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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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slide1

Management Review

October 2003

5 6 management review
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
    • Recommendations for improvement
follow up from previous mgt reviews
Follow up from previous mgt reviews
  • We will maintain 1% as our next 6 months RMA goal.
    • Kyle to update goal on charts
  • Open customer CAR stands at 8 and will need to be actively reviewed and followed through.
    • Kyle and Christy to review
  • Instead of reporting in fiscal week such as 3303, we will begin to report in week ending date such as 08/16/03.
    • Kyle to update charts
  • Bev requested that we report our internal audit finding details in our next management review meeting.
    • Christy added in Mgt. Review for Oct.
  • We need to come up with a way to report supplier score card. This is to combine our quality and on-time delivery performance so we can send it to our supplier on a regular basis.
    • Christy Issued a Preventive Action Request
results of audits
Results of audits

Open audits With no Corrective Action:

  • During Audit it was noticed the Final Assembly Area has no area/container identifying rejects that are found during test process. Observed in Electronics' Area was shelves with product haphazardly placed no trays. A pallet with suspect packaged material in middle of work area without identifiable paperwork or labels. Noticed in all mentioned Areas poor identifiable labeling technique on product throughout various stages in process and location. In Shipping area observed also were boxes on floor without any label or identifying paperwork. This was corrected during audit.
  • Observation : Certain records have been transferred from hard paper copies to electronic media. Quality record matrix has not been updated. Could not find any evidence that prototype feedback form was being used . Doc. W90460018 recommend if not being used update matrix.
  • During interview asked to show record of W90260004 First Article /laylot Request. Interview concluded that this form was not being used in the process. Recommend that if this form is not being used to be dropped from Quality Record Matrix.
7 4 purchasing
7.4 Purchasing
  • Finding: No records of evaluation on Suppliers that have a “Grandfathered” status. Procedure W90620002 rev. D States in (Step # 2, bullets 1 and 2) Short form will be used for minor level of procurement needed – bullet 2 states- the detailed form will be used for major levels of procurement
  • Finding: No criteria in place for the re-evaluation of suppliers.

Comments: Currently only tracking top dollar suppliers.

  • Finding: No Records of evaluation of suppliers of Unisys product.
  • Finding: No evidence or records available that subcontractors performing calibration of inspection, test and measuring equipment affecting product quality have been approved for the performance of this service.
  • Observation: No formal process in place to issue supplier corrective action or how to preclude the use of disapproved suppliers
7 4 continued
7.4 continued
  • Requirement 4.1 General Requirements: and 7.4.2 Purchasing Information (see above)Where an organization chooses to outsource any process that affects product conformity with requirements, the organization shall ensure control over such processes. Control of such outsourced processes shall be identified within the quality management system.
  • Finding: Methods of control for any outsourced processes such as embossing or calibration need to be identified in the quality manual (see 4.2.2) or other documentation such as purchasing information.
7 4 continued1
7.4 continued
  • Requirement 7.4.2 Purchasing Information

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.

  • Finding: No evidence that adequate information covering these requirements is being flowed down to suppliers of calibration services, especially in regards to ISO9001 7.6 a) requirement “Where necessary ensure valid results, measuring equipment shall…

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.”

closed findings
Closed Findings….
  • Customer satisfaction survey is not being utilized.
  • 1) No project timeline is established to track progress of new/revised design as specified in procedure W90410011 2) Product Specification Form is not used all the time as specified in the same procedure 3) Prototype feedback report is not used as described in procedure W90420016
  • The electronic file for Customer Communication is not kept up to date.
  • 1) Current procedure and practice do not clearly define who is required to approve what kind of document. 2) Documents of external origin are not being controlled
  • Observations: 1) An update to the Quality Policy could provide a more meaningful statement. 2) Lack of any formal Preventive Actions indicates a 'reactive' rather than 'proactive' organization.
  • Under section 4.1.b the sequence of interactions was not documented; Under section 4.1.f there was no documented improvement plans; Under 4.2.1.c there was no document for preventive actions, Under section 4.2.2.c the quality manual did not describe the interaction between the processes of the quality management system
internal audit summary
Internal Audit Summary
  • Need process approach
  • Corrective Actions need to be issued via the CAR System
  • Not all audit findings are clear or valid
  • Need a Gap of the 94’ vs. 2000 standard
  • Robust follow up process
slide10

