ISO 13485 Document Control - Document Changes - Needing Suggestions

love02eat

Involved In Discussions
#1
I am needing some suggestions on how to make changes to a work instruction that will keep the company incompliance with ISO13485. We are a manufacturing company that makes tubing for medical devices we are not a finished product we are not audited by FDA but we keep all rules in accordance. My dilemma is that different operators can finish the same job do to the fact that the product goes to different depts. to get finalized. Also accountability is not a strong point in this work place so someone is quick to say they didn't do that. (1.)There is already limited spacing for the techs to write all there measurements down but there can some times be mistakes and they correct them more then once. Also if the work order says they don't have to measure certain areas those spaces are blank. So the prior employee who created a work instruction just made it worse with using this rule 8.13.1 Use an asterisk ( * ) next to each error per person. The asterisk
will identify each error and who made the correction.
so on some docs you will 3 or 4 **** plus date and signature then she said no blanks all must put a line thru all blank data with N/A and initial and date it in the areas that doesn't get filled out. I need to know a better way for the techs to do there job with out extras and making internal audits task full because if they put the line and N/A but not there signature now its a noncompliance..



 

Attachments

Elsmar Forum Sponsor

yodon

Staff member
Super Moderator
#2
Without knowing your processes, it's going to be difficult for anyone to give appropriate suggestions. And there are a wide range of options. For example, can you move to an electronic-based system with appropriate checks and balances? Another option may be to have an in-process Quality (peer) check before the operator signs off. Another method may be to just provide more space on the form!

You do point out some pretty serious issues. The biggest of which, in my mind, is the loss of accountability. The documentation should be set up to where it's clear who did what and why (including mark-up corrections).

(Not sure what "rule 8.13.1" is and why recording asterisks is a good idea.)

I don't know how helpful that was. Probably the ideal approach would be to get all the stakeholders together to (re)define an optimized process that captures the required information, has checks along the way to minimize the need to do corrections after the fact, and covers all regulatory and customer requirements.
 
