Quality Management System Question

Calgirl319

Starting to get Involved
#1
Question, I'm literally the only Quality person at my new job. Not enough people have time or want to help with documentation. I have a lot of back log CARs, SCARs and NCRs that need to be documented. Can I create a folder for each and write them up little by little calling it a back log? Or any suggestions on how to handle this?
 
Elsmar Forum Sponsor

Tagin

Trusted Information Resource
#2
Might sound a bit ironic, but I'd create a corrective action for this issue.
Then, this CAR is used to track:
  • Containment - e.g., I'd review this backlog for urgent issues or other things that require containment actions now
  • Root Cause - how did things degrade into this mess that you inherited?
  • Correction - record your whittling down of the backlog over time
  • Corrective - what are you going to do to prevent this recurring?
This gives you a way to track the backlog, and also to take credit for fixing it.
 

Mike S.

Happy to be Alive
Trusted Information Resource
#4
Tagin has given great advice.

I started a job once where I wasn't the only QA person in the company, but I was the only QA person assigned to the company's largest customer. The job opening existed in large part because my predecessor was way behind on answering customer CAR's. It was a real mess, and the customer was highly upset.

There is no way you can do them all at once, or do them all alone, so your only choice is to prioritize them, put your nose to the grindstone, and show steady progress. I made sure to communicate frequently with my customer to let them know I was working diligently to get caught-up and keep them apprised of my progress. I also gave them a personal assurance that once I did get caught-up, I would never let this happen again on my watch. And I didn't.

The point being, you may have a real mess on your hands, but maybe you can use this as an opportunity to make a big difference to your company and the affected customers. I was true to my word and eventually had our biggest customer regularly praising me to our top management. It helped pave the way to a bonus and a promotion and a pretty secure job, relatively speaking. I was never close to the top of the layoff list when times got hard. Good luck.
 

qualprod

Trusted Information Resource
#5
Question, I'm literally the only Quality person at my new job. Not enough people have time or want to help with documentation. I have a lot of back log CARs, SCARs and NCRs that need to be documented. Can I create a folder for each and write them up little by little calling it a back log? Or any suggestions on how to handle this?
-----------------Calgirl319
Could you explain a little bit more? if you refer that people is not interested in the QMS.......
Your first concern should be this" Not enough people have time or want to help with documentation." not in the creation of a folder.
In my experience when this is happening, you´ll face a lot of troubles.
Everybody should be interested in the QMS, is not only your responsibility, try to involve to the Top management so that
all the people in the organization be involved enough in the system, in order to have good results.

Regards
 

Ninja

Looking for Reality
Trusted Information Resource
#6
Tagin's response is good, but left out another benefit of writing yourself up...
You issuing a CA on yourself when you find a problem is exactly how a QMS should work...if it were me, I would lay that CA on the table right up front in an audit (not a customer audit) and say "I was brought in to get things up to date, and I'm working on it...here's my plan".

If the auditor is competent, they'll find it anyway...and taking the surprise away can only work in your favor and let them know you're on top of things.
 

skb76

Involved In Discussions
#7
only Quality person at my new job. Not enough people have time or want to help with documentation. I have a lot of back log CARs, SCARs and NCRs that need to be documented

When documented this car/ncr give yourself a timeline (since are own your own)

-the most important point
~ Stat the immediate corrective action first for every car/ncr in your hand) - (to prevent internal/external auditor give 'extra car/ncr') AND GIVE TIMELINE TO DO BELOW ACTIONS :..

By then, you have time to do below
Containment - e.g., I'd review this backlog for urgent issues or other things that require containment actions now
Root Cause - how did things degrade into this mess that you inherited?
Correction - record your whittling down of the backlog over time
Corrective - what are you going to do to prevent this recurring?


So, after doing above, you can close or revisiting(if needed) each car/ncr in your hand (when next round of internal/external auditor ask you)
 

Calgirl319

Starting to get Involved
#8
-----------------Calgirl319
Could you explain a little bit more? if you refer that people is not interested in the QMS.......
Your first concern should be this" Not enough people have time or want to help with documentation." not in the creation of a folder.
In my experience when this is happening, you´ll face a lot of troubles.
Everybody should be interested in the QMS, is not only your responsibility, try to involve to the Top management so that
all the people in the organization be involved enough in the system, in order to have good results.

Regards
this is my current battle these people dont care about quality
 

Calgirl319

Starting to get Involved
#9
only Quality person at my new job. Not enough people have time or want to help with documentation. I have a lot of back log CARs, SCARs and NCRs that need to be documented

When documented this car/ncr give yourself a timeline (since are own your own)

-the most important point
~ Stat the immediate corrective action first for every car/ncr in your hand) - (to prevent internal/external auditor give 'extra car/ncr') AND GIVE TIMELINE TO DO BELOW ACTIONS :..

By then, you have time to do below
Containment - e.g., I'd review this backlog for urgent issues or other things that require containment actions now
Root Cause - how did things degrade into this mess that you inherited?
Correction - record your whittling down of the backlog over time
Corrective - what are you going to do to prevent this recurring?


So, after doing above, you can close or revisiting(if needed) each car/ncr in your hand (when next round of internal/external auditor ask you)
Thank you for your input, are you saying that I can create a CAR for this back log of ncrs, cars:
Containment: We are aware of the issue and we have issued Corrective Actions for the urgent matters
Root Cause - Person before me did not issue any corrective actions at all
Correction - record the corrective actions i create.
Corrective - stay on top of corrective actions get people involved and help to create follow trough and close

is this accurate example of how to handle?
 