Controls

  • How is the process defined ?
  • Who is responsible for the process and how is their responsibility and authority defined ?
  • What statutory and regulatory requirements apply ?
  • What are the customer requirements and how are they defined ?
  • What are the product/service specifications and how are they defined ?
  • What objectives and targets are relative to this process ?
  • What controls/check points are there ?
  • What acceptance criteria exists ?

CHECKLIST FOR A PROCESS AUDIT

  • Inputs
  • What triggers the process ?
  • What inputs are required ?
  • Where do the inputs come from ?
  • Are they received in a timely manner ?
  • Are they fit for purpose ?
  • Process
  • What are the process steps ?
  • What happens at each process step ?
  • What documents and/or records are generated ?
  • Is the process implemented as described in procedures, instructions or plans ?
  • Are controls applied as described ?
  • Have the activities been carried out by the responsible people ?
  • Outputs
  • What is the product or service produced by this process ?
  • Are product measures in place to ensure that product meets requirements ?
  • How are processes measured ?
  • Are product and process measures achieved ?
  • What feedback is received from internal or external customers of the process ?
  • Mechanism
  • Equipment
  • What equipment and resources are required to complete the process ?
  • Is equipment suitable and maintained ?
  • People
  • What are the competence requirements for the activities ?
  • Is there evidence that people are suitably trained ?
  • Effectiveness Checks
  • What is the purpose of the process ?
  • How does it impact on the customer/downstream processes and activities ?
  • Is there evidence that quality objectives and targets affected by this process are being achieved ?
  • Where will the impact of the effectiveness of the process be felt ?
  • Where might failures of this process be identified ?
other audits
Other Audits
  • Supplier Audits-
        • Nonewith US suppliers
  • Customer Audits –
        • Unisys has given IDS an “Approved Supplier Status”
  • Surveillance Audit – Oct 23rd& 24th
        • ISO FYI Flyer given out on paychecks (Oct 16th)
        • Suggest awareness training on the new 2000 standard
        • Suggest “News Letter” with contest and updates/ changes on the QMS. (This will also help us comply with element 5.5.3 Internal Communication)
iso 9000 2000 para 0 2 h

Supplier Quality

ISO 9000:2000 Para 0.2-h

Mutually beneficial supplier relationships

An organization and its suppliers are interdependent and a mutually beneficial relationship enhances the ability of both to create value.

customer feedback
Customer Feedback

Customer Focus

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

process performance product conformity
Process Performance & Product Conformity

Process approach

A desired result is achieved more efficiently when activities and related resources are managed as a process

ISO 9000:2000 Para 0.2-d

changes that could affect the qms
Changes that could affect the QMS

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.

training follow up
Training Follow Up

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.

training system improvement

1. Define training needs

4. Evaluate training outcomes

MONITOR

2. Design and plan training

3. Provide the training

Training System Improvement

Employee surveys

Internal Audits

Process monitoring

Training evaluations

Performance Reviews

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

OTJ Checklist

Liaison from Doc Control to the affected personnel on procedure changes

Competence based training modules

Certification test/demos

1st day training

Create awareness training modules

Provide the Training

Cross training

Training request

Create training matrix

Maintain records

which of the following is most likely to cause good employees to quit their jobs
Which of the following is most likely to cause good employees to quit their jobs?

Source: Robert Half International, Menlo Park, CA / ASTD Training Magazine, June 2002

output
Output…
  • The output from the management review shall include any decisions and actions related to
    • a) improvement of the effectiveness of the quality management system and its processes,
    • b) improvement of product related to customer requirements, and
    • c) resource needs.

Output of mgt review ….Input to the Continual Improvement Process….