Top 10 areas where most NC's are found during CB audits?

S

samsung

#1
Recently I happened to ask my CB auditor "Which are the top 10 business areas where you generally find most nonconformances/ gaps during the surveillance or registration assessments (9001)?"

And his answer quite surprised me.

1. Lack of proper identification as well as interaction of processes. (4.1)
2. Inadequate documentation and improper Document/ Record Control (4.2.3/ 4.24 but the CB admitted that nowadays they generally ignore this area)
3. Competence, awareness and training (6.2.2)
4. Poorly implemented Corrective Action process and evaluation of CA effectiveness.
5. Internal auditing - improper planning and execution (8.2.2 (b) in particular)
6. Top management commitment (5.1, 5.5.1, 5.5.3 & 6.1)
7. Irrelevant or inconsistent middle level objectives/ poor linkage with higher business objectives and organizational mission (5.4.1)
8. Lack of effective control & monitoring of processes (8.2.1, 8.2.3, 4.1,)
9. Ineffective processes of data collection, analysis and improvement actions (8.4)
10. Lack of general understanding of basic Quality Management Principles.

I tried my best to arrange the clauses in the order he narrated to me.

Are your opinions consistent with the above or you have some different experience?

Thanks
 
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somashekar

Staff member
Super Moderator
#3
No clause 7 listed goes to show that even top managements are happy with something DONE and pay little or no attention to PLANING quality, MONITORING quality and IMPROVEMENT quality.
 

qusys

Trusted Information Resource
#4
Recently I happened to ask my CB auditor "Which are the top 10 business areas where you generally find most nonconformances/ gaps during the surveillance or registration assessments (9001)?"

And his answer quite surprised me.

1. Lack of proper identification as well as interaction of processes. (4.1)
2. Inadequate documentation and improper Document/ Record Control (4.2.3/ 4.24 but the CB admitted that nowadays they generally ignore this area)
3. Competence, awareness and training (6.2.2)
4. Poorly implemented Corrective Action process and evaluation of CA effectiveness.
5. Internal auditing - improper planning and execution (8.2.2 (b) in particular)
6. Top management commitment (5.1, 5.5.1, 5.5.3 & 6.1)
7. Irrelevant or inconsistent middle level objectives/ poor linkage with higher business objectives and organizational mission (5.4.1)
8. Lack of effective control & monitoring of processes (8.2.1, 8.2.3, 4.1,)
9. Ineffective processes of data collection, analysis and improvement actions (8.4)
10. Lack of general understanding of basic Quality Management Principles.

I tried my best to arrange the clauses in the order he narrated to me.

Are your opinions consistent with the above or you have some different experience?

Thanks
Agree in general.
I also think that major finding can come from Product realization and planning.
Product design and development is another area of huge problem.
ISO9001 does not emphatize the importance of Process Design and Development as ISO TS does.

Besides , also 7.6 for Control of monitoring and measurement devices is another fieldwhere lots of non conformities can be generated.:bigwave:
 
S

samsung

#5
Less number of NC's in clause 7.0 was quite surprising to me as well but when asked I was given to believe that this section mainly deals with core business processes (Production, Product Quality, Purchase, packaging, distribution etc.) directly contributing to the bottomline and so the organizations take great care to allocate their utmost resources and efforts in order to manage them well.

Secondly, in view of certain regulatory concerns as well, these processes always remain at the forefront and hence these are likely to attract less number of NCs compared to other processes.
 
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