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Control of Quality Records
DOC ID: 432

PURPOSE:

To ensure that quality records are identified, collected, indexed, accessible, filed, stored and maintained to prevent damage or deterioration.

SCOPE:

Quality Records Matrix
Element Record Responsibility Location Storage Type Retention Time(minimum)
5.0 Management Review Minutes Facility/OPS Manager Facility Manager File Hard Copy 3 Years
Weekly Customer Focus Meetings Functional Leads Visual Display Board Visual 1 Week
7.0

8.2.1

Proposal Business Development Manager Customer files Hard Copy Until expired
Quotes Business Development Manager & Business Admin. RFQ/ Sales Order File Hard Copy 1 Year
Sales Order Business Admin. Customer Files Hard Copy 7 Years
Customer Feedback Log Business Development Manager & Business Admin. Customer Feedback Files Hard Copy & Electronic 3 Years
7.4

7.4.3

7.5

Supplier Survey Purchasing Supplier Files Hard Copy & Electronic Life of Product (+10years for EN/ISO)
Supplier Non-conformance Trends Purchasing/ Quality QA Non-conformance Database Electronic 3 Years
Supplier Notifications Purchasing Supplier Files Hard Copy Life of Product
Supplier Corrective Action Requests Quality CAR/PAR/SCAR binder Hard Copy 3 Years
Deviation/ Concession Requests Quality Deviation/ Concession binder Hard Copy 3 Years
Purchase Orders Purchasing/ Quality Supplier Files Hard Copy 7 Years
7.2.1 Notification to Customer Business Administrator Customer Files Hard Copy 10 Years
8.2.3

8.2.4

Work order Traveler Operations Quality File Hard Copy Life of Product (+10years for EN/ISO)
Cylinder Production/ Test Log Operations Quality File Hard Copy Life of Product (+10years for EN/ISO)
MFG. Material Record Operations Quality File Hard Copy Life of Product (+10years for EN/ISO)
Cure Chart Operations Quality File Hard Copy Life of Product (+10years for EN/ISO)
Resin Mix Form Operations Quality File Hard Copy Life of Product (+10years for EN/ISO)
Certificate of Conformance Project Engineer (non-commercial only) or Shipping Coordinator Product Notebook (non-commercial only) Hard Copy Life of Product (non-commercial only)
New Equipment Validation Form Maintenance Lead Validation Notebook Hard Copy 15 Years
First Article Inspection Form QA or Project Engineer (non-commercial only) Quality File or Product Notebook (non-commercial only) Hard Copy or On-Line Life of Product (+10years for EN/ISO)
4.2.3 Cylinder Production/ Test Log Operations Quality File Hard Copy Life of Product (+10years for EN/ISO)
Final Inspection Form QA Quality File Hard Copy & Electronic Life of Product (+10years for EN/ISO)
Acceptance Test Plan Data Project Engineer Product Notebook Hard Copy Life of Product (+10years for EN/ISO)
Qualification Test Plan Data Project Engineer Product Development Notebook Hard Copy Life of Product (+10years for EN/ISO)
Manufacturing Plan Data Project Engineer Product Notebook Hard Copy Life of Product (+10years for EN/ISO)
Inspection Form Project Engineer Quality File Hard Copy Life of Product (+10years for EN/ISO)
Mfg. Material Record Operations Quality File or Product Notebook Hard Copy Life of Product (+10years for EN/ISO)
First Article Inspection Form QA or Project Engineer (non-commercial only) Quality File or Product Notebook (non-commercial only) Hard Copy or On-line Life of Product (+10years for EN/ISO)
7.6 Calibration Records QA Calibration File Hard Copy & Electronic 15 Years
Calibration Procedures QA Calibration File Hard Copy & Electronic 15 Years
Calibration Certs. QA Calibration File Hard Copy 15 Years
7.5 Non-conforming Material Report (NCMR) QA NCMR Binder Hard Copy & Electronic "use as is" Life of product (all other dispositions for 1 Year)
Rework Traveler QA Quality File Hard Copy Life of Product (+10years for EN/ISO)
Work Order Traveler QA Quality File Hard Copy Life of Product (+10years for EN/ISO)
8.5 Corrective/ Preventive Action (CAR/PAR) Requests QA CAR/PAR/SCAR Binder Hard Copy 3 Years
Return Material Authorization (RMA) Form QA RMA Binder Hard Copy Life of Product
Supplier Corrective Action Requests (SCAR) QA & Purchasing CAR/PAR/SCAR Binder Hard Copy 3 Years
8.2.2 Internal Quality Audit Summary Reports QA Engineer Internal Audit File Hard Copy 3 Years
Audit Finding Reports QA Internal/ External Audit File Hard Copy 3 Years
6.0 Training Records & Certificates Team Leads Personnel files, On-line & Visual Matrix Hard Copy & Electronic Length of Employment


RESPONSIBILITY:

  • Quality Record Maintenance:

    • Quality Records are to be filed in a manner to ensure they are easily accessible and maintained in an environment, which will prevent loss, damage or deterioration during storage.

    • Quality Records will be made available for review for regulatory bodies or for customers, when required by contract.

    • Quality Records, for space-limiting reasons, may be stored off-site at an approved vendor.  This vendor will be selected and approved in accordance with Process # PTD-4.6 (Purchasing).

    • Electronic Quality Records will be backed-up on a weekly basis and be kept for a period of one month.  Those back-up tapes will be stored in a fireproof safe to prevent damage.

    References:

    • Section 4.16 of AS9100-2001 (Control of Quality Records)

    • TPED Annex 4 (EN/ISO) - Transportation Protection Equipment Directive

    • PED (EN/ISO) - Protective Equipment Directive

PROCEDURE:



REFERENCES:

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