Integrated Consulting Solutions

1. Integrated Consulting Solutions Module 8: Maintenance and Calibration

2. What you need to know about maintenance in ISO 9001 The organisation shall determine and maintain the infrastructure necessary to achieve conformity of product. This means maintaining equipment which is critical. The organization determines the type and frequency.

3. What you need to know about calibration in ISO 9001 The business itself must decide: what equipment, what monitoring and measuring equipment requires calibration; and when and where the equipment is to be used.

4. What you need to know about calibration in ISO 9001 You need to: ensure all calibration is traceable to a national standard. Have evidence of being calibrated e.g. a sticker Protect equipment from damage or adjustment have a process for determining what you do if a piece of equipment is inaccurate; keep records of your calibration; ensure that the capability of any software you use matches your requirements.

5. Why do Maintenance? How important is maintenance? If you want confidence that machines are behaving and performing as designed, then you institute a regular maintenance program.

6. Why do Calibration? To be able to know that the measure of that test equipment is accurate, you need to have it calibrate against a known standard.

7. What This Module Covers In this module we will be: Considering whether you need a maintenance process and if necessary creating a maintenance process. Creating a maintenance schedule Creating a calibration schedule Creating a calibration process or procedure

8. In Your Pack In your pack you will find: A sample Maintenance Schedule. A sampleCalibration Schedule.

9. Exercise One Workbook Look back at the first page and ask yourself the questions in the first paragraph. e.g. Is there any equipment whose reliable operation is critical to your product/ service conformity? Document Script Do you need a maintenance process ?/ creating a maintenance process

10. Exercise One Choosing a maintenance system There are many alternatives. Also, consider the following Software? In-house or external? Frequency of maintenance? Do a regular review of your system. Breakdown Contracts with external providers. Do you need a maintenance process ?/ creating a maintenance process

11. Exercise One Instruction Take the time now to work out the simplest and most suitable method in your organization. Consider what software or system you are CURRENTLY using and try to integrate whatever maintenance system into that- to minimize change. Do you need a maintenance process ?/ creating a maintenance process

12. Exercise Two Workbook Question 1: Brainstorm/ create a list of all those pieces of infrastructure, transport and production equipment that need a regular preventive maintenance program. Document Calibration Schedule Creating a Maintenance Schedule

13. Exercise Two • Instruction • Take time now to look at the template provided. • Fill in those columns that you need to. Creating a Maintenance Schedule

14. Exercise Two • Very important to determine who is responsible for the implementation of the maintenance system. • Records are important in your system and need to be stored adequately. • Instruction • Add these points to your process/ procedure Creating a Maintenance Schedule

15. Exercise Three Workbook Determine if you will be “seeking exclusion for calibration” based on calibrateable equipment NOT being critical to your product/ service conformity. Creating a Calibration Schedule

16. Exercise Three • Workbook • If you have a piece of measuring equipment that is only an indicative measurement, you don't need to have that calibrated. • If it is used to measure an absolute value, then you need to have it calibrated. Creating a Calibration Schedule

17. Exercise Three Instruction Take time to list all those pieces of monitoring and measuring equipment that require calibration at some frequency. Then complete as many of the columns in the register as you can. Creating a Calibration Schedule

18. Exercise Four • A procedure or a simple paragraph? • You may not need a formal procedure. • If you do, use one of the procedure templates. • Fairly simple needs?:- create a short paragraph describing your process and covering the points given. Creating a calibration process or procedure

19. Exercise Four What to include: the person or persons responsible how that calibration is to be carried out how the equipment is to be identified where the records are kept who is responsible for keeping the records possibly include the service provider Process when equipment out of tolerance. Creating a calibration process or procedure

20. Exercise Four What to include: the person or persons responsible how that calibration is to be carried out how the equipment is to be identified where the records are kept who is responsible for keeping the records possibly include the service provider Process when equipment out of tolerance. Creating a calibration process or procedure

21. Exercise Four Workbook. Take the time now to formulate a process (or procedure) for how you will handle calibration referencing the previous points. Creating a calibration process or procedure

22. Congratulations! That is the end of module eight. You are ready to contact your consultant to check your work.