The QMS Audit Frequent Asked Question No Questions 1 Responsibility 1.

1 What goes on in this work area and who is responsible for product 1.2 What is the quality policy and how does what you do contribute to its achievement? 2 Resources and performance Do you have adequate resources (i.e. training/time, 2.1 facilities/equipment/support services, materials, and information) to perform your daily work assignments? 2.2 3 What are the performance goals for this work area? How do you measure them and when do you know to address shortcomings? Training

Evidences 5.5.1, Responsibility and authority 5.3, Quality policy 6.2.2 Competence, awareness and training

6.1, Resource provision 5.4.1, Quality objectives 8.5.1, Continual improvement

3.1 What training or other qualifications are required for jobs in this work area? Please show me your employee training/qualification records. 6.2.2 Competence, awareness and training 4 Document and records control What procedures, flow charts, instructions or other documents are used 4.1 to guide work performed in this area? How do you know they are 4.2.3, Control of documents current? Are they followed? What forms, logs or other records are created as a result of work 4.2 4.2.4, Control of records performed in this area? What do you do with them? 5 Equipment 6.3.b, Process equipment Who maintains equipment in this work area? Please show me the 7.5.1b, Availability of work instructions 5.1 maintenance plan/schedule, any related check lists or work instructions, 7.5.1c, Use of suitable equipment and records of maintenance completed. 4..2.4, Control of records 6 Measurement equipment 7.5.1b, Availability of work instructions 6.1 How do you know the gages (or other devices) you use are accurate? 7.5.1d, Use of monitoring and measuring devices 7.6, Control of monitoring and measuring devices 7 Identification and traceability How do you know the identity and status of raw material, work in 7.1 process and finished goods used or processed in this work area? Are there any special records or other documents created to maintain this identification or provide traceability? 8 Process and product control What process inputs (i.e. people, equipment/facilities, material and 8.1 information) are not always correct or in place prior to beginning work? What kind of things do you look for to help ensure the processes you perform accomplish the desired results? How do you know when a product is good or bad? Please show me the documents (or samples) 8.2 that guide you and the records, logs or other documents used to record the results of process checks or product inspections you perform. Are you aware of any problems experienced by those who use the products (or other outputs) of your work? 8.3 9 Are the components and work in process treated properly? Is FIFO in use? Is the stock inspected? Improvement 7.5.3, Identification and traceability

4.2.3, Control of records 6.1, Provision of resources 7.5.1, Control of production and service provision

7.1, Planning of product realization 7.5.1a, Information re: product characteristics 8.2.3, Monitoring and measurement of processes 8.2.4, Monitoring and measurement of product 8.3, Control of nonconforming product 4.2.4, Control of records

8.5.1, Continual improvement 9.1 How do you try to reduce the number of nonconformances? How do you try to prevent nonconformities from happening in the first place? 8.5.2, Corrective action How do you get involved in product or process improvement activities? 8.5.3, Preventive action