Manufacture Smarter Blog

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ISO: Leave the Pyramids to the Pharaohs

3/1/2019 - BY: ANDY NICHOLS
ISO 9001 was released with the visual metaphor of a pyramid often being used to represent the documentation requirements of the standard for Quality Management Systems (QMS). Despite not being a model directly described in the ISO standard or any related guidance, like ISO 9004, some quality teams preferred to envision the hierarchy of documents mentioned in ISO 9001 as a pyramid.


Looking to Diversify Industries? Consider Aerospace

2/15/2019 - BY: RON QUINKERT
As we discussed in a recent blog, many manufacturers are deciding now is the time to diversify. With a potential recession on the horizon, organizations are faced with a few different diversification options to pursue: develop new types of products, sell to new geographic areas or expand into new industries.


It Ain’t What You Do, It’s the Way That You Do It…

12/14/2018 - BY: ANDY NICHOLS
While these lyrics to the Ella Fitzgerald song (or Bananarama, if you prefer) are typically seen in a fun musical context, they also can be applied to a very different context: an ISO 9001 Certification Body Non-Conformity Report. When this report is issued, it is common for an organization to have to respond with a corrective action within a timeframe of 30 days. But what action is really needed?


Open Wide! It’s Time for a Dose of MedAccred

11/2/2018 - BY: ANDY NICHOLS
The medical device industry is ill! According to the FDA’s medical device recall data, this year alone there have been 22 recalls, tarnishing thousands of medical products. Research also has shown that most of these recalls came from manufacturing-related defects, making this a critical issue for medical device manufacturers to tackle. Recalls like these are costing the industry between $1.3 and $5 billion each year.


Making Management Reviews Beneficial - Are We There Yet?

9/28/2018 - BY: ANDY NICHOLS
If you are registered to ISO 9001:2015 or one of the quality management requirements built on the international standard, like IATF 16949 or AS9100D, your management must comply with the requirements of the “Management Review” clause 9.3. When complying with this requirement, commonly asked questions include how often and when to do the review.


Not All Food Failures Are Hazardous, but All Are Costly

8/10/2018 - BY: JOHN SPILLSON
Everything we do as manufacturers, and food processors, can be described as a process.  FMEAs help identify what can go wrong within a process as you create, make or assemble your product. Although this is often associated with a manufacturing process, it can be applied to any process (which involves inputs being turned into outputs). FMEAs are used to analyze possible failures or risks, along with the potential severity, chance of occurrence and detection rate of each risk.


Internal Audits Made Easy – And Practical

8/3/2018 - BY: DALE WICKER
If your company is registered to one of the ISO Quality Management Systems (ISO 9001, AS9100, ISO 13485, IATF 16949), then you are required to perform internal audits at planned intervals to verify the conformance of your system.


The Power of Policy Deployment for Your Business

7/27/2018 - BY: MIGUEL GOMEZ
What is the vision that drives your company? Why do you operate each day? What do you hope to achieve? Do your employees have the same goals? Many organizations find that their larger company visions can be forgotten in day-to-day firefighting. This is detrimental to success as workers at every level are left unaware of what they should be doing or how their work contributes to larger business goals.


What Does a Food Safety Plan Really Consist Of?

6/22/2018 - BY: JOHN SPILLSON
In 2011 President Obama signed the Food Safety Modernization Act (FSMA) into law, bringing about the most sweeping changes the food safety industry has seen in 70 years. This introduced the Food Safety Plan (FSP), which is the primary document that guides your Preventive Controls Food Safety System.


How Football Can Help with Auditing a Process-Based QMS

6/1/2018 - BY: ANDY NICHOLS
An important requirement of ISO 9001 (and its “cousins,” AS9100 and IATF 16949) deals with internal quality management audits. One purpose of this internal audit program is to look at the processes within the quality management system. Common questions that internal auditors raise during this practice include, “How do I audit a process?” and “Which processes should I start with?”


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