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Food Safety: Challenge or Opportunity?

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Food safety standards are becoming increasingly stringent.

When All Else Fails, Lower Your Standards

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My definition of “specification” is rather simple: It’s a promise.

Lean, Health Care, and Quality

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A recent article appearing in the Quality Digest Daily e-newsletter (“Why Lean?

You’re Worth Your Weight in Gold

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It is no secret that the health care industry is undergoing revolutionary changes. Are you responding by re-evaluating your approach to process improvement?

A Cure for Customer-Activated Tone Deafness

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We hear much about the importance of listening to customers and meeting their needs. Lean Six Sigma devotees say that metrics from the customer’s vantage point are at the center of their philosophy.

Savvy Compliance Strategy, Part IV

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Three Reasons the General Public Doesn’t Think Health Care Can Improve

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Lean thinkers see the waste in health care when they are at the hospital gemba. I think this is true whether you are a lean person who is new to health care or if you’re a long-time hospital person who has learned lean.

Seeing Melanoma

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Melanoma is one of the less common types of skin cancer, but it accounts for the majority of skin cancer deaths (about 75%).

Quality Assurance: To Count the Cost—or Not?

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One of the regulatory responsibilities of the quality control department is the release decision for drug batches into the market.

21 CFR Part 11: Auditors Are at Your Door

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On July 8, the Food and Drug Administration (FDA) announced an initiative “… to evaluate industry’s compliance and understanding of Part 11 in light of the enforcement discretion described in the August 2003 Guidance for Industry Part 11, Electronic Records; Electro

Pagination

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