Quality for value adding or certification?

W

wileycomet

#1
I'm having a crisis of faith in the way the quality management system is certified and implemented in some instances.

The company I work for have 6 sites across the country and all are now certified to 9001. However, they often receive non-conformance in surveillance audits and from all accounts and purposes don't seem to action them.

Specifically, the company has never conducted internal audits. They always plan to, but they never happen. I'm currently in the process of rejuvenating the QMS, but because there is a lack of understanding on what the quality management system is and how it should be integrated into the business, it's seen as a separate entity and something that we do to comply with an audit, rather than as a tool to improve business.

I'm trying to get across to senior management that have 1 trained auditor in a national company (me) is not enough to fully conduct value adding audits of key business processes, and as I am responsible for building the QMS/EMS/SMS, it isn't practical to have me audit my own work. However senior management claim that they have always been compliant to the standard in the past without the need for an audit team or process auditing, so why start now.

I'd like to grab some expert opinions on whether this is a common issue, and whether ISO9001 certification really means anything if it can be granted and maintained when the business really has not integrated a quality management system into their business and does not utilize it for continuous improvement.
 
Elsmar Forum Sponsor
W

wileycomet

#3
Unsure - last CB audit I can find from 2013 had major non-conformance for internal audit and management review, however I also can't find any results from a follow up audit or any action plan to rectify the non-conformances. Nobody seems to know anything about any of it...
 
#4
It is time to dust off your resume. You belong somewhere that you will be appreciated and not simply treated as window dressing. Seriously, if no one has got through to your upper management yet, why do you think you can change it?
 
W

wileycomet

#5
I've not been with this company long and I'm not ready to admit defeat yet. I think I need to prove how a strong QMS can improve a business rather than be an administrative chore to tick a compliance box.

Hopefully I can get the CB on side for our upcoming surveillance audits and they can add a bit of clout to my arguments.
 
A

Alpine

#6
I question how any CB can ignore major system non-conformances such as no internal audit regime and management review. If the external auditor is going to be the same, I would seriously consider requesting another. The other thing is to come up with a plan on how you intend to get things back on track. However no plan will be worth anything if there is no senior management commitment. Just for the record, certification does mean something and has much to offer organisations, especially large ones, which without systems, procedures and discipline are likely to become a free for all. Good luck :)
 
