General nonconformity treatment for unresponsive personnel

Graciel

Involved In Discussions
#1
Hi all.
Currently, the company I work for started to use a software for registering and answering all kind of non conformities (Internal issues, customer, Iso audit, 5S audit....) But.....the areas are not giving the proper attention to it. Even though the softwares sends notification to responsibles. How do you guys manage this types of situations?
 
Elsmar Forum Sponsor

Zero_yield

No cost too great...for Quality
#3
There's small things to make things easier for everyone: Sending out weekly and monthly reminders of actions coming due, asking for regular status updates at different intervals, KPIs like # of overdue records, # of extended records, etc.

Ultimately, it's a management issue. Management defines responsibilities and divides up resources. If those in charge say "A priority for the department is zero overdue nonconformance actions and no more than X% extensions," and follows up on that with both words and actions, people take nonconformance actions seriously. If management says "Your top priority is Project Alpha. Don't worry about that CAPA until Project Alpha is complete," people will prioritize accordingly.
 

qualprod

Trusted Information Resource
#4
Hi all.
Currently, the company I work for started to use a software for registering and answering all kind of non conformities (Internal issues, customer, Iso audit, 5S audit....) But.....the areas are not giving the proper attention to it. Even though the softwares sends notification to responsibles. How do you guys manage this types of situations?
With software or not, is a comittment issue.
What about top management?
is he/she aware of it?
If he /she is interested in the system, ok, you have more options to get what you want.
If is the contrary, start to faind other job, is frustrating and difficult this matter when you are the only one interested in the QMS.
 

Sidney Vianna

Post Responsibly
Leader
Admin
#5
Hi all.
But.....the areas are not giving the proper attention to it. Even though the softwares sends notification to responsibles. How do you guys manage this types of situations?
This has been discussed here so many times. Have you tried a search? Ultimately, it is a matter of corporate culture towards accountability. If top management allows an environment where people does not feel they have to respond to issues they are responsible for, there is no software, hardware, humanware or miracleware that will fix that.

C/A (Corrective Action) not closed in a timely manner
Corrective/Preventive Action response time - best practices?
Timeframe to resolve Corrective Actions (Undue Delay)
 

Mike S.

Happy to be Alive
Trusted Information Resource
#7
Maybe it's an accountability issue. Maybe no one can understand how to use the %^$# new software, or the new software method takes twice as long and no one has the time.
 

optomist1

A Sea of Statistics
Super Moderator
#8
Hi Graciel,

my three (3) Euros worth...until one ties the whole NCs, Issues process to personnel AND department goals & Objectives....measurable and used in the review and pay process, you will likely be spinning your wheels...my humble recommendation based upon many similar situations

