4.0 Quality Management System

  • 4.2.3 Control of Documents

  • Do you have a documented procedure for document control?

  • Are the issued documents (policy, procedures, forms manual) with effectivity date, revision number and proof of approval? This include the quality objectives, master lists.

  • Are the documents available or accessible to the relevant functions?

  • Are obsolete documents identified? Does the personnel know if there are already obsolete documents in the organization?

  • 4.2.4 Control of Records

  • Ask for the Master List of Quality Records and see if all the records being used are included in the Master List. Are all records that are being used included in the master list?

  • Get a sample record and see if these are filled up properly and if the forms used are the ones indicated in the forms manual.

  • Ask for samples of records and see if alterations and corrections are done as prescribed.

5.0 Management Responsibility

  • Ask the personnel: Do you know your quality policy? How do you explain it?

  • Ask the personnel: what is your understanding of the quality policy?

  • Ask the personnel: what are your corporate objectives? Have the personnel present a signed copy of the corporate objectives. See if they have an updated corporate objective.

  • Ask the personnel: what is your role in achieving the quality policy? See if the personnel can relate their duties and responsibilities with this. Ask for a copy of their signed duties and responsibilities.

6.2.2 Competence, Awareness and Training

  • Ask the personnel: What training or other activities do you need in order to become more effective in your work?
    Look at the HRD plan to see if this need has been identified and included.

  • Ask the personnel: what are your duties and responsibilities? Look for a copy of the actual duties and responsibilities. (6.2.2 Competence, Awareness and Training)
    Ask the personnel? What skills and experience and knowledge do you have so that you can perform your duties and responsibilities? Determine if there is record for these competencies.

  • Ask Management: What training or other activities have you identified for your personnel?
    Look at the HRD plan to see if this need has been identified and included.

  • Ask the personnel: Do you know what equipment you need in order to do your job? How are these maintained? (6.3 Infrastructure)

  • Ask the personnel: Do you have a maintenance plan for the equipment that you use?
    Ask for the maintenance record and see if this is updated. Look at the procedure, if any, on maintenance and interview the personnel to see if this is being followed.
    (6.3 Infrastructure)

7.0 Product Realization

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