Managing New and Revised Electronic Documents (Procedures) - Share Point

J

jyngers

#1
Hi,

We recently implemented posting our procedures in our company's Share Point system. i also included alerts on every changes so everyone is aware of the new or revised process. But what about getting an evidence of distribution and acknowledgment.

On our printed copies we asked them to sign an acknowledgment receipt as an evidence that they received a copy but now that its electronic it seems irrelevant since they didnt actually received any copy but was placed instead in the share point. If i asked them to send me an email to acknoweldge it... it wont work.:mad:

Thanks to all in advance.. I know that it seems a bit petty but am a bit lost.

Advance Merry Christmas
 
Elsmar Forum Sponsor

pkost

Trusted Information Resource
#2
Re: Managing Electronic Procedures

Do you have a list of people who should be regularly accessing the procedure? If so, keep a record of access logs to the files. After a week/month/whatever is suitable review the access logs and verify that all regular users have accessed the new procedure. If they haven't give the a prod.

You should also train into people that they shouldn't be printing off uncontrolled copies and if this is absolutely necessary include an expiry date or train in that they should verify their copy is current before use. If un controlled copies continue to be an issue convert the documents to pdf and prevent printing in the security settings. You can then control printed copies if absolutely necessary


Edit: Do you work in a regulated industry such as medical devices? do you have to comply with the FDA regulations, if so did you configure sharepoint in house or did you get an off the shelf modification to make it compliant? I am currently looking into electronic document control and signatures for where I work.
 
N

nayone - 2012

#3
Re: Managing Electronic Procedures

we have a signature sheet that is signed & scanned into a table in the SOP at the start of the procedure detailing that everyone is happy with the changes & what they are. This is then uploaded to share point
 

Wes Bucey

Quite Involved in Discussions
#4
Re: Managing Electronic Procedures

There are other software solutons for collaboration which contain tracking to determine who has viewed documents, but almost all I know of [today] require input from the reader to acknowledge agreement or acquiescence to the document - there is NEVER a case in Quality Management Systems where an author can assume someone agrees with his document just because he hasn't made a formal declaration he disagrees.
 
#5
Re: Managing Electronic Procedures

Hi,

We recently implemented posting our procedures in our company's Share Point system. i also included alerts on every changes so everyone is aware of the new or revised process. But what about getting an evidence of distribution and acknowledgment.

On our printed copies we asked them to sign an acknowledgment receipt as an evidence that they received a copy but now that its electronic it seems irrelevant since they didnt actually received any copy but was placed instead in the share point. If i asked them to send me an email to acknoweldge it... it wont work.:mad:

Thanks to all in advance.. I know that it seems a bit petty but am a bit lost.

Advance Merry Christmas
I'm not sure I understand the problem. If you only allow specific individuals to place the documents into SharePoint, then you control the approval process. And if everyone who needs documents have access to SharePoint, then the documents are available at points of use. Why would you need some documentation that someone received a document that is on line? If they have access to SharePoint, they "received" the document. I think all you would have to do is to remove all paper copies and use SharePoint as the only control mechanism...
 
G

George Weiss

#6
Re: Managing Electronic Procedures

In agreement with the why sign off by each user for some information.
In the case of training or other health/safety annual presentations, I have been "exposed" to online electronic sign-off of modules in classes being taken at individual speed online at work. This tracks the process of employee training in less sophisticated software applications. This would be a question choice example: [completed module], or [hold for later completion], and or other. Online indication of read/understand the latest QMS rev. update is a replacement for the routing of new hard copies with sign-off page attached.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#7
Re: Managing Electronic Procedures

But what about getting an evidence of distribution and acknowledgment.
Where is the requirement for that?

It is so easy for people to confuse bureaucracy with QMS. If your Sharepoint system makes the documents available to people, if the users of such documents are aware of the system and use it, problem solved.

Having an acknowledgment form, electronic or hard copy, that people received a newer version of a document is, for the most part, non-value added bureaucracy. Be careful not to negatively impact people's productivity with it.

If, based on a risk assessment, you believe certain people most definitely must be aware of a document revision, institute a mandatory training session and keep records of such training. But again, be selective with those sessions. In most cases, people can become aware and acquainted with a document revision, just by reading it and understanding the nature of the changes.

Cheers.
 
G

George Weiss

#8
Re: Managing Electronic Procedures

A sign-off sheet might not be a requirement, but a means of knowing who has viewed the rev. and who might still benifit from viewing it. A non-binding circulation of a news worthy change, in hard copy, can get stuck, if there is no where-it-has-been list. A "where-it-has-been" list sounds so much more cheesy than "reviewed-and-awareness" list.
Cheesy is avoided, Quality sells....................
 
J

jyngers

#9
The printed copy of the procedures are signed by the process owners. Afterwhich, this will be scanned and coverted as a secured pdf file that disables printing the document before it will be uploaded to Share Point. Restriction was set as well per procedure (or folder) to ensure that the right group or department can access certain procedures.

