Tip of the week quality records

Quality records are the very thing that your registrar will be looking at to ensure that you are compliant with AS/ISO/QS 9000. Therefore it's a mystery to me why people pay so little attention to this section of the standards. There are eight requirements that must be addressed by your quality records procedure. When I consult with companies, I usually find that they have addressed only one or two of the eight requirements. Another mistake I see is that they try to address the requirements in each procedure. The best way to address quality records is to reference a records procedure/matrix from each of your quality system procedures. Here is a sample of a generic records procedure you can use in your company:

1. Purpose: To control ABC Quality Records and related Subcontractor records.

2. Scope: Records that demonstrate conformance to requirements and effective operation of the quality system.

3. Responsibility for Quality Records is identified in the matrix at the end of the procedure.

4. Records are identifiable to the product, person, or event to which they pertain. Records are dated, and indexed or grouped to facilitate their retrieval.

5. Quality Records will be collected, filed, indexed and maintained in such a manner as to allow the records to be easily and readily retrievable. Quality Records will be filed in the general area that the records are generated and normally maintained by the personnel that originally generated the records.

6. Data on Quality Records must be legible. Corrections of data will be made by drawing one thin line through the error and writing the corrected data onto the form by the person that wrote the incorrect information on the form. The employee will initial and date the correction.

7. Quality Records will be stored in a dry environment utilizing methods of storage that will prevent damage and deterioration.

9. The departments/positions identified in the collection and maintenance column of the matrix are responsible for the timely purging and destruction of outdated Quality Records. Retention times listed below are minimums.

Your procedures should all reference this procedure.
Example:
Records: ECNs are filed in accordance with QPRO4.16.01
or Records: NA

You can contact us at:
    E-Mail:     DBoland@QSD.NET
    Phone:     (616) 363-3032
    Address: 2728 Johnathan
                      P.O. Box 150068
                      Grand Rapids, Michigan 49515             Home

Procedure Number: QPRO4.16.01	Revision: A
Subject: Quality Records	Effective Date: now
	Approved By: WXYZ Signature on File

Record Name	Location/Access	Indexed By	Collection/Maintenance	Retention Time
Management Review Records	Management Rep. Files	Date	Management Rep.	3 Years
ECN	Engineering	ECN Number	Engineering Clerk	7 Years
CAR	N:\QAADMIN\CAR.DBF	Number	QA Tech.	3 Years

Location/Access