Grant Ramaley’s picture

By: Grant Ramaley

As the 2020 pandemic threatened world health, a large number of unscrupulous companies began generating fake International Organization for Standardization (ISO) quality management system (QMS) certificates in an attempt to fool governments into buying personal protective equipment (PPE), ventilators, thermometers, and Covid-19 test kits. The credibility of ISO 13485 certificates used to certify medical devices suddenly became a crisis.

Aside from the obvious fake certificates, other companies were paying to get certificates with little or no oversight as to how they were earned. If the goal of getting certified is to gain worldwide recognition, it’s important to understand what makes an ISO certificate valid, especially when paying thousands of dollars for an ISO QMS certificate that may not be considered valid by ISO. Companies may think they are getting a credible certificate but find themselves exposed later when trying to sell their products to those who require certificates issued from accredited certification bodies.

Natalie Weber’s picture

By: Natalie Weber

Unlike Covid-19, remote audits aren’t unprecedented. Remote audits didn’t start with the pandemic, although it has forced more companies to use them than previously. At MasterControl, we’ve been doing remote audits for years for our international customers. It saves time and expense, and it’s every bit as effective as an in-person audit.

However, this is only true because we operate in a digital environment. Using a paper system would significantly hinder remote audits.

This is largely still the case. The difference between pre-pandemic remote audits and those of the “new normal” is the sheer number that are being done, in many cases by those who have never done them before. Doing a remote audit is difficult to wrap your head around if your audit usually requires scouring binders for paperwork and completing a site walk. Mastering remote audits now will be worth it even after the pandemic is over.

Suneel Kumar’s picture

By: Suneel Kumar

Remote auditing (RA) has become a norm during the Covid-19 pandemic. Remote auditing is one of the audit methods prescribed in ISO 19011:2018—“Guidelines for Auditing Management Systems.” Although RA has surged due to pandemic constraints, this method of operation will surely gain ground as a routine audit technique.

During a remote audit, auditors engage with a company via technology to assess its QMS as per ISO 9001:2015. The audit covers the usual steps, including a documented information review, interviews, and presentation of the findings, by using various information and communications technology (ICT) platforms.

Remote audits can be divided into:
• Fully off-site remote audit
• Partial off-site remote audit
• Onsite remote audit

In the case of a fully off-site remote audit, the assessment audit is carried out completely away from the site. Partial off-site audits are conducted through a combination of remote and onsite checks to verify compliance. For onsite remote audits, the audit is carried out at the site but through synchronous ICT platforms.

Tom Taormina’s picture

By: Tom Taormina

Each article in this series presents new tools for increasing return on investment (ROI), enhancing customer satisfaction, creating process excellence, and driving risk from an ISO 9001:2015-based quality management system (QMS). They will help implementers evolve quality management to overall business management. In this article we look at the clauses and subclauses of Section 10 of the standard.

10 Improvement

Define “improvement.” In quality parlance it typically means reducing defects and making processes more efficient and mistake-proof. For the CFO it might be improving the return on investment numbers on the financials. For the marketing director it might be expanding market share. For the CEO it might be exceeding the expectations of the board of directors.

The theme of this series includes “presents new tools for increasing return on investment (ROI), enhancing customer satisfaction, creating process excellence, and driving risk from an ISO 9001:2015-based quality management system (QMS).” To conclude the theme, we will look at Clause 10 from a more holistic perspective.

10.1 General

10.1 and excellence

Del Williams’s picture

By: Del Williams

Approximately 48 million people in the United States (one in six) get sick, 128,000 are hospitalized, and 3,000 die each year from foodborne diseases, according to the Centers for Disease Control and Prevention. Consequently, the FDA Food Safety Modernization Act (FSMA) is transforming the nation’s food safety system by shifting the focus from responding to foodborne illness to preventing it.

As part of the focus on preventing foodborne illness, 3-A Sanitary Standards, an independent, not-for-profit corporation for advancing hygienic equipment design for the food, beverage, and pharmaceutical industries, has recently updated its standards. The company, which maintains a large inventory of design criteria for equipment and processing systems developed to promote acceptance by USDA, FDA, and state regulatory authorities, no longer accepts “3-A compliant” as a legitimate claim.

