Objectives are set as part of your performance metrics. Most businesses measure something -- usually more than one thing. What are you measuring now? You can set "quality objectives" for those things as part of meeting this requirement.

If you are not measuring anything, quality-wise, now, here are some ideas. When establishing performance metrics, it's best to focus on things that impact the customer. All quality measureables fall under three general categories: quality, cost, and time.

• (Cost metric) Cost of poor/deficient quality. What is the cost of reworking bad products, handling products returned from customers, warranty claims, etc. (if this is pertinent to what you do)? Start tracking that, figure out what your "baseline" is (i.e. what the actual cost is now), and then set an objective for improvement (i.e. make the objective less than the baseline).
• (Time metric) Time to resolve customer complaints. How long does it take? Start tracking that, figure out baseline, set objective, etc.
• (Time metric) Adherence to delivery requirements. To what extent do you meet your commitment to customers for when you'll deliver product? Start tracking that, figure out baseline, etc.
• (Quality metric) Percentage of acceptable product delivered. What percentage (in terms of units, batches, etc.) of product is accepted by customer without problems? Start tracking that, figure out baseline, etc.

The auditor should check on the objectives to evaluate the extent to which they are being achieved. The auditor should also verify that Company management is doing that and taking action when objectives are not being achieved. The Standard says that objectives must be set at "relevant levels and functions of the organization," which gives you plenty of latitude as to where to set objectives. Make them meaningful, measurable, and few.

First of all, I applaud you for putting some real thought into the corrective action process. Sometimes people just look at trees instead of stepping back to take a look at the forest.

Absolutely: it is acceptable to bundle these types of CARs together and take care of them with a global process of identifying root cause, corrective action, preventive action, verification, and close-out. By doing it this way you're calling attention to the fact that you're dealing with a systemic problem rather than just a hiccup.

Nice job -- keep up the good work!

I don't see a problem with this approach as long as you do it consistently, objectively (i.e. don't just talk to the customers who like you), track and trend results, and take action on adverse feedback. Hope this helps.

A well implemented corrective action process:

There are probably more, but these are the major ones in my view.

Surveys need to be very quick, easy, and convenient for the respondent. Oftentimes companies get carried away with surveys and add so many things that people simply discard them.

Here's what we have our clients do. They fax surveys to customers, with a fax-back response. We have them ask customers to respond with their opinion on only three areas:

The customer is asked to rate each of these in one of only three categories: Excellent, Average, Needs improvement. They include a box for comments. Comments, as well as name and company name, are optional.

Responses are analyzed on a numerical basis. Each Excellent gets a 2, each Average gets a 1, and each Needs Improvement gets a 0. Then the results are compiled as a percent of the total possible. And that percentage is tracked over time.

With this scheme, clients have gotten a minimum of 31% response, which is excellent considering the customer gets nothing for replying. (And because the responses come by fax, you have 99% of them within a couple of days.) All "needs improvement" responses get investigated via the corrective action system. Companies set objectives for each of the dimensions (once they know what the baseline is) and report on results at management review. It's not flashy, but it gets good information, and by golly, it works.

Companies new to 9001, 14001, 18001, and similar management systems often struggle with the Corrective Action process. This is especially true when they are presented with the typical formats and lists of steps known as 8-D, 7-D, etc.

Here on one piece of paper is an explanation of effective Corrective Action steps lined up beside the typical 8-D list.

The only way to be sure that corrective / preventive actions are addressed in a timely manner is to become a professional pest. You have to be organized with ticklers, etc.; get people's commitments as to when processing will be complete; and then pester the dickens out of them. I don't know of any other way to get it done --especially with that segment of management / supervision who are not, shall we say, fully and enthusiastically convinced of the efficacy of ISO 9000 and its various subsystems.

ISO/TS 16949 (8.5.2) requires that corrective action be carried out appropriate to the effects of the nonconformities encountered. It does not specifically say that all problems must be solved. ISO 9004, the guidance document for ISO 9001 (2000), says, "The organization should balance the investment in the corrective action against the impact of the problem being considered."

That said, you need to show that you have made a good-faith investigation to attempt to determine root causes and potential solutions. If as a result you truly run into a blank wall, or determine that the solution does not make sense from a investment / return standpoint, at least you can show that you have done the research.

If the problems you're talking about are repeaters, adversely affect the customer, and/or cause significant problems for the company processes in terms of quality, cost, or time, you would be expected to invest more time and resources into finding and implementing solutions. In short, it's a balancing act.