Some departments don't have Quality Objectives - Non Conformity?

[AndyN]

Does this constitute a minor non conformity in regard to 5.4.1 or should we just classify it as a RFI ( recommendation for improvement)

Neither! As an internal audit where's the objectivity here? It's certainly NOT an NC and what would be gained as an improvement? I think the improvement needs to be with the internal audit/auditor...

 

[Rameshwar25]

The purchase and HR-both are very important functions of any organization. Purchase procures the material which affects the product quality. HR keeps an eye on skills of employee who perform work affecting product quality. therefore i suggest to take Q.Objectives for both functions.
Moreover, the internal audit should be conducted more strictly than an external audit. e.g. any minor NC raised by external auditor should be treated as Major during internal audit. More number of NCs should be raised and OFI should also be treated as NC. This is to exert a pressure on personnel to strictly follow the system.
When we make process interaction sheet, the Q.Obj should be taken for each process. Benefits should not be taken for the term 'relevant functions' as there is no criteria for 'relevant' and 'non-relevant function'.
While implementing ISO 9001, if you just implement the standard requirements, it will be a dilute system and may fail to meet organization's vision/ policy.

Rameshwar

 

[Sardokar]

Neither! As an internal audit where's the objectivity here? It's certainly NOT an NC and what would be gained as an improvement? I think the improvement needs to be with the internal audit/auditor...

I fail to understand what you mean .

As per answers of a few people in this topic they tend to think it should be treated as a non conformity

the "objectivity" is that purchasing makes sure that we are purchasing the right product from the right supplier at the right price

HR makes sure we recruit the right employees and try to ensure proper training and proper employee satisfaction


IMHO if these 2 support processes (forget that i used the word department) dont have quality objectives it will impact the product quality (directly and indirectly) and thus IMHO it constitues non conformities

i was trying to see if other people feel the same way ... obviously some do , but you dont AndyN ...

and i am confused about the reason ? your answer doesnt make sense to me honestly

please clarify

 

[Big Jim]

Re: Some departments don't have quality objectives - Non Conformity ?

First, don't confuse a department with a process. Departments aren't mentioned anywhere in ISO 9001 for a reason.

The standard requires the organization to establish quality objectives at "relevant functions and levels." There may be objectives established for the overall organization that may apply to the purchasing and HR processes. I don't see evidence of a nonconformity against 5.4.1.

Instead of looking at objectives, I'd look at process measurements. Please read clause 8.2.3:


As you can see, each process is required to have some method to monitor/measure it to determine its ability to achieve "planned results." I suspect that this is really what you are talking about. If the organization has no method to do this, then it IS a nonconformity to 8.2.3.

Well said!

This topic reaches into another topic, KPI, or Key Performance Indicators (some people call them Key Process Indicators). KPI are a form of quality objectives, or at least are closely related. The term KPI is not used in the standard, but it is there as I will explain. Most importantly, Certification Bodies are looking for KPI during registration and surveillance audits for an organization's core processes.

Where is KPI in the standard?

It starts in 0.2 where the process approach is explained (but with no shalls attached). This sets the tone.

0.2 b & c

When used within the quality management system, such an approach emphasizes the importance of . . . obtaining results of process performance and effectiveness . . . continual improvement of process based on objective measurements"

4.1 starts the shalls involved with the process approach.

"The organization shall:
a) determine the processes needed for the quality management system . . . c) determine criteria and methods needed to ensure that both the operation and control of these processes are effective . . . e) monitor, measure where applicable, and analyse these processes . . . f) implement actions necessary to achieve planned results and continual improvement of these processes."

(emphasis added)

As was already mentioned by others, 5.4.1 includes the need to have quality objectives "at relevant functions and levels within the organization".

As Howste pointed out, 8.2.3 requires the monitoring and measurement of your processes. 8.2.3 somewhat repeats what was in 4.1.

"The organization shall apply suitable methods for monitoring and, where applicable, measurement of the quality management system processes. These methods shall demonstrate the ability of the processes to achieve planned results. When planned results are not achieved, correction and corrective action shall be taken, as appropriate."

Perhaps even more telling is from 8.4 c.

"The organization shall determine, collect and analyse appropriate data to demonstrate the suitability and effectiveness of the quality management system and to evaluate where continual improvement of the effectiveness of the quality management system can be made . . . The analysis of data shall provide information relating to . . . c) characteristics and trends of processes . . . "

The Certification Bodies are being pushed by their Accreditation Bodies to continue to expand the application of the process approach. The use of KPI is a fairly recent one. An even more recent one is the question in at least some audit workbooks is the question for the top manager or top managers that in effect asks "Do you feel that your quality management system is effective as a whole" (where knowledge of KPI and how they are tracking would be very useful in answering the question) and the question for process owners "Is your process effective and do you have any performance data to support your response".

The short answer is that you are expected to have some sort of measurable objective that you are tracking for whatever processes lend themselves to such measurements and these objectives / KPI are expected to be at relevant functions and levels within the organization (core processes).

 

[Bogie]

The purchase and HR-both are very important functions of any organization. Purchase procures the material which affects the product quality. HR keeps an eye on skills of employee who perform work affecting product quality. therefore i suggest to take Q.Objectives for both functions.

