SBS - The best value in QMS software

What are the common questions during surveillance audit for top management?

Elsmar Forum Sponsor
B

Britman - 2012

#12
Morning KidPaddy - I have our sureillance audit tomorrow (19/9/7) a timely question, my audits of management have been based on the attached file, as always it not only what you say, it's the evidence the audit reviews.

Were a small company 30 - 40 people

Good luck
Hi, KidPaddy have just had our sureillance audit and a strategic review, the main audit focused on top management, the auditor reviewed the Management Review Reports, then proceeded to review documented evidence, focusing on the responsibilities of personel within the company - methods of defining responsibilities, approved signatures, operators endorsements, endorsement through training records of the "management representative".

There were simple interviews with personel to ensure alignment and communication between top management and employee's.

He confirmed our stated objectives were measurable and consistent with a planned revised Quality Policy and the method of obtaining the results were understood and communicated to all employees' (current Quality Policy was also confirmed acceptable, controlled and understood)

On the audit we have a continuation of registration, however one issue requiring attention - currently due to planned changes in our objectives we stated the current measured results, and not a "goal" within a time frame (time frame is listed but not filled in)- the auditor did accept these were presented and dicussed at the last MRM, the current measured result being quoted to enable the "defining of an achievable goal".

One objective was at 60% (for the year), therefore a goal 90% in a short timescale could result in a negative message to employees, would rather state 70% in 3 months and achieve 72%, than 95% in 3 months and achieve 72%.

Hope this helps
 

Paul Simpson

Trusted Information Resource
#13
As everyone else has noted, they are just trying to verify management involvement.
Exactly. The point of the discussion with the top honcho is to verify that top management is involved.

There isn't a checklist for these types of interview. I am trying to get a feel for how involved they are by asking what they do .... normally starting with their role in setting goals for the organization and how they are involved in measuring how those goals are met. Obviously I'm only interested in quality goals ;) although I don't mind hearing about other areas of the business if s / he wants to talk about them.

In fact, after reviewing management review minutes (6 pages long - 12 hours over 3 days) he didn't bother asking top management any questions during my recent surveillance audit (btw, no findings at all!).
What a poor audit! Firstly having the time in an audit programme to set aside 12 hours for management review ... if only! :rolleyes:

Next - to carry out an audit of top management without interviewing them strikes me as a cop out. Any wonder there were no findings if this is the standard approach. :(

Reminds me of a letter I wrote to a UK magazine a little while ago (2003) in response to a request from someone (who shall remain nameless) that the standard be rewritten to require interviews of the MD:

Quality World said:
If you choose to have your management system assessed by a third party certification body then I hope you choose one that uses auditors who are comfortable with the standard they are using.

The standard should not be rewritten to mandate a meeting with top management. They should be confident enough to ask for a meeting with the MD to discuss elements of the standard and his / her role in leading the organisation’s quality efforts.

At a convenient time, in language relevant to the senior manager the interview should cover topics of objective and policy setting, communications and measures of effectiveness and efficiency.

In my experience the main barriers to getting to talk to the MD (apart from their busy schedule) is past experience within the company of dealing with auditors who know the standard but not business. These auditors have left a legacy behind based on reams of non conformities which are factually correct but leave a negative contribution to the organisation’s quality efforts. I call these individuals “three dot auditors”, they can demonstrate they have covered clause 4.1.2.1 and will happily ask the MD how he / she satisfies this requirement – without explaining to these busy people what it means or why it is relevant.

The point of this is that the standard numbering and structure and, to a lesser extent, the content is less relevant than the assessment process which should be focused on the organisation’s processes and measures of effectiveness and efficiency.
 
M

MoniUY

#14
Some very good replies so far (as usual) but I also like to ask a few others such as:

How is the QMS helping you to run the business?

What benefits are you getting out of having the QMS?

Have you gained any new business or retained business as a result of having the QMS?

What future plans do you have for the QMS?

I think that as the system matures, the auditor can start to ask more of this type of question.
Hi,

I have my surveillance audit last week and also they ask to my boss "how good is the management process"?

Moni
 
M

MoniUY

#17
This is not a joke, the idea is as the audit will be focused in processes and Management (Strategic Planning, Resources asignation and Management Review, as well as customer related processs) is one of them, the High managment of the company must show the performance of it.

I don´t know exactly the background in your company but the system and the interviewed should have evidences of:

Processes, systems and products are understood better. Prevention is emphasized. Mistakes are detected and controlled further up the value chain. Business objectives are operationalized. Risks are managed. Opportunities are found. Priorities are refocused.

And also risks maybe are specials for your bussiness and should have the ORCA cycle complete:
• Identify business and process objectives.
• Identify operational and other risks.
• Define business or other controls.
• Assess and ensure the effectiveness of the business process to satisfy objectives.

This answer the question.
RGds, Moni
 
S

somerqc

#18
Although there was obvious sarcasm in the last 2 responses, they are also pointing out a truth of the auditing process.

It is virtually impossible for an auditor in 30 minutes to figure out whether the top management person is truthful or not. In fact, if the people lower (re: MR) is effective in their job it may take years for the auditor to figure it out.

One night of review by top management can create the perception that top management is on board IF the rest of the system is solid regarding management review, internal audit, continuous improvement, and CAPA. (gee...think I am talking about personal experience :notme:)

They are not trying to offend you, just trying to make a point regarding dealing with top management and audits. There may also be some difficulty due to the format (internet) and translation of the english language (hard for those of us with English as a first language!)

John
 

Paul Simpson

Trusted Information Resource
#19
Thanks, John. Good points, well put.
Although there was obvious sarcasm in the last 2 responses, they are also pointing out a truth of the auditing process.
They tell the truth about auditing as it is practised by some - not as it should be done!

