to satisfy.

Scope:

This procedure provides guidelines for preparation and control of all Operational Manuals/Procedures tailored to the specific needs of Results International and reflects documented quality system procedures required by the ISO 9000 Series Standards. It is also used to develop operational manuals and procedures relating to general good business practices and operational system requirements other than the ISO 9000 Series Standards.

Supporting Document Reference:

RI Procedure Measurement, Analysis, and Improvement
RI Work Instruction Control of Documents

Definitions:

For the purpose of this procedure the following definitions apply.

Results International (RI) Procedures Manual - A series of documents stating the company quality policy, describing operating systems and containing Results International Procedures, Work Instructions and RI Forms. CONTROLLED DOCUMENT - FOR INTERNAL USE ONLY.

Note: The Results International Procedures Manual addresses level I, II, III & IV documentation requirements and contains "proprietary information".

Results International (RI) Work Instruction - A procedure reflecting how day-to-day operations are accomplished in support of established operational systems, processes, and procedures. CONTROLLED DOCUMENT - FOR INTERNAL USE ONLY.

Note: Work Instructions may contain proprietary information.

Procedure / Responsibility:

General Requirements (Ref: Measurement, Analysis, and Improvement)

The Program Manager is responsible for and has:

• Established processes needed in support of Results International Process-Based Quality Management System,
• Determined the sequence of interaction of these processes (Project Realization Process Map),
• Identified Results International “Key Processes” and performed process analysis via development of “Process Diagram Worksheets”,
• Determined criteria and methods needed to ensure that both the operation and control of key processes are effective and efficient and issue “Process Performance Reports”, and
• Via periodic Management Review ensures the availability of resources and information necessary to support Results International operations, ongoing monitoring of key processes, and implementation of actions necessary to achieve planned results and continual improvement.

Documentation Requirements

General

Quality Policy

The Program Manager has established the Results International Quality Policy which is to:

1. Provide consulting and training services customized to meet specific project requirements,
2. Establish, implement, and maintain operational processes that focus on customer needs, customer expectations, and good business practices, and
3. Ensure continual improvement via ongoing monitoring, measurement, and evaluation of key Results International processes for effectiveness and efficiency of operations.

Quality Objectives (Ref: Measurement, Analysis, and Improvement)

The Program Manager is responsible for establishment of quality objectives that:

• Are needed to meet project requirements,
• Are relevant to key processes,
• Are measurable, and
• Are consistent with the Quality Policy.

Quality Manual

The Results International Procedure Manual has been established to define and document all relevant activities, processes, and records needed to establish, implement and maintain the Results International Quality Management System and to support effective and efficient operations.

Control of Documents

Document Approval and Issue (Ref: Work Instruction – Control of Documents)

Results International Procedures, Work Instructions, Controlled Forms, and Basic Product/Service Profiles are reviewed by the functions having responsibility for implementation and approved by the Program Manager, or his designee, prior to issue. The Document and Data Control Representative maintains the electronic master and one hardcopy of each document. Coordination activities are documented on a Document Coordination/Release Notification Record.

Note: The Document and Data Control Representative is the alternate approval authority for Results International Procedures, Work Instructions, Controlled Forms, and Basic Product/Service Profiles.

“Controlled” hard copy documents (Results International Procedures, Work Instructions, Controlled Forms and Basic Product/Service Profiles) are identified with a “Teal” company logo or name.

By identifying their issue date the Table-of-Contents serves as the "Master List" for all Results International Procedures, Work Instructions, Controlled Forms and Basic Product/Service Profiles. The Table-of Contents for each manual (Procedures Manual and Basic Products/Services Manual) also serves as the manuals “Master Distribution List” by identifying the number of hard copies printed and their distribution. The Document and Data Control Representative maintains all Results International Procedures Manuals and Basic Products/Services Manuals (electronic and hard copy). This control ensures that:

• The “pertinent” issues of Results International Procedures, Work Instructions, Controlled Forms, and Basic Product/Service Profiles are available at all locations where operations essential to the effective functioning of the operating system are performed, and
• Obsolete documents/data are promptly removed from all points of issue or use.

Document Changes

Changes to documents are reviewed and approved by the same functions/organizations that performed the original review and approval unless specifically designated otherwise. For Procedures and Work Instructions, shading identifies the area(s) revised.

