Auditing the Packing Dept. - What is the Packer Required to Have Available?

[Andrews]

Auditing packing dept.

If the person who packs the products does not have the packing specification and packing procedure.Under what clause of ISO 9001-2000 will it be a non-conformance ?

 

[Mike S.]

Can you give more details? I think part of the answer depends on what your internal procedures say. There may be several NC's depending on what you say you will do vs. what you are doing/not doing.

However, depending on the above, some possibilities are 4.1d, 4.2.1d, 4.2.3d, and 7.5.5.

JMO -- others may have more or better insights.

 

[Claes Gefvenberg]

I'd use 7.5.1b.

"the availability of work instructions, as necessary"

/Claes

 

[Mike S.]

Duh

Yep, Claes, I missed the one that might be the most relevant!

 

[Aaron Lupo]

Claes Gefvenberg said:

I'd use 7.5.1b.

"the availability of work instructions, as necessary"

/Claes

That is the question you need to ask yourself before you give a N/C, are the work instructions necessary???

 

[db]

Packing instructions

are the work instructions necessary???

If I may, Johnny Bravo, I would also add, are the specifications necessary? As part of my job, I must on occasion mail out information to potential and existing customers. We have no specifications for this, nor are there work instructions. But I am intelligent enough to know what sized envelop to use, and how to insert what information into the envelop.

We must not tie the hands of individuals when they don’t need to be tied. Now, if the customer, or organization has exact specifications, or if the packer needs work instructions, then it is a different matter. As far as what clause I would write against, I’m not convinced we need to get this exactly right. The important thing is to have an effective corrective action. I really don’t care if it is to 7.5.1 b), or to 7.5.5, or even to 6.2.2, just make sure the employees are doing what needs to be done.

 

[Claes Gefvenberg]

I couldn't agree more db... and ISO GUY's comment is entirely correct too. This is a good time to have a look at 4.2.1, note 2:

NOTE 2 The extent of the quality management system documentation can differ from one organization to another due to

a) the size of organization and type of activities,
b) the complexity of processes and their interactions, and
c) the competence of personnel.


On the other hand: Andrews said that there was in fact a packing specification as well as a packing procedure, so I'll assume that those were in fact needed...

/Claes

 

[Mike S.]

I made the same assumption, Claes. But I too agree the questions db and Isoguy brought up are valid. After all, we all know what happens sometimes when we "***-u-me" things!

 

[M Greenaway]

This sort of audit finding is always difficult to address. Claes has given a good clause to hang this on, but really the auditor should assess the necessity of such documents by looking at the effectiveness of the process based on the process output.

If the job routing (or whatever) tells the packer to pack to spec XYZ then what I think you should do in the audit is determine first whether the product was packed to spec XYZ. If not then you have a solid audit finding, root cause of which might be lack of training or indeed unavailability of the specification to the packer.

 

[Michael T]

Okay - how 'bout if I throw an obscure element at you folks:

Human Resources
6.2.1 Personnel performing work affecting product quality shall be competent on the basis of appropriate education, training, skills and experience.

So... this guy has been appropriately trained, has been packing the product the same way, day-in and day-out, with no change to the product, no change to the package, no change to the packing material, and is performing his job to the customer's satisfaction (evidenced by either a lack of complaints concerning packing {which might be shaky evidence} or by affirmative satisfaction through surveys).

Hence, no procedures are necessary...

Can anyone find the flaw in this?

Cheers!!!