Title Page
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Brookville Site
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Conducted on
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Prepared by
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Location
Quality
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Is the area clean and organized / 5S followed?
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Is there quality signage?
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Is there safety signage?
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Is proper PPE being worn?
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Are there uncontrolled or outdated documents?
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Verify at least two gauges. Are calibrations current?
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Are QRQC postings - action register, trending, and complaint postings current?
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Are there any late QRQC investigations?
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Are there any late QRQC action items?
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Is the quality corner bulletin board current?
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Employee Interview Question: Do you have a daily safety discussion with your supervisor?
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Employee Interview Question: Do you have monthly shift meetings with your manager / supervisor?
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Employee Interview Question: Do you know a recent external quality issue or complaint?
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Employee Interview Question: Is your Ensur training current? (Then verify training record.)
Injection Production
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Is the area clean and organized / 5S followed?
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Is there quality signage?
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Is there safety signage?
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Is proper PPE being worn?
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Are there any slip hazards for oil or water on the floor?
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Is there evidence of proper LOTO completed?
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Are there parts on the floor or the ways of the press?
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Are there uncontrolled or outdated documents?
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Review a batch record. Are the documents completed properly?
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Review a batch record. Are there quality risks not properly addressed?
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Employee Interview Question: Do you have a daily safety discussion with your supervisor?
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Employee Interview Question: Do you have monthly shift meetings your your manager/supervisor?
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Employee Interview Question: Do you know a recent external quality issue or complaint?
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Employee Interview Question: Is your Ensur training current? (Then verify training record.)
Lining - CRC Production
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Is the area clean and organized / 5S followed?
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Is there quality signage?
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Is there safety signage?
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Is proper PPE being worn?
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Are there any slip hazards for oil or water on the floor?
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Is there evidence of proper LOTO completed?
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Are there parts on the floor?
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Are there uncontrolled or outdated documents?
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Review a batch record. Are the documents completed properly?
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Review a batch record. Are there quality risks not properly addressed?
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Employee Interview Question: Do you have a daily safety discussion with your supervisor?
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Employee Interview Question: Do you have monthly shift meetings your your manager/supervisor?
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Employee Interview Question: Do you know a recent external quality issue or complaint?
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Employee Interview Question: Is your Ensur training current? (Then verify training record.)
Tandem Production
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Is the area clean and organized / 5S followed?
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Is there quality signage?
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Is there safety signage?
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Is proper PPE being worn?
-
Are there any slip hazards for oil or water on the floor?
-
Is there evidence of proper LOTO completed?
-
Are there parts on the floor or the ways of the press?
-
Are there uncontrolled or outdated documents?
-
Review a batch record. Are the documents completed properly?
-
Review a batch record. Are there quality risks not properly addressed?
-
Employee Interview Question: Do you have a daily safety discussion with your supervisor?
-
Employee Interview Question: Do you have monthly shift meetings your your manager/supervisor?
-
Employee Interview Question: Do you know a recent external quality issue or complaint?
-
Employee Interview Question: Is your Ensur training current? (Then verify training record.)