Q1 2021
One Step Ahead with AS 9100 Certification
ANGELES PRECISION ENGINEERING WEATHERED THE PANDEMIC THANKS TO THE FORESIGHT TO EXPAND ITS CERTIFICATIONS AT THE START OF THE YEAR

Story by Mike Flenniken, IAPMO

Business was booming for Angeles Precision Engineering LLC. With the ISO 9001 certification it received from IAPMO R&T, the family-owned and operated machine shop in Ontario, California, had moved into a larger building, hired more staff and invested in new equipment.
 
Then the COVID-19 pandemic hit, and work orders from Angeles Precision's largest client dried up.
 
Fortunately, Angeles Precision had already obtained certification to AS 9100D, Quality Management Systems — Requirements for Aviation, Space, and Defense Organizations, from IAPMO R&T shortly before the pandemic had begun to spread throughout the United States.
 
"In the beginning of the year we became AS 9100 certified," said Mario Angeles, whose father started the business in 1999. "It's a good thing that we did, because if not it'd be hard to get business because that's what aerospace companies need."
Boosting Sales for California Manufacturers
On February 23, IAPMO R&T hosted a free webinar titled "Boosting Sales for California Manufacturers. This webinar was presented by IAPMO R&T, U.S. Commercial Service of the United States of America Department of Commerce, and EMG Global Business Solution. The main objective of this webinar is share information to California manufacturers on how exporting their products can increase sales. If you missed this webinar, recording is available via link below.
Good Manufacturing Practices (GMP) Certification – What it is and its benefit?
GMP refers to the Good Manufacturing Practice regulations promulgated by the US Food and Drug Administration under the authority of the Federal Food, Drug, and Cosmetic Act. These regulations, which have the force of law, require that manufacturers, processors, and packagers of drugs, medical devices, some food, and blood take proactive steps to ensure that their products are of consistent high quality, appropriate for their intended use, and meet all applicable requirements.

GMP is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any production that cannot be eliminated through testing the final product. Here are key benefits of GMP certification:
·      Prove an organization's management capabilities in product quality, safety assurance 
·      Enable employees to develop good production / operational habits 
·      Reduce safety risk
·      Timely detection of production and management problems, reduce cost 
·      Better understand and comply with the relevant laws and regulations 
·      Enhance international credibility and public image 
·      Increase customer's long-term confidence in the enterprise 

Essentially, GMP protects the consumer from purchasing a product which is not effective or even dangerous as well as protecting the company because failure to comply with GMP regulations can result in very serious consequences including recall, seizure, fines, and jail time.

To learn more how IAPMO R&T can help your company to obtain GMP certification and to download a free GMP checklist, please click here.
What is NIST-SP-800-171 and Who Needs to Follow It?
Source: www.nist.gov | By: Traci Spencer

Manufacturers involved in supply chains tied to government contracts can anticipate those awards bringing in additional revenue at levels that might not be possible otherwise. However, being successful in getting and keeping such work means complying with the Federal Acquisition Regulation (FAR) and Defense Federal Acquisition Regulation Supplement (DFARS).

FAR is a set of regulations that governs all acquisitions and contracting procedures associated with the U.S. government. DFARS accompanies FAR as an addition. The Department of Defense (DoD) is the administrative body behind DFARS, but the reach of DFARS requirements extends to more than that organization.
To learn more on how IAPMO R&T can help you demonstrate compliance to NIST-SP-800-171, please click here.
Tips to Help Your Organization Prepare for a Remote Audit
COVID-19 pandemic has certainly changed the world. In a blink of an eye, everyone must change the way we do things. We must adapt very quickly. Practically, most of us are working from home this past year. Same things with audits for your management systems certifications. We at IAPMO R&T has to make similar adjustment on the way we conduct audits. We quickly adjusted most of our audits to remote audits to allow our clients maintain their certifications in good standing while protecting the health and safety of both our clients and our auditors. 

We understand that remote audits can be challenging for some companies, so here are some tips to help your organization prepare so your organization can have a successful and effective remote audit:

TIP ONE
Appoint an on-site staff as facilitator to manage audit logistics and resolve any technology-related problems.

TIP TWO
Have a good collaboration between our auditor and your organization representative during the audit planning phase. This step is especially important if the auditor has not been on-site and is not familiar with your organization processes and culture.

TIP THREE
Work with your auditor to agree upon the Information and Communication Technology (ICT) means to be used for the remote audit and make sure that they meet your organization's cyber-security measures for confidentiality, security, and data protection.

TIP FOUR
Make sure that your organization representative is familiar with the remote technology platform prior to your audit. It is always a good idea to test the system in advance to be sure that it can be accessed by both the auditors and auditees. Know how to share documents using the platform. 

TIP FIVE
Determine technological infrastructure needs to support a virtual tour of your facility or production areas. Will internet access be available in those areas? Will you be using a smart phone, tablet, webcam, etc. to share videos, photos, or documents in those areas? Also, consider ways to deal with high background noise in case you need to have conversation with your auditor in certain areas. 

TIP SIX
Make sure that all staffs that are part of the audit receive meeting invitations and are available for the audit at the designated time specified on the audit plan. Also, please make sure that they are familiar with the technology chosen for the audit. 

TIP SEVEN
Your auditor will usually tell you in advance the documents needed for the audit. If the documents are only available in hard copy, it is a good idea to scan the document in advance, so you can easily share the document electronically during the audit. 

We hope that you find the tips helpful, and we wish you all the very best on your upcoming remote audits!
ISO 9001:2015 Corner - How Do We Demonstrate and Provide Evidence for Risk-based Thinking?
When planning for your management system, your organization is required to establish risks and opportunities that need to be addressed. The concept of risk has always been implicit in ISO 9001 standard, by requiring the organization to plan its processes and manage its business to avoid undesirable results.

Organizations have typically done this by putting greater emphasis on planning and controlling processes that have the biggest impact on the quality of the products and services they provide. The way in which organizations manage risk varies depending on their business context (e.g., the criticality of the products and services being provided, complexity of the processes, and the potential consequences of failure). Use of the phrase risk-based thinking is intended to make it clear that while an awareness of risk is important, formal risk management methodologies and risk assessment are not necessarily appropriate for all business situations and organizations.

It is important to remember that ISO 9001:2015 does not require any formal risk management and there is no specific requirement on how to document the results of risks and opportunities. It is up to the organization to determine to the extent of the documentation and how they use this documentation to provide sufficient evidence of application of risk-based thinking.

For further information about risk-based thinking, please see ISO TC 176 paper on risk-based thinking.
AS 9100D Corner – Resource to Obtain Clarification on AS 9100:2016 Series Standard
It is not unusual even for aerospace industry experts to come across some unique situations and uncertain whether it would comply with the AS 9100 standard and/or how to resolve such situation so it becomes compliance with the standard. For this reason, International Aerospace Quality Group (IAQG) provide a process to provide the needed clarification. All the clarifications that the IAQG and Sector Document Representatives provided have been summarized and published on the IAQG website. You may access the latest clarification table here.
IAPMO Group was established in 1926 and has offices in the USA, Canada, Australia, China, Indonesia, India, Mexico, Germany and Argentine. To learn more for the IAPMO Group complete services, please visit our website at www.iapmo.org.