#7
~~~ Good Luck wileycomet ~~~
Small steps
Major's first
Is there a process in place ? Yes / No (Fix it)
Is the process not being followed ? Yes / No (Fix it)
Is the process followed not being effective ? Yes / No (Improve it)
 

John Broomfield

Leader
Super Moderator
#8
wileycomet,

How thoroughly are the processes monitored by the people doing the work and their supervisors?

Does this monitoring result in timely preventive action, correction (or slightly later corrective action) during the design, planning and operation of the processes?

After all, our management systems are meant to work well without internal audit. Missing internal audit may mean the processes are monitored well.

You could start by quickly determining if any other processes are completely missing (system audit) and then auditing the effectiveness of process monitoring.

Be careful not to disrupt whatever is making these management systems effective.

But you may also need to replace your registrar so your certification actually is valued both internally and externally.

John
 

dsanabria

Quite Involved in Discussions
#9
I'm having a crisis of faith in the way the quality management system is certified and implemented in some instances.

The company I work for have 6 sites across the country and all are now certified to 9001. However, they often receive non-conformance in surveillance audits and from all accounts and purposes don't seem to action them.

Specifically, the company has never conducted internal audits. They always plan to, but they never happen. I'm currently in the process of rejuvenating the QMS, but because there is a lack of understanding on what the quality management system is and how it should be integrated into the business, it's seen as a separate entity and something that we do to comply with an audit, rather than as a tool to improve business.

I'm trying to get across to senior management that have 1 trained auditor in a national company (me) is not enough to fully conduct value adding audits of key business processes, and as I am responsible for building the QMS/EMS/SMS, it isn't practical to have me audit my own work. However senior management claim that they have always been compliant to the standard in the past without the need for an audit team or process auditing, so why start now.

I'd like to grab some expert opinions on whether this is a common issue, and whether ISO9001 certification really means anything if it can be granted and maintained when the business really has not integrated a quality management system into their business and does not utilize it for continuous improvement.
First - Purchase a copy (or borrow) of ISO 9001:2015 and begin to implement the process audit concepts, Quality Objectives (use Analysis of data as a beginning point)) and goals.

Note: it appears by your statement that management does not understand "Process Audit" - just do them (they will never know).

Second - Write as many non conformance that you could find - don't be shy.

Note: If management ignores it - then go to the next step.

Third - Develop a professional and discreet relationship with your third party auditor. If you can't then request for another auditor - preferably one with aerospace experiences.

Note: You will share with your third party auditor your biases and lack of management support. in fact, request from the auditor to spend valuable time in your internal audits - you will see results.

If that does not work - find another registrar.

Finally - if you are still finding resistance from management - dust off your RESUME and move on - you are not going to change the culture.
 
Last edited by a moderator:
#10
Unsure - last CB audit I can find from 2013 had major non-conformance for internal audit and management review, however I also can't find any results from a follow up audit or any action plan to rectify the non-conformances. Nobody seems to know anything about any of it...
By rights, you should have been suspended and your certificate removed, so don't count on your CB being an ally here. Find another one! Get the past audit reports from your current CB and review what they've been reporting.

I'm with Jim in the bigger picture. Unless you're experienced in creating different cultures, then you're wasting time. Of course, if you inherited a mess from an incompetent predecessor, then you MIGHT have a chance. If you demonstrate where things are working well - as John B is really suggesting.

However, unless you have at least one advocate who "gets it", enlisting the help of a lowly CB auditor (who seems to have been ignored in the past) is a futile action, IMHO.
 
Thread starter Similar threads Forum Replies Date
V What are the Value Adding Quality Assurance Processes and how to measure them? Quality Tools, Improvement and Analysis 3
B Value adding for Internal Quality Audit training General Auditing Discussions 18
M Is quality control a value adding process? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 112
M Is there any value in monthly quality reporting? Manufacturing and Related Processes 8
Ashok sunder What are the criteria for setting a target KPI value against a quality objective? Benchmarking 7
B Justifying the Value of a Quality Engineer Quality Manager and Management Related Issues 14
D What is the value of a fully registered Quality Manual? Coffee Break and Water Cooler Discussions 17
D What is the value of a Supplier Quality Engineer? Supplier Quality Assurance and other Supplier Issues 3
S Review Quality Value of a company against its Effectiveness and how? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
S History and Value of a Supplier Quality Engineer Quality Manager and Management Related Issues 1
S Criteria for setting a target value against a quality objective/KPI? Benchmarking 6
eternal_atlas NC for poorly communicated Quality Policy - Does it add value to an audit? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 29
C Value of Quality Manual - Is there value in having a Quality Manual anymore? Philosophy, Gurus, Innovation and Evolution 7
W How to show the value of quality department to highest boss ? Career and Occupation Discussions 8
T Increasing Quality: Cost vs. Value Added Misc. Quality Assurance and Business Systems Related Topics 3
R Cost of Quality - Cost value for all the quality activities ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
Marc ASQ (American Society for Quality) Certification Exams - Any Real Value? Professional Certifications and Degrees 28
P How to convince management that Quality Assurance adds Value Misc. Quality Assurance and Business Systems Related Topics 27
J Average number of Nonconformances during internal quality audit for Medical Device Manufacturers Internal Auditing 3
Sidney Vianna Interesting Discussion Accreditation Matters: Our Role in The Quality Infrastructure ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 0
qualprod Do sum of results of quality objectives should met a high level goal? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
Q What are Quality Requirements for Design? Quality Management System (QMS) Manuals 8
R Quality System Software AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
R Authorities of Quality Manager IATF 16949 - Automotive Quality Systems Standard 2
GStough Audit Nonconformances (?) for Suppliers Not Registered to ISO and No Supplier Quality Agreement Exists General Auditing Discussions 24
C Supplier Audit - Looking for a quality audit checklist General Auditing Discussions 3
A How would a candidate for Quality Systems Manager role answer questions in a med device manufacturing org ISO 13485:2016 - Medical Device Quality Management Systems 11
F EU MDR Quality Plan template CE Marking (Conformité Européene) / CB Scheme 3
M Quality Manager and Production Manager Advice Quality Manager and Management Related Issues 10
T What is a Quality Management System? Manufacturing and Related Processes 20
FRA 2 FDA Product NCRs- Quality Review Nonconformance and Corrective Action 6
W Posting Non-Quality System instructions on the Production Floor Manufacturing and Related Processes 13
CaliperJim Cost of Quality calculation Quality Tools, Improvement and Analysis 4
Cats Clause Certified Quality Systems Ltd (CQS) accredited by International Accreditation Board Registrars and Notified Bodies 4
T Quality toolbox decision tree Quality Tools, Improvement and Analysis 5
Sidney Vianna A young Steve Jobs take on Quality, Marketing & Business Processes. Coffee Break and Water Cooler Discussions 0
hogheavenfarm Free Quality Professional Books Buy, Sell or Trade - NO Commercial Advertisements 11
T Stellantis supplier quality manual Supplier Quality Assurance and other Supplier Issues 5
lyobovnik Work From Home Exception for Quality Managers? Quality Manager and Management Related Issues 19
T Accreditations as part of 9001 - Quality checks on your company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
P Product Quality Review API-GMP Manufacturing and Related Processes 0
M Who is performing quality control? IATF 16949 - Automotive Quality Systems Standard 2
C I need your help to find the action plan for these quality objectives Misc. Quality Assurance and Business Systems Related Topics 23
R Quality policy review document IATF 16949 - Automotive Quality Systems Standard 3
T ISO quality system software such as MQ1 (which is what we currently use) Document Control Systems, Procedures, Forms and Templates 9
M Quality 'Engagement' Effort Misc. Quality Assurance and Business Systems Related Topics 5
Q Quality role Human Factors and Ergonomics in Engineering 2
bobdoering Is your quality department having a "No Chili" day? Funny Stuff - Jokes and Humour 2
E Compressed air quality in ME equipment (used in OR) IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
Steve Prevette I need a template to solve world hunger, a world class Quality Program, and make lots of money Coffee Break and Water Cooler Discussions 5

Similar threads

Top Bottom