Control of Documents and Records
Based on TS 16949 Requirement
Training Duration 2 Hrs: Ravi
Index
➨ TS Requirement for Control of Documents and Records
What is a Document and Record ?
Document requirements
Record requirements
➨ Document Hierarchy
➨ Process Landscape
➨ ZF India Document Numbering System
➨ Numbering and Process Flow of Control of documents and
record
➨ Document Template
TS Requirement for Control of
Documents and Records
4.2.3 Control of documents
Documents required by the quality management system shall be controlled. Records are a special
type of document and shall be controlled according to the requirements given in 4.2.4.
A documented procedure shall be established to define the controls needed
a) to approve documents for adequacy prior to issue,
b) to review and update as necessary and re-approve documents,
c) to ensure that changes and the current revision status of documents are identified,
d) to ensure that relevant versions of applicable documents are available at points of use,
e) to ensure that documents remain legible and readily identifiable,
f) to ensure that documents of external origin are identified and their distribution controlled, and
g) to prevent the unintended use of obsolete documents, and to apply suitable identification to them
if they are retained for any purpose .
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.
NOTE 1 “Disposition” above includes disposal.
NOTE 2 “Records” also include customer-specified records.
[Link] Records retention
The control of records shall satisfy regulatory and customer requirements
What is a Document and Record ?
➨ Document
Information and its support medium
➨ Record
Document stating results achieved or providing evidence of
activities carried out.
➨ Procedure
Specified way to carry out an activity or a process
Document requirements
➨ a) to approve documents for adequacy prior to issue,
Draft Document Approved Document
Document requirements
➨ b) to review and update as necessary and re-approve
documents,
Approved Document Re-approved Document
Document requirements
➨ c) to ensure that changes and the current revision
status of documents are identified,
Rev. 00 XXX Pvt. Ltd.
XXX Pvt. Ltd.
Rev. 01 Quality Policy
Quality Policy
Rev. 02 We are committed to
We are committed to
Rev. 03 consistently meet our
consistently meet our
customer’s needs and
customer’s needs on
Rev. 04 product quality……..
expectation on product
quality …………………
…….. Dated 12.12.06 Rev.00 Dated 06.12.09 Rev.01 …….
Document requirements
➨ d) to ensure that relevant versions of applicable
documents are available at points of use,
e.g. Procedure (Handling of Customer Complaint) dated 12.12.09 rev.01
Procedure available at. Procedure available at.
• QMS: Hard copy (rev. 01) • QMS: Hard copy (rev. 01)
• Z directory: Soft Copy (rev. 00) • Z directory: Soft Copy (rev. 01)
• C. Quality: Hard Copy (rev. 00) • C. Quality: Hard Copy (rev. 01)
• logistic: Hard Copy (rev. 00)
• Production: Soft Copy (rev. 01)
Not OK OK
Document requirements
➨ e) to ensure that documents remain legible and readily
identifiable,
Handling of Customer Complaint Handling of Customer Complaint
Doc. No. QA/12/004
Scope: …….. Scope: ……..
Purpose: …… Purpose: ……
Process Flow: …. Process Flow: ….
opy
olC
r
ont
C
Dated 12.12.09 Rev. 01 N div. QA Dated 12.12.09 Rev. 01
Document requirements
➨ f) to ensure that documents of external origin are
identified and their distribution controlled, and
Documents of external origin
• ISO/TS 16949 standard
• Other ISO standards
• AIAG manuals
• Customer specific requirements
• etc
Document requirements
➨ g) to prevent the unintended use of obsolete
documents, and to apply suitable identification to them
if they are retained for any purpose .
Handling of Customer Complaint Recall all copy
Doc. No. QA/12/004 of obsolete
documents by
Scope: …….. QMS and
destroy it.
Purpose: …… Handling of Customer Complaint
Doc. No. QA/12/004
Process Flow: ….
Scope: ……..
Purpose: ……
Process Flow: ….
N div. QA Dated 06.12.09 Rev. 00
N div. QA Dated 06.12.09 Rev. 00
Record requirements
➨ Statement: Records are a special type of document
and shall be controlled according to the requirements
given in 4.2.4.
Record requirements
➨ legible,
➨ readily identifiable and
➨ retrievable
Customer Complaint Monitoring sheet
S. No No. Of Customer Complaint for the month of Dec’09
X
01.12 02.12 03.12 04.12 05.12 06.12 07.12 08.12 09.12
+
2 0 0 1
GM
0 0 1 0
AL
Storage
Can be recovered when required
QA/R/006 Dated: 07.06
Record requirements
➨ identification,
➨ storage,
➨ protection,
➨ retrieval,
➨ retention time and
➨ disposition
Record requirements
➨ Storage
Record requirements
➨ Protection
against unintentional damage or destruction
Record requirements
➨ Retention time
It represents the period of time a document should be kept or
"retained".
At the termination of the retention period, the document is
usually destroyed.
legal, customer-specific
and company evidence
Date of creation of record End of period of use requirements
Period of Use Archiving Period
Retention Period
Document Hierarchy
Quality
Management
Manual
Increasing Level of Detail
(QMM)
Business process
Procedures
Work Instructions
Checklist, Form etc.
Process Flow of Control of Document
and Record
➨ Process Flow Responsibility
Document creation/
modification; data acquisition;
Originator Dept.
standards, customer
document ...
ok
Not ok
Document Respective Dept Head
check and
approval
ok
Not ok
Document
check and Final MR/QMS
approval
Registration of Document QMS
Storage/archiving of original
QMS
Document or info in mandatory
mailing list (w/ instruction:
"destroy invalidated version")
QMS
A
Control of Document and Record
➨ Process Flow Responsibility
A
Use of new document, destruction
of invalidated document ,
or mark and archive.
Ensure of permanent availability QMS
and legibility.
Thanks for the kind attention
