SBS - The Best Value in QMS software

How to understand this words that the planning of internal audit shall take into consideration the results of previous audits?

lanley liao

Involved In Discussions
#1
Greeting,

I have a question that how to understand correctly this sentence that the planning of internal audit shall take into consideration the results of previous audits from section 6.2.2.1 of API Spec Q1. the results of previous audits, which means is it the results of previous internal audit or the results of external audit, both.

Many thanks!

Langley Liao.
April,16,2021.
 
Elsmar Forum Sponsor

jmech

Trusted Information Resource
#3
The requirement is not clear. It does not explicitly limit it to internal audits or explicitly include external audits. It is in the section titled "Internal Audit". The first sentence in the paragraph refers to "internal audit" and the second sentence in the paragraph refers to "audit" but is realistically only applicable to internal audits, so a reasonable interpretation could be that this requirement in the third sentence is primarily applicable to internal audits. However, this is not the only way to interpret it, and I could see an API auditor having a different view.

I recommend including both, even if the requirement is not explicit about it, because it can benefit the organization for almost no cost and prevents a potential finding at your next API audit.

What I have most commonly seen is considering findings from both the previous internal audit and the previous API audit and spending extra time/effort to verify that the nonconformances identified in these findings are not recurring. This has been accepted by API auditors when they have reviewed these internal audits. As well, if carried out effectively, it can allow the organization to correct an issue before it becomes a repeat finding from API.
 

Mikey324

Quite Involved in Discussions
#5
just seems reasonable to think about anything that may have come up in a previous audit, whether it be internal or external. For example, i wouldn't neglect to follow up on a C/M from an external audit because i got hung up on standard wording. It's in my best interest to make sure anything from an audit, regardless of its origin, is implemented effectively and still working.
 

Ninja

Looking for Reality
Staff member
Super Moderator
#6
Put the words aside and think about what makes sense...

We found out a while back that XYZ was not going according to plan.
We addressed the issue when we found out about it.
Now we're going to plan how we are going to take a look around again to find out if everything is ship shape.
While we're reviewing things anyway, it makes sense to plan to specifically check on that thing that broke before to make sure everything we fixed stayed fixed.

That's all the words are saying, they just say it in 'quality-ese'.
 

Mikey324

Quite Involved in Discussions
#7
"Put the words aside and think about what makes sense"

@Ninja, this is what it means to make the standard work for your organization. Do it in a way that makes sense and adds value, not in way to check a box that a requirement has been met.
 

Ninja

Looking for Reality
Staff member
Super Moderator
#8
Do it in a way that makes sense and adds value, not in way to check a box that a requirement has been met.
I sorta agree, and thank you for helping connect the dots.
All the same, the wording makes me wonder if the cart isn't still in front of the horse...

Don't "Do it in a way that makes sense and adds value"....
Instead, do what makes sense and adds value without any standard in mind...then see if you haven't already covered 99+% of what the standard requires.
Only let the standard guide you only on that last 0.1% that common sense didn't already cover.
IMO, Standards are not particularly useful as guides before the fact, they are useful as measuring rods after the fact.

Perhaps we're saying the same thing...but perhaps not so I figured I'd chime back in.
Funny how it's so much easier to 'comply with a standard' if you flatly ignore the standard until the business is running well.

I dislike the misleading phrase "Make the standard work for the company"...it never does, it can't...
Instead, I work for the company and my performance is measured against the standard.
Not semantics, just keeping cause and effect in the right order...HTH
 

Mikey324

Quite Involved in Discussions
#9
I sorta agree, and thank you for helping connect the dots.
All the same, the wording makes me wonder if the cart isn't still in front of the horse...

Don't "Do it in a way that makes sense and adds value"....
Instead, do what makes sense and adds value without any standard in mind...then see if you haven't already covered 99+% of what the standard requires.
Only let the standard guide you only on that last 0.1% that common sense didn't already cover.
IMO, Standards are not particularly useful as guides before the fact, they are useful as measuring rods after the fact.

Perhaps we're saying the same thing...but perhaps not so I figured I'd chime back in.
Funny how it's so much easier to 'comply with a standard' if you flatly ignore the standard until the business is running well.

I dislike the misleading phrase "Make the standard work for the company"...it never does, it can't...
Instead, I work for the company and my performance is measured against the standard.
Not semantics, just keeping cause and effect in the right order...HTH

I believe we are saying the same thing. I just use fewer words as I get older lol!
 
