Review and Approval in Quality Records?

H

harinandu2003

#1
Ours is a small organization, and currently the major obstacle for me as Quality Manager is the opposition of the colleagues to sign on the form. Most of them prefer to just have their names typed on fields in the form and route it via email. I have tried to convince most of them that system won’t work in terms of traceability and accountability and that either we have to go for Enterprise Content Management System such as SharePoint or ERP solutions if we are to have traceability in a paperless medium. But, none is interested in the idea. To give you an idea about our organization, we are a technology innovation company of size less than 30. I would be grateful if any of you have experienced similar issues and what they have done to counter it.

Many thanks!
 
Elsmar Forum Sponsor

Jim Wynne

Leader
Admin
#2
Ours is a small organization, and currently the major obstacle for me as Quality Manager is the opposition of the colleagues to sign on the form. Most of them prefer to just have their names typed on fields in the form and route it via email. I have tried to convince most of them that system won’t work in terms of traceability and accountability and that either we have to go for Enterprise Content Management System such as SharePoint or ERP solutions if we are to have traceability in a paperless medium. But, none is interested in the idea. To give you an idea about our organization, we are a technology innovation company of size less than 30. I would be grateful if any of you have experienced similar issues and what they have done to counter it.

Many thanks!
If you're using MS Office and an Exchange server, you can use Outlook voting buttons for obtaining and recording approvals. If you look at this page from Microsoft you can see how to use voting buttons, and how to export the results to Excel.

If you're not using Outlook and an Exchange server, you can still use e-mail responses as approvals, but it takes more work--allowing for it in your document control procedure, training and a filing system--electronic or paper--to keep the records. The time to move away from paper-based systems is when your company is small and the task is more manageable. The longer you wait to set up a system, the more difficult it will become.
 
J

JaneB

#3
Harinandu
I can quite understand why a tech firm would not want to go down the 'sign the paper form' route, and shouldn't have to. Jim's given you one good suggestion. I don't necessarily see that you have to start on ERPs nor Share Point Portal, both of which might be a bit beyond your needs & budget/resources at the moment.

What's wrong (in your opinion) with using email? And why do you think "that system won’t work in terms of traceability and accountability"? I've used a range of email-based systems successfully. You do need to think carefully about how and where the records are stored, and how retrieved, but I do urge against the 'paper signature' thing - it has never worked in my experience in an IT-type organisation/environment.
 
B

Bill Marshall

#4
I agree with Jim that forms attached to emails are perfectly traceable as long as they're effectively filed at the end of the process.

Another option would be to use a facility in later versions of Office which limit input to predefined email addresses. eg only certain people have authority to type in a particular box on an excel form. That way the form can stay in one place, and the number of internal emails can be reduced.
 
Thread starter Similar threads Forum Replies Date
J Quality Manual Review and Approval - For each & every page? Quality Management System (QMS) Manuals 12
S Customer audit report review and approval ISO 13485:2016 - Medical Device Quality Management Systems 3
A Document Review and Document Approval --- 2 Signatures needed acc. §820.40? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
D Engineering Drawing Review and Approval Requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
W ISO 9001:2015 Clause 7.5.2 - Is Review and Approval applicable to Records? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 30
T Inspection Form Review And Approval - FDA Requirements ISO 13485:2016 - Medical Device Quality Management Systems 2
A Procedure for Labeling Review and Approval and Specifications Matrix US Food and Drug Administration (FDA) 2
J ISO 17665-1 & 2 Review and approval of validation (of moist heat sterilizers) Other ISO and International Standards and European Regulations 3
J Requirements for Review and Approval of QMS Documents Document Control Systems, Procedures, Forms and Templates 14
S Showing Evidence of Review and Approval of Blank Forms and Templates 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
V Supplier?s PPAP - Production Process Control Plan Review, Evaluation and Approval? FMEA and Control Plans 5
V How do you manage the Review Comments post to Approval of a Document Document Control Systems, Procedures, Forms and Templates 3
K Human Factor Assessment for IRB (Institutional Review Board) Approval? EU Medical Device Regulations 7
L ISO 9001 Document Review and Approval Form Requirements Document Control Systems, Procedures, Forms and Templates 6
B Requirement for Review and Re-Approval of Documents - ISO 9001 Clause 4.2.3 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
J Supplier Purchase Order Review and Approval Requirements IATF 16949 - Automotive Quality Systems Standard 3
S Review/Revision and Approval sections of SOP's and WI's Document Control Systems, Procedures, Forms and Templates 2
P A SAP DMS Q: Sequantial work flow for DMS review and Approval Document Control Systems, Procedures, Forms and Templates 1
G Enquiry and Contract Records - Review and Approval Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
F Delivery before PPAP review and/or approval APQP and PPAP 5
S Defining Document Review and Approval responsibilities - ISO 13485 - Medical Device Document Control Systems, Procedures, Forms and Templates 3
J Using Forum software as review and approval system. Document Control Systems, Procedures, Forms and Templates 9
M TS 16949 - 7.5.2 - Process Validation - Criteria for review and approval of processes IATF 16949 - Automotive Quality Systems Standard 8
P Review and approval methodology Document Control Systems, Procedures, Forms and Templates 1
T Document Review and Approval Form - Examples Attached Document Control Systems, Procedures, Forms and Templates 11
S Evidence of Review and Approval ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
P Purchasing Review and Approval Process QS-9000 - American Automotive Manufacturers Standard 6
Marc Do signatures need to appear on procedures to indicate review and approval? Document Control Systems, Procedures, Forms and Templates 2
Y EU MDR Technical Documentation - Defined Review EU Medical Device Regulations 1
V Review of the Requirements of products and services ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
CPhelan Optimizing Training Review Training - Internal, External, Online and Distance Learning 4
T FDA PMA review process - advisory panel timing? Other Medical Device and Orthopedic Related Topics 0
J Periodic review of Documents during management review Document Control Systems, Procedures, Forms and Templates 24
I Section 8.2.3.1 Order Review ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
J Old procedure review and training requirements Document Control Systems, Procedures, Forms and Templates 9
D Increasing efficiency - Capt. Proj. Document Review Matrix Document Control Systems, Procedures, Forms and Templates 4
M Is complete testing required as per ISO 10993 for materials used in orthopedic implants or is literature review route possible Other Medical Device Related Standards 3
S Scope of management review ISO 13485:2016 - Medical Device Quality Management Systems 5
M Are we getting scammed by our Notified Body? They are asking to review all changes to determine if they are Significant CE Marking (Conformité Européene) / CB Scheme 4
M Review of work - independent review? or can it be the same person ? ISO 17025 related Discussions 1
H Management review IATF 16949 - Automotive Quality Systems Standard 9
C Bulk Record Retention Review Records and Data - Quality, Legal and Other Evidence 4
FRA 2 FDA Product NCRs- Quality Review Nonconformance and Corrective Action 6
J How to evaluate the effectiveness of management review? IATF 16949 - Automotive Quality Systems Standard 2
D 62304 code review, unit test, integration test example IEC 62304 - Medical Device Software Life Cycle Processes 2
P Product Quality Review API-GMP Manufacturing and Related Processes 0
R Quality policy review document IATF 16949 - Automotive Quality Systems Standard 3
Q Management Review ISO 9001-2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 36
M ISO27001 18.2.1 - Internal Independent review IEC 27001 - Information Security Management Systems (ISMS) 1
M CER Review EU Medical Device Regulations 2

Similar threads

Top Bottom