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Quality Manual

By Rosa Grant,2014-06-09 19:57
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Quality Manual

Quality Manual

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410 Operations System

411 Policy

    This document establishes the framework and requirements for Alger’s Operation System. Alger maintains a documented system that meets all ISO 9001:2000 requirements. Appropriate processes have been established, documented and implemented. The system also incorporates Safety/Environmental and software concerns. A primary goal of the system is to provide complete Customer Satisfaction. The elements of the Operations System are:

    a. Process approach

    The processes needed for an effective Operations system are identified. With reference to ISO

    9001:2000, Alger excludes 7.3 Design and development as the company only manufactures

    Customer specified products. These processes include: management activities, provision of

    resources, product realization and monitoring, measurement and analysis.

    b. System approach to management

    Identifying and managing interrelated processes as a system contributes to Alger’s effectiveness and

    efficiency.

    c. Establish criteria and methods

    Alger has determined ways to help ensure that both the operation and control of these processes are

    effective. They are documented in this Operations System.

    d. Leadership

    Resources and the necessary information to support the operation and monitoring of these processes

    will be made available.

    e. Factual approach to decision making

    The processes are monitored; measured and analyzed so effective decisions can be based on this data.

    f. Continual improvement

    Actions necessary to achieve planned results and continual improvement will be taken.

    g. Customer focus

    Alger strives to meet customer requirements and exceed customer expectations.

    h. Involvement of people

    The essence of this operating system lies with each employee’s full involvement and fulfilling their

    specific function, following the appropriate documented procedures and instructions.

    i. Mutually beneficial supplier relationships

    Alger and its suppliers are interdependent and a mutually beneficial relationship enhances

    performance for both. Alger ensures control of any outsourced processes.

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    412 Operations System Flowchart

This flowchart describes the procedures, processes, and inspections used to produce, control and

    achieve acceptable quality products that meet contract requirements. The table correlates the ISO clauses to

    specific SOP’s that explain sub-processes.

     Flowchart # ISO 9001:2000 Section

    All 410 Operations System Customer Service All 420 Operations System Documentation

    All 500 Management Responsibility All 620 Human Resources

    1, 2, 3, 4, 5, 720 Customer-Related Processes 1326, 12, 15, 16 Customer RFQSales740 Purchasing 9, 12 Need

    7, 11, 12, 15, 750 Production Provision

    16

    8 760 Control of Monitoring and Measuring Devices 410, 11, 14 810 Measurement

    EstimatingAll 822 Internal Audit

    10, 11, 14 830 Control of Nonconforming Product

    All 850 Corrective & Preventive Actions

     5Order Entry17

    Accounting

    6Engineering

    97Purchase Production SchedulingRaw Material

    11810Quality ProductionReceivingAssurance

    12Outside 13ProcessesHuman

    Resources161415Completed Inventory Finished Product to ControlProductCustomer

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420 Operations System Documentation

421 Documentation requirements

    The quality policy for Alger is shown in the 500 Management Responsibility section, in 530 Policy. The quality objectives are recorded in 540 Planning. The Operations System documentation required by Alger and the ISO 9001:2000 standard is included in these SOP’s (Standard Operating Procedures) as listed in the

    master list of Quality System SOP’s on the intranet. Reference is made to required records at the end of each

    documented procedure.

422 Alger’s quality manual and documented procedures are recorded together in this Operations

    System. The system documentation combines policies and procedures, typically arranged in a functional manner so the authorized individuals are aware of their responsibilities. It is also blended with a process approach, modeled after the sections and requirements of the ISO 9001:2000 standard to identify the interaction of the processes.

    There is no section for Design and development because Alger does not do any product design and development. If in the future they do, a section will be added to the Operations System for it.

    Section 410, Operations System explains the principles of Alger and provides a flowchart describing the interaction between the processes of the quality management system.

423 Control of Documents Policy

    This policy and SOP (Standard Operating Procedure) outlines the process for the approval, issue, and changes of controlled Alger documentation. Responsibility and authority for specific SOP documentation is identified in 500 Management Responsibility, section 551.2. All employees are responsible for using current revisions of appropriate documents.

423.1 Business System Documentation Structure

    Alger has established and maintains a documented business system as a means of ensuring that Customer requirements are satisfied or exceeded and that best practices within operations are standardized company wide as applicable.

    Operations system processes have been developed, documented, implemented and are maintained in accordance with the requirements of ISO 9001:2001. Appropriate documents are revision controlled, implemented and available as appropriate to Alger personnel.

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423.2 System Documentation Consists Of:

    1. Controlled Documents that are reviewed and approved prior to issue and include the policies, SOPs,

    and the Controlled Documents listed within the SOPs. The responsible authority as noted in section

    551.2 Responsibility and Authority (within procedure 500 Management Responsibility) approves

    controlled Documents.

    2. Non-Controlled Documents (those that contribute to the system, but have no set format and/or are

    liberally available to personnel, and/or their importance maybe achieved through their completion or

    signatures) including the forms listed as Non-Controlled in the SOPs are authorized as needed.

    3. Once completed, a Controlled and/or a Non-Controlled Document may become a Quality Record.

423.3 Procedure

    The flowchart is keyed numerically to the procedure. Documents are listed in bold and underlined in the task section.

    Documents that relate to a specific Customer Job are initiated, approved, and issued through the process defined in section 720 Customer-Related Processes. However, the process of changing Customer Job related documents is contained in this procedure. All changes are processed in a timely manner as appropriate.

