SBS - The best value in QMS software

How often should we have Assessment / Surveillance Visits?

C

cncmarine

#11
#11
I agree with you regarding the whole concept of accreditation. But we need to have a standard.

What I don't like is the RAB and Registrars losing focus and getting greedy. "Value added auditing" is a scam and none of us need to invest in it. The creation of new programs and revisions are all based on their bottom line.
 
Free Trial of DISCUS Desktop
Elsmar Forum Sponsor
C

Carl Keller

#12
#12
CNC, yes, I think having a standard is a good thing.

Having a standard that is not universally and consistently applied is a BAD thing.

"Findings" that have no merit based directly on the standard are a very BAD thing.

"Value added" auditing that is actually "non-value added" is a very, VERY BAD thing.

While I recognize the value of a QMS, I have little faith in the current registration/accreditation system for ISO 9001. It is a scam. I can make better use of the money by implementing initiatives from internal sources (like the employee running the equipment)

Carl-
 
Paul Simpson

Paul Simpson

Trusted Information Resource
#14
#14
By agreement

cncmarine said:
I have only yearly registration audits. I advise every company to go that route.
Click to expand...
I am happy you have a system that suits you. It sounds like you and your registrar have agreed an assessment process that both satisfies your needs and meets the requiremtns of the accreditation body. The process for deciding visit frequency and duration is a joint one based on
  • meeting the requirements of the accreditation rules (see comments from Sidney Vianna and howste above
  • giving you a gap between audits
  • keeping the assessment duration down to a manageable time
depending on how well you communicate with your registrar depends on how involved you are in the process.

cncmarine said:
For some of us (and customers) accreditation is the only way. But I believe that the registrars are starting to lose their creditability with some of their new ideas.

Concepts such as process auditing and value added auditing are moving away from the evidence based approach.
Click to expand...
I don't understand this comment. Registrar credibility depends on how well they are seen to assess to the requirements and on how credible their registrations are to their registered firms' customers. The only way to audit process based systems is by using a process audit approach - still by looking for evidence - that much hasn't changed. Value added auditing is alittle more difficult to define but tends to come from identifying areas for improvement by auditing a clients (process based) system.
 
C

cncmarine

#15
#15
Paul,

The only way to audit process based systems is by using a process audit approach - still by looking for evidence

That’s the key isn't it.....I agree that process auditing is different than Value Added but Paul you can't tell me that interpretation isn’t moving into the system.


Value added auditing is a little more difficult to define but tends to come from identifying areas for improvement by auditing a clients (process based) system

In other words…its Consulting not Auditing

Thanks for you thoughts Paul…but I think you do understand
 
C

Carl Keller

#16
#16
Paul,

Audit frequency is rarely a "joint" decision based on my experience.

Usually a registrar has a set frequency spelled out on their contract.

As far as "value added auditing" , I really don't need a third party coming in and telling me how to run my system "better".

It is bad enough they interpret the standard any which way they feel like, having someone unfamiliar with our processes and customers needs is definitely not something I would choose to pay for. I can think of better things to do with the company dollar.

Carl-
 
Paul Simpson

Paul Simpson

Trusted Information Resource
#18
#18
Choose your partner carefully.

Carl Keller said:
Paul,

Audit frequency is rarely a "joint" decision based on my experience.

Usually a registrar has a set frequency spelled out on their contract.
Click to expand...
It depends who you talk to. The registrar I work for gives the client the option. In most industries there are advantages with 6 monthly visits - the visit duration is more manageable and doesn't take the management representative's time for too long. Believe it of not some clients prefer to see their auditor more frequently and use them as a sounding board for their system. Other clients have simple systems and can have their annual audit duration covered in the one visit. With some companies the discussion is more in depth to understand what would be best for them. The accreditaion criteria allows for a number of ways of delivering a credible registration.