It is virtually impossible for an auditor in 30 minutes to figure out whether the top management person is truthful or not. In fact, if the people lower (re: MR) is effective in their job it may take years for the auditor to figure it out.
An auditor's job is not to tell if the MD is lying but just to tease out some facts as to how the Top mgmt. see quality in the organization.

One night of review by top management can create the perception that top management is on board IF the rest of the system is solid regarding management review, internal audit, continuous improvement, and CAPA. (gee...think I am talking about personal experience :notme:)
Exactly - well put. The top mgmt are working nights, now? :lmao:
 
Thread starter Similar threads Forum Replies Date
G ISO 17025 Calibration Laboratory Assessor's Common Questions and Procedures ISO 17025 related Discussions 11
Z Common Certification Body Audit Questions and Answers? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
D Common practices in ISO 9001 deployment ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
R EU-MDR Article 9-common specifications Other ISO and International Standards and European Regulations 2
Z Is Op Amp Common-Mode Rejection Ratio (CMRR) test applicable to battery operated devices? Other Medical Device Related Standards 0
Sidney Vianna IATF 16949 News Update on the IATF CARA Project (“Common Audit Report Application”) - 12/2020 IATF 16949 - Automotive Quality Systems Standard 1
M MDR "Common Specifications" (CS) - If not standards, then what? EU Medical Device Regulations 5
G Is it common to do a repeatability check during calibration of an instrument? General Measurement Device and Calibration Topics 5
M Medical Device Directive - Seeking common nonconformance write up scenarios CE Marking (Conformité Européene) / CB Scheme 2
K PFMEA (Process FMEA) - Can be common for 3000 products? FMEA and Control Plans 2
Sidney Vianna What do these things have in common? Surge in new ISO Committees & Standards Other ISO and International Standards and European Regulations 7
A CTD (Common Technical Document) for a Topical Preparation Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 2
W IMDS - Help (Common Warning and Error Fixes) RoHS, REACH, ELV, IMDS and Restricted Substances 9
M CB and Internal auditors most common nonconformities against AS9100D AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 16
W Can 2 different sites under different Quality System have a common management review? ISO 13485:2016 - Medical Device Quality Management Systems 4
M IATF:16949 Common Quality Manual - Company is in Country A and Country B Quality Management System (QMS) Manuals 5
I Is it common practice for a bake oven to require a CQI-9? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
P Converting DMF III into eCTD (Electronic Common Technical Document) Medical Information Technology, Medical Software and Health Informatics 4
R Common Statistical Errors Using Minitab Software 1
cscalise Separate Forms or Procedure Attachments - What's more common? Document Control Systems, Procedures, Forms and Templates 2
J What is the most common industry requesting ISO 9001 Certification ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
2 Is it common to employ part time dental assistants ? Coffee Break and Water Cooler Discussions 3
P What do you think is the most common root cause of NCRs in a construction project? Quality Manager and Management Related Issues 3
BHobbs_Busche ISO/TS16949:2009 - MSA requirements for common gages IATF 16949 - Automotive Quality Systems Standard 5
S Common Electric Fan Motor Problems Reliability Analysis - Predictions, Testing and Standards 3
AnaMariaVR2 Finding a Common Language for Disaster-resistant Supply Chains Supply Chain Security Management Systems 1
M Common Reasons for Out Of Tolerance condition of DC Calibrator or any reference std General Measurement Device and Calibration Topics 1
V Most Common Internal/External Audit Observations on Risk Management ISO 14971 - Medical Device Risk Management 4
V Common Root Cause for Failures in Scaleup & Commercial (Validation) Batches 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
S ISO 13485 - Moving towards common (single) certification for multiple locations ISO 13485:2016 - Medical Device Quality Management Systems 13
J Is this practice common? 1 Quality Manager covering QA, QC, QE, SQE IATF 16949 - Automotive Quality Systems Standard 20
S How to do Adjustments & Repairs on Common Inspection Equipment General Measurement Device and Calibration Topics 7
J TL9000 Common Measurements - Design and Development for Telecommunication Products TL 9000 Telecommunications Standard and QuEST 5
M VDA Specifications - Common definitions, acronyms, etc. VDA Standards - Germany's Automotive Standards 1
V Common Failure Modes for a Product/Process Line ISO 14971 - Medical Device Risk Management 1
V Common Errors while Implementing Risk Management Process ISO 14971 - Medical Device Risk Management 9
V Common Coating Problems in Refinery Manufacturing and Related Processes 1
P The most common name for specifications? Design and Development of Products and Processes 3
M Do all common polymers have estrogenic activity? Other Medical Device and Orthopedic Related Topics 5
S What are the common Problems preventing (Gaps) Implementation of ISO 14001? ISO 14001:2015 Specific Discussions 7
B Common Sterilization Methods in Hospital - Prevalence? Hospitals, Clinics & other Health Care Providers 2
B ISO Clause Reference for Developing Common Customer Service Standards ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
N CMC File Content and what is common to share with the customer ISO 13485:2016 - Medical Device Quality Management Systems 4
somashekar Definition Evaluate and Select ... What are the most common understandings of these words. Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 12
Wes Bucey Privacy of communications - a common myth Career and Occupation Discussions 3
A Common causes of Corrosion on Alm 7075 Material Annodized, Tumbled, and Plated Manufacturing and Related Processes 6
P Are all standards based from common sense? Coffee Break and Water Cooler Discussions 11
B MSA (Measurement Systems Analysis) with One Operator using a CMM or Common Calipers Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
M General decline in good manners / common courtesy? Coffee Break and Water Cooler Discussions 26
E Which standard Cpk value intervals are common or frequently used? Statistical Analysis Tools, Techniques and SPC 5

Similar threads

Top Bottom