1 Responsibility
What goes on in this work area and who is
1.1 5.5.1, Responsibility and authority
responsible for product quality?
What is the quality policy and how does 5.3, Quality policy
1.2 6.2.2 Competence, awareness and training
what you do contribute to its achievement?
2 Resources and performance
Do you have adequate resources (i.e.
training/time, facilities/equipment/support
2.1 6.1, Resource provision
services, materials, and information) to
perform your daily work assignments?
Ask the supervisor: What are the
performance goals for this work area? How 5.4.1, Quality objectives
2.2 8.5.1, Continual improvement
do you measure them and when do you
know to address shortcomings?
3 Training
Ask the supervisor: What training or other
qualifications are required for jobs in this
3.1 6.2.2 Competence, awareness and training
work area? Please show me your employee
training/qualification records.
4 Document and records control
What procedures, flow charts, instructions
or other documents are used to guide work
4.1 4.2.3, Control of documents
performed in this area? How do you know
they are current? Are they followed?
What forms, logs or other records are
4.2 created as a result of work performed in this 4.2.4, Control of records
area? What do you do with them?
5 Equipment
Ask the supervisor: Who maintains
equipment in this work area? Please show 6.3.b, Process equipment
me the maintenance plan/schedule, any 7.5.1b, Availability of work instructions
5.1 7.5.1c, Use of suitable equipment
related check lists or work instructions, and
4..2.4, Control of records
records of maintenance completed.
6 Measurement equipment
7.5.1b, Availability of work instructions
How do you know the gages (or other
6.1 7.5.1d, Use of monitoring and measuring devices
devices) you use are accurate? 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 process and finished
goods used or processed in this work area? 7.5.3, Identification and traceability
7.1 4.2.3, Control of records
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 6.1, Provision of resources
8.1 7.5.1, Control of production and service provision
information) are not always correct or in
place prior to beginning work?
8.2 What kind of things do you look for to help 7.1, Planning of product realization
7.5.1a, Information re: product characteristics
ensure the processes you perform 8.2.3, Monitoring and measurement of processes
accomplish the desired results? How do 8.2.4, Monitoring and measurement of product
you know when a product is good or bad? 8.3, Control of nonconforming product
Please show me the documents (or samples) 4.2.4, Control of records
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?
Are the components and work in process
8.3 treated properly? Is FIFO in use? Is the
stock inspected?
9 Improvement
How do you try to reduce the number of
nonconformances? How do you try to 8.5.1, Continual improvement
9.1 prevent nonconformities from happening in 8.5.2, Corrective action
the first place? How do you get involved in 8.5.3, Preventive action
product or process improvement activities?
when you perform a process audit whether it is a manufacturing process
or an administrative process such as purchasing you audit the manner in
which the inputs were turned into the outputs.
To do this you audit according to the legs of the turtle:
With what
With who
How many
How
You in fact audit the system through the process. Just as document and
record control are not audited separately but in the context that the
auditor is then the resource management or management commitment is
audited where you are and the same with all other aspects, it is just a
matter of connecting the clauses and showing that you have covered
them all.