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

[somashekar]

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

5.4.1 Quality objectives
Top management shall ensure that quality objectives, including those needed to meet requirements for product [see 7.1 a)], are established at relevant functions and levels within the organization. The quality objectives shall be measurable and consistent with the quality policy.

Above is the 5.4.1
Does your top management feel that quality objectives need to be established at the purchase and HR function. As a MR (I guess you are) would you like to do this bit about you honest opinion :
From 5.5.2 b) report to top management on the performance of the quality management system and any need for improvement
In your present scene there is no any NC.
Help bring about through top management newer objectives towards improvement, and then your audits can begin dealing with them.

 

[AndyN]

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

True - we know that ISO 19011 is out of step with ISO 9001, maybe that's something that will be revised in the current changes underway...

 

[AndyN]

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

6.3, Sidney, 6.3....

 

[Rameshwar25]

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.

ISO 9001 is a process approach based standard. The process of HR (like freezing qualification matrix, competency gap analysis, training need identification and much more ) should take place. It does not matter who does these activities. It may be a security man to President of company. The activities will be well defined and responsible person will have to take his/her quality objective for the same.
So it does not matter what HR was doing your Ex-company. The required activity might be taking place elsewhere.
This is at least one of Q.Obj of purchase department to timely procure the raw material/ brought out parts to ensure on-timely delivery to customer.
And this is at least one q.obj of HR to employ personnel which meet requirements of product.

Rameshwar

 

[Sidney Vianna]

6.3, Sidney, 6.3....

The OP had mentioned this to be part of an internal audit exercise. The guidance on the internal audit aspect of documentation from ANSI/ISO/ASQ QE19011S-2004 reads

S6.3.1 First-party (internal) audits
For internal audits, where the audit team is already familiar with the management system to be audited and with associated documents, a less comprehensive review may be all that is necessary. For example, the audit team may only need to review those documents in which changes have been made since the last audit of that area. Often documents specific to a
particular area (e.g., area-specific work instructions) can be reviewed while auditing that area, rather than during a separate document review.
If any documents are found to be inadequate, the situation is normally identified through the organization’s corrective action system.
Documents to be reviewed for an internal audit may include:
a) requirements of the standards and regulations relative to the processes and products being audited,
b) sections of the quality manual that relate to the processes being audited,
c) any procedures that relate to the audit,
d) process models or other documentation describing the process(es) being audited and their interaction with other processes, and
e) work instructions, forms and records that are pertinent to the audit.

 

[AndyN]

The OP had mentioned this to be part of an internal audit exercise. The guidance on the internal audit aspect of documentation from ANSI/ISO/ASQ QE19011S-2004 reads

I didn't want to quote the USA version, since I understood the OP to be from outside the US and probably doesn't have access to that version...

 

[Big Jim]

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

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.

What do you think 8.4 is included in the standard for? The organization is directed to determine, collect and analyze data that provides insight on the health of the quality management system. What are they to use that analyzed data for? Doesn't it make sense to at least in part to help you monitor your processes and give you guidance for quality objectives?

I think that is why it is there. If it is there, why not use it. Why do something completely different for quality objectives when you have to do this anyway?

Let me fix your question to how I'm trying to express it.

"Are you saying that the requirement to analyse the groups of data mentioned in 8.4 CAN used to define the quality objectives of the business?"

Of course you can.

 

[AndyN]

Jim, it sounds like you're putting the 'Do, Check' before the 'Plan'...

 

[Sardokar]

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?

5.4.1 Quality objectives
Top management shall ensure that quality objectives, including those needed to meet requirements for product [see 7.1 a)], are established at relevant functions and levels within the organization. The quality objectives shall be measurable and consistent with the quality policy.


My question is this :

Are the "relevant functions " necessary to meet product requirements a subjective notion ?

can a company that sells to a customer a product X really pretend that the function (purchasing) that allows it to BUY product X from its supplier is not "relevant" to meet product requirements ?

i find that hard to understand

furthermore how can HR not be a "relevant" function to meet product requirements when HR is in charge of recruitment and training of employees??? Even more so when the product is a service like support ?

I'm really having a hard time understanding

Another question :

If my Quality Manual says that quality objectives must be created at the HR and purchasing levels , would the abscence of quality objective constitte a non conformity then ?

 

[Big Jim]

Jim, it sounds like you're putting the 'Do, Check' before the 'Plan'...

How is that?

Is not determining how to monitor your processes part of planning?