9001 audit checklist-production support

ISO 9001:2000 General Requirements – Production Support

Reviewer Checks Reviewer Checks

Planning the Process Audit

Define key inputs and resources for each of the processes to be reviewed. Use process documentation, flowcharts or SIPOC diagrams to identify these.

Determine the processes/activities to be included in the scope of the audit. The scope may be provided as part of an audit schedule or plan, or it may need to be developed by the audit program manager. List the process(es) below:Processes Document No.

Maintenance Tooling Management Calibration Testing Servicing

Process Key Inputs and Resources

Based on your review, add, delete, or modify the questions on this checklist to focus your evaluation and to incorporate local requirements and inputs. Recognize that most of the requirements that must be verified will be called out in local procedures and instructions.

Consider the following information relating to the processes to be examined.

Previous audit results related to the selected processes Current process metrics relating to the selected processes Significant corrective actions or complaints relating to the

selected processes Auditee management

Other (list) _____________________________________

Corrective Actions and Current/Recent problemsList any problems, CARs, or items from previous audits that should be evaluated or verified during this audit.Problems noted for later examination:

Review the core process metrics relating to production support.Metric Recent Performance Trend

1.

2.

3.

4.

5.Objectives and/or targets to review:

1.

2.

2003 Joe Kausek & Associates 1

Maintenance ProgramInterview the Director or Manager of Maintenance. Ask him/her the following questions:

What are the primary activities that make up the maintenance program? Examples include PM, predictive maintenance, maintenance planning, spare part use and stocking, maintenance improvement, and machinery history. List these in the space to the right. Note lack of controls for any core maintenance processes.

How are each of these activities controlled? List these in the space to the right.

Are critical infrastructure components (pumps, tanks, air compressors, forklifts, etc.) included in the maintenance program?

How are maintenance requirements identified? How are they documented and communicated?

Once established, how do we control the accomplishment of maintenance requirements?

How do we assess the performance of our maintenance process? Review the metrics. Ask to see action plans for problem areas.

This items looks at the overall preventive maintenance program. Individual process audits will evaluate maintenance scheduling and performance for related process equipment. The focus of this review should be on the centralized aspects of the maintenance program, such as how maintenance requirements are initially set, the process for issuance and documentation of work/repair orders, the program for predictive maintenance, identification and performance in achieving maintenance objectives, and monitoring of the overall maintenance programs performance.

Maintenance Activities Method of Control

Overall evaluation: Conforms. No deficiencies identified. Opportunity for improvement (OFI). Detail below. Best Practice (BP). Detail below. Be specific. Nonconformity (NC). Provide details below. Reference the specific

requirement violated.

Comments and Findings


Identify any maintenance procedures, work instructions, and/or related guidelines (see previous page). Verify through actual observation that these instructions are being followed. If possible, go to a maintenance job and observe the conduct of maintenance. Answer the following questions for each process/activity observed:

Are the instructions complete and accurate? Do they appear to be at the right level of detail, considering task complexity and worker training? Ask maintenance personnel for their opinions and recommendations on how the procedures might be improved. These may become OFIs.

Do the workers appear competent both in their familiarity with the procedures and with the conduct of the work?

Do the maintenance personnel have the required competencies and training? Note the names of several to check later.

Are maintenance activities properly recorded? Are historical records of maintenance actions maintained? Are maintenance documents and records controlled?

Are instruments used for adjustments and/or alignment calibrated?

This item continues our evaluation of the maintenance program by examining any local procedures or instructions governing specific tasks.


requirement violated. Instructions/Procedures Evaluated?

Competencies OK?Worker 1:

Worker 2:

Worker 3:

Calibration OK?Device 1:

Device 2:


Tooling ManagementDiscuss the following questions with owner of the tooling management program.

What are the core activities associated with tooling management?

How are these processes controlled (e.g. procedures, outsourcing, training)? Ask to see copies of any procedures, instructions, service contracts and/or competency matrices.