Carl Keller said:
As far as "value added auditing" , I really don't need a third party coming in and telling me how to run my system "better".
Click to expand...
Unfotunately the "third party knows best" idea has been around for a long time - a lot of organizations use consultants to help them take their systems forward. With third party registrars you don't get the consultancy but you get the outside view. As someone who does both consultancy and third party auditing I am in a good position to ask a Quality Manager why they do something and ask if they have considered any other alternatives to make the system more efficient or effective.

Carl Keller said:
It is bad enough they interpret the standard any which way they feel like,
Click to expand...
Different problem. dealt with ad nauseam in other threads but I have only one suggestion. The next time you see an interpretation you don't agree with challenge it. Third party auditors are not there to impose their wills on companies.
Carl Keller said:
having someone unfamiliar with our processes and customers needs is definitely not something I would choose to pay for. I can think of better things to do with the company dollar.

Carl-
Click to expand...
I take it then your company is not registered?

What you have described is, after all, what an independent third party assessment and registration is about. Albeit the assessor should at least be familiar with the technology you use and the market place you are operating in.
 
C

Carl Keller

#19
#19
Paul,

I am sure some registrars do have the option and most will do whatever is necessary to seperate you from your money, I only meant that typically, they have a boiler plate contract that spells out the expectation and fees.

I am not against third party consulting, but I don't want it forced upon me by my registrar. If I want a consultant, I will contract one specifically for the task at hand.

Interpretation- you are right, dealt with ad-nauseum. BTW, I have challenged many times, and won every time. It is pretty easy, just say this "show me specifically in ISO 9001 2000 where it says we have to do it" If they can show you, you have to do it, if not, you don't.

Yes, we are registered. I have worked for registered, unregistered and declared compliant organizations. The latter being the most effective I have had the pleasure of developing.

An independent third party assessment should be focused on whether your organization meets the applicable standard. No more, no less. No "interpretation", no "it would be more effective if..." Just tell me if I meet the standard and move on. If I want a huckster in a leisure suit to sell me a dog and pony show with no merit and no ROI, I'll hire a black belt.

Carl-
 
Sidney Vianna

Sidney Vianna

Post Responsibly
Staff member
Admin
#20
#20
cncmarine said:
Paul,

The only way to audit process based systems is by using a process audit approach - still by looking for evidence

That’s the key isn't it.....I agree that process auditing is different than Value Added but Paul you can't tell me that interpretation isn’t moving into the system.


Value added auditing is a little more difficult to define but tends to come from identifying areas for improvement by auditing a clients (process based) system

In other words…its Consulting not Auditing

Thanks for you thoughts Paul…but I think you do understand
Click to expand...
If you would be so kind to review the document available at http://isotc.iso.org/livelink/livelink/3553372/APG-HowtoAddValue.doc?func=doc.Fetch&nodeid=3553372

