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ISO Update aims to provide information, resources, and updates around the Standards and Certification industry. We believe that organizational standards can help businesses of all shapes and sizes become more efficient and successful on a local, federal, or global scale.
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document_control_isoupdate

By Pierre Servan CEO, Principal Consultant, Factor Quality Inc.

Do I need Document Control?

In my years of performing third party Quality Management System (QMS) audits, gap assessments and internal audits, a common question about document control people ask is:

 “Do I need to control this document?”

Over the years I’ve noticed Document Control has received “a bad reputation” in quality circles.  It does not matter if it’s a procedure, work instruction, or form; One of these pesky documents is bound to be in the wrong place at the wrong time.

Recently, I have noticed that these document control issues are decreasing due to new tech solutions that help organizations manage documents. Nevertheless, the question persists, “to control or not control a document?”

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To Control or not Control a Document?

Without dwelling in the details of ISO 9001 requirements regarding document control and in the spirit of keeping it simple, the intent of the standard’s requirement is straightforward. The aim of the standard is once your organization determines the need for a document (i.e. means to convey critical information or template to collect data) then logic dictates that you want to make it available to those who need it and want to make sure the information is always accurate.

“Document Control is having a way to ensure that information remains relevant, up-to-date, accessible and aligned to the strategy”. – Pierre Survan, Factor Quality

ISO 9001 does not handcuff organizations in dictating specific required procedures. Each organization is free to decide what documents need to be created and controlled.

The expectation is that when you make the decision you ensure the document aligns with the nature of the business and any requirements that need to be met.

Thou shall not use the standard’s name in vain

The ISO gives general rules for document control, that when used appropriately, do help businesses.

At Factor Quality, we’ve heard statements about document control such as:

“This document cannot be used because it is not in an ISO format.”

“That document requires to be approved by two supervisors, a manager and the CEO per ISO requirements.”

“That document is missing a document #, what section of the standard it belongs to so that I know how to number it.”

“That document is only important to our department, so it does not need to be controlled.”

Did you know ISO provides a general requirement for organizations, it does not tell you how many approvers certain documents need to have?

Nor does it prescribe a document format or a document ID# (i.e. QAP-1001ab). These are misconceptions that have been circulating for a long time.

Let’s clear some misconceptions:

  1. ISO 9001 does not establish a minimum of approvals required,
  2. ISO 9001 it does not provide a format for documents nor does it require you to have a document number.

“In my opinion, the “bad rep” of document control has mostly been driven by the way companies have decided to control their documents and some lack of understanding of the standard, leaving many confused and somewhat irritated. All these requirements are self-imposed by each organization. The company defines the policy of how many approvers are needed for documents, what type of format is to be used and how to identify it.” – Pierre Survan, Factor Quality

Important Note: Stay Curious and Question Decision Making – If you don’t like current document control methods within your organization, ask the owners of document control why they consider the current method correct. And under no circumstance should you accept “Because ISO requires it,” as an answer.

How Do We Control Documents?

While ISO 9001 does not mandate specific formats, identifier or number of approvals, the documents created for the organization must meet a certain set of criteria to be considered as controlled effectively.

Remember –when you create a document you need to make sure the correct version is available to all in the business.

Requirements You Need to be Aware of with ISO 9001

Documents can be in any media

“Any Media” means document scan be written in paper, electronic, even video formats. The documents can be written, pictorials, flow charts, or a combination of these. Just remember it needs to make sense to your organization.

Documents Need to be Identified

There is no need to have document numbers unless you believe these are needed and are helpful to your business. A simple identifier is the title of the document and if this appears in the footer or header of each page, the document is indeed identified.

Documents Need to be Approved

Designate a person or group of people with the authority to determine suitability for your business. Ideally, that person is always aligned to the strategic direction of the business and understands the implications of such a document.

Documents Need to be Controlled

  • Version Control: Documents must have an identifiable version visible throughout the document. This allows you to determine if the right version of the document is being used. The version can be alphanumeric or by date.
  • Distribution Control: Documents must be made available and accessible for use. They need to be maintained in a manner so points of use can be readily updated when changes occur, that only authorized changes are made, and documents remain legible over time.

