5.4.1 Thoughts


Fully vaccinated are you?
On 10/29/02 3:51 PM, Someone wrote:

> To satisfy the requirements of 5.4.1, a client of ours recently submitted
> the following:
> For example - Productions' quality objectives are:
> - Zero defects
> - 100% on-time deliveries
> - Customer Satisfaction
> - 100% efficiency
> 5.4.1 says, "The quality objectives shall be measurable and consistant
> with the quality policy"
> Our Quality Policy:
> - Customer satisfaction based on high quality, competitive pricing and
> 100% on-time delivery
> - Employee involvement with quality circles focused on continuous improvements
> - Providing our customers with reliable, durable and maintainable products
> - Providing our customers with technical support/services necessary to
> aid them in achieving their goals.
> 5.4.1 in its entirety states - "Top management shall ensure that quality
> objectives, including those needed to meet requirements for product (see
> 7.1a) are established at relevant functions and levels within the
> organization.
> The quality objectives shall be measureable and consistent with the quality
> policy"

> As the above company has departmental objectives (see Production dept's
> above) they meet 2/3 of 5.4.1, but Production alone, or the total departmental
> objectives, do not meet the requirement for - "including those needed
> to meet requirements for the product" . This is achieved via the "Purpose"
> statement seen in a procedure (another word for purpose is objective).
> Therefore in future on-site doc. reviews and pre-assessments please make
> sure procedures/work instructions contain a Purpose/Objective statements.

I'm not sure how this will fit in sometimes. I am from the 'old school' of 'proper' procedures with a statement of scope, a stated scope and such. The military manufacturing environment I worked in required very regimented, structured procedures - Purpose, Scope, Related Procedures, Relevant Specifications, etc., etc. However, in today's world there are a lot of flow charts and other formats. Much which used to be written is now 'trained' and not documented at all. I feel comfortable if, when I interview, the interviewee(s) can articulate the purpose and scope. I may ask, for example, why they need the procedure - written or 'trained' (purpose) and to what it pertains (the scope). I also consider the size and nature of the business, the complexity of the product and processes and such.

> If a company reads the standard literally, and has only the mandatory
> six procedures, we should point them to 5.4.1 and ask them how they can
> meet the requirement.

Here I look for measureables in each department. I must admit I have never seen a company with only 6 documented procedures and had not envisioned a company with only the required 6 documented procedures. I would ask how the measureables they cite, one or more, pertain to the quality of the product. As for the "...must be consistent with the quality policy..." requirement, it's a call by comparison. I ask them to explain and then ask myself if their explanation makes sense - is rational. 'Cop outs' are where one looks at the wiggle word "...relevant...". I ask why a department is excluded (as not relevant). Accounting typically escapes on this one, for example.

> I look forward to your input to this interpretation, before I make this
> our policy.
> I propose adding another class of QSIR between major and minor, i.e. medium.
> Where two mediums would make a major. An example of a medium would be
> where a company has fully documented its procedure for training all employees,
> but can only show evidence of its training for shop floor employees, and
> not monthly paid staff.

I would not like to see a complication of an additional classification. IMHO if a company writes that they train all employees, they're lying to begin with (how many plant managers, for example, are 'trained' per se?). I guess what I'd say here is that if the company wrote one thing but didn't fulfill it's own requirements, I'd give them a major at a registration audit. I would like to read their procedure before going further as the words can make all the difference. However, my experience has been that in most companies just about everyone receives some training whether it be OJT (such as a materials person), training on relevant internal procedures (some of which often times are 'known' procedures - not formal, documented procedures). This training should be documented, but often is not. Sales folks may be trained, for example, but this is often a department which does not document training when I first see them.


Comments folks?


Comments folks?


A couple of things here; first, "including those needed to meet requirements for the product" I interpret as being filled (by in large) through the sales process and the production order/control plan process. I have a hard time seeing where a “procedure” will outline these requirements.

As far as training, no procedure is required, but I recommend one. I agree that many organizations fail to consider the carpet side of manufacturing, and only stress the concrete side. Training needs to incorporate both hard and soft skills, both management and labor. Also, remember the standards says “provide training or take other actions” Hence, we can use this language to eliminate Marc’s concern of:

“IMHO if a company writes that they train all employees, they're lying to begin with (how many plant managers, for example, are 'trained' per se?).”

BTW, my three recommended procedures are:

  • Management Review
  • Contract Review (yes, I even keep the ’94 version name)
  • Training


Training only

We have approached the training aspect by requiring a Training Schedule for ALL positions. Sales and "Representatives" that work on Commission from selling our product in various areas of the country are included. No position, except the CEO, is excluded. We will probably grandfather all our Senior personnel who have set up the Company and are instrumental in its operation. All personnel who report to the CEO actually wrote their own with the requirement that they think about the skills they would like their replacements to have. As usual, the hardest part was getting them to do it.

As for having Departmental goals, I intend to try to develop measurable goals upstream, rather than setting goals for our weld shop or coating operations. This group works like a well oiled machine. They will continue at a pace that makes it difficult for me to keep up with the minimum QA checks we have established. There's no conceivable way to increase their productivity or the Quality of their work. In other words, they are B***s to the wall, all the time. We will have measurable goals and objectives that will combine groups and not focus on individual departments. After all, we decide what we want to measure. All levels has more to do with what we call levels. JMHO. Nice to see you back, Cheech!:ko: :smokin:

Randy Stewart

This is thin

"including those needed to meet requirements for the product"
I'm trying to keep my personal feelings out of this. I don't like this set up but that doesn't make it wrong. I would be very interested in seeing their corrective actions if the the product is rejected. Plus how are the customer requirements made known.
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