Thread starter Similar threads Forum Replies Date
lanley liao How to understand and master the requirements of each section in API monogram product. Oil and Gas Industry Standards and Regulations 5
lanley liao How to understand correctly the section of 5.11 MOC in API Spec Q1? Oil and Gas Industry Standards and Regulations 3
lanley liao How to correctly understand the bullet list d) of 6.3 Analysis of Data for API Spec Q1 Oil and Gas Industry Standards and Regulations 7
lanley liao How to understand this bulleted list from API 600 Oil and Gas Industry Standards and Regulations 0
A Tips and Tricks to understand ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
lanley liao How to understand the clause 6 Planning of ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
lanley liao How to understand the term 3.1.21 'Servicing' and the clause 5.7.1.2 'Servicing' of API Spec Q1? Oil and Gas Industry Standards and Regulations 19
sutie How to understand VDA 6.3 2016 P4.1 VDA Standards - Germany's Automotive Standards 6
Ajit Basrur Need help to understand HIPAA requirements ISO 13485:2016 - Medical Device Quality Management Systems 17
H Embedded Software - I don't understand that Calibration and Metrology Software and Hardware 2
J IATF 16949 Clause 9.3.2.1 - How to understand "measures" IATF 16949 - Automotive Quality Systems Standard 4
J Please help me understand what a process is ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
J Please Recommend books that explain how to understand IATF 16949 IATF 16949 - Automotive Quality Systems Standard 3
J How to understand the word "include" in IATF 16949 IATF 16949 - Automotive Quality Systems Standard 2
J How to understand IATF 16949 Clause 8.5.6.1.1 - Process Controls IATF 16949 - Automotive Quality Systems Standard 2
J How to understand IATF 16949 Clause 8.5.2.1 - Traceability IATF 16949 - Automotive Quality Systems Standard 5
S Trying to understand 7.2.1(d) of ISO 13485 - Medical Device User Training ISO 13485:2016 - Medical Device Quality Management Systems 8
M Help me understand how to conduct a Chi Square Test Statistical Analysis Tools, Techniques and SPC 3
S Informational Please help this newbie understand ISO 9001 Work Instructions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 44
F Help me understand the ANOVA Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
M Kindly help me to understand MSA Acceptance Level Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 5
T Help me understand how to define Processes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 40
N Help me understand the ISO section 7.5.2 from API Q1 perspective Oil and Gas Industry Standards and Regulations 4
A Help me understand the applicability of 21 CFR Part 820.198 (Customer Complaints) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
D Pls hlep me understand the "Total Anaerobic Plate Count" Food Safety - ISO 22000, HACCP (21 CFR 120) 1
A How to understand the source of variability and "stream-to-stream variation" Six Sigma 8
K Training the absolute beginner to understand AQL Training - Internal, External, Online and Distance Learning 1
R How to understand the exception of IEC 60601 sub-clause 8.11.5 IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
B I want to understand the ISO certification process. ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
M Reference to understand ISO9001 Book, Video, Blog and Web Site Reviews and Recommendations 1
N Owner of Company Doesn't Understand Corrective Action.... Quality Manager and Management Related Issues 12
R How to understand the IEC 60601 50 ms limit? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
L Fourier Analysis for NVH - Reference info to understand the Fourier Analysis method General Measurement Device and Calibration Topics 4
R How to understand the "full scale peak-to-valley output" mentioned in IEC 60601-2-27 IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
A Help Engineers understand the differences between Bill of Materials and Routers Document Control Systems, Procedures, Forms and Templates 9
G Numbers that will help us understand what the Cost of Rework is Misc. Quality Assurance and Business Systems Related Topics 7
Z How to understand Processes, Procedures and Documented Procedures Misc. Quality Assurance and Business Systems Related Topics 7
G Newbie in IMDS - Please help me understand what I have to do RoHS, REACH, ELV, IMDS and Restricted Substances 4
J Knowledge of CAR/PAR Procedures - Should the entire organization know/understand? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
K General Term for Inspection Process of Sample Parts that everyone can understand Supplier Quality Assurance and other Supplier Issues 10
B ISO 9001:2008 - Can any one help me to understand this paragraph? Clause 8.3 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
Z Don't quite understand interpretation of ISO17025: 2005 clause 1.4 and 1.2 ISO 17025 related Discussions 13
L What's the best way to understand IEC 60601-1 standards IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
J How to understand NOTE 2 in the ISO 9000 definition of defect? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
R Please help us to understand clause 5.5.2 of ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
Q An Engineer that does not understand gage R&R? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 17
D Can Someone help me to understand....... Imported Legacy Blogs 3
B Books to Understand FMEA Book, Video, Blog and Web Site Reviews and Recommendations 5
G Upper Management Pay - I seriously don't understand this Quality Manager and Management Related Issues 30
B Games to understand SPC concepts - Variation, Tampering, (Deming funnel experiment) Statistical Analysis Tools, Techniques and SPC 2

Similar threads

Top Bottom