Identifying and Controlling External Documents

S

Sardokar

#1
Hello to all

I am having a bit of trouble identifying what falls under the "external document" denomination

Are customer bids ( private and public )considered external documents? As such do we need to determine their location of retention and by whom they are seen?

How about manufacturer's manuals ? do these NEED to be considered external documents and controlled? one of our departments deals with software design and development, another with SUN products assembly configuration and installation, another with internet and network security...

Are manuals and hand out our employees bring back from their training sessions considered external documents?

Thanks for any help, i really am a bit lost :tg:
 
Elsmar Forum Sponsor

CarolX

Super Moderator
Super Moderator
#2
Re: Controlling External Documents

I moved your thread to the documentation board.

I am having a bit of trouble identifying what falls under the "external document" denomination
If you scroll down to the bottom of this page you will find links to similar threads.

Are customer bids ( private and public )considered external documents? As such do we need to determine their location of retention and by whom they are seen?
I would - do you want everybody seeing your quotes and bids?


How about manufacturer's manuals ? do these NEED to be considered external documents and controlled? one of our departments deals with software design and development, another with SUN products assembly configuration and installation, another with internet and network security...
Not really - but you may need to address it within your system. Something like "equipment manuals used for PM are kept in the maintenece area in binders".

Are manuals and hand out our employees bring back from their training sessions considered external documents?
Only from the standpoint of training records. If they receive some sort of certificate of completion - I would keep a copy in their training records. The rest does not need control.
 

Colin

Quite Involved in Discussions
#3
Re: Controlling External Documents

I have a general 'rule of thumb' for which documents need controlling - if a document is subject to change and someone getting the wrong version could cause a problem, control it.

Customer bids - 7.2.2 b) requires us to make sure that we are quoting for the 'right thing' so I would limit their distribution and have a system for circulating changes if they happen.

Manufacturer's manuals - unlikely to need controlling.

Course notes given to your staff - unlikely to need controlling - they are right at the time of issue (hopefully!) but are not subject to updating, unless they offer to do that for you.
 
D

danpa

#4
My opinion is to keep it simple. Set a definition of what external documents will be controlled and then execute. I control the standards and external documents referenced within our QMS procedures and vendor documents that are used as part of the process (like OS installation manuals).
As a software company we have 5 3" binders that contain all our controled external documentation. Request for Proposals/Bids are kept in our customer files.
 

Helmut Jilling

Auditor / Consultant
#5
Re: Controlling External Documents

I have a general 'rule of thumb' for which documents need controlling - if a document is subject to change and someone getting the wrong version could cause a problem, control it.

Customer bids - 7.2.2 b) requires us to make sure that we are quoting for the 'right thing' so I would limit their distribution and have a system for circulating changes if they happen.

Manufacturer's manuals - unlikely to need controlling.

Course notes given to your staff - unlikely to need controlling - they are right at the time of issue (hopefully!) but are not subject to updating, unless they offer to do that for you.
Excellent advice! :applause: I especially like your approach that you "would limit their distribution and have a system for circulating changes if they happen." Consider putting them on your server network in a read only folder as a further control.
 

harry

Super Moderator
#6
I think the subject of Machine/Manufacturer's manual needs special consideration. As a regular user of the Cove for the past 2.5 years, I witnessed several cases of people coming here seeking help because they had lost their machine manuals. The usual reasons were because the person in charge previously had left employment.

I had previous experience of trying to buy used process machines which were upgraded and modified over the years but without proper records and details. Often, we just offer a fraction of its actual value because you don't know whether you could eventually use it without further modifications.

Such manuals, blueprints and file may not need 'control' per-se, but a copy may need to be safely kept or archived somewhere.
 

Colin

Quite Involved in Discussions
#7
Harry, good point on the manuals - I normally control them as records rather than documents.
 

Raffy

Quite Involved in Discussions
#8
Hi Sardokar,
In our end, we define External document (ED) are documents of external origin from customer, certifying bodies, Vendors or subcontractors which compose of the following such as: Engineering/Technical Data Sheets, Technical Specifications, Specific Customer Quality Requirements & Industry standards such as ISO18001, ISO/TS16949, ISO22000, ISO17025.
Hope this helps.
Best regards,
Raffy:cool:
 
