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Quality Records
By: Neal Stiemert


Quality Records
One of the requirements of the ISO 9001:2000 standard is that you have a process to create, maintain and safeguard records. As an auditor, I will share with you some typical audit findings related to the records process. I will also provide you with a sample section from a quality manual and a records procedure.

Typical audit findings are:
  • Records required by the standard were not available
  • Records were not stored to prevent damage, deterioration and loss
  • Electronic records were not backed-up
  • Records were not completely filled out
  • Records were not legible
ISO Requirement:

(Key requirements are italicized)

4.2.4 Control of records

Records shall be established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system. Records shall remain legible, readily identifiable and retrievable. A documented procedure shall be established to define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records.

Section from a typical quality manual:

Control of Records

A documented procedure is established for the identification, storage, retrieval, protection, retention time and disposition of quality records. Records are maintained to provide evidence of conformance to requirements and the effective operation of the quality management system. Records are maintained to remain legible, readily identifiable and retrievable.

Sample Operating Procedure:

Acme
Operating Procedure
Title: Records

No.   XXX       Rev.   A

Approved By:     Ronnie Records                   Date:     2-12-05      

SCOPE:

This procedure applies to quality records created and retained by Acme.

1.0 CREATE RECORDS

Records are created and filed as indicated in Acme operating procedures.

2.0 FILE AND RETAIN RECORDS

The following are required quality records:

Record Minimum Retention Time/Years
Inspection, measuring and test equipment calibration
Internal inspection forms
Contract reviews
Management reviews
Internal quality audits
Training records
Customer complaints
Document changes
Equipment maintenance
Corrective actions
Preventive actions
Approved supplier list
Non-conforming product
Traceability 		2
2
2
2
2
2
2
2
2
2
2
2
2
2

Records shall be legible, properly indexed and stored to prevent deterioration and loss. Storage methods for records shall allow for rapid retrieval. Records may be in hard copy or electronic media. If records are stored on electronic media, they shall be backed up in accordance with Acme procedures.

3.0 PURGE RECORDS

If determined by the Q.A. Coordinator, records which have been stored for their minimum retention time may be purged form records storage and destroyed.

End of Document

Summary

The importance of keeping good records cannot be stressed enough; we are required to keep records to maintain our certification. We may also be required to keep records by our customer or regulatory agencies such as FDA, NASA, or the FAA. In my past, I have been involved in three lawsuits. The company that I worked for at that time won all three suits because our records provided evidence that our products were made in accordance with procedures and met specifications.

Here is a copy of the Records sample procedure in PDF format:

  Records Operating Procedure


I hope this information helps you with your transition. Feel free to contact me with any questions at 800-959-0632.


Neal Stiemert
President
Independent Quality Consultants, Inc.

About the Author

Neal StiemertNeal D. Stiemert is President of Independent Quality Consultants, Inc. and holds a Bachelor of Science degree from Indiana University school of business. Neal is an ASQ Certified Quality Engineer, a certified lead auditor and has over 24 years of management, auditing, consulting and training experience in the quality profession.

Neal has served as an examiner for the Minnesota Quality Award, an SPC instructor at Purdue University and an officer and committee member in the Chicago and Minnesota sections of ASQ. Neal also conducts registration audits for Smithers Quality Assessments and SAI Global Assurance Services.

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