Determining the Status and Importance of the Processes and Areas to be Audited

W

wywy2020

#1
If you were looking specifically for the word risk, then you would be correct, but, if you understand the term "managing risks" as identifying the critical aspects that could lead to a failure and prioritize the use of the resources wisely, then ISO 9001:2008 is full of examples for that line of thought.

I will offer one example. In ISO 9001:2008, we have the following requirement

the bold font clearly indicates a "risk-based" approach to develop an audit schedule and the intent is clear to identify processes/areas which represent a higher risk to product conformity and customer satisfaction, and prioritize, emphasize, scrutinize, etc. such processes/areas with a higher intensity, frequency, depth, etc.

In my mind, this is a typical case where the authors of 9001:2008 wrote a requirement using a risk-based mindset, without using the word risk. So, from that perspective, I am in the field of those who believe that, (if well understood) ISO 9001 has always been supposed to be a risk-based approach to managing quality.
how u demonstrate to auditor that ur audit program is taking into consideration the status and importance of the processes and areas to be audited, as well as the results of previous audits?
 
Elsmar Forum Sponsor

AMIT BALLAL

Trusted Information Resource
#2
Re: "Context of the Organization" in 4.1 of ISO 9001

how u demonstrate to auditor that ur audit program is taking into consideration the status and importance of the processes and areas to be audited, as well as the results of previous audits?

Divide processes in three categories:
1. Customer oriented / core (PPC, Quality, etc.),
2. Supporting (Stores, Purchasing, etc.),
3. Managerial (Business Planning, QMS, etc.).

Define frequency of auditing of these processes eg. Category-1 processes to be audited more frequently as compared to other 2, category-2 processes to be audited more frequently than category-3- but less than category-1.

THIS WILL DEMONSTRATE IMPORTANCE BASED AUDITING.

Based on the performance of processes (Monitored through effectiveness, efficiency measures, Quality objectives), frequency to modified. Or additional audits to be conducted whenever performance found poor.

THIS WILL DEMONSTRATE AUDITING BASED ON PROCESS PERFORMANCE.


Thanks,
Amit
 
W

wywy2020

#3
9.2 Internal audit - consideration

9.2 Internal audit it stated that audit programme shall take into consideration the importance of the processes concerned, changes affecting the organization, and the results of previous audits;

How do you all demonstrate this to the auditor that the above consideration has been taken?
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#4
How do you all demonstrate this to the auditor that the above consideration has been taken?
You discuss and show him your audit schedule. How do you plan your audit schedule? It's a matter of explaining that to the auditor.

Discussions on the "status and importance" requirements go back some years here. Here are some of the "status and importance" discussions from the past.

I look forward to contemporary responses in this thread.
 

tony s

Information Seeker
Trusted Information Resource
#5
Unlike in 2008, the 2015 version no longer includes the STATUS as one of the things to consider in establishing, implementing and maintaining an audit program.

At any rate, when I consider status, I look into the maturity, adequacy of resources, knowledge/skills/experience of personnel, complexity, stability of a the process. If we have just established a new process, this process will be scheduled for a more frequent audit.

For IMPORTANCE, my approach is the same with the others. Processes that are more critical in the realization of the company's products and services have more frequent audits. These will include processes that have direct interaction with the customer including the specifications, materials, equipment needed to realize the products and services.
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#6
Unlike in 2008, the 2015 version no longer includes the STATUS as one of the things to consider in establishing, implementing and maintaining an audit program... <snip>
Yes, but as you say - You still consider status in your audit planning. The standard may not explicitly state it as a requirement, but it is part of good internal audit procedure/system and audit planning practices.
 

Colin

Quite Involved in Discussions
#8
how u demonstrate to auditor that ur audit program is taking into consideration the status and importance of the processes and areas to be audited, as well as the results of previous audits?
By not just re-issuing last year's programme with a new date on it!

Look at your processes, which would have the biggest impact if it went wrong? - you might even do a simple risk assessment on each process. That will give you a start point until you can use historical data to help you.
 
