Implementing a Paperless Documentation, Forms and Records System

R

Roberto Carvajal

#1
Paperless System

We are in the process of implementing a paperless system. Right now we are in the analysis phase, we are asking people what they beliefs are about a paperless system, in order to avoid change resistance or at least forecast the amount of change resistance.
Has somebody had experincen with implementing paperless systems ?
 
Elsmar Forum Sponsor
A

Al Dyer

#2
Roberto,

A paperless sytem is the way to go if you can allocate the proper resources ($$$) to ensure that people have access to needed documents.

I believe that going to a paperless system will not reduce document change requests, but make those requests easier to handle.

Documents need change all the time to ensure a functioning system and also give all individuals a voice in how they perform their functions.

What software system are you looking at to go paperless?

I guess my only advice would be to ensure that the system you are looking at can integrate with the many different types of electronic documents that we all use, and are network compatible.

ASD...
 
C

Carl Keller

#3
I implemented a paperless system for a manufacturing facility with 60 employees.

All employees had relatively easy access to a PC.

We placed all the documents, Quality manual, Procedures and all work instructions on the shared drive in WORD folders. All employees had access to all documents, however each department had a specific folder. Printing was not allowed. One folder was marked "general Work instructions" and contained WI's which were used throughout the facility, such as "how to write a work instruction" and "how to submit a corrective action". We placed a shortcut icon on each computer. We also placed the training file on the shared drive. We never experienced a finding relating to this system and it is still in place after 3 years. The only documents which were not paperless were corrective actions (which could be submitted hard copy or electronically)

No fancy software, no intensive system training.

Hope this helps

Carl-
 
A

Al Dyer

#4
Carl,

Did you have to devise a system where ACAD or non-networked files (MPACT/APACT/Powerway etc...) were accessible?

ASD...
 
D

Dan Larsen

#5
Originally posted by Carl Keller:
We placed all the documents, Quality manual, Procedures and all work instructions on the shared drive in WORD folders. All employees had access to all documents, however each department had a specific folder. Printing was not allowed.
Carl...

NO PRINTING! That had to drive at least a FEW of the employees crazy! :)
 
C

Carl Keller

#6
Al,

We did not have a good system for our Non-Word based files such as drawing files. This we DID have findings for from our Registrar, and rightly so. The drawings were largely out of control and my frustration with the Engineering Department eventually led to my leaving the company because I felt they were asking me to violate the ASQ code of ethics. Obviously I chose to leave rather than practice unethical behavior. I did have a plan to scan the drawings in and place them on the shared drive in PDF format, however I moved on to greener pastures rather than have a battle of wits with unarmed opponents.

Dan,
Actually the hourly worked force embraced it quite well, some supervisors wanted print access but most of the operators felt that they had enough training that they rarely felt the need to reference the WI's. More highly complex facilities or those who perform many "Non-routine" tasks may need to provide a header which reads "Uncontrolled after 48 hours" and a time/date stamp or some similar system to allow printing.

Carl-
 
R

Roberto Carvajal

#7
We are using Lotus Notes as our Tool for the Documentation System. But now, we are looking the possibility of using the Manufacturing System as a Media to Display, work instructions, customer specs, etc... instead of using a lot paperwork....

We are using Oracle as a database and a Network based system....