I was just a bit confused on how to handle it since we previously issue a hard copy to all departments and asking them to sign a receving document that they have received a copy. Now that its electronic, i dont find the relevance of asking them to sign something that was electronic in nature.

Thank you guys for the enlightenment. :applause:
 
Thread starter Similar threads Forum Replies Date
Q Managing a "special" customer into the QMS? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
D Recent changes to ISO 14971 - SOP required for managing standard revisions ISO 13485:2016 - Medical Device Quality Management Systems 1
A Managing overseas travel risks to food handlers Food Safety - ISO 22000, HACCP (21 CFR 120) 3
S Managing specification changes on standard parts purchased through trading companies Document Control Systems, Procedures, Forms and Templates 2
L Managing design projects: New Medical Device Project or Change Design and Development of Products and Processes 1
M Medical Device News DHS – Health Industry Cybersecurity Practices: Managing Threats and Protecting Patients Medical Device and FDA Regulations and Standards News 0
F Device Standards - Managing Changes to existing standards that apply to our devices Other Medical Device Related Standards 1
J Design Verification - Managing Changes Design and Development of Products and Processes 4
Jane's You may or may not have the same person managing Operations and QA ISO 13485:2016 - Medical Device Quality Management Systems 18
Q Managing Internal/External RNC and Complaints in same Format ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
L Managing Finance Processes - Identification of Sub Processes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
J Microbiology Testing - Managing a Microbiology Process Hospitals, Clinics & other Health Care Providers 2
R Managing Level 3 Production Documents - Document Control System Help Document Control Systems, Procedures, Forms and Templates 6
G Managing Ongoing Compliance to Standards when they are Changed Misc. Quality Assurance and Business Systems Related Topics 3
R Managing Employee Training Files - 21 CFR Part 820.25 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
P Need ideas on managing Shelf Life Studies within an organization ISO 13485:2016 - Medical Device Quality Management Systems 1
I Any recommendations on software for managing the APQP, PPAP, PFMEA, Control Plan etc? Quality Assurance and Compliance Software Tools and Solutions 2
R Managing Tooling Condition at Suppliers Supplier Quality Assurance and other Supplier Issues 6
B Subsidiary - No Managing Director - Is ISO 9001 Certification Possible? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
R Looking for Practical Advice in Managing Measurement Uncertainties Measurement Uncertainty (MU) 3
L Managing ITP with an ERP system Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
Q Form for Managing Coating Process Parameter Changes during Production Document Control Systems, Procedures, Forms and Templates 2
S Managing a Significant Number of Outstanding Non-Conformities Nonconformance and Corrective Action 6
A Software Tools for managing a QMS (Quality Management System) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
C Managing Inspection Records with a Database and Destroying Paper Records Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
D Process for Managing Documents which are Overdue for Review Document Control Systems, Procedures, Forms and Templates 17
S Q1 Manufacturing Site Assessment - Managing Post-Job 1 Changes Procedure Manufacturing and Related Processes 1
B Are there any Standards related to Managing an Airport Various Other Specifications, Standards, and related Requirements 3
Q Managing Internal and Client Complaints ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
S Industry Best Practices for managing outside Engineering Consultants Design and Development of Products and Processes 3
Q Process or Departments - Document Content and Managing the Process Approach ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
Q Filtering ECR/ECO by quality management? Managing Engineering Changes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
C Managing the Unexpected - Book Recommendation Book, Video, Blog and Web Site Reviews and Recommendations 1
T Internal Conflict of Interest in Managing Suppliers Supplier Quality Assurance and other Supplier Issues 2
L Managing Certificates of Analysis or Conformance for Products Quality Assurance and Compliance Software Tools and Solutions 4
T Managing Audit Reports and Schedules General Auditing Discussions 3
M Managing Changes to an SFDA Registered Device China Medical Device Regulations 6
F Who manages QI projects? Quality or PMO? Managing Six Sigma and Lean Projects Six Sigma 2
Hami812 Attribute Data Gage R&R - Managing Data Sets - Minitab Using Minitab Software 2
E Nonconformity on managing documents for Electric Arc Furnace Manufacturing and Related Processes 4
D Managing an Employee Suggestion Program Quality Manager and Management Related Issues 4
K Managing Prerequisite Programme Activities Food Safety - ISO 22000, HACCP (21 CFR 120) 2
M Non Normal Data Managing - Clements Method to get Process Characteristics Statistical Analysis Tools, Techniques and SPC 8
N Managing Subcontracting Process - Material Traceability from Warehouse to Processing ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
G Should ISO/QMS policy be signed by the Managing Director or anyone from Top Mgt? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
M Managing Quality Risks in Construction Quality Manager and Management Related Issues 14
D Managing Product Risk Management ISO 14971 - Medical Device Risk Management 1
S EOQ (Economic Order Quantity) - Use for managing Customer Orders - asking help Lean in Manufacturing and Service Industries 5
Michael Malis Managing Use Error Risk - FDA Position: Use Error is Manufacturer's responsilbility 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 23
A Managing and Scheduling Internal Audits Internal Auditing 5
Similar threads


















































Top Bottom