Corrective Action for Discrepancy - Where to start and how to document

V

Vash Stampede

#1
Hello everyone,

Right now we are in the process of documenting all of our discrepancies into the 8D format, however I have some concerns that may soon affect our system. Last week, our server was down and then our IT group tweak on some of the parts on the network.

My concern(s):
1. How are we going to document this discrepancy?
2. Where are we going to start?
3. On what particular element does the IT group belongs?
4. Do we still need a procedure for designing the network? and How?

Please advice.

Any feedback would be appreciated.

Thank you very much.

Vash Stampede
 
Elsmar Forum Sponsor
A

Al Dyer

#2
Vash,

1: Is this really a discrepancy or part of the acceptable norms when administering a computer network? We all know that the network is going to take a walk sooner or later so could we think of running this through a continuous improvement project?

2: See above.

3: In my experience the network is used to control data and documents. We have always included the network system under element 4.5.

4: Designing the network should not call for a stand alone procedure but could be run through some type of project management/continuous improvement system.

Food For Thought

ASD...

------------------
Al Dyer
Mngt. Rep.
[email protected]
 

Marc

Fully vaccinated are you?
Leader
#3
I agree with Al's response. But - what is the role of IT/IS in your company? For example, some companies have work instructions online so if the system goes down it's a manufacturing problem and as such I would classify an unscheduled down 'event' of any 'significant' length of time as a nonconformance. But if only 'non-critical' documents are on the server and the down time is not very long I wouldn't seee that as reason to classify the down time as a non-conformance.

Just a few thoughts.
 
Thread starter Similar threads Forum Replies Date
M Root Cause and Corrective Action for CAPA's lacking validation/verification ISO 13485:2016 - Medical Device Quality Management Systems 19
H Ever given an Operations Manager an internal Corrective Action Request? Nonconformance and Corrective Action 5
B Human error corrective action 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 15
G Use of Supplier's Corrective Action Form vs. Corporate Form Supplier Quality Assurance and other Supplier Issues 4
M Corrective action for a defect from customer's mistaken Nonconformance and Corrective Action 1
Q Corrective action ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
H Streamlining audit response and corrective action processes ISO 13485:2016 - Medical Device Quality Management Systems 9
Q Corrective Action Notification - Registration Audit ISO 13485:2016 - Medical Device Quality Management Systems 12
S I need help in corrective action plan Nonconformance and Corrective Action 15
B NADCAP Rejection Response to Root Cause Analysis and Corrective Action. Nonconformance and Corrective Action 1
T Continual Improvement as Result of Corrective Action? Preventive Action and Continuous Improvement 32
3 Non-conformance Register vs Corrective Action Register ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 18
A Corrective Action Training ISO 13485:2016 - Medical Device Quality Management Systems 1
R Not every INCIDENT report will lead to a corrective action EU Medical Device Regulations 7
L Separate Corrective Action and Preventive Action Procedures ISO 13485:2016 - Medical Device Quality Management Systems 13
T AS9100D Clause 10.2.1g Supplier Corrective Action for each and every nonconformity? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
R Non conformance (NC) or Corrective & Preventive action (CAPA) CE Marking (Conformité Européene) / CB Scheme 7
D Corrective Action Timing - IATF CB Deadline IATF 16949 - Automotive Quality Systems Standard 2
R AS 9100D - Containment and Corrective action AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
P Customer Corrective Action Requests in OASIS? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
C Corrective action for failure in documents control ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
G Assignable cause/corrective action list for SPC Software Statistical Analysis Tools, Techniques and SPC 3
S Can we provide training plan as corrective action for IATF 16949 Non conformity? IATF 16949 - Automotive Quality Systems Standard 9
P Corrective Action Response for Missed bumps on brake press Manufacturing and Related Processes 2
B Stakeholder Initiated Corrective and Preventive Action Misc. Quality Assurance and Business Systems Related Topics 5
B Corrective and Preventive Action (CAPA) A Key Process of the Quality Management System Dec 17... Training - Internal, External, Online and Distance Learning 0
I When exactly can a corrective action be closed? Nonconformance and Corrective Action 3
L What to do if a Corrective Action requires several extensions Nonconformance and Corrective Action 7
qualprod Best criteria to measure Corrective Action effectiveness - Poor Maintenance ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
Ashok sunder Is it possible to reduce Risk likelihood and impact Post control Ranking after corrective action taken for risk? FMEA and Control Plans 1
E CAR (Corrective Action Report) with questionable Root Cause ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
B How to reply NCR on ineffectiveness of corrective action during IATF external audit? This is repeated issue whereby some mistake was done. IATF 16949 - Automotive Quality Systems Standard 7
I AS9100D Non-conformance for 10.2.1 b 2 and 10.2.1. b 3 e and f - Corrective Action AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
I Corrective Action Tracking for Product and Process in the same system? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
Ashok sunder Is it possible to reduce FMEA Occurrence and Detection Ranking after corrective action taken for customer complaints? FMEA and Control Plans 6
R CIP (Corrective Action) requirements - ISO 9001 clause 10.2 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
E CAR (Corrective Action Request) Due Dates ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
E Corrective Action or Customer Complaint ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
J If Corrective and Preventive Action were truly Effective IATF 16949 - Automotive Quality Systems Standard 3
qualprod Is a Corrective Action Expected if a Quality Objective is not in compliance? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 38
M Corrective Action Effectiveness Nonconformance and Corrective Action 5
P Documentation for correction, corrective action, mini CAPA Nonconformance and Corrective Action 9
P Interesting Discussion Addressing Human Factors in Corrective Action AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 23
S Formal written response to a corrective action? Nonconformance and Corrective Action 9
Q AS9100D Corrective Action Procedure needed Document Control Systems, Procedures, Forms and Templates 1
S Corrective Action from Internal Audits not performed ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 24
J We don't have enough Corrective action entries AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
T Timely Closure and "Ongoing" Corrective Action Nonconformance and Corrective Action 20
P Examples of Nonconformance, Corrective Action Requests, and Root Cause Analysis Nonconformance and Corrective Action 2
S How to Politely Close out a Nuisance Customer Corrective Action? Nonconformance and Corrective Action 11

Similar threads

Top Bottom