What is the proper date to use as effective date? Old 'procedures', New documents

I

Ingeniero1

#1
We are 90% done writing our procedures, and have even conducted a few internal audits as practice for the Internal Auditors In-Training. We have used the newly created procedures for the audits, so besides training the IA, we are double-checking the procedures as well.

We have written the procedures based on what we do, and with very few exceptions, which primarily had to do with record-keeping, the procedures describe exactly what has been done for many years.

Since the procedures have been in effect for many years, but the documentation itself is new, what is the proper date to use as effective date:

a) Several years ago - best guess? (Will not be the same for all procedures, as some departments have gone more recent changes than others, but we are still talking years back for any of them.)

b) The day the department or area manager 'approved' the actual document we (I) just wrote? (Will be different for each procedure, but all will be within February through May 2004.)

c) The day we conduct our first, official internal audit? (Same for all procedures.)

What have you done in this regard?

Thanks -

Alex
 
Elsmar Forum Sponsor

RoxaneB

Super Moderator
Super Moderator
#2
My personal opinion is that your Option #2 is the best out of the choices you gave us. My reasoning is this....for many of us, the processes were established long before the documentation. The date should be reflective of the document's initial release. Following that, the evolution of the process will be captured in subsequent releases of the document.

Don't try to hide that you didn't have documentation before. It serves no purpose. You have it now...the date of now should be there.

Having it the date of the audit serves, imho, no purpose.
 

Tom W

Living the Dream...
#3
I agree - issue the documents with a "Release" revision - then through you audits and other improvements methods move on to revision A then B then so on and so on. History of changes and continual improvement is improtant to keep to make sure you are not re-creating the wheel and truely making improvements. The date should be the actual date you release the document for use. When we did QS back in 1999, we actually had already revised several of our procedures before our audit. We kept revision them and making improvements where we could, not only to the procedure but to the process on the floor. It made us look at the things we were doing and ask how we can improve.
 

The Taz!

Quite Involved in Discussions
#4
I agree. . but will add that any new procedure that requires training may have different Approval and Implementation dates. Implementation of a process change/introduction ( or procedure) includes training as appropriate.

The effective date could either be the date the procedure became "effective" (Approved), or the implementation date which would (could) include training.

Don't mean to add questions for you, but this is a point to consider in any implementation.
 
#5
Good replys all, but why have a date? You are required to ensure the revision status is identified. In order to know the status, I need to know:

1) what the revision of the document is. It can be a date, letter, name, color, whatever.
2) what revision I should be using.

IF we are using dates, then I would agree that the date used would be the date it was approved (based on this scenario). If it is a new process, then perhaps the date all of the affected employees are trained, and the document begins to govern.

:2cents:
 

RoxaneB

Super Moderator
Super Moderator
#6
db said:
Good replys all, but why have a date?
Good question! I know that for us the date is critical because our document control process is set-up such that all documents are reviewed/audited once every 365 days for adequacy (unless it is modified within that 365 day timeframe...then the annual countdown starts from the revision date).
 
#7
RCBeyette said:
Good question! I know that for us the date is critical because our document control process is set-up such that all documents are reviewed/audited once every 365 days for adequacy (unless it is modified within that 365 day timeframe...then the annual countdown starts from the revision date).
Ahh Roxy, That's what I like to hear! :agree1: Rather than saying "because ISO (or our registrar) says so", you are saying "because it makes sense for us". You have re-affirmed my faith in QMS, and I can sleep well tonight.
 

RoxaneB

Super Moderator
Super Moderator
#8
db said:
Ahh Roxy, That's what I like to hear! :agree1: Rather than saying "because ISO (or our registrar) says so", you are saying "because it makes sense for us". You have re-affirmed my faith in QMS, and I can sleep well tonight.
Shucks, Dave! I'm going all :eek: ! Of course, you of all people should know by now that I'm a strong advocate of "Make ISO conform to you...you don't conform to ISO."

It's funny, but recently I was remembering what I was like just 3 years ago when I started at my current place of employment. The very thought of a Quality Manual got me all excited! :D Now I've spent an amazing 3 years with a company that has not just ISO 9001, but a system in place...a Business Management System, complete with tools and methodologies. I think I might have even posted my little bit of BMS poetry here somewhere...

It's not about the shall's, the must's or even the rules.
It's all about the system, the process and the tools.


Okay, so I'm no Shakespeare... :lol:
 
I

Ingeniero1

#9
The date when the document is first approved is probably best.

What I believe I will do is to replace the word 'effective' with 'revision' such that instead of reading "Effective Date" it will be "Revision Date". This way, the document 'date' won't have anything to do with how long the actual procedure has been in place, but pertains only to 'that' specific document version.

...or something like that... minor point anyway...

Thanks to all!

