We begin the New Year with a review of Clause 4.16 Control of Quality Records.

Four additional ISO Clauses remain and the series will be completed. However,
with the introduction of ISO 9001:2000, the series will continue with
comparisons and updates to help you and your company better understand
QS9000-2000 requirements and conversion from ISO 9000 1994 documentation.

ISO 9001-2000 Second Committee Draft (CD) has been available since February
1999 (see the March 1999 issue of MoldMaking Technology magazine.) The Draft
International Standard ISO 9001-2000 will be available for purchase January 15,
2000.

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Introduction
ANSI/ISO/ASQ Q9000-2-1997 states: "The supplier's quality records should give
evidence that quality system elements falling within the requirements of Q9001-2
or 9003 have been implemented. If the results have not proved satisfactory,
quality records should indicate what has been done to correct the situation."

The approach for control of quality records is to identify the records required in
each of your procedures to support or provide objective evidence that the
procedure has been followed. It is suggested that you develop one procedure to
comply with Clause 4.16.

The following list of clauses is provided to identify Clause 4.16 quality record
requirements.
4.1.3 Management Review
4.2.3 Quality Planning
4.3 Contract Review
4.4.5 Design Output
4.4.6 Design Review
4.4.7 Design Verification
4.6.2 Acceptable Subcontractors
4.7 Control of Customer Supplied Product
4.8 Product Traceability
4.9 Process Control
4.10.2.3 Urgent Production Release
4.10.4 Final Inspection & Testing
4.10.5 Inspection and Test Records
4.11.1 Control of Inspection, M & T Equipment
4.11.2.e Control Procedure
4.13.2 Review and Disposition Nonconforming Product
4.14.1 Corrective/Preventive Action
4.14.2 b Results of Nonconforming Work
4.16 Subcontractor Quality Records
4.17 Internal Quality Audits Training

One easy method of meeting quality records requirements is to develop a record

matrix as part of your Clause 4.16 procedure. The matrix headers (see Table I)
provide clear guidance for each responsible party within your organization.

Clause 4.16 Control of Quality Records

"The supplier shall establish and maintain documented procedures for
identification, collection, indexing, access, filing, storage, maintenance and
disposition of quality records."

There are eight specific procedural requirements that will be individually

addressed:
1. Identification of Quality Records
Action Item
Refer to Table I. The matrix identifies each of the quality records by department.
Identification is also accomplished in each of your procedures addressing the 20
elements of the standard. Within each procedure, identify forms, reports, lists,
charts or any other required quality record.

2. Collection of Quality Records

Action Item
When you identify a quality record in a procedure be sure to include what
happens to the record after a specification is completed. This direction will
explain whom the record passes on to, is submitted to or where the records are
collected. For example: the in-process inspector initials block "x" on the traveler
indicating inspection passed. The traveler remains with the part until final
inspection.