Document Number: Q-1600-1 / Issued: 9/10/07
Subject: Control of Records / Revised: 10/25/10
1. PURPOSE
To establish a global procedure for identifying and controlling quality records.
2. SCOPE
This procedure applies to all personnel within the DQS UL family that are responsible for controlling quality records.
3. APPLICABLE DOCUMENTS
Q-0000, Policy Manual for Management System Registration
All Procedures
4. DEFINITIONS
See Definitions document, Q-0000-3.
5. GENERAL
This procedure defines the requirements for identification, storage, protection, retrieval, retention time and disposition of quality records.
6. PROCEDURE
6.1 Records shall be retained to provide evidence the management system has been effectively implemented. All records will be legible and protected so the integrity of the record is maintained. The following matrix defines who is responsible for storing the records, accessibility and how the records will be readily retrievable.
6.2 Any hard copy records that contain confidential customer information or personnel information are to be destroyed via shredding or some other means prior to disposal. Electronic records are disposed via deletion.
6.3 In cases where a single audit report is prepared for multiple file numbers, the audit records may be filed in EASY under one file number. However a reference record is to be uploaded in EASY or review tracking method (i.e. WFT) under the other file number stating what file to refer to for the audit records. The record is to be uploaded one time under the next audit date where this occurs as a “CA” or “RA” content group as applicable. A record is not required for every audit date.
Record / Resp. / Storage / Protection / Retrieval / Retention /Pre-Contract Sales Records – Contract Review Forms, Quotes, Signed Quotes, Preliminary Information Forms / Sales / Sales Shared Drive within Each Region and EASY / Authorized Access via secure network / Authorized personnel / Retain on shared drive until contracts issued with BR. Move to EASY for life of contract.
Contracts – Contract Review Forms / Sales/Auditor / EASY and Sales Shared Drive within Each Region / Employee ID & password / Authorized personnel / Life of contract
Customer contracts / Sales or Customer Service / Shared Drive within each region and EASY / Employee ID & password / Authorized personnel / Indefinite
Client Preliminary Information Forms / Customer &
Sales / EASY and Shared Drive within each region / Employee ID & password / Authorized personnel / Life of contract
Monthly Sales Report / Sales / Sales Shared Drive within each region / Authorized access via secure network / Authorized personnel / Minimum 2 years
Audit Reports / Auditor / EASY / Employee ID & password / Authorized personnel / Current cert cycle plus one cycle
Lead Assessor Notes Page / Auditor / EASY / Employee ID & password / Authorized personnel / Current cert cycle plus one cycle
Agenda / Auditor / EASY / Employee ID & password / Authorized personnel / Current cert cycle plus one cycle
Program Checklists / Auditor / EASY / Employee ID & password / Authorized personnel / Current cert cycle plus one cycle
Incident Report Form / Auditor / EASY / Employee ID & password / Authorized personnel / Current cert cycle plus one cycle
Lead Auditor Planning Worksheet & Continuous Assessment Planning Matrix / Auditor / EASY / Employee ID & password / Authorized personnel / Current cert cycle plus one cycle
TS 16949 CSR Mapping Tool for Organizations / Auditor / EASY / Employee ID & password / Authorized personnel / Current cert cycle plus one cycle
TS 16949 Requirements Mapping Tool for Organizations / Auditor / EASY / Employee ID & password / Authorized personnel / Current cert cycle plus one cycle
TS 2 Audit Days Calculator / Sales/Auditor / EASY / Employee ID & password / Authorized personnel / Current cert cycle plus one cycle
TS 16949 Information Sheet / Auditor / EASY / Employee ID & password / Authorized personnel / Current cert cycle plus one cycle
TS16949 Requirements Tracking Tool - TSA / Auditor / EASY / Employee ID & password / Authorized personnel / Current cert cycle plus one cycle
