Unannounced Random Audits

Marc

Fully vaccinated are you?
Leader
#1
Subject: Re: Q: Random audits? /Martins/Naish
Date: Mon, 6 Dec 1999 14:31:35 -0600
From: ISO Standards Discussion

From: PNaish

David,

I agree the company should be prepared at any time for their audit. And I know a number of companies who do exactly what you said. So random unscheduled audits would possibly catch them with their ISO down. However, they would lilely find ways to hide what they don't want you to see anyway. And what of the companies who are prepared year round and don't stop just before their audit? They would not care except for one thing.

In all cases you are asking a company to have the represenetative available or the people who are being audited available to answer questions. How can an auditor do a good job if the people are not there because you did not let them know you were coming. As an example, what if I were the registrar and decided to make a trip to your city on the week of Easter. I did 2 other companies earlier in the week and you are small so I planned on doing you on Good friday. I show up at 8 AM and guess what? Your company takes Good friday off. Now your time is wasted and you have to charge me more because you will have to make a separate trip to stop by to see my company.

Or any time of the year: I have a document control clerk and an assistant. The assistant had schedueld vacation months in advance and the document control clerk was in an accident on the way to work that day and doesn't make it in. The company will get by for the day but how do you audit the master list and controls that the clerk and their assistant control?

Those are reasons why I think the audit might not be successful. In addition, is the adversarial implication which can cause a poor attitude also making the audit not go well. I may be at work but my work load today since it is the first of the month and I am trying to get reports to everyone is so great that I know when you come in I am going to have to spend an hour or two with you and everyone is going to be unhappy with me because their reports are late. I am not going to be as cooperative as I would be if I could have planned for your visit and planned to come in early to get my reports done before you got there.

In addition it leaves me with a bad taste in my mouth. You are just another policeman out there hiding in the bushes trying to catch me breaking the law. I for one went through unscheduled audits with UL and the timing could be a killer at the end of the month when you were trying to meet the customers needs. This would mean a company might have to place an ISO audit before meeting the needs of the customer which seems to be diabolically opposed to what ISO was developed for.

I don't condone systems that "clean everything up" at the last minute. But is that is the mind set that one believes the companies have then what makes you think they aren't hiding things even if you come unplanned? I think you have to believe that most people want to do the right thing and do the right thing. These people would only be penalized by lack of planning if you went to random unscheduled audits.

Phyllis
 
Elsmar Forum Sponsor
D

David Guffey

#2
The registrar who "drops in" for an audit for my company will soon be a former registrar.

Anyone properly trained in Quality Auditing KNOWS not to pull a surprise audit (regulatory or statute compliance excepted).
 
Thread starter Similar threads Forum Replies Date
D Unannounced Audit - Remote ISO 13485:2016 - Medical Device Quality Management Systems 6
ScottK How's the unannounced inspection by notified bodies going? EU Medical Device Regulations 3
M Incomplete Unannounced Audit - No Active Production at the time ISO 13485:2016 - Medical Device Quality Management Systems 11
B MHRA Unannounced Audits Frequency Changed? EU Medical Device Regulations 2
S EN ISO 13485:2016 vs. ISO 13485:2016 - Unannounced MDD Audit yesterday ISO 13485:2016 - Medical Device Quality Management Systems 4
L Unannounced Audits EU Medical Device Regulations 6
S Unannounced Audits - Commision Recommendation 2013/473/EU Published 25.9.2013 CE Marking (Conformité Européene) / CB Scheme 6
P EU Commission requires NB (Notified Body) Unannounced Visits EU Medical Device Regulations 48
Q Question on Unannounced Registrar Audits - Plant manager suggested no advance notice General Auditing Discussions 16
J Internal audit random sampling methodology Internal Auditing 2
C Random defects vs systematic (designed in) errors or faults. Design and Development of Products and Processes 1
Ron Rompen Random data generation in Minitab Statistical Analysis Tools, Techniques and SPC 2
M Stratified Random Sampling Calculations Statistical Analysis Tools, Techniques and SPC 1
A Random Sampling Statistical Analysis Tools, Techniques and SPC 10
G Sampling Question - Random Sample of 100 pcs and 11 pcs. have been rejected Inspection, Prints (Drawings), Testing, Sampling and Related Topics 30
L Do all non-random patterns apply to attributes and variable charts including R chart? Statistical Analysis Tools, Techniques and SPC 5
S Random Sampling of Chickens Inspection, Prints (Drawings), Testing, Sampling and Related Topics 7
P Random Sampling at Receiving Inspection: A Practical Implementation needed Inspection, Prints (Drawings), Testing, Sampling and Related Topics 13
S Probability Density Function of a Function of a Random Variable Statistical Analysis Tools, Techniques and SPC 13
I Multiple Comparisons for a Random Factor Using Minitab Software 2
D How to perform Random Sampling Statement Inspection, Prints (Drawings), Testing, Sampling and Related Topics 10
P Individuals Chart for Non-Sequential Data - Random Sample without Reference to Time Statistical Analysis Tools, Techniques and SPC 4
A Random Sampling for in-process inspection Inspection, Prints (Drawings), Testing, Sampling and Related Topics 7
P Random Sampling vs. Thorough Review - Records to be Reviewed - Audit Finding Inspection, Prints (Drawings), Testing, Sampling and Related Topics 13
S Random Sampling question - taking samples from the same spot! Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
H Part Number Assignment, Should be coded or Random? Manufacturing and Related Processes 11
Marc Solving "Random" Puzzles Key To Scoring A-List Tech Jobs Career and Occupation Discussions 8
Ajit Basrur Random Insult Generator (RIG) Coffee Break and Water Cooler Discussions 2
M Random 'Normal Distribution' Numbers in Excel Excel .xls Spreadsheet Templates and Tools 26
M Creating a "random disturbance" for each observation via MINITAB Using Minitab Software 1
S Using AQL to get true random sampling using General Inspection Level II AQL - Acceptable Quality Level 4
C Random Uncertainties - Can anyone explain "Random Uncertainties"? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
T OASIS and External Audits AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
D What are the rules regarding coverage in internal audits? IATF 16949 - Automotive Quality Systems Standard 5
D What are the IATF rules regarding doing internal audits remotely? IATF 16949 - Automotive Quality Systems Standard 5
GStough Suppliers Starting to Charge A Fee for Customer Audits Supplier Quality Assurance and other Supplier Issues 14
A Internal Audits - skipped clauses? Internal Auditing 11
L Internal Audits during the MDR Transition Period EU Medical Device Regulations 5
L Internal audits for IATF IATF 16949 - Automotive Quality Systems Standard 7
E FDA & Internal Audits US Medical Device Regulations 3
D Integrated Management System (IMS) - Process Vs Clause Based Audits ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 19
qualprod Statements into a procedure against audits ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
Sidney Vianna Informational ISO/NP TS 17012 - Guidelines for use of remote methods in conducting audits of management systems Other ISO and International Standards and European Regulations 0
G NC criteria during internal audits ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
Stefan Mundt Split Scope = Separate Audits ??? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
Ed Panek Audit Protocol? Simultaneous surveillance and recertification audits. ISO 13485:2016 - Medical Device Quality Management Systems 11
A Layered Process Audits for Medical Device Manufacturing? ISO 13485:2016 - Medical Device Quality Management Systems 3
Quality Specialist Quick question on the sequence of ISO 17025 external audits ISO 17025 related Discussions 14
B Consistently Late Internal Audits- Any Suggestions? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 116
John C. Abnet GM sqr- second party audits IATF 16949 - Automotive Quality Systems Standard 4

Similar threads

Top Bottom