Keeping Document Control Effective

Over the years some of the most infamous controls deployed by overly careful document control administrators have been:

  • Document Stamps: Stamps showing the document status such as: “Reference Only,” “Uncontrolled,” “Not a Controlled Document,” “Master Copy,” etc.
  • Footer Controls: “Not valid if printed,” “Check system for latest version,” “Not valid after 24 Hours,” etc.
  • Watermark Controls: Using watermark to notate “Draft”, “Controlled”, “Uncontrolled”, etc.

All these are methods of control but can be misunderstood by those using them. For example, could you have the correct stamp, footer, or watermark, but have no way to ensure that people do not change the document, even on accident? Can these controls show that the document approvals were adequate? Can a stamp prevent someone from receiving an outdated version of the process?

Do not assume that if the correct stamp, footer, or watermark is used, that is enough to demonstrate robust document controls.

Remember, these are just controls and as such, auditors will always check for effectiveness.

It doesn’t matter how big and bright the stamp, footer, or watermark is – when evaluating Document Control, auditors will consider valid the document the employee/operator points or shows.

What is the Most Common Document Control Issue When Employees are Asked: “What Document do you Use?”

“Employees proudly say, ’this one’, as they pull it out from their toolbox or desk drawer, and in most cases, these copies are out of date”. – Pierre Survan, Factor Quality

Summary of document control

Document Control’s purpose is to help the business document those items that are critical to its own functionality. 

These documents should align with the strategy and help the business meet requirements in a consistent manner.

How much or how little you control these documents is a decision made by each company.

At Factor Quality, our best advice is to Keep it Simple! The well-being of the organization should always be put before the need of a group or department. Make sure every document is needed, because when a document is really needed it will be easy to control, maintain and keep relevant.

Document control structures can be reviewed, revamped and reset during the lifetime of a Quality Management System. Organizations should review their systems and ensure that they are leveraging existing and available resources to support their own documented systems. Factor Quality is here to guide you through this unpopular mythical creature called Document Control without Process Improvement Services. We have experience using several document control systems, from software solutions to self-contained systems, we can recommend the best simple, but effective solution for your business.

Let us help you set a new document control structure or revamp your current system to its most effective. Take advantage of our knowledge in the industry! This article was originally published here by Factor Quality and has been published on ISOUpdate with permission from Pierre Servan.

About the Author

Pierre Servan | CEO, Principal Consultant, Factor Quality Inc.

Factor Quality - ISOUpdate.comFactor Quality was founded in 2011, with a vision to help fix quality issues, improve businesses, and help them get certified. Pierre never thought he would encounter such a rewarding industry with clients that appreciated his work, students that appreciated his words, partners that helped him and consultants/colleagues that appreciated him and what he had to say. Today, Factor Quality helps organizations take the next step in their quality journey and service the following certification: ISO 9001, ISO 14001, ISO 13485, ISO 16949, ISO 17025, ISO 45001, AS9100, AS9110 & AS9120. If you are interested in learning more about Factory Quality, visit them at www.factorquality.com/

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Easily Overlooked ISO 9001 Tricks - Video ISOUpdate.com

Ready to implement ISO 9001 in your organization? Here are some ISO 9001 tricks to the process to be aware of and prepare for.

Trick: Only Hire a Consultant if…

If an organization’s staff does not have the time or skills to develop the QMS by themselves, a good consultant will make possible a speedy transfer of knowledge and skills. If the staff does have the time, there are enough published materials available from the web that will help staff obtain the necessary skills to develop the QMS.

Certification Bodies also often offer in-class and online training that are specifically designed to fit your industry needs. If you cannot find a course, seek CB’s that offer to tailor courses to your needs, or offer on-site training and will bring their training to your office, making the process easier for you and your staff.

Find a Training Program

Trick: Define SMART Objectives

Many organizations set quality objectives that are impossible to meet. Objectives need to be specific and relevant to the process or task to which they are being applied. They also need to be measurable and achievable within the resources that can be made available in a realistic and timely manner.

It’s helpful to have a start and completion date.

Read the full article here

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Risk Management in ISO 9001 - ISOUpdate.com

Organizations today work in highly volatile market conditions and deal with a number of risks. Changing trends, new technologies, a surge of social media, concerns over the environment, globalization and many other such factors have changed the way markets operate and move today. Apart from these external factors, internal team structures and dynamics, our own competencies and capabilities play an important role in determining the ability of a company to deal with the changing conditions. Understanding of all these factors, external or internal; referred to as “Context” in ISO 9001; and strategically planning measures to handle these situations are critical to the success of any company today.