Thread starter Similar threads Forum Replies Date
C Identifying and Controlling External Documents Document Control Systems, Procedures, Forms and Templates 3
S Identifying and Controlling Documents of External Origin Document Control Systems, Procedures, Forms and Templates 1
M Identifying Applied Parts IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
DuncanGibbons Best practice for identifying "items" of parts for DFMEA analysis AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
M Identifying Hazards - Risk management process ISO 14971 - Medical Device Risk Management 6
O Identifying KPI for AS9100 8.1.4 - Prevention of Counterfeit Parts - PCB assembly contract manufacturer AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 16
M Identifying Technologies for Non Destructive Examination of steel brazed joints Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
R Identifying internal issues.. at what level? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
D Identifying externally provided services referenced by IATF16949 IATF 16949 - Automotive Quality Systems Standard 2
Marc ISO 9001:2015 - Identifying interested parties, or stakeholders ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
B Identifying AS9100 for a Legacy Product Manufacturing and Related Processes 11
H Identifying Guidance on Medical Device Software Level of Concern for the EU EU Medical Device Regulations 2
S Identifying Objectives & Targets for Quality Control ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
J API Q1 5.6.1.2 (iii) Identifying how the supplied product conforms Oil and Gas Industry Standards and Regulations 1
A Identifying context for every process in an organization ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 43
T "Indication for Use" Identifying Specific Procedures US Food and Drug Administration (FDA) 2
LRE67 Need help identifying this "thing" Coffee Break and Water Cooler Discussions 9
Y Identifying lighting requirements for in house Calibrations General Measurement Device and Calibration Topics 8
A Identifying and Tracking Customer Specific Requirements Customer and Company Specific Requirements 1
P Identifying Medical Device Class and Applied Part IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
S Identifying gaps over ISO 13485 to be compliant to MDD 93/42/EEC requirements EU Medical Device Regulations 5
A Please suggest analysis for identifying the warranty Reliability Analysis - Predictions, Testing and Standards 1
P Renault CSR - Identifying the difference between an ASES and ASAS-P Audit IATF 16949 - Automotive Quality Systems Standard 4
Q Identifying Critical Items and Key Characteristics - Product Realization Process AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
D Procedure for Maintaining Industry Standards and Identifying Revisions Document Control Systems, Procedures, Forms and Templates 1
S Identifying Processes in a Company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
Q Risk Factors Checklist identifying the Risks for meeting the Customer Indent AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
J Identifying version of Standards in Functional Specification of a New Device ISO 13485:2016 - Medical Device Quality Management Systems 6
K Identifying Required Testing to comply with IEC 60601 EU Medical Device Regulations 4
C Document Control and Identifying Distribution ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
H Identifying Potential Automotive Suppliers before Developing New Products Supplier Quality Assurance and other Supplier Issues 2
R Identifying procedures that are NOT required by ISO 9001 Quality Manager and Management Related Issues 17
N Identifying Changes and Revisions in QMS Documents - 4.2.3.c Requirements Document Control Systems, Procedures, Forms and Templates 13
J Help in identifying Legal and other requirements for Indian localisation Miscellaneous Environmental Standards and EMS Related Discussions 4
A Audit NC - Not identifying our Customer Specific Requirements - TS16949 (7.3.6.3) General Auditing Discussions 7
8 Introducing a Balance Line - Identifying potential future pitfalls etc. Lean in Manufacturing and Service Industries 2
V Identifying Significant Factors - Regression Analysis vs Correlation vs ANOVA vs DOE Quality Tools, Improvement and Analysis 7
F Requesting Help in Identifying Ford Suppliers Supplier Quality Assurance and other Supplier Issues 6
A Document Control File - Identifying all documents which need to be controlled Document Control Systems, Procedures, Forms and Templates 11
A Identifying the Clean Room Requirements for a Medical Device in US and EU ISO 13485:2016 - Medical Device Quality Management Systems 3
M Identifying Routine and Non-Routine Activities: OSHA OHSAS 18001 Occupational Health & Safety Management Standards 6
E Developing the Essential Requirements Checklist - Identifying Requirements Other US Medical Device Regulations 3
E Identifying the Elements of Informed Consent expected by the IRB and FDA Other US Medical Device Regulations 4
F Identifying Calibration on Small Tools (Measurement Equipment) General Measurement Device and Calibration Topics 2
C Identifying Response Times for CAPAs (Corrective and Preventive Actions) Nonconformance and Corrective Action 2
J Need help identifying nonconformities in internal audits Internal Auditing 2
A Identifying trends in QMS Nonconformities Quality Manager and Management Related Issues 1
B Looking for a Standard identifying SME's (Standard Measuring Equipment) General Measurement Device and Calibration Topics 1
C CB Client Contract Agreement - Identifying nonconformances - AS9100 Registrars and Notified Bodies 7
M Identifying Rework in Maintenance or Craftsman Operations Lean in Manufacturing and Service Industries 12

Similar threads

Top Bottom