------------------
 
Thread starter Similar threads Forum Replies Date
C Implementing Paperless for small IT Staffing Firm <10 Employees ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
Sravan Manchikanti How to interpret '8.3 Control of nonconforming product' for SaMD device while implementing ISO 13485 & MDSAP ISO 13485:2016 - Medical Device Quality Management Systems 4
L Implementing the PRRC role in a company EU Medical Device Regulations 5
A Implementing ISO 20000-1 - Where to start Other ISO and International Standards and European Regulations 2
B Lessons Learned Implementing ISO 50001 (Chemical Engineering Progress) Other ISO and International Standards and European Regulations 0
C How medical device manufacturers are implementing standards like GDPR and HIPAA Other ISO and International Standards and European Regulations 5
M Informational EU – Commission Implementing Decision (EU) as regards the designation of expert panels in the field of medical devices Medical Device and FDA Regulations and Standards News 0
R Implementing Design History Documents/ Technical Documents in the QMS ISO 13485:2016 - Medical Device Quality Management Systems 3
tnorton Lessons learned from implementing Customer Complaints Customer Complaints 1
M Informational Update – MDR and IVDR implementing measures rolling plan – 2 more NBs designated under the new regulations Medical Device and FDA Regulations and Standards News 0
S Implementing a 45001 Health & Safety standard - Internal audit plan wanted Internal Auditing 1
M Informational Commission Implementing Decision (EU) 2019/939 of 6 June 2019 designating issuing entities designated to operate a system for the assignment of Unique Medical Device and FDA Regulations and Standards News 0
jjmusicjr Implementing Machine Replacement Part Reverse engineering technology Manufacturing and Related Processes 3
Q Does anyone have experience implementing a QMS without ISO certification? Quality Manager and Management Related Issues 2
M Informational EU – April 2019 update of the MDR and IVDR implementing measures rolling plan Medical Device and FDA Regulations and Standards News 0
I First Time Implementing Document Control for ISO-9001 - how far back do you go? Document Control Systems, Procedures, Forms and Templates 15
M Medical Device News Last update of the MDR and IVDR implementing measures rolling plan – December 2018 Medical Device and FDA Regulations and Standards News 0
J Implementing EN 62304:2006 on existing and proven medical devices IEC 62304 - Medical Device Software Life Cycle Processes 6
M Medical Device News MDR and IVDR implementing measures rolling plan EU Medical Device Regulations 0
B Implementing an Escalation Process and Andon system Supplier Quality Assurance and other Supplier Issues 1
K EQMS question - Implementing an electronic QMS to support ISO 13485:2016 Quality Assurance and Compliance Software Tools and Solutions 4
T Is there any requirement to be compliant with IEC 62304 while implementing ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 5
A Compliance Obligations - Implementing 6.1.1 and 6.1.3 NOTE - Determine risks and... ISO 14001:2015 Specific Discussions 1
G Heavy Civil Construction Company Implementing ISO 9001:2015 for Certification ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
K Implementing ISO13485:2016 in the Middle of a New Device Project ISO 13485:2016 - Medical Device Quality Management Systems 1
D Implementing 5S for Multiple Shop Floor Layout Workstations Lean in Manufacturing and Service Industries 2
N FDA Guidelines for implementing Continuous Improvement Process US Food and Drug Administration (FDA) 5
Q Easy Way of "Implementing" Risk in ISO 9001 2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
N Implementing ISO 17025 in a Calibration Laboratory ISO 17025 related Discussions 8
E Does anyone have experience implementing a Tiered QMS? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
A Implementing an AS9100 Aerospace Quality System AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 9
L Implementing ISO 9001 in small Trading Company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
C Implementing a set of bore gages at a machine Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
A Implementing Risk Management in a Medical Device "Distributor Only" company ISO 13485:2016 - Medical Device Quality Management Systems 2
T Implementing a Suspect Counterfeit Identification Program Quality Manager and Management Related Issues 3
O Implementing Lean Intranet Sharepoint Lean in Manufacturing and Service Industries 6
F Implementing ISO 9001:2008 in a new Food Processing company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
J ISO 22301 - Implementing a Business Continuity Management System Business Continuity & Resiliency Planning (BCRP) 15
M Does anyone here have experience implementing PCI DSS (Data Security Standard) IEC 27001 - Information Security Management Systems (ISMS) 10
L Implementing a new quality management system for a new engineering company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
M Implementing ISO 9001 in an Assembly Plant ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
D Understanding and implementing ISO 17025 ISO 17025 related Discussions 9
Q Implementing ISO 9001 and ISO 22000 systems at the same time Document Control Systems, Procedures, Forms and Templates 2
E Implementing a Production Accountability Program Manufacturing and Related Processes 3
J Implementing a TrackWise eQMS System Quality Assurance and Compliance Software Tools and Solutions 3
S Help for Implementing a Quality Management System Quality Management System (QMS) Manuals 3
L Implementing an improvement program is like cooking! Imported Legacy Blogs 0
S Implementing a Quality Assurance Program Service Industry Specific Topics 3
L Implementing ISO 27001 A12.1.1 Security Requirements Analysis and Specification IEC 27001 - Information Security Management Systems (ISMS) 2
C Implementing ISO 9001 - Getting whole team buy-in? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 25

Similar threads

Top Bottom