Auditing Customer Requirements
Case Study #1
In your designated teams, read the following incident and determine if a nonconformance exists.
What objective evidence would we need to ask for?
The company president has received a request for a quote on for a military program from an OEM, and was awarded the contract. Because this was a new program the Source representative arranged a program review with the supplier’s management team including employees in key positions such as, purchasing, engineering, quality, manufacturing, etc…
Prior to the beginning of the presentation the field representative asked the participants if they were aware ofdesign data (e.g., part marking,approved special processors, special process specifications, documentation requirements, contractual requirements, statutory and regulatory etc…)?The customer representative was surprised to learn that these critical customer requirements, and many more,had not been reviewed prior to the submittal of the quote.
After the presentation the quality manager informed the customer representative that the contract was awarded but not yet accepted. They still needed time to review all the other customer requirements before actually signing the contract.
Conforming or Nonconforming?
Why? Why not?
Case Study #2
In your designated teams, read the following incident and determine if a nonconformance exists. What objective evidence would we ask for?
All customer requests for new or modified product come through the Sales department. The salesperson is responsible for carefully documenting the needs and expectations of the customer and applicable regulatory requirements. This information is then passed to and reviewed by the Engineering Manager. The Engineering Manager develops a project plan that identifies the assigned engineer and a timing chart. The plan and progress of design activities are reviewed at weekly department meetings. The plans are updated as the design evolves.
Upon completion, the design is reviewed by the Design Engineer to verify that it meets all input requirements. Acceptance criteria for production and special characteristics are identified. A prototype is made and tested to ensure it meets customer requirements. The design is released for production after compliance to requirements is validated by the Design Engineer and a review of pertinent design records is completed. The Engineering Manager has the final authorizing release for a design.
The auditor reviews the suppliers purchase order and notices a supplemental quality code called out on the purchase order in another document and asks to review the document. The auditor asks about a special requirement regarding fracture testing of the material for high stress locations on the aircraft. The design engineer and quality manager could not provide evidence that this requirement was included in the review. The test report for the material did not include data regarding this fracture critical item.
Conforming or Nonconforming?
Why? Why not?
Case Study #3
The FaultlessMissile Company
Background
The Faultless Missile Company has been in business for the last twenty-five years. They design and manufacture missiles components for a variety of domestic and international customers. A year ago, one of their largest accounts placed an order with the provision that the missile components be designed and manufactured within an AS9100 Quality Management System environment. The Faultless Missile Company agreed at that time to transition their quality system to compliance with AS9100 within a one year period.
A year has now past, and your company, Dewey, Cheatham and Howe Registrar has directed you to lead an audit at Faultless Missile. A second auditor has been assigned (a missile components expert) to assist with the audit. The Faultless Missile Company’s Quality Manager has provided you with a copy of the quality manual and other related documentation.
Your audit objectives are to determine whether the quality system at Faultless Missile Company complies with the requirements of AS9100 and will ensure that quality products are provided to their customers.
Instructions
Meet with your team and review the ten audit situations given on the following pages. Based on your knowledge of AS9100, and a review of the audit situation, provide the following for each audit situation:
- Does a nonconformance exist?
- If so, state the nature of the nonconformance and applicable AS9100 clause(s).
- What is the objective evidence of the nonconformance?
The Audit Situations
After the opening meeting, the auditor was taken to the sales department to start the audit. There, the auditor asked the Sales Manager if they could examine 10 sales orders, chosen at random.
1)Upon examination the auditor found that eight of the sales orders stated the quantity of missile components, billing and shipping instructions only. When the Sales Manager was asked how she knew what types of components were being ordered she stated, “I always remember what my customers want from my earlier sales calls.”
The next day, while in the shipping and receiving department, the auditor reviewed the customer complaints and returned components folder. The returned components folder indicated that two of the ten orders examined the previous day had been returned for being the wrong items. A review of the customer complaints folder indicated that one complaint had been received from the ten orders over the wrong item being shipped. The auditor also noted that approximately 30% of all orders shipped were being returned for a variety of reasons including field failures, installation difficulties, etc.
2)The auditor left the sales department and was taken to the design department. There, the auditor spent several hours examining documents and records. The auditor picked out a drawing and asked to see the design plan for that design. The Chief Designer replied that they usually didn’t have enough personnel available to prepare and coordinate design plans, and besides, “my job is to design it, someone else has to build it.”
