QP7501 Document Control: General, Creating, Updating

PURPOSE

The purpose of this procedure is to:

a) Identify documents defining the quality management system, production processes, and products: and

b) Assign responsibilities for establishing and maintaining the documentation.

c) Review procedures for Creating and Updating documentation

APPLICATION

Scope: This process pertains to all documents utilized in the Harrington quality system.

PROCEDURE

1. General

1.1 The scope and extent of quality system documentation is determined on the basis of the complexity and interaction of processes, elements, and activities; and on competence of personnel. The documentation is sufficient to ensure the effective planning, operation and control of the quality system, processes, and products.

The documentation structure that is used in this quality system consists of four tiers:

  • The first tier of the quality system documentation structure is the quality manual (including documented Quality Policy), which covers all requirements of the standard, makes reference to quality system procedures, outlines the documentation structure and illustrates Harrington’s positive commitment to fulfill these requirements.
  • The second tier consists of documented procedures, which are specified methods for managing activities. These procedures are consistent with the requirements of the standard and Harrington’s quality policy, and are to be implemented effectively.
  • The third tier is work instructions, which are highly specific ways to perform activities.
  • The fourth tier consists of records, forms, tags and other documentation.”

Creating and Updating Documentation

General

Scope: This process pertains to all documents utilized in the Harrington quality system.

  1. Definitions
    1. QM- Quality Manual.
    2. QP- Quality Operations Procedure.
    3. QF- Quality Form.
    4. Authorized – Issued password authority to access edit functions
  2. Responsibilities
    1. The overall R&A for activities relating to this element of the standard have been assigned to the President and authorized team members.  Team Members are charged with the responsibility to implement the procedure as written, and have been granted appropriate freedom and authority to do so.
  3. Procedure
    1. Harrington makes every effort to create a paperless environment for quality documentation. Controls are in place to ensure accessibility and security.  The goal is to have 0 paper documents that are used to run and operate the business processes, creating tight control by having only the current and valid reference document available at any given time.  Even when “paper” documents are created (ie. Pick labels, Status Cards, Receiving labels, Pack Slips, etc..), they are controlled by digital system masters that are always the most current revision level.
    2. The quality system documentation consists of four levels, as described in QM 7.5 of the Quality Manual.
    3. Level I through Level IV documentation, and a corresponding Work Instruction List, is embedded into WebECIS, and is accessible by all employees.
    4. Documentation on the Intranet website and network is maintained in a read-only format. Only the President and authorized team members are permitted to alter the format or content of our Quality System documentation.
    5. Requests for changes to quality documents are submitted to the President or authorized team members by way of an electronic Document Change Request, identifying the originator of the change, the approval of the change by the original approval authority, and background information explaining the reason(s) for the change. The Document Change Request is associated electronically with the revised document so that the change history is always available.
    6. Quality document change requests are reviewed and approved by the the President or Vice President of Quality, verbally or via electronic mail for entry into controlled documents.
    7. Quality Manual and Procedure last changes will be highlighted in bold type.
    8. Harrington can control external documents if it has need to do so.
      1. Each external document is scanned into an electronic document, if on paper, and placed in I:\ drive appropriate Client/Part # folder.
      2. Old version of document is deleted from electronic file folder when the new version is placed in electronic file folder
      3. Verify that current document replaces any old document we are using in paper form

Revision History:

Revision Date Description of Changes Approved By
0.0 07/03/17 Initial Release Jim Theesfeld
1.0 8/17/18 Digitized version, procedure changes to make accurate, sustainable, and reasonable Todd Gifford
2.0 3/25/2020 Updated Master List to reference Work Instruction and WEbECIS.  Updated Quality Document Change requests to allow VP of quality Dave Zirkelbach
3.0 11/20/2020 Changed VP of Quality to authorized team members & added definition of authorized Todd Gifford