TS 16949 Process Turtle / Auditor / EASY / Employee ID & password / Authorized personnel / Current cert cycle plus one cycle
Medical Device Multi-program Report Forms / Auditor / EASY / Employee ID & password / Authorized personnel / Current cert cycle plus one cycle
Medical: Assessment Planning and Record Summary / Auditor / EASY / Employee ID & password / Authorized personnel / Current cert cycle plus one cycle
Opening and Closing Meeting Attendance List / Auditor / EASY / Employee ID & password / Authorized personnel / Current cert cycle plus one cycle
ISO 13485 Quality System Evidence Documentation / Auditor / EASY / Employee ID & password / Authorized personnel / Current cert cycle plus one cycle
Certificate Generation, Change & Maintenance Form, Reviewer checklist, e-mail / Technical Reviewer; VG / EASY / Employee ID & password / Authorized personnel / Current cert cycle plus one cycle
Audit Planning records / Planners, / STATS (historical only) and Dynamics / Employee ID & password / Authorized personnel / Indefinite (In Archive database after 5 years)
Client Information Records / CS, VG, Auditors / Dynamics / Employee ID & password / Authorized personnel / Indefinite
Suspension/Probation letters / Probation Coordinator/ BLM / M: Drive or EASY / Employee ID & password / Authorized personnel / Current cert cycle plus one cycle
Certificates, Letter of Compliance / CG / EASY and/or Dynamics / Employee ID & password / Authorized personnel / Life of Certificate
Online Certification Directory / IT / Online Certification Directory / Employee ID & password / Public / Life of registration plus 6 months
IATF Database / CG / IATF Database / User ID & password / Authorized personnel / External Retention
OASIS Database / CG / OASIS Database / User ID & password / Authorized personnel / External Retention
Qualification & Training records (experience, affiliations, professional status, competence and any relevant consultancy services) / CG / Hard copy - Personnel Qualification files in CG
–Dynamics database / Hard Copy - Locked storage
Restricted Access to Update Capability
Soft copy - Dynamics database / CG or HR staff
Any staff with Dynamics Access / Life of employment
L-65, list of firms & insurance coverage / Regional management / Regional Office / Employee ID & password / Authorized personnel / Minimum 3 years
Blanket purchase orders, release orders & invoices / CS / Dynamics / Employee ID & password / Authorized personnel / Minimum 1 year
Approved Subcontractors / CG / Dynamics / Employee ID & password / Authorized personnel / Minimum 1 year
Internal Audit Report including turtles / Internal Audit Coordinator / M: Drive / Employee ID & password / Authorized personnel / Minimum 3 years
MSAC Meeting Minuets / CG / VP –
Certifications / Backup Soft Copy / Authorized personnel / Minimum 3 years
Corrective/Preventive Actions, complaints / CAR Coordinator / M: Drive or equivalent / Password / Authorized personnel / Minimum 5 years
Appeals / Audit Management / EASY / Employee ID & password / Authorized personnel / Current cert cycle plus one cycle
UL DQS Inc.
Revision History Sheet
Document Number: Q-1600-1
Issue Date: 9/10/07
Document Title: Control of Records
Date / Description of Change / Originator9/10/07 / Initial Release / A. Tucker
1/16/08 / Added records: Pre-contract Sales records, Audit Schedules, Client Information, Reviewer checklist, Audit reports, ePro, Suspension/Probation letters; experience, affiliations, professional status, competence and any relevant consultancy services); Appeals, complaints, Monthly Sales Report, separate row for appeals; L-65, list of firms, insurance coverage, blanket PO’s, release orders, invoices and approved subcontractors and Signed Quotes. Added Section 6.3 regarding file of audit reports where multiple file numbers are applicable. / A. Tucker
1/12/09 / Updated to match new IT systems used for records storage – EASY and DMS / M. Garrett, L. Hamilton
1/20/09 / Additional revisions made to match new IT systems used for records storage – EASY and DMS / M. Garrett, L. Hamilton
10/25/10 / Updated records to match current practice / A. Tucker