    4123

    Change Initiate a new Approve Issue

    requireddocumentdocumentdocument

    5

    Review &

    Process

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Responsibility Task

1. Anyone ; Use a format for policies and SOPs similar to this SOP.

    ; Individual SOPs define and control documentation as

    appropriate for Non-Controlled Documents, Controlled

    Documents and Quality Records that are used in the process

    defined in the SOP. The Documentation section serves as the

    master list. This includes external documents such as standards

    and codes, which are updated as required or stated in the SOP.

    ; Revisions are identified by letter &/or date as appropriate.

    ; Anyone may propose a change to a SOP by printing out the SOP

    to be changed and marking up the change on the copy. They then

    send the marked up copy to the section owner who will review

    the change and if approved forward it to the management

    representative. He will verify that the changes do not adversely

    affect any of the other sections. If he approves the change it will

    be sent to the administrative assistant who will make the changes

    in the computer and forward the new SOP to the MIS manager

    to be posted to the Intranet.

    ; The administrative assistant will maintain a copy of all old

    revisions in a file at her desk.

    ; Users assume responsibility for verifying current revision

    against Master list on the intranet or appropriate SOP.

    ; Reference 720 Customer-Related Processes for Customer job

    related documentation.

2. Approval authority as Approves new or revised documents and forwards to the designated

    defined in each SOP Administrator. Documents can be hard copy, redlined or, preferred,

     (See 551.2) on disk/ e-mail.

    Routee(s) Change Orders

    Review and approve desired changes, initial the appropriate routing

    block and forward to next routee or return to Executive Vice

    President or VP California Operations. Historical manufacturing

    notes, dimensions or data will be allowable on customer prints,

    without the need for a change order form to be completed or the

    customer having to be notified.

    3. MIS System ; Policies & SOPs are maintained electronically on the company

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Responsibility Task

Administrator intranet. Printed copies are uncontrolled,

    ; A master list of Quality System SOPs is maintained on the

    intranet with the current date and revision.

    ; Binders with copies of SOPs are used as required. Users assume

    responsibility of verifying revision level with the master list.

    ; Users are responsible to remove obsolete documents from use.

    Obsolete documents kept as records are clearly identified as

    “Obsolete or Reference Only”.

     Order Entry Change Orders

    Complete data entry for approved changes to job. File approved

    Change Order with Green Card. Issue changes to personnel who

    are responsible for replacing affected documents.

4. Anyone Initiate a change to a Job by completing the header and type of

    change sections on the Change Order.

    “Initiating change to specific Layout of Operations (non-

    administrative) requires submission of revised Layout of Operation

    to engineering for review and approval.”

    5. Executive Vice President Reviews desired change and determine appropriate routing. or VP Operations. Approves change(s) and forwards Change Order to Order Entry.

    Changes to due dates must be confirmed before any changes are

    approved.

424 Control of Records

Development and planning for product realization includes completing and maintaining the records needed

    to provide evidence that the realization process and resulting product meet requirements. (reference ISO

    9001-2000 (d))

There are two types of Quality Records: Hard copy and Electronic. Records are listed in a table located at

    the end of each documented procedure for which quality records would be generated. The table identifies

    each record, the retention time, storage location, and how they are organized. See 426 Documentation in

    this procedure for an example.

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    All Quality Records are legible and identifiable to the process involved. Quality Records are being stored and maintained in such a way that they are readily retrievable in facilities that provide a suitable environment to minimize deterioration or damage and to prevent loss.

    Retention times of Quality Records are established and recorded. The responsibility of individual record retention is given to each person of authority for his or her SOP.

    Where agreed contractually, the customer or the customer’s representative will make quality records available to Alger Manufacturing as required. Alger Manufacturing will provide appropriate records to a customer as applicable.

    Records are typically kept in these locations for a portion of the total retention time.

    ; Order Entry

    ; Quality Assurance

    ; Shipping/Receiving

    ; Inventory Control

    ; Accounting

    ; Computer Systems

    ; Engineering

    After a period of time, records may be moved from the listed location to Storage for the duration of the specified retention time. Records in Storage are stored by Customer/alphabetically, chronologically, and by vendor.

    The Accounting and Order Entry Departments review stored records and discard records past their stated retention times.

When a Job Card or entire Job Folder is needed from an active/open customer file, an Out Card is used.

    The person removing must note their initials and the date removed. In Accounting, when an entire file is removed from any current location an Out Card is to be used.

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425 Software Backup and Recovery

    Backup

     Alger data is kept on two servers:

     Server one Esti-Track

     Server two SPC/ MAS 90/ E-mail

    Each server is backed up daily, Monday through Thursday. One tape for each day of the week is

    used. The MIS manager or designated person in Accounting/Human Resources group will rotate the

    tape sets as follows: Monday’s backup tape is removed on Tuesday to an off-site location and

    returned the following Monday for a new backup. This follows for each day of the week. The

    backup routines are run at night and back up data files only. Application programs are kept in the

    MIS Manager’s office.

    Recovery

     Hardware or software problem

    If any of the servers have a hardware problem, the computer in question is repaired, put back in

    service, and the application/data files restored. If the server cannot be repaired quickly enough,

    either a loaner is arranged or the MIS manager’s computer is put online as a temporary replacement

    until the server is repaired.

    Catastrophic Disaster

    In the event of a natural disaster or any other situation that makes bringing servers back on line in

    the Ontario location impossible, the off site tapes are taken to another location and restored on the

    computer there.

    Personal Computer Software

    Only company purchased software is allowed on Alger computers. Approved software purchases

    are forwarded to the MIS System Administrator for procurement and installation/maintenance.

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