Preparation & Release of Controlled Documents
Quality System Work Instruction
10-10-0401: QCS - Preparation & Release of Controlled Documents
Rev-00 / date 08-16-07 - Approved by: David C. Hagen
1.0Purpose and Scope
The purpose of this document is to describe the process of preparing, revising, and issuing a controlled document, which significantly affects the quality system. This document pertains to all departments whose documents have an impact on the quality system as defined by BQ-9000 program requirements.
1.1Definitions
Controlled Document: any document whose content has a significant impact on the quality system. This includes the Quality Manual, Quality System Procedures, operating procedures, and associated forms.
QCS_Quality Control Solution: web-based software to manage the BQ-9000 required business processes - corrective & preventive actions, nonconformance, document control, internal audits, and management reviews. Also, provide the electronic distribution of company’s quality documents.
1.2Discussion
Documents that affect the biodiesel production, process, and/or equipment are candidates for document controls. These documents include internal (policies, procedures, work instructions, forms, specifications,…...) and external (industry standards, supplier/customer documents, change-notices) documents.
Most documents are assigned “standard” numbers, which includes codes for identification of owner department, type of document, and revision control. Document Control can approve a “non-standard” numbering system to handle special identification needs. ASTM specifications are an obvious example where any numbering change would add confusion.
2.0Work Instructions
01 / Owner / Create or Revise Document
Status: In-Work
a) Using QCS - select 4.0 Document & Data Control / Tab Closed-Case
ref: 10-10-0001 QCS - Access to Online Quality Control System
b) Download – current revision (or standard template if new) from QCS
ref: 10-30-0401 - Template (table method) & 10-30-0402 - Template (list method)
- select appropriate document
- from attachment section, select File to download
- viewing document, file to local PC using “save-as” feature
c) Author Changes – using local PC
- coordinate changes and requirements with affected areas
- update document as appropriate
d) Submit Document for Review using QCS
- create new 4.0 Document Control Record using new case tab
- enter appropriate data fields(see online help for details)
- attach document(s)
02 / Document Control / Standardize Document
Status: In-Work
ref: QM 4.0, QSP 4.1
a) Select Document from QCS
- select 4.0 Document & Data Control / Tab Open-Case
- select & view appropriate document
b) ValidateDocument Number & Revision
- correct as-required working with Owner
c) Validate Standard Format
- correct as-required working with Owner
- No changes to technical content allowed.
d) Review / UpdateInformation for Completeness
- validate all data fields
- validate appropriate document attachment(s)
- correct as-required working with Owner
03 / Document Control / Coordinate Review
Status: In-Review
a) Coordinate resolution of any issues
b) Distribute for Review & Approvalby email
to ownerother affected areas based on documented responsibilities
04 / Approver(s) / Review: Accept or Reject
Status: In-Review
a) Review document
- view (or print) document from QCS - 4.0 document control
- review details for approval
b) Accept or Reject – by Reply email to Document Control
- identify accept, or reject
-note: if reject, requires reason-for-rejection.
document markups may be attached for added clarity
c) Next Step
- if accept: go to step-5
- if reject: return to step-3
05 / Document Control / Final Release
Status: ACTIVE, Superseded or Obsolete
a) Select Documents from QCS
- select 4.0 Document & Data Control / Tab Open-Case
b) Release New/Revised Document
- select approved document
-set status to “ACTIVE”
c) Archive previous revision
- select previous document revision
-setstatus to “Superseded” if replaced by Active Document
-setstatus to “Obsolete” if no longer applicable & no Active replacement
3.0 References
3.1 Normative References - The following reference contains provisions which through reference in this text, constitutes provisions of the procedure. References, which are subject to revision, should always be used in the most recent form.
QM 4.0 - Document and Data Control
QSP4.1 - Document and Data Control
3.2 Informative References - The following references are included as bibliographic information, which may contain material useful in the execution of this procedure. References, which are subject to revision, should always be used in the most recent form.
10-10-0001–QCS - Access to Online Quality Control System
3.3 Documentation/Records - The implementation of this procedure requires the use of the below listed forms or reasonable facsimiles thereof and may result in records as so indicated in addition to retained completed forms. References, which are subject to revision, should always be used in the most recent form.
10-30-0001 - WI template (table method)
10-30-0002 - WI template (list method)
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