Note: Shading is not used on Results International Controlled Forms or Basic Product/Service Profiles.

Coordination activities are documented on a Document Coordination/Release Notification Record.

In order to preclude the use of obsolete Procedures, Work Instructions, Controlled Forms, or Basic Product/Service Profiles a complete reissue of the applicable document is accomplished whenever a change is made.

Results International Associates are notified of controlled document updates via e-mail or posting.

Identification of retained “obsolete” controlled documents

An electronic copy of obsolete Procedures, Work Instructions, Controlled Forms, and Basic Product/Service Profiles are retained in the appropriate “OBSOLETE” file on the C Drive.

Obsolete hard copy “controlled documents” retained for legal or training purposes are stamped “OBSOLETE”.

Responsibility

Program Manager

Responsible for approving initial release, and all changes, to Results International:

• Procedures,
• Work Instructions,
• Controlled Forms, and
• Basic Product/Service Profiles.

Document and Data Control Representative

Responsible for:

• Up-dating the Procedures Manual and Basic Products & Services Manual Table-of-Contents,
• Maintaining the document coordination process via Results International Document Coordination/Release Notification Record,
• Maintaining the “electronic” master for Results International Procedures, Work Instructions, Controlled Forms, and Basic Product/Service Profiles,
• Maintaining the “hard copy” Manuals, and
• Notifying (via e-mail or posting) Results International Associates of changes to Results International Procedures, Work Instructions, Controlled Forms, and Basic Product/Service Profiles.

Results International Associates

• Responsible for ensuring they remain current on the latest revisions to Results International Procedures, Work Instructions, Controlled Forms, and Basic Product/Service Profiles, and
• Following established procedures when performing day-to-day activities in support of project realization.

Control of Records (Ref: Important Documents Matrix)

Note: All records identified and developed in support of customer projects are retained in the client’s folder.

Important Documents and Data - Important Documents or Data (regardless of media type) contain one or more record of information pertaining to the establishment, acceptability/unacceptability, or in-process/final status of Results International services prepared for and/or provided to our customers. This definition includes supporting documents and data provided by suppliers when applicable.

Important documents and data are maintained to demonstrate achievement of the required quality and the effective operation of the Results International operating system. Results International has established and maintains procedures for identification, collection, indexing, storage, access, maintenance, and disposition of important documents and data.

Identification

Important documents and data are identified in the applicable Results International procedures that address their generation and on the Important Documents Matrix.

Collection and Indexing

General

When generated or upon completion, important documents are gathered, reviewed for legibility, completeness and accuracy and appropriately filed to facilitate reasonable access and retrieval.

Project Specific Documents (Ref: Planning of Project Realization)

Project Manager

The Project Manager performs a Post Project Documentation Review at the completion of each major project. Once it has been determined that all required hard copy documents and electronic data needed to address contractual requirements has been acquired the hard copy documents and a copy of the electronic data are retained in the client file.

Filing and Storage

Project Manager

Filing and storage of important documents and data is the responsibility of the generating Project Manager and overseen by the Program Manager.

Storage methods will be such that the possibility of damage, deterioration or loss of documents and data is minimized, or totally eliminated, while still allowing for ready retrieval.

Access

Access to important documentsand data is limited to those personnel with responsibilities for the maintenance, disposition and/or retrieval of information as identified by the Program Manager.

Where agreed upon, access to important documents and data can be granted to the customer, or the customer’s representative, for a determined period.

Retention and Disposition

Retention times and disposition instructions for specific documents and data are determined by the Program Manager and are documented on the Important Documents Matrix.

Responsibility

Program Manager

The Program Manager is responsible for:

• Determining which documents or data generated in the course of day-to-day operations contain "records” that need to be retained,
• Identification of appropriate storage locations,
• Establishment of retention requirements, and
• Determination of disposition instructions.

Document & Data Control Representative

The Document & Data Control Representative is responsible for development and maintenance of the Important Documents Matrix.

Collection, filing and storage of important documents and data are the responsibility of the Results International function identified in the Important Documents Matrix.

Documentation:

Document Coordination/Release Notification Record
Important Documents Matrix

See Important Documents Matrix for document and data storage, retention, and disposition instructions.