Control of Documents and Record

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 documentsDocuments 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 neededa) 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, andg) 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 recordsRecords 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.

4.2.4.1 Records retentionThe 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


b) to review and update as necessary and re-approve documents,

Approved Document Re-approved Document


c) to ensure that changes and the current revision status of documents are identified,

Rev. 00Rev. 01Rev. 02Rev. 03Rev. 04……..

XXX Pvt. Ltd.

Quality Policy

We are committed to consistently meet our customer’s needs on product quality……..

Dated 12.12.06 Rev.00

XXX Pvt. Ltd.

Quality Policy

We are committed to consistently meet our customer’s needs and expectation on product quality …………………

Dated 06.12.09 Rev.01 …….


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.• QMS: Hard copy (rev. 01)• Z directory: Soft Copy (rev. 00)• C. Quality: Hard Copy (rev. 00)• logistic: Hard Copy (rev. 00)• Production: Soft Copy (rev. 01)

Procedure available at.• QMS: Hard copy (rev. 01)• Z directory: Soft Copy (rev. 01)• C. Quality: Hard Copy (rev. 01)

OKNot OK


e) to ensure that documents remain legible and readily identifiable,

Handling of Customer ComplaintDoc. No. QA/12/004

N div. QA Dated 12.12.09 Rev. 01

Scope: ……..

Purpose: ……

Process Flow: ….

Handling of Customer Complaint

Dated 12.12.09 Rev. 01

Scope: ……..

Purpose: ……

Process Flow: ….

Control C

opy

Control C

opy


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

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

Doc. No. QA/12/004


Scope: ……..

Purpose: ……

Process Flow: ….


Handling of Customer ComplaintDoc. No. QA/12/004


Scope: ……..

Purpose: ……

Process Flow: ….

Recall all copy of obsolete documents by QMS and destroy it.

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

2 0 0 1

0 0 1 0

01.12 02.12 03.12 04.12 05.12 06.12 07.12 08.12 09.12

GM

AL

QA/R/006 Dated: 07.06

+Storage

Can be recovered when required

X

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.

Date of creation of record

Retention Period

Archiving Period

End of period of use

legal, customer-specific and company evidence requirements

Period of Use

Document Hierarchy

Business process

Work Instructions

In

cre

asi

ng

Le

vel o

f D

eta

il

Procedures

QualityManagement

Manual(QMM)

Checklist, Form etc.

Process Flow of Control of Document and Record

Process Flow ResponsibilityOriginator Dept.

Respective Dept Head

MR/QMS

QMS

QMS

QMS

Document creation/ modification; data acquisition; standards, customer document ...

Document check and approval

Document check and Final

approval

ok

Not ok

Not ok

Registration of Document

Document or info in mandatory mailing list (w/ instruction:

"destroy invalidated version")

A

Storage/archiving of original

ok

Control of Document and Record

Process Flow Responsibility

QMS

A

Use of new document, destruction of invalidated document ,

or mark and archive. Ensure of permanent availability

and legibility.

Thanks for the kind attention