2000 Scenarios

December's question:

While auditing Element 4.4 Design Control. You ask the Design Engineer to see the evidence of the formal documented reviews required in Clause 4.4.6. She responds that she is the only person involved in design because product design is straightforward, and the only changes are modification to the base design. Because this does concern her, she maintains a checklist to ensure nothing is left out. She completes the checklist as she goes, so a formal review is not necessary. Why have a formal review when she would be the only person there? She states the checklist meets all of the requirements, and intent of the review, as well as serves as the required review record. She adds that she has done it this way for over eight years without any problems.

Is this conforming, or non-conforming?  Let's hear from you!

November's question:

Your procedure outlines the Sales Manager as the one responsible for customer-initiated corrective actions. You are auditing a sample of applicable corrective actions since the last audit. Although your sample size should be five, only three corrective actions were initiated by customers during the time frame. One complaint catches you eye. The complaint is about sudden product failure with no advance warning. Knowing your product, you realize that this could have catastrophic consequences, include potential loss of life. The corrective action determines that less than one-half of one percent of the product may be subject to this type of failure. The cost of correcting the defect is extremely high, and there is no way to determine if a product has the defect without destructive testing. The decision was made not to enact any type of corrective action. When questioned about this, the Sales Manager responds that the standard allow organizations to limit the corrective action to those whose magnitude and risk make the corrective action practical. The problem was identified, a root cause was determined, but the corrective action was not economically feasible. 

Is this conforming, or non-conforming?  Let's hear from you!

October's question:

You are auditing manufacturing. At a particular station, there is a poster showing product and various abnormalities that can occur during production. It is stamped "For Reference Only". The supervisor indicates that because it is marked as reference only, it does not have to be in the document control system. While interviewing employees, several indicate that they regularly use the poster to identify the abnormalities they discover. They further use the poster to help determine why the abnormality occurred, and how to make the necessary adjustments to prevent recurrence. 

Is this conforming, or non-conforming?  Let's hear from you!

September's question:

You are conducting an audit of element 4.20. An operator provides you a copy of a set of instructions on how to fill out the SPC chart. The instructions also indicate reaction plans to such things as trends, runs, and assignable cause variation. You notice some of the reaction plans have been changed, in ink. The page was signed with a new revision level. When questioned about this, the operator states this is the only operation that uses that work instruction and the supervisor (who has authority to change the document) said the hand written changes were okay. A check of the master shows the updated revision level is current. 

Is this conforming, or non-conforming?  Let's hear from you!

August's question:

You are auditing 4.18 in the production area. According to their procedures, all forklift operators will be "certified", and licensed by the company. Copies of the certification and license are to be on file in the Quality Office. You enter the Quality Office to check on the three sample drivers. While you are there, you notice a technician using a gauge that is marked "Out of Calibration". When asked about this, the technician explains the gauge is off by exactly .006". Because this is the only gauge available, he must use it. All of his calculations are adjusted to reflect the gauge being off. The Quality Manager steps in and states that you shouldn't even be looking at the gauge because you are not auditing Quality, and this is out-of-scope.

Do you write a nonconformance based on the gauge?

July's question:

During an internal audit, you are interviewing a machine operator to determine if he knows the procedures, and if he follows them. The operator's answers indicate that he does in fact know and follow all the procedures that apply to him. Just as you are starting to thank him for his participation, he responds about an exception to the operational procedures. There is one part that is handled differently from all others. The setup is entirely different, as is the actual operation and the inspection criteria is not the same. It requires a special form, which he shows you a copy of. A review of the procedures indicates that this particular product  is not governed by any procedure. When questioned about this, the production manager responds that this part is rarely run, and the specifications are ever changing. Procedures would tie the department down and remove the required flexibility. Besides, she challenges, where are you required to have procedures that cover all your products and operations?

Is this conforming, or non-conforming?  Let's hear from you!

June's question:

During an audit of your company's inspection procedures, you notice that receiving inspection is located under a different procedure (P-4.15-1 Receiving Procedures). According to that procedure, the receiving inspection is performed by the receiving clerk. You continue the audit in the receiving area. The receiving clerk indicates that receiving inspection is not her job, but she does it anyway because the quality inspectors are too lazy to come down to receiving. She states she is unaware of any particular procedures, but she does have different forms for different materials or vendors. Although she doesn't like the task and performs it under duress, she stresses that she knows the importance of receiving inspections and makes sure that it is done properly. As she walks you through how she performs the inspection, it is quite apparent that she does, in fact, follow the procedure. All the forms used are referenced by the procedure, and she appears to use the proper form at the proper time. 

Is this conforming, or non-conforming?  Let's hear from you!

May's question:

You are performing an audit of contract review. The procedure indicates that once a RFQ (Request for Quote) is received and the review is completed, a Formal Quote form is filled out and faxed to the customer for review and approval. They have one customer that has several reorders per month. The customer has indicated he does not want the fax unless there is an engineering change. For all others, the order is verbal only. The sales manager states that this is not a violation of the procedure because this customer does not send a RFQ just an order, so contract review is not necessary. 

Is this conforming, or non-conforming?  Let's hear from you!

April's question:

You are auditing the manufacturing area for 4.8, 4.12 and 4.13. While interviewing an operator on what happens when non-conforming product is discovered, you notice cutting fluid leaking from the machine and running down the drain. When questioned about this, the operator states that maintenance is well aware of the problem. The supervisor of the area questions you about the relevance of the fluid leak to the audit.

Is this conforming, or non-conforming?  Let's hear from you!

Response #1

March's question:

While auditing 4.18 (Training), you observe the procedure which reads in part: "Employee qualifications and training effectiveness are evaluated during the employee's 6 month review." The HR manager indicated that this is accomplished at each review. Several department managers indicate that there is only one 6 month review, which occurs 6 months following initial hire. They further contend that this one-time review is sufficient because after that they know who is qualified and who needs training. After all, they watch their employees everyday, so they know who can't perform.

Is this conforming, or non-conforming?  Let's hear from you!

February's question:   

While auditing Document and Data Control (Element 4.5), you find that price sheets are sent to your distributors. These sheets contain product specifications, including price. There are three different color sheets, indicating different pricing levels (based on order volume). None of the sheets are marked with your required document control identification required by procedure. Sales does have a list of which distributors get which color sheet, but that is all that is indicated. The sales rep claims that this information is outside of the quality system and therefore the procedure for document and data control does not apply.

Is this conforming, or non-conforming?  Let's hear from you!

Response #1

January's question:

While auditing production, you observe an operation that uses a two-part resin to manufacture parts. The resin does not have an expiration date, but the hardener does. The operator checks the hardener, prior to use to ensure only valid hardener is used. If the hardener is out of date, the operator sets the out-of-date hardener on a shelf under the machine, with the top off. After several days, the hardener becomes solid, and is thrown out. By waiting until it hardens, the hardener does not have to be treated as toxic, or hazardous waste. Although the container is not marked, everyone who is qualified to operate the machine knows, and follows these rules. Because of this, they feel no need to bother QA to verify the expiration date, and tag (or remove) the product.  There is no mention of the hardener expiration in either the procedure, or work instruction.

Is this conforming, or non-conforming?  Let's hear from you!

Have a scenario you wish to share?  Tell us about it and you might just see it here.  One thing to remember though, the consensus of the group might not be the way you handled it.