9.2 Internal Audits

GENERAL POLICY

Customer satisfaction is the principal objective of the quality system, and the level of customer satisfaction is the most important measure of the effectiveness of the system. Customer satisfaction is measured by collecting and analyzing direct customer feedback, and by measuring secondary indicators of customer satisfaction. Customer satisfaction data is used by the top management to identify opportunities and priorities for improvement.

All activities and areas relevant to the quality system are audited at least once a year. Audits are scheduled on the basis of the status and importance of the activity. Internal auditors are independent of those having direct responsibility for the audited activity. Identified nonconforming conditions are brought to the attention of the responsible managers and corrective actions are implemented in response to audit findings.

Quality system processes are monitored to ensure that they achieve planned results. Relevant product characteristics are measured through inspections and product verification activities, as specified in control plans. Evidence of product conformity is recorded. Products are released for delivery only after all specified activities have been satisfactorily completed and verified.

PROCEDURAL POLICIES

1. INTERNAL AUDIT

1.1 Planning and scheduling

1.1.1 The Quality Manger establishes an internal audit plan and schedule. Every activity and area is audited at least once a year. Selected activities are audited more frequently, depending on their importance and quality performance history.

1.2 Audit team and preparation for audit

1.2.1 Only personnel independent of the audited activities are assigned to conduct internal audits. Normally, Quality Assurance coordinator leads the audit team except when QA activities are being audited. Audits of QA activities are conducted by other trained Internal Quality Auditors from other departments.

1.2.2 Auditors prepare for audits by reviewing applicable standards and procedures, analyzing quality records, and establishing questionnaires and checklists.  Harrington follows the ISO 9001:2015 standard

1.3 Conducting the audit

1.3.1 Conducting the audit, auditors seek objective evidence indicating whether the audited activities comply with the requirements of the documented quality system and ISO 9001:2015, and whether the quality system is effective. The evidence is collected by observing activities, interviewing personnel, and examining records.

1.3.2 Nonconformities are recorded in the Internal Audit/Management Corrective and Preventive Action Form.

1.3.3 Audits are conducted in a way that minimizes disruption of the audited activities.

1.4 Corrective action and follow up

1.4.1 When nonconforming conditions are identified, the Corrective Action process is followed, developing a Corrective Action solution(s). Implementation and effectiveness of the action are verified by the Corrective Action process. The Internal Audit/Management Corrective and Preventive Action Form is used for monitoring and recording the implementation of the corrective actions.

1.5 Audit Records / Reporting

1.5.1  When the auditing cycle is completed, all nonconformity/corrective action reports established during the cycle are compiled and analyzed, and key results/findings are presented and reviewed at the management review meeting. Top Management or the appropriate department manager will ensure that any necessary corrections and corrective actions are taken without delay to eliminate detected nonconformities and their causes.

Referenced Procedures

QP1020 Internal Audits

QP1040 Nonconformity Corrective Action

QF-92-01-02 IQA Report

Internal Quality Audit Reports

Revision History:

Revision Date Description of Changes Approved By
0.0 07/03/17 Initial Release Jim Theesfeld
1.0 8/17/18 Digitized version Todd Gifford
2.0 3/25/2020 1.3.2, removed references to Internal Quality Checklist Dave Zirkelbach