Tagin

Trusted Information Resource
#10
Root Cause - Person before me did not issue any corrective actions at all
But how did this person get away with creating no corrective actions? Weren't there complaints and/or ongoing quality issues due to problems not being fixed? In other words, what about the quality system allowed the previous person to continue to act that way?

It sounds like management was not performing the necessary oversight through management review, customer feedback review, performance monitoring, etc., which allowed this problem to fester. Usually, we don't identify a person as a root cause, but instead something about the QMS that allowed that person to act that way ongoingly.
 
Thread starter Similar threads Forum Replies Date
O Quality Management System Implementation framework and Gap analysis checklist Manufacturing and Related Processes 7
Thee Bouyyy Quality Management System Q1 and Q2 Interpretations Misc. Quality Assurance and Business Systems Related Topics 0
Sidney Vianna Informational ISO/CD 7101 Health Care Quality Management System Standard Hospitals, Clinics & other Health Care Providers 0
M Unique Quality Management System for 2 sites ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
D Big companies suffer from quality management system? ISO 13485:2016 - Medical Device Quality Management Systems 1
R How would you work without a quality management system? IATF 16949 - Automotive Quality Systems Standard 3
P Conformity assessment based on a quality management system or production quality assurance EU Medical Device Regulations 3
S Quality management system (Well head installation & maintenance) Quality Management System (QMS) Manuals 5
P How to develop executable quality management system for rookies? IATF 16949 - Automotive Quality Systems Standard 9
M Requirement to manufacture under a quality management system EU Medical Device Regulations 4
A IATF 16949 4.3.1 - Determining the scope of the quality management system - supplemental IATF 16949 - Automotive Quality Systems Standard 9
A Building up a global quality management system ISO 13485:2016 - Medical Device Quality Management Systems 2
A Building up a global quality management system 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
T Ideas for developing a Supplier Quality Management System, non automotive ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
M MDR requires the NB to perform "tests in order to check that the quality management system" EU Medical Device Regulations 3
B Corrective and Preventive Action (CAPA) A Key Process of the Quality Management System Dec 17... Training - Internal, External, Online and Distance Learning 0
J Quality Assurance in China - Developing a quality management system for a California company Misc. Quality Assurance and Business Systems Related Topics 9
I Date of Quality Management System - Training Records ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 19
S Procedure on Privacy Policy in the ISO 13485 quality management system ISO 13485:2016 - Medical Device Quality Management Systems 3
T ISO 13485 8.2.5. Monitoring and measurement of quality management system processes ISO 13485:2016 - Medical Device Quality Management Systems 1
D Templates for Environmental, Safety and quality Management System wanted Document Control Systems, Procedures, Forms and Templates 3
B Quality Management System documentation identification Document Control Systems, Procedures, Forms and Templates 11
eule del ayre Lean Six Sigma for Quality Management System Lean in Manufacturing and Service Industries 10
L IATF 16949 Clause 9.2.2.2 Quality Management System Audit IATF 16949 - Automotive Quality Systems Standard 9
John Predmore Explain Quality Management System (QMS) for the uninitiated ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
S What are you looking for in an automated quality management system? Quality Assurance and Compliance Software Tools and Solutions 8
W Can 2 different sites under different Quality System have a common management review? ISO 13485:2016 - Medical Device Quality Management Systems 4
J Support and guidance with supplier quality management system Supplier Quality Assurance and other Supplier Issues 1
J IATF Minimum Automotive Quality Management System Requirements for Sub-Tier Suppliers IATF 16949 - Automotive Quality Systems Standard 12
F ISO 9001:2015 4.3 - Determining the scope of the quality management system ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
C IATF Cl. 9.2.2.2 Quality Management System Audit - CQI-23 Molding System Assessment IATF 16949 - Automotive Quality Systems Standard 1
Q Thoughts on Communications relevant to the Quality Management System ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
Y Quality Management System Manual (Wood Manufacturing Company) Quality Management System (QMS) Manuals 4
J IATF 16949 Cl. 8.4.2.3 - Supplier Quality Management System Development IATF 16949 - Automotive Quality Systems Standard 59
S "Quality Management System" Certificate vs. "Quality" Certificate? Other Medical Device Regulations World-Wide 2
T IATF 16949 Quality Management System (QMS) Scope Requirements IATF 16949 - Automotive Quality Systems Standard 18
B Control Plans for Quality Management System Processes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
F Regulatory Compliant Quality Management System - Bare Minimum EU Medical Device Regulations 2
J What does "effective implementation of quality management system" mean? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
A Leadership Responsibility in an ISO 9001:2015 Quality Management System ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
J Add API Q1 & Q2 to Quality Management System Standards Oil and Gas Industry Standards and Regulations 1
M Requirements of the quality management system - TS 16949 clause 5.6.1.1 IATF 16949 - Automotive Quality Systems Standard 1
A Quality Management System Strategy Misc. Quality Assurance and Business Systems Related Topics 15
T Guidance - Setting up an integrated quality & environmental management system Career and Occupation Discussions 12
A QMS (Quality Management System) for Logistic Agency ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
D Where does the QMS (Quality Management System) fit in your organization? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
L Implementing a new quality management system for a new engineering company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
M Heard of MS1900: 2014. Quality Management System from Islamic Perspective? Quality Manager and Management Related Issues 2
M EN 62304 and Quality Management System Requirements IEC 62304 - Medical Device Software Life Cycle Processes 4
P What is a QMS (Quality Management System), really? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 18

Similar threads

Top Bottom