Carson MacPherson-Krutsky’s picture

By: Carson MacPherson-Krutsky

Since the days of painting on cave walls, people have been representing information through figures and images. Nowadays, data visualization experts know that presenting information visually helps people better understand complicated data. The problem is that data visualizations can also leave you with the wrong idea—whether the images are sloppily made or intentionally misleading.

Take, for example, the bar graph presented during an April 6, 2020, press briefing by members of the White House Coronavirus Task Force. It’s titled “COVID-19 testing in the U.S.” and illustrates almost 2 million coronavirus tests completed up to that point. President Trump used the graph to support his assertion that testing was “going up at a rapid rate.” Based on this graphic, many viewers likely took away the same conclusion—but it is incorrect.

Tom Taormina’s picture

By: Tom Taormina

Each article in this series presents new tools for increasing return on investment (ROI), enhancing customer satisfaction, creating process excellence, and driving risk from an ISO 9001:2015-based quality management system (QMS). They will help implementers evolve quality management to overall business management. In this article we look at the clauses and subclauses of Section 9 of the standard.

Clause 9—Performance evaluation

Clause 9 is the part of the standard that we can use to truly quantify business excellence and risk avoidance. I will propose paradigm shifts that will make the outputs of this clause more informative for senior management and will include actionable recommendations that can contribute to the success factors that are immediately palatable and implementable for the leadership.

9.1.1 Monitoring, measurement, analysis, and evaluation—General

9.1.1 and excellence
This subclause requires that the organization must establish what needs to be monitored, measured, analyzed, and evaluated.

William A. Levinson’s picture

By: William A. Levinson

The U.S. House of Representatives has passed the HEROES Act (Health and Economic Recovery Omnibus Emergency Solutions Act)1 which will, if approved by the Senate and president, require OSHA to develop a standard for workplace protection against Covid-19.

Under section 120302 the legislation says specifically (emphasis is mine):

“(a) EMERGENCY TEMPORARY STANDARD

(1) In general—in consideration of the grave danger presented by COVID-19 and the need to strengthen protections for employees, notwithstanding the provisions of law and the Executive orders listed in paragraph (7), not later than 7 days after the date of enactment of this Act, the Secretary of Labor shall promulgate an emergency temporary standard to protect from occupational exposure to SARS-CoV-2

(A) employees of health care sector employers;
(B) employees of employers in the paramedic and emergency medical services, including such services provided by firefighters and other emergency responders; and
(C) other employees at occupational risk of such exposure. ...

Tom Taormina’s picture

By: Tom Taormina

Each article in this series presents new tools for increasing return on investment (ROI), enhancing customer satisfaction, creating process excellence, and driving risk from an ISO 9001:2015-based quality management system (QMS). They will help implementers evolve quality management to overall business management. In this article we look at the clauses and subclauses of section 8 of the standard.

Clause 8: Operation

Clause 8 contains the requirements for planning, designing, and bringing to fruition your products or services. The processes within this clause must be robustly implemented to achieve business excellence. They must also be continually scrutinized for foreseeable risk.

8.1 Operational planning and control

8.1 and excellence
The “plan” is a series of interrelated process, each with acceptance criteria, and each with metrics that tie to the organization’s key objectives and key process indicators. Or, at least that has been my interpretation while leading scores of implementations.

Mary Rowzee’s picture

By: Mary Rowzee

During the first six months after the publication of its first edition in June 2019, the AIAG & VDA FMEA Handbook gained popularity in the global automotive industry. Both U.S. and European OEMs have started to require the AIAG VDA approach to failure mode and effects analysis (FMEA) in their programs. Like the AIAG Guidebook, fourth edition, the handbook provides guidance, instruction, and illustrative examples of the requisite analytical techniques. The activities and analyses historically involved in FMEA have been formalized as discrete steps in the handbook.

 The seven-step approach described in the handbook and outlined here guides the development of design, process, and supplemental monitoring and system response of FMEA through the sequencing (and the iteration) of described activities.

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