and enlighten us about the conceptual flaws or weaknesses contained therein, it would be appreciated.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
N Is there a standard which states how often instruments should be calibrated? Calibration Frequency (Interval) 12
S Internal Auditor Training - How often should an internal auditor be trained? Training - Internal, External, Online and Distance Learning 15
L How often should the contract review be done? TS 16949 Contract Review Process 2
W Gage R&R study frequency - How often should a Gage R&R be performed? Capability, Accuracy and Stability - Processes, Machines, etc. 8
P How often should CMM attribute gages be 3rd party calibrated General Measurement Device and Calibration Topics 1
T Process Capability Data (TS16949 8.2.3.1) - How often should it be reviewed? Capability, Accuracy and Stability - Processes, Machines, etc. 9
A When or how often should we update SPC (UCL and LCL) Control Limits? Every month? Statistical Analysis Tools, Techniques and SPC 7
M How often should Lead Auditors take a refresher course? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
William55401 How Often Does FDA State Consultant Recommended in a Pharma WL? US Food and Drug Administration (FDA) 1
Ashland78 IATF 16949 9.2.2.1 - How often do we have to audit entire IATF Manual IATF 16949 - Automotive Quality Systems Standard 4
R OSHA - How often an employee needs to be Re-Trained on Safety Methods Occupational Health & Safety Management Standards 4
U Must We Audit Critical Suppliers? How often? Supplier Quality Assurance and other Supplier Issues 7
J How often can AS9102 FAI be invoked? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 16
A Why Copper Wirebonded Devices often fail at uHAST (130C, 85%RH, 96hrs) Nonconformance and Corrective Action 2
B How often do you clean your ESD mat? Manufacturing and Related Processes 4
J Guidance on how often company SOPs need to be reviewed per FDA Regulations 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
J What are the most often asked questions in an interview? Career and Occupation Discussions 10
K Food safety auditors are often paid by the firms they audit Food Safety - ISO 22000, HACCP (21 CFR 120) 2
AnaMariaVR2 Change them often Funny Stuff - Jokes and Humour 2
F Medical Device Clinical Evaluations - How often are Clinical Evaluations required? EU Medical Device Regulations 2
E Supplier Audits - How often do you need to Audit your Supplier Supplier Quality Assurance and other Supplier Issues 22
Marc A Measure of Trade not often talked about - Cargo Ships Treading Water World News 1
K Gage R&R Frequency - How often to perform the GR&R? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 6
ScottK Industry Snobs - do you run into this very often? (a rant) Career and Occupation Discussions 10
S How often does the FDA inspect organisations outside of the USA? US Food and Drug Administration (FDA) 12
S How often do you audit your suppliers? Supplier Quality Assurance and other Supplier Issues 19
P How often do you have to repeat a Gage R&R study? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 27
A "Impossible" Is Often The "Untried" Coffee Break and Water Cooler Discussions 3
C How often will I update the quality records list? We have about 189 quality records Document Control Systems, Procedures, Forms and Templates 6
H How often is Attribute Gage R&R required to be performed? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 10
J How long (how often) do you check your SPC chart? Statistical Analysis Tools, Techniques and SPC 10
A NO2 Output - 4.5.1. How often to measure? Who defines an 'appropriate' period? Miscellaneous Environmental Standards and EMS Related Discussions 2
A 8.2.4.1 Layout inspection - When is a full layout required and how often? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 8
N How often do objectives and Q-Policy change ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
S How often for micrometer calibration? General Measurement Device and Calibration Topics 10
T Management Review of the QMS (Quality Management System) - How often (Frequency) Management Review Meetings and related Processes 90
M Some people here at the Cove are often brutally honest - Dual/Secret Identities? Coffee Break and Water Cooler Discussions 43
J How & how often to perform verification of Test Software of Automatic Test Equipment? General Measurement Device and Calibration Topics 3
D On-going capability - Can we decide for ourselves how often to measure cpk? Capability, Accuracy and Stability - Processes, Machines, etc. 6
A Should we assign the PRRC before the date of application of MDR (26 May 2021)? EU Medical Device Regulations 0
J UDI-DI how should we interpret Device version or model to determine if a new UDI-DI is needed? EU Medical Device Regulations 0
Sidney Vianna Interesting Discussion Should ISO 9004 be changed from a guidance document to a requirements standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
A Should I take an online course for a career in Occupational Health and Safety? Career and Occupation Discussions 2
J Should a Class 1 medical device with an option to measure body weight be considered Class 1m? EU Medical Device Regulations 0
K Should APQP/PPAP has its own section in a QM? Quality Management System (QMS) Manuals 1
S What should i choose for "testing procedure" characteristics? (N95) General Information Resources 0
P Should eIFU link per ISO 15223-1:2016 be added to labels out of scope of Reg 207/2012? EU Medical Device Regulations 1
S Which Sampling Plan(s) Should I Use? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 7
A Document release vs its related training. Which should come first? ISO 13485:2016 - Medical Device Quality Management Systems 18
S Which department should prepare the control plan? could you show me a standard regarding to this matter. FMEA and Control Plans 17

Similar threads

Top Bottom