Changing Document Names/Control Numbers and Obsoleting

C

carlosl123

#1
Hello everyone,
We work for a small manufacturing company and we started it from scratch, i.e., we have no system in place other than the one we initiated since the beggining. Back then, a few documents were made and controlled through our document control procedure (first procedure in the house) but as we keep architecturing our QMS some of those documents (level 4 forms mainly) are no longer valid, at least, they don't belong to the procedures that were thought originally. let me try to explain myself, there is a training record named B04-05 Training record, but the procedure B04 is no longer dealing with training, we chose it to be the product realization one, therefore, training record shall now become part of procedure B06 (to name one...) thus named B06-01 (form number 1 derived from B06 procedure). Now that we are facing this, I need to revise Document Control procedure to deal with this type of situations, however, I want to know what your ideas are about doing so. Should I make a "Request for Obsolesence" form, should I just keep both? (dangerous and incorrect) or what would you do, i.e., how would you shape the revision to document control?
Thanks in advance.
 
Elsmar Forum Sponsor
R

RMain

#2
Sounds like you should start from a clean slate if your obsoleting the previous documents then get rid of them and restart with your new system/numbering sequence.

Just my 2 cents
 
C

carlosl123

#3
yeah, but I already have a bunch of training records that will support the competency of the people already working. Starting to write SOPs now, does not mean that the facility was ISO focused from the very begginging, and if I delete all those records, then I have no information back up.
 
S

Shoes

#4
If you don't restructure now, the problem will only get worse. Is it your charter to maintain the quality system or do you have authority to change it? If you are responsible to both create and maintain the system - I recommend correcting things as soon as possible.
 
R

RMain

#5
yeah, but I already have a bunch of training records that will support the competency of the people already working. Starting to write SOPs now, does not mean that the facility was ISO focused from the very begginging, and if I delete all those records, then I have no information back up.
Just write it into you new procedure that prior to XX/XXX/XXXX document ABC existed and provided objective evidence of XXXXXX. Place a stick in the sand and move forward continuous improvement etc....
 
C

carlosl123

#6
Just write it into you new procedure that prior to XX/XXX/XXXX document ABC existed and provided objective evidence of XXXXXX. Place a stick in the sand and move forward continuous improvement etc....
That sounds like a very good idea, will go ahead and proceed that way!
 
Thread starter Similar threads Forum Replies Date
S Changing revision status of a reviewed document Manufacturing and Related Processes 4
R Changing Document Control software. Must I transfer EVERYTHING? Document Control Systems, Procedures, Forms and Templates 3
N Document Control - Changing Company Logo Document Control Systems, Procedures, Forms and Templates 10
N Changing Document Control Identification of Job Descriptions Document Control Systems, Procedures, Forms and Templates 5
A Changing a Document used in Procedure for Quoting ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
I Changing Career Path - Document Controller to Continuous Improvement Specialist Career and Occupation Discussions 8
J Control of Obsolete Documents - Changing document control software ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
Q Global change software where changing one document changes all documents Quality Assurance and Compliance Software Tools and Solutions 1
S Sterilization validation after changing sterilization process provider Qualification and Validation (including 21 CFR Part 11) 3
R Impact of changing manufacturer post clinical investigation CE Marking (Conformité Européene) / CB Scheme 3
D Clothes changing in pharmaceutical factory Manufacturing and Related Processes 8
M Changing supplier of critical raw material (III class device) Other Medical Device and Orthopedic Related Topics 1
K Changing the Address in 510(K) Approved Product 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
T AS9100 - Changing PEARs target AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 41
C FDA on changing acceptance criteria re: analytical method validation US Food and Drug Administration (FDA) 1
V Statistical basis and justification while comparing / changing sampling plans Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 11
K Changing from Procedure based to Process based Competency Evaluations General Auditing Discussions 5
J Steps when changing material for class 1 medical device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
Marc Email Addresses - Changing your email address Elsmar Xenforo Forum Software Instructions and Help 0
supadrai OEM Changing the name of the manufacturer - length of process? Is 1-3 months correct? Other Medical Device Regulations World-Wide 0
A IMDS - Changing the Locked Weight Value RoHS, REACH, ELV, IMDS and Restricted Substances 1
D Changing Templates Approval Field Document Control Systems, Procedures, Forms and Templates 5
P Romer Arm - Profile of a Surface Changing General Measurement Device and Calibration Topics 4
D Changing software classification via software - IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 3
L MINITAB 17 - Changing Data Using Minitab Software 3
S Process validation when changing location ISO 13485:2016 - Medical Device Quality Management Systems 10
Don Fardie CAPA vs. Risk Assessment - Changing a product material for better performance ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
C Changing Registrars Registrars and Notified Bodies 15
MDD_QNA Changing the Layout of Medical Device Label(s) CE Marking (Conformité Européene) / CB Scheme 3
S Keeping track of the changing Medical Device Standards Other Medical Device Related Standards 3
J Changing of our New Hire Orientation Training Records Training - Internal, External, Online and Distance Learning 12
A Changing a Form Template & Updating Records ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
D Is anyone changing their ISO 14001:2004 EMS Policy? ISO 14001:2015 Specific Discussions 8
Q Changing Terminology in ISO 9001:2015 - Documentation Content ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
V Changing Indication of Use for a Class IIa Medical Device EU Medical Device Regulations 2
B Changing out Thermocouple - Is new calibration required? General Measurement Device and Calibration Topics 1
F Rules to respect when changing from Certification Body ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
MDD_QNA Clinical data requirements - Changing a Class I Medical Device to Class II EU Medical Device Regulations 5
shimonv Changing the Label of a Medical Device product in the field Other US Medical Device Regulations 5
E Information required about changing an off shelf part 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
M Changing FMEA template to include Detection Ranking for the PFMEA FMEA and Control Plans 2
WCHorn Changing Sampling Accept Number to Zero, Arbitrarily AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 15
M Amending CFDA Registration for changing site of shipment China Medical Device Regulations 2
S Gage R&R on Potentially Changing Parts - Guidance Needed Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
R Re-registration of medical device in Russia - "changing holder" Other Medical Device Regulations World-Wide 1
R Changing CE Mark on Documentation ISO 13485:2016 - Medical Device Quality Management Systems 2
K Changing the Auditor within a Notified Body ISO 13485:2016 - Medical Device Quality Management Systems 4
B Process Capability - Changing Limits to Improve Cpk or find Root Causes? Capability, Accuracy and Stability - Processes, Machines, etc. 6
M Changing Notified Body - Anyone have stories to share CE Marking (Conformité Européene) / CB Scheme 3
R Changing ISO 9001 Certification Scope Quality Manager and Management Related Issues 4

Similar threads

Top Bottom