How are these processes monitored? Review the metrics presented. Look for problem areas, bad trends, ect. Ensure added attention is given to these areas during the remainder of the audit.

Are actions underway to improve performance where needed?

Verify the following are included in the tooling management program, as appropriate to the level of tooling management employed:

Maintenance and repair facilities and personnel

Tooling storage and recovery Tooling setup Change out programs for perishable tools Documentation of tooling and tooling

design modifications Tooling identification and status

Note these items are required by ISO/TS 16949, but not for ISO 9001. Even so, they form the backbone of a robust tooling management program.

Reference ISO 9001, 6.3 and 7.5.1

The questions in this section focus on tooling management. Some of these questions may have been covered in other process-based audits. These questions focus on the centralized tooling management program, rather than on any specific tool or machine.



Activities Controls/Procedures Evaluated?

Metrics Performance/Trend

1. Good Poor

2. Good Poor

3. Good Poor

Comments and Findings


Servicing Ask the service manager or process owner to walk you through the organization’s servicing activities using the following questions:

What kinds of servicing activities do we perform? List in the space to the right.

Who are the customers of these activities? What are their expectations for our services? How do we know? List in the space to the right.

How do we measure these activities to ensure they are meeting customer, as well as our own expectations? How are these processes performing? Review the metrics, link them to customers and expectations, and review performance. During the remainder of the audit place more attention on areas of weakness.

How is feedback from the customer communicated back throughout the organization?

How are these activities controlled? The remainder of the audit should focus on verification of the compliance and performance to the activities listed above. Interview process operators, verify training, examine records, and in general verify processes are effective. Pay particular attention to problem areas as indicated by metrics or manager feedback.

Reference ISO 90017.5.1

These questions apply to service operations, provided after sale of the product to the customer. The intent of the requirements evaluated here is to ensure that services provided off-site receive the same level of control and care as do those activities we perform at our own facility.


requirement violated. Activities Controls/Procedures Evaluated?

Customers Expectations Metrics


Calibration/Lab Testing

Ask the laboratory manager or process owner to walk you through the scope of laboratory operations. Use the laboratory scope, organization chart, and/or process flowchart as applicable to get a feel for the operations and testing performed.

Who are the customers for laboratory services? What are their expectations? List in space to the right

Which of our activities/processes support these customers/expectations? List in space to the right

How do we measure our performance in performing these activities? Is performance okay? List in space to the right

What kinds of calibrations and/or tests are performed in the laboratory? Is there a laboratory scope? Verify a laboratory scope exists the includes all the relevant tests and calibrations.

How are calibration frequencies determined? Verify the basis (tech manual, mnfr. recommendation, etc.)

How is measurement uncertainty determined?

The questions in this section focus on monitoring and measuring device management and component testing. Some of these questions may have been covered in other process-based audits. These questions focus on the centralized calibration program, rather than on any specific measurement device or test.

Customers Expectations

Processes Metrics Performance

1. Good Poor

2. Good Poor

3. Good Poor



List standards evaluated below.

Standard Set No. Calibrated? Properly Controlled? Yes No Yes No

Yes No Yes No


Review the control and verification of laboratory standards. Are they periodically checked against higher level standards? Are there records? Are they reserved for use in the lab?

Are standard/industry methods used for testing and calibrations? Where available, industry or other stnd methods should be used (e.g. ASTM, ASTD, etc.). If not, the basis for the cal/test should be documented.

Are laboratory environmental conditions defined? Are they monitored? How are they controlled?

What actions are taken when calibration reports/results indicate that equipment was out of calibration when received? Thumb through the calibration records to identify instances where the device was received OOC or damaged. Verify that a analysis of impact on product inspected with the device was conducted.

Reference ISO 90017.6

Yes No Yes No

Yes No Yes No

Yes No Yes No

List occurrences where equipment was found to be out of calibration when received for calibration.

Item/Device Cal. Cert. Evaluation Performed?

Yes No

Yes No

Yes No

Yes No




9001 audit checklist-production support

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