Rameshwar

Although for many companies, HR tracks skills, I have worked for two companies where HR was not part of that function and the HR position was part time only. That function was part of Management's responsibility. HR was responsible for Benefits and interaction between employees and Management (if an intermediary was needed).

Also, for the last company I worked for (software and assembly of systems that used the software), Engineering was responsible for testing and approving components - Purchasing just purchased parts that they were allowed to buy. Although yes, Purchasing was expected to procure components in a timely manner, the product quality was not a responsibility of Purchasing.

I don't see where there is a NC, unless somewhere the company has written down that those functions will have Qual Objectives.

 

[Big Jim]

I fail to understand what you mean .

As per answers of a few people in this topic they tend to think it should be treated as a non conformity

the "objectivity" is that purchasing makes sure that we are purchasing the right product from the right supplier at the right price

HR makes sure we recruit the right employees and try to ensure proper training and proper employee satisfaction


IMHO if these 2 support processes (forget that i used the word department) dont have quality objectives it will impact the product quality (directly and indirectly) and thus IMHO it constitues non conformities

i was trying to see if other people feel the same way ... obviously some do , but you dont AndyN ...

and i am confused about the reason ? your answer doesnt make sense to me honestly

please clarify

Your thinking is sound. Those are processes and they lend themselves to having measurable objectives / KPI.

A frequently used objective for purchasing is either supplier on-time delivery or supplier accuracy (wrong or defective parts shipped).

A possible measurement of the competency of your personnel would be your product quality (scrap rate, reject rate, first pass yield, warranty returns, etc.).

Element 8.4 provides some guidance on the types of things to measure. Paraphrased it says that you need to determine, collect, and analyze data that demonstrates the health of you quality management system. There are four topic that you must do this for. You can certainly have more than one measure for each topic. The four topics are customer satisfaction, product quality, process performance, and supplier performance. Two of them fit the processes in your example.

 

[Big Jim]

Re: Some departments don't have quality objectives - Non Conformity ?

Another factor is that an organization can overwhelm itself with various parts having objectives and measurements etc. It really should be kept very simple - a bit like a car dashboard, as I've written before - there are multiple 'things' which could be measured and monitored on a vehicle - but basically, to get anywhere - the primary objective of using a car, there are really only 2-4 that need to be displayed on the dashboard - speed, gas, mile/kms etc.

For departments to 'come up' with some objectives e.g. 'conduct trainings' ensures that they will HAVE them, but not understand how this contributes to the overall objectives of the business towards the customer etc. I vividly remember one large corporation which had an objective of everyone having 40 hrs of training a year...whether they needed it or not!

Simple to a point. It is possible to have four quality objectives that align with the requirements of 8.4 and cover each of your processes by using some the objectives for more than one process.

The question that must be asked though is do you have enough to be effective. In some situations, the answer would be no.

The dashboard needs to have enough to be effective for the organization involved. By nature, some will be more elaborate than others, and by choice some companies will have more elaborate dashboards.

 

[AndyN]

I fail to understand what you mean .

As per answers of a few people in this topic they tend to think it should be treated as a non conformity

the "objectivity" is that purchasing makes sure that we are purchasing the right product from the right supplier at the right price

HR makes sure we recruit the right employees and try to ensure proper training and proper employee satisfaction


IMHO if these 2 support processes (forget that i used the word department) dont have quality objectives it will impact the product quality (directly and indirectly) and thus IMHO it constitues non conformities

i was trying to see if other people feel the same way ... obviously some do , but you dont AndyN ...

and i am confused about the reason ? your answer doesnt make sense to me honestly

please clarify

Sardokar: You originally posted "during our internal audits we found that the support , implementations and almost all processes had quality objectives

except the Purchasing and HR departments which had none

Does this constitute a minor non conformity in regard to 5.4.1 or should we just classify it as a RFI ( recommendation for improvement)"

This is not a non-conformity because there is no requirement for these functions/processes to have quality objectives in ISO 9001! It cannot, therefore be classified either as a minor or RFI, either. If an internal audit is conducted and the auditors do not know what audit criteria and, therefore, the applicability of their 'findings' to the situation, then the auditors need to be coached to improve their understanding.

I'd hazard a guess that if the QMS documentation didn't in some way reference objectives in these two areas, an audit wouldn't have been necessary to find this out - a quick chat with the process owner(s) would have revealed this. ISO 19011 makes it clear that unless the documentation is sufficient to support the outcome of the audit, then the audit shouldn't be conducted...

Does this help?

 

[Paul Simpson]

Re: Some departments don't have quality objectives - Non Conformity ?

<snip>It is possible to have four quality objectives that align with the requirements of 8.4 and cover each of your processes by using some the objectives for more than one process. </snip>

Now I'm really confused. Are you saying that the requirement to analyse the groups of data mentioned in 8.4 are used to define the quality objectives of the business?

I haven't gone through all the thread but IMHO the answer to the OP is no - not without investigating a lot further to establish if the existing set of objectives is relevant and appropriate.

 

[Sidney Vianna]

ISO 19011 makes it clear that unless the documentation is sufficient to support the outcome of the audit, then the audit shouldn't be conducted...

Andy, for my edification, can you let me know the section in ISO 19011 mentioning that? I am a little confused with this concept because, as we know well, there are many processes that are not supported by documented command media. So, I would like to read exactly the guidance coming from ISO 19011 on that.

Thanks