Alex
 
Thread starter Similar threads Forum Replies Date
M Proper way to develop LCL when only given a lower spec limit Reliability Analysis - Predictions, Testing and Standards 7
K Proper document of SMPS used in infant warmer for IEC 60601-1 testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
L How to write a proper defect description in a NCR Nonconformance and Corrective Action 4
M Proper method to test flow of a regulator Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
M Proper terms for describing Hardness General Measurement Device and Calibration Topics 5
M Proper ISO standard for Pressure Testing and Leak Rates Inspection, Prints (Drawings), Testing, Sampling and Related Topics 6
C Proper Thickness Gauge for Foam/Felt and Soft Materials General Measurement Device and Calibration Topics 5
D Proper Tool to Measure Wall Thickness (ISO 3611 - Micrometers) Manufacturing and Related Processes 7
X Proper Document Control Requests Document Control Systems, Procedures, Forms and Templates 1
M Proper Gauging - GD&T - Attribute gage to check true positioning on the shop floor Inspection, Prints (Drawings), Testing, Sampling and Related Topics 6
S Proper Record/Document Manipulation Document Control Systems, Procedures, Forms and Templates 2
I Proper gauging of tight tolerance (reamed) holes General Measurement Device and Calibration Topics 4
kedarg6500 Selection of proper modifying agent for Aluminium Silicon Alloy Manufacturing and Related Processes 2
J Proper Amount of Data Points for Cpk Capability, Accuracy and Stability - Processes, Machines, etc. 12
K Proper YTD PPM Supplier Calculation Six Sigma 3
S Proper FDA Classification for a DICOM Viewer 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 29
E Measuring Parts without Proper Tools - Measurement Device Resolution Inspection, Prints (Drawings), Testing, Sampling and Related Topics 10
J Proper Method of Measuring Hex Socket Heads Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
B Getting the proper information from the supplier - Returning Nonconforming Material Nonconformance and Corrective Action 4
G What is the proper Thanks Giving turkey sampling size? Coffee Break and Water Cooler Discussions 9
B How to Determine the Proper Solder Class Manufacturing and Related Processes 5
S What is the proper flow to feedback the defective found during QA sampling check? Quality Tools, Improvement and Analysis 8
M Proper Format for a Manufacturing Route Sheet Manufacturing and Related Processes 6
K Putting a regulated device on the market without the proper ISO Certs and CE Marking EU Medical Device Regulations 9
L Proper Personnel Ratio - Quality to Manufacturing Manufacturing and Related Processes 6
M ISO14001 nonconformance - no proper treatment of wastewater prior to discharge ISO 14001:2015 Specific Discussions 6
A What is the proper definition for Class 1 & 2 design changes AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 5
C Proper GD&T for spindle & housing Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
A Proper term for 'Easy Identification'? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
M How to implement a proper Calibration System? General Measurement Device and Calibration Topics 5
F Is there a proper protocol to follow for Self Certification? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 23
B True Position without tertiary datum? Establishing a proper rotation Inspection, Prints (Drawings), Testing, Sampling and Related Topics 12
J Proper way to calibrate a check fixture General Measurement Device and Calibration Topics 7
G Proper Poundage for Checking XX Tolerance Plain Plug Gages? General Measurement Device and Calibration Topics 2
Gert Sorensen Labeling Responsibility - Manufacturer vs. Repacker? Proper Component Use ISO 13485:2016 - Medical Device Quality Management Systems 7
L Procedure for proper use and protection of Registration and Accreditation Marks Document Control Systems, Procedures, Forms and Templates 21
C What is the proper method for cleaning dial calipers? General Measurement Device and Calibration Topics 4
N Proper use of the Blueing process when inspecting the taper of bushings General Measurement Device and Calibration Topics 6
J Proper use of gauge pins - Inspecting thru holes of plastic parts General Measurement Device and Calibration Topics 19
D Rockwell vs. Vickers vs. Knoop - Does Thickness Determine the Proper Test? General Measurement Device and Calibration Topics 1
M What is the proper way to use a GO NO/GO guage? General Measurement Device and Calibration Topics 3
B Preventive and Corrective Action Mapping - Proper Sequencing ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
T Registered or Certified - What is the proper terminology? QS-9000 - American Automotive Manufacturers Standard 17
T Commission proposal being drawn up for postponement for date of application of MDR (2017/745) EU Medical Device Regulations 7
H CQI-15 2nd Edition - Date of initial assessment? IATF 16949 - Automotive Quality Systems Standard 3
I Revision History Date - date of updates or date of release? ISO 13485:2016 - Medical Device Quality Management Systems 2
J Sterile medical device expiration date 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
T CE mark start date for a device EU Medical Device Regulations 7
Z Role of economic operators (EO) post the EU MDR Date of application in May 2020 EU Medical Device Regulations 1
I Date of Quality Management System - Training Records ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 19
Similar threads


















































Top Bottom