Quality Management System Document Control QP1

1
Quality Management SystemDocument Control (QP-1)
Quality

• Prepared by CPHST Quality Management Unit
• August 2006

2
Purpose

• Describes how quality system documents are
  established, distributed, revised, recalled and
  archived

3
Scope

• All CPHST Quality System Documents
• Quality Manual
• Quality Procedures
• Technical Procedures
• Work Instructions
• Flow Charts
• Forms
• Documents from External Sources

4
ISO Document Levels
Level 1
Defines the policy
Quality Manual
Policy Implementation Defines the who, what,
when of the process. Quality Technical
Procedures
Level 2
Procedures
Answers how the process is accomplished Any
format includes blank forms
Work Instructions Blank Forms
Level 3
Provides current historic evidence of process
status
Level 4
Records Completed Forms
5
Document Identification

• All Quality Management System documents are
  identified by a unique document identification
  number.

6
Document Control Numbers

• Quality Procedures
• QP -
• Work Instructions
• WI - (CPHST Work Instructions)
• Laboratory Specific Work Instruction control
  numbers are assigned by the laboratory Quality
  Manager and will begin with WI

7
Document Control Numbers (cont)

• Forms
• Form - (CPHST Forms)
• Laboratory Specific Form control numbers are
  assigned by the laboratory Quality Manager and
  will begin with Form
• Technical Procedures
• TP -

8
Document Format

• Quality Manual
• Technical Procedures
• Protocols
• CPHST Quality Procedures
• Work Instructions
• Work Plans

• WI 1-2
• WI 1-3
• WI 1-3
• WI 1-4
• WI 1-5
• WI 1-6

9
Definitions

• Corrective Action Action taken to eliminate
  causes of an existing nonconformity, defects, or
  other undesirable situations.
• Preventive Action Action taken to identify and
  eliminate the causes of potential
  nonconformities, defects or sources of variance
  and to improve the overall quality and
  productivity of CPHST.

10
Document Review

• Annual Review
• At any time when reason dictates
• Audit results
• Corrective action
• Management review

11
Document Revisions

• Documents can be revised as a result of
• Annual review cycle comments
• Change in policy or procedure
• CAR or PAR
• Result of audit nonconformance
• Result of Management Review
• All documents contain a revision history

12
Document Approval

• Quality Manual and CPHST Quality Procedures
• Technical Procedures Minimum requirements as
  applicable

• CPHST Director
• CPHST Director of Quality Management
• Author
• Laboratory Quality Manager
• Laboratory Technical Manager
• Laboratory Director

13
Document Approval (cont)

• CPHST Work Instructions
• Laboratory Work Instructions

• CPHST Director of Quality Management
• Laboratory Quality Manager
• Laboratory Technical Manager

14
Document Approval (cont)

• Work Plans
• Ad-hoc Work Plans

• Laboratory Director
• NSPL
• Associate CPHST Director

15
Document Distribution

• CPHST Documents distributed via
  http//cphst.aphis.usda.gov web site
• Laboratory Documents distributed as stated in
  laboratory specific work instructions.

16
Document Recall

• Obsolete documents removed from CPHST web site.
• Original, signed hard copies are archived and
  marked Obsolete Copy

17
Document Revisions

• Form 1-2 Document Change Form
• Use this form to initiate changes in any quality
  system document.

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What are External Documents?

• Documents that are developed and maintained by
  an entity other than CPHST but are critical to
  product quality and must be available for use.

19
External Documents

• Maintained on Document Master List
• Uniquely Identified
• Readily Accessible

20
Laboratory Work Instructions Needed

• Document Maintenance and Distribution
• Document Recall Procedure
• External Document Identification and Maintenance

21
Questions or Comments

• Please Contact CPHST Quality Management Unit
• John Gallagher, CPHST Director of Quality
  Management
• [phone]
• john.b.gallagher_at_aphis.usda.gov
• Or
• Kathy Burch, CPHST Senior Quality Auditor
• [phone] or [phone]
• katherine.j.burch_at_aphis.usda.gov