Example Audit Checklist ISO 9001

AUDIT CHECKLIST FOR PRODUCTION PLANNING

1.    How is production planning performed? Eg. scheduling production runs (7.5.1)
2.    How do you ensure that the design is capable of being manufactured properly and consistently? (7.2.2)
3.    How do you make sure all the required materials are available and are available at the right time? (7.5.1)
4.    How do you make sure staff are suitably trained and/or qualified (6.2.2)
5.    How do you make sure the associated the documentation is produced and available? Eg: (7.5.1)
-       Procedures/work instructions
-       Codes of practice
-       Quality plans
-       drawings
6.    How do you ensure the environment is correct? (6.4)
7.    How do you make sure that production equipment has the right capability? (6.3)
8.    How do you establish the route the manufacturing process will follow? (??)
9.    How do you identify the stage, tests or inspections each product has reached in the process? (7.5.3)
10.  How do you establish workmanships standards? Eg. photographs, actual samples, codes of practice, etc (7.5.1)
11.  How do you ensure that the product is correctly handled and not damaged? (7.5.5)
12.  How do you identify how nonconforming product is stores and identified? (8.3)
13.  How do you approve processes? (??)
14.  How do you ensure the correct monitoring and/or controls? (7.5.1d&e)
15.  What statistical techniques do you use and why? (8.4)
16.  How do you ensure the correct maintenance of production equipment? (??)
17.  How do you identify inspections, controls, verifications and tests (and the appropriate equipment)? (7.5.1)
18.  How do you control subcontracted processes? (7.4.1)
19.  What quality records are required? (4.2.4)
20.  How do you control special processes, if any? (7.5.2)
21.  How do you ensure that improvements/corrections from previous product feedback are incorporated? (8.5.2)
22.  How do you ensure appropriate statutory and regulatory requirements are followed? (7.2.1c)
23.  How do you incorporate changes/improvements to the production process? (8.5.3)
24.  How do you ensure that work instructions are consistently documented and available for the personnel? Note: Changeover, cleaning and start-up procedures are documented.(7.2.3)
25.  How do you ensure that specifications are consistently documented and available for the personnel?(7.2.3)
26.  What kind of system do you have in place to establish and update process and material specifications (manufacturing change control)?(7.2.3)
27.  How are responsibilities for updating specifications and communication to appropriate personnel defined?(7.2.3)
28.  What kind of system do you have in place for cleaning and sanitizing to avoid contamination of customer product?(7.2.3)
29.  How do you ensure that materials are identified by suitable means throughout the production process?(7.5.3)

Comments

  1. Great! This checklist will serve as an important tool kit for every business to ensure their readiness to face the ISO 9001 audit. It’s a big help since some of the clauses mentioned above are focused on particular areas of the business, such as actions towards development. This will guarantee you that your requirements in getting the certificate are being applied accordingly.

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