Management Review . October 2003. 5.6 Management Review. Review Inputs: Follow up from previous mgt reviews Results of audits (ALL) Customer Feedback Process Performance & Product Conformity Status of preventive and corrective actions Changes that could affect the QMS
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Open audits With no Corrective Action:
Comments: Currently only tracking top dollar suppliers.
Purchasing information shall describe the product to be purchased, including where appropriate
a) requirements for approval of product, procedures, processes and equipment,
b) requirements for qualification of personnel, and
c) quality management system requirements.
a) be calibrated or verified at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; where no such standards exist, the basis used for calibration or verification shall be recorded;.” No evidence that requirements are flowed down to calibration supplier to allow compliance to requiring calibration “…against certified equipment having a known valid relationship to internationally or nationally recognized standards.”
CHECKLIST FOR A PROCESS AUDIT
Organizations depend on their customers and therefore should understand current and future customer needs, should meet customer requirements and strive to exceed customer expectation.
ISO 9000:2000 Para 0.2-a
A desired result is achieved more efficiently when activities and related resources are managed as a process
ISO 9000:2000 Para 0.2-d
ISO 9000:2000 Para 0.2-C
Involvement of People
People at all levels are the essence of an organization and their full involvement enables their abilities to be used for the organization's benefit.
Effectiveness of Action Taken:
Although the corrective action has been complete, opportunities still exist between what is currently taking place and what is documented in internal procedures and ISO 9000 2000.
Opportunities are as Follows:
1.) Requirement: ISO9000:2000 clause 6.2.2 Competence, awareness and training “The organization shall…..para e) maintain appropriate records of education, training, skills and experience.
Internal Requirements: Procedure W91810008 rev F “Personnel Training Records” states in step # 3 ….”OJT Checklist should be appropriately filled out and signed by the Trainer when training is completed. The Trainer should forward the forms to the HR department or designate for inclusion in the employee’s training record”
Nonconformance: No records of job specific training (OTJ) currently being maintained in the employees folder by HR.
Observation: The OJT Performance Checklist (W91840004) only covers tasks performed in basic assembly. No other OJT checklist could be found.
2.)Requirement: ISO9000;2000 clause 6.2.2 Competence, awareness and training
“The organization shall…para c) evaluate the effectiveness of actions taken”
Internal Requirements: None
Nonconformance: No objective evidence that training is evaluated for effectiveness.
4. Evaluate training outcomes
2. Design and plan training
3. Provide the trainingTraining System Improvement
Identify each process area
Identify “Critical To Quality” points
Create core competencies based on the above (IPC Training/ ESD)
Define other non-process specific training (QMS training/awareness)
Training plans by process area
Liaison from Doc Control to the affected personnel on procedure changes
Competence based training modules
1st day training
Create awareness training modules
Provide the Training
Create training matrix
Source: Robert Half International, Menlo Park, CA / ASTD Training Magazine, June 2002
Output of mgt review ….Input to the Continual Improvement Process….