Thread starter Similar threads Forum Replies Date
A IATF 16949 4.3.1 - Determining the scope of the quality management system - supplemental IATF 16949 - Automotive Quality Systems Standard 9
D ISO 9001:2015 4.3 Determining the Scope of the QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
J Determining SPC tolerance Statistical Analysis Tools, Techniques and SPC 21
B Determining SAT Offsets vs TUS Offsets per SAE AMS 2750E AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
B Determining sample size for device sterility Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
D Determining of sample size for 'Operational Qualification' AQL - Acceptable Quality Level 3
R Question on determining defective units - I am not recording fixture to part rejected Statistical Analysis Tools, Techniques and SPC 5
S Clause 8.2.2 Determining the requirements for products and services ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
D Determining Calibration Frequency schedule for items used in production Manufacturing and Related Processes 2
C Determining if Maintenance Contractor is an External Service subject to ISO 9001 Clause 8.4 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 43
S AS9100D PEAR - Examples for organization's method for determining process results? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
I Determining Calibration Tolerance of a Measurement Device General Measurement Device and Calibration Topics 2
J ISO 17025 Documented Procedure for 6.2.5 - Determining competency ISO 17025 related Discussions 4
V Determining FDA 820 (registration) vs ISO 13485 - Supplier gives us the kit ISO 13485:2016 - Medical Device Quality Management Systems 1
J ISO 9001 8.4.1 - Determining controls applied to externally provided processes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
E Determining what is good and what is bad can be subjective - when is it a quality issue? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
F Determining what type of scrap to include in my internal PPM calculation Quality Manager and Management Related Issues 5
M Determining number of employees within the "Scope" of the QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
A Determining the Scope of the QMS during Stage 1? Registrars and Notified Bodies 11
W Minor Audit Nonconformance Against Determining the scope of QMS IATF 16949 - Automotive Quality Systems Standard 12
D Determining Critical Components for conformity with IEC 60601-1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 21
Q ISO 9001, section 4.3 Determining the scope of our QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
R Determining Sample Size for Medical Device Component Validation Inspection, Prints (Drawings), Testing, Sampling and Related Topics 0
A What does 8.2.2.1, Determining the requirements related to products and services,mean IATF 16949 - Automotive Quality Systems Standard 1
A Determining Retention Period for Medical Device QMS documents Document Control Systems, Procedures, Forms and Templates 5
S Surveillance Sampling Test - Determining Sample Size Inspection, Prints (Drawings), Testing, Sampling and Related Topics 5
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
B Standards Needed In House - Determining what standards are applicable Various Other Specifications, Standards, and related Requirements 3
W Determining Medical Device Classification in Mexico Other Medical Device Regulations World-Wide 5
K Determining Effect of Failure without a DFMEA (Design FMEA) FMEA and Control Plans 1
T Determining Customer Requirements for the US Postal Service (USPS) IATF 16949 - Automotive Quality Systems Standard 4
Crimpshrine13 Rules of achieving and maintaining IATF recognition - Determining audit days IATF 16949 - Automotive Quality Systems Standard 2
R Developing procedure for Determining Company's Context And Interested Parties ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 53
W Determining Asset Life or Depreciation Life for M&TE General Measurement Device and Calibration Topics 1
N Reason for determining no adverse effect on reworked product ISO 13485:2016 - Medical Device Quality Management Systems 7
N Procedure for determining pinhole position in condom Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
alonFAI Determining PCBA Xray Test Sampling Size Statistical Analysis Tools, Techniques and SPC 1
S Determining sample size for inspection to achieve x% confidence re defects Misc. Quality Assurance and Business Systems Related Topics 10
S Determining Sample Size - AQL & LQ AQL - Acceptable Quality Level 10
R Determining the feasibility/scope for FDA IQ/OQ against a very simple application US Food and Drug Administration (FDA) 2
B Determining the "storage volume" (ISO 8536-8:2004 clause 6.14) Other Medical Device Related Standards 4
N Procedure/calculation for determining the foot pressure of dial thickness gauge General Measurement Device and Calibration Topics 10
B Bayes Success-Run on Attribute Data - Determining Sample Size Statistical Analysis Tools, Techniques and SPC 2
H Determining Takt Time in Metal Stamping Lean in Manufacturing and Service Industries 9
J Determining if there is Tin Plating on an Aluminum Bar Inspection, Prints (Drawings), Testing, Sampling and Related Topics 6
C Determining PFMEA Severity for Armored Parts FMEA and Control Plans 5
E Correlated data or not? Determining the significance of differences in means Statistical Analysis Tools, Techniques and SPC 3
T Determining What to Test - Prop 65 Testing RoHS, REACH, ELV, IMDS and Restricted Substances 2
M Determining c=0 AQL numbers Misc. Quality Assurance and Business Systems Related Topics 3
M AMS2770 Aluminum Heat Treat - Determining Soak Time Various Other Specifications, Standards, and related Requirements 1

Similar threads

Top Bottom