Thread starter Similar threads Forum Replies Date
B Do IFU designs have to be document controlled under ISO 13485? Document Control Systems, Procedures, Forms and Templates 2
T Document control ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 5
S What is the intent of the term "document" in ISO 13485:2016? ISO 13485:2016 - Medical Device Quality Management Systems 1
G Migrating to an ISO 13485:2016 Compliant Document Control System ISO 13485:2016 - Medical Device Quality Management Systems 6
I Does ISO 13485 have a Periodic Document Review Requirement? ISO 13485:2016 - Medical Device Quality Management Systems 7
C Document Numbering and Hierarchy Requirements for ISO 13485 Document Control Systems, Procedures, Forms and Templates 3
A Document Approval Requirements in an ISO 13485 and FDA System Document Control Systems, Procedures, Forms and Templates 7
D ISO 13485 Help - Determining what processes I specifically need to document ISO 13485:2016 - Medical Device Quality Management Systems 9
A ISO 13485, Document Control and Software Validation ISO 13485:2016 - Medical Device Quality Management Systems 9
E Document Retention Schedule Requirements per ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 4
P ISO 13485 Audit - EN 62366:2008 not in External Document File IEC 62366 - Medical Device Usability Engineering 1
I Document that summarizes the ISO 13485 and based on ISO 14969 ISO 13485:2016 - Medical Device Quality Management Systems 2
S Defining Document Review and Approval responsibilities - ISO 13485 - Medical Device Document Control Systems, Procedures, Forms and Templates 3
O ISO 13485 sample document or template - Class II medical device ISO 13485:2016 - Medical Device Quality Management Systems 16
J Document control - ISO 13485:2003 - Obsolete controlled documents shall be retained? Document Control Systems, Procedures, Forms and Templates 7
R Where to Document Exclusions per ISO 13485 and ISO 9001 ISO 13485:2016 - Medical Device Quality Management Systems 2
J ISO 13485 System 'soft start' - How to best reflect this in initial audits, management review minutes and other records? ISO 13485:2016 - Medical Device Quality Management Systems 3
D ISO 13485 - 7.3.6 Design and development verification - Do most folks create a separate SOP? ISO 13485:2016 - Medical Device Quality Management Systems 4
C ISO 13485 :2016 - CAPA - Does every CAPA need to be checked by regulations? ISO 13485:2016 - Medical Device Quality Management Systems 9
D ISO 13485 8.2.1 and 8.2.2 - Customer Feedback and Customer Complaints ISO 13485:2016 - Medical Device Quality Management Systems 5
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
M Getting started in ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 21
P ISO 13485:2016 MDSAP Certification Fee Survey ISO 13485:2016 - Medical Device Quality Management Systems 6
C SOP Template needed for ISO 13485 6.3 Infrastructure ISO 13485:2016 - Medical Device Quality Management Systems 9
T ISO 13485 8.3 - Non-Conforming Materials - on-line rework or part of process? ISO 13485:2016 - Medical Device Quality Management Systems 11
H ISO 13485 - Separate Microbiology Audits ISO 13485:2016 - Medical Device Quality Management Systems 3
C Production and Post Production feedback - ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 4
T ISO 13485 - 5.5.1 Responsibility and authority - Small Company Independence ISO 13485:2016 - Medical Device Quality Management Systems 13
D Test summary report example for design validation wanted - ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 1
T ISO 13485 - Process validation at critical suppliers ISO 13485:2016 - Medical Device Quality Management Systems 7
O ISO 13485 vs. GMP - Comparison matrix wanted EU Medical Device Regulations 3
O ISO 13485 - Is management review required before stage 1? ISO 13485:2016 - Medical Device Quality Management Systems 6
O In addition to the standard, what other ISO 13485 sources do people recommend? ISO 13485:2016 - Medical Device Quality Management Systems 5
Watchcat ISO 13485 for IVD (In-vitro Diagnostic Device) Manufacturers? ISO 13485:2016 - Medical Device Quality Management Systems 9
K Contamination Control - Class Is medical devices (Clause 6.4.2 ISO 13485:2016 (E)) ISO 13485:2016 - Medical Device Quality Management Systems 12
H ISO 13485:2016 Gap Analysis by NB ISO 13485:2016 - Medical Device Quality Management Systems 7
F ISO 13485 - EU countries that could request another audit ISO 13485:2016 - Medical Device Quality Management Systems 2
O Adding ISO 13485 to an AS9100 QMS ISO 13485:2016 - Medical Device Quality Management Systems 10
JoCam Increase to bi-annual ISO 13485 audits ISO 13485:2016 - Medical Device Quality Management Systems 2
S ISO 13485 Lead Auditor - Debate between our Quality Team and Regulatory Auditor - Internal Auditor Training ISO 13485:2016 - Medical Device Quality Management Systems 17
A ISO 13485 - Clause 8.3.3 appropriate actions in response to nonconforming product ISO 13485:2016 - Medical Device Quality Management Systems 2
N Address of Legal Manufacturing Site in ISO 13485 certificates? ISO 13485:2016 - Medical Device Quality Management Systems 1
M ISO 13485 for general purpose disinfectants? ISO 13485:2016 - Medical Device Quality Management Systems 9
L How to deal with an ISO 13485 Supplier Audit nonconformance ISO 13485:2016 - Medical Device Quality Management Systems 17
D ISO 13485, FDA 21 CFR 820 and Auditing the Accounting Department ISO 13485:2016 - Medical Device Quality Management Systems 5
M ISO 13485 extended Site (Two companies) ISO 13485:2016 - Medical Device Quality Management Systems 2
S SOP for ISO 13485:2016 Quality related Software validation ISO 13485:2016 - Medical Device Quality Management Systems 9
C ISO 13485 Requirement in Australia/NZ for class 1? ISO 13485:2016 - Medical Device Quality Management Systems 1
E Sharepoint for ISO 13485 QMS for small IVD company ISO 13485:2016 - Medical Device Quality Management Systems 7
K Restricted Scope of ISO 13485 Certification ISO 13485:2016 - Medical Device Quality Management Systems 7

Similar threads

Top Bottom