hope this helps...
Optomist1
 
Thread starter Similar threads Forum Replies Date
R General Obligations of Importers under EU MDR EU Medical Device Regulations 2
A Difference between general PMCF and PMS EU Medical Device Regulations 0
Dan Pare Density Column setup for Measuring General Purpose ABS General Measurement Device and Calibration Topics 0
Watchcat REGULATORY WATCHCAT - De Novo Proposed Rule - General Comments Other US Medical Device Regulations 2
E Technical documentation for IVDD General/ other CE Marking (Conformité Européene) / CB Scheme 3
C Certification vs Accreditation Training (General) Training - Internal, External, Online and Distance Learning 1
Judy Abbott General temperature used in the blasting process and laser process Manufacturing and Related Processes 2
D Preventive Maintenance vs. General Cleaning ISO 13485:2016 - Medical Device Quality Management Systems 2
Y What are different Special Inspection Level 1-4 and General spesification 1-3 ? AQL - Acceptable Quality Level 0
B General Motors and Honda Alliance - What does this mean to suppliers? IATF 16949 - Automotive Quality Systems Standard 3
F General Data Protection Regulation (GDRP) CE Marking (Conformité Européene) / CB Scheme 6
A Interpretation of GMP Requirements for class 1 medical device manufacturer (device GMP exempt, only General controls applicable) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
D Importing a general wellness low risk product Other US Medical Device Regulations 3
M ISO 13485 for general purpose disinfectants? ISO 13485:2016 - Medical Device Quality Management Systems 9
M Do you need an Applicable general safety and performance requirements Checklist? EU Medical Device Regulations 2
DitchDigger UDI, Labeling Accessories, General Insanity, Etc. US Food and Drug Administration (FDA) 1
G Problem Resolution Report Monitoring - Customer complaint or PRR as general motors use Customer Complaints 12
P Is there a counterpart to the General Safety and Performance Regulations for the USA? Other US Medical Device Regulations 4
C CE marking for general IVD (self-certified) & ISO 13485 QMS requirements - auditing EU Medical Device Regulations 7
M Informational WHO – Report by the Director-General – Standardization of medical devices nomenclature Medical Device and FDA Regulations and Standards News 0
J General Motors SSE Launch Algorithm - SCMS's Service Industry Specific Topics 0
D Incoming (Receiving) Inspection - General form for incoming part inspection Document Control Systems, Procedures, Forms and Templates 17
M Informational 2019 Meeting Materials of the General and Plastic Surgery Devices Panel Medical Device and FDA Regulations and Standards News 0
M FDA Guidance - general wellness products - wearables Other Medical Device Related Standards 5
MrTetris GDPR - General Data Protection Regulation - Only applicable to EU data? Other ISO and International Standards and European Regulations 6
M Informational The USFDA Announces General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting on March 25-26, 2019 Medical Device and FDA Regulations and Standards News 0
M Oxygen enriched environment applicability - Operating table used in general surgeries in hospital IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
Marc Definition GSPR - General Safety and Performance Requirements Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 0
M Annex I - General Safety and Performance Requirements. Precise identity - how provided EU Medical Device Regulations 6
E What is the general time line to prepare for IATF Letter of Conformance? IATF 16949 - Automotive Quality Systems Standard 1
S General Awareness Training for AS9100 Rev.D AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
B IVD or a general product test kit (if such a thing exists) EU Medical Device Regulations 0
L GDPR scope - "Personal data" definition - General Data Protection Regulation EU Medical Device Regulations 5
S GDPR (General Data Protection Regulation) - My company is ISMS certified IEC 27001 - Information Security Management Systems (ISMS) 5
S Business development and support - Getting business general liability insurance Career and Occupation Discussions 5
DietCokeofEvil What is the general consensus on Caliper tolerances? General Measurement Device and Calibration Topics 1
W EU GDPR General Data Protection Regulation - What we need to update for our QMS EU Medical Device Regulations 14
Y Change Control - General Processes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
D General questions about Medical Device MOPs and MOPPs IEC 60601 - Medical Electrical Equipment Safety Standards Series 31
Albert G. What are general examples of audit findings with ISO 9001:2015? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
H ISO 9001:2015 Cl. 9.3.1 - General Director doesn't participate in Management Review ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
T GDPR - General Data Protection Regulation (EU and UK 2018) Other ISO and International Standards and European Regulations 7
S AS9100D Transitional Audit General Question Checklist AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
S Dates on Labels acceptable to the USA - GS1 General Specification 3.4.4 Other US Medical Device Regulations 3
K Thoughts on the impact of the General Data Protection Regulation? Medical Information Technology, Medical Software and Health Informatics 5
Pmarszal Clarification for 21 CFR Part 11.100 - General Requirements Other US Medical Device Regulations 14
T Difference betwee General vs. Follow-up Inspections US Food and Drug Administration (FDA) 3
L Wrist Actigraph Device - IEC 60601-1 general questions IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
C When is a device considered "sold to the general public?" Canada Medical Device Regulations 2
C Iran - Who is holder of an Iranian registration in general? Other Medical Device Regulations World-Wide 2

Similar threads

Top Bottom