3)The auditor then asked to see the design procedures and work instructions. The Chief Designer responded that due to the work load, He hadn’t gotten around to writing any yet. The auditor asked how many people worked in the design department. The answer was that as a result of a recent boom in sales, there were nine designers, a CAD technician and one clerk in addition to the Chief Designer.
4)Finally, the Chief Designer was asked how new designs were verified. He asked the auditor what was meant by verified? The auditor restated the question by asking, “Do you hold design reviews, qualification tests, calculations, design comparisons or other methods to ensure that the design output meets the design input requirements?” The Chief Designer stated that he been in the business for twenty years and there was nothing wrong with his designs. He then got up and stormed out of the office. The auditor then went to the office of the Quality Manager.
5)The auditor asked the Quality Manager to explain the company’s internal audit program. The manager explained that each department audited themselves monthly, and then forwarded the results to him for review.
6)The auditor asked to review the company’s system for the processing of quality records. The Quality Manager opened the quality manual to the procedure on quality records and invited the auditors to “read for themselves.” The auditor informed the Quality Manager that they had read the procedures, however, now wanted to examine the actual quality records. The Quality Manager walked across his office and pointed to several large file cabinets. Patting the top of one file cabinet, he stated that all of the quality records for the last twenty years were kept there.The auditor looked into one of the file cabinets and was surprised to find that the records were kept in large hanging folders with the year marked on them. Examining one folder, the auditor noted that different types of records (including customer complaints, returned goods, self audits, inspection records, etc.) were all in the same folder and filed without order. The auditor asked how anyone found the record they needed? The Quality Manager responded that until today, no one had ever asked for them.The auditor noticed that a coffee maker was sitting on top of the other file cabinet containing quality records. Looking closer they saw water was leaking around the base. Opening the top drawer it was discovered that water had leaked into most of the file hangers, damaging the contents.
7)The auditor then asked if they could take a look at the manufacturing areas. They were taken to the missile components assembly area and turned over to the Manufacturing Manager. After introductions, and a very quick tour, the auditor asked to examine the work instructions used in the area. The manager explained that since many of the workers in that area had been there twenty years or more, they didn’t use work instructions. Instead, the older workers demonstrated the assembly operations to the newer workers. The manager was asked if there were many product rejections due to the inexperience of the new workers. The manager conceded that it was a problem; however, they were too busy to bother with writing work instructions.
8)The auditor then asked what became of the product that was rejected off the floor. The manager pointed to a large area that was stacked with an assortment of missile component parts. As they watched, one of the workers went to the area of component parts, disassembled several, and took a handful of the parts with them.
The auditor asked what the worker was doing with the rejected material. The manager replied that they sometimes ran short of one of the component parts used in assembly and had to “scrounge” parts where they could to keep the line moving. The auditor noted that the rejected parts were not identified in any special way.
9)At this point the auditor asked to speak with the Plant Manager. They went to a large office where the Plant Manager shook hands with the auditor and invited the auditor to sit down.The auditor asked the Plant Manager if he would show them the company’s policy for, and objectives for quality. The Plant Manager replied that all his workers knew that “quality comes first.” When asked if that policy was in a procedure anywhere, the Plant Manager said that he had been considering putting up some signs and posters in the plant but hadn’t got around to it yet. He then wrote something on a memo pad and asked if the auditor had any other questions for him.
10)The auditor then asked if the Plant Manager had any plans to hire the necessary staff to support the quality system in the plant. The Plant Manager asked, in surprise, “what staff?” The auditor replied that several of the managers had informed the auditor that they needed more staff to implement and maintain the quality system. The Plant Manager stated that no one had told him about any problems. The auditor asked the Plant Manager what he and his staff discussed at their management reviews. The Plant Manager responded that they never held “reviews.” He provided the managers with sales and manufacturing goals and they reported their progress periodically.
At this point the auditor concluded the audit and went back to a roomto prepare for the closing meeting.
NOTE: Based upon the audit situations reviewed above, what conclusions have you made regarding the compliance of the Faultless Missile Company’s quality system?
References
Gladhill & Associates International