The Context of a company may lead to many risks that companies face today. Consider how a complaint on social media regarding your company can go a long way to disrupt a potential client’s impression and may ruin prospects.

Your competition offering higher salaries may lead to high attrition in your own company.

Government plans to change regulations may impact the way you operate and escalate your cost.

Are you ready to deal with these situations?

Companies need to plan effective responses to these risks because if these responses are weak, unplanned or ill-timed, it may have a very dramatic effect on the future of any business.

Efficient Risk Management is important to ensure companies are ready for adverse situations and can deal with them. ISO 9001 requires that a company shall create a sound approach for handling risks and be ready for any unforeseen situations.

What is Risk as Defined in ISO 9001?

ISO defines risk as ‘effect of uncertainty on the expected result’. ISO also defines opportunities which are “Positive Side of Risk”. The context of an organization may also present a number of opportunities and should also be addressed adequately. For example, advancement in technology may make your current methods of operation obsolete and you run the risk of going out of business but it also presents an opportunity for you to venture into newer areas of business. ISO 9001 not only focuses on risks but also emphasizes on capturing opportunities and enlarging them.

How to Identify Risks and Opportunities?

Based on the context and the requirements of interested parties, a company shall determine the risks in its company. This can be done by a simple SWOT Analysis.

As per Wikipedia, SWOT analysis (or SWOT matrix) is a strategic planning technique used to help a person or organization identify strengths, weaknesses, opportunities, and threats related to business competition or project planning.

The Strengths and Weaknesses are internal (Internal Factors) to the organization.

Opportunities and Threats are external (External Factors) to the organization.

Here’s a sample SWOT analysis done by a new food joint:

SWOT Analysis from ISOGlobal

The SWOT matrix points to a number of risks and opportunities. The opportunity of business growth in the age group less than 25 can be easily enhanced with the introduction of food items that this age group likes. This will also handle the risk of lower sales which the business may face of their weakness: “Lack of variety in food items”. ISO 9001 requires that you identify these risks and opportunities and address them appropriately in a timely manner.

How to Address Risks?

Once risks are identified, it is very important for an organization to address it to reduce either the probability of its occurrence and/or reduce the impact of the risk. This could be as simple as identifying actions to mitigate the risks and ensuring timely closure of the actions. However, based on the complexity and size of an organization, a detailed risk evaluation may be carried out. An organization may define a detailed risk methodology to handle risks. This methodology may involve evaluating the risk, giving it a rating to compare it against an acceptance limit and then deciding adequate response to the risk.

Risk Evaluation Methodology

There can be several risk matrixes that can be used to derive risk levels. A simple method is to evaluate risk to give a rating to risk. Below are some of the factors that could be rated:

  • Risk Impact/ Severity: Typical severity level of an outcome of risk may be rated based on the impact of risk. The impact may be high, medium, low or rated in terms of numbers on a scale (Say 1 to 10).
  • Risk Probability / Likelihood: This involves rating the probability of occurrence of the risk. These may be rated as high, medium, low or rated in terms of % of likelihood of occurrence or simply in numbers.
  • Risk Rating may be calculated by simply multiplying Probability and Impact.

Risk Rating= Probability x Impact

  • Risk Acceptance Level: Organization may establish a Risk Acceptance level. This means coming up with an acceptable limit of risk.

This risk rating may be used to establish priority in addressing identified risks and deciding on an adequate level of response to the risk.

How to control risk?

Once the risk rating and acceptance level are decided, the next step is to understand if the risks that are identified falls within the acceptable limit or not. If risk rating lies below the acceptable limit, this would mean already in place and applied controls over the risk are working well and organizations may not need any additional controls on the risk. If the risk is not adequately controlled (i.e. Risk Rating is beyond the acceptable limit), new control procedures or actions may need to be defined. Actions need to be taken on risk to:

  1. Reduce the probability of the risk occurrence (called Mitigation) and /or
  2. Reduce the impact of the risk (called Contingency)

Wherever possible, both the above actions should be taken to control risk.

Review and Monitor Risks

The risks need to be monitored and tracked on a regular basis. Monitoring risks help in understanding the effectiveness of actions planned. Once the control measures are implemented, you may need to check whether the risk is within the acceptable levels or not.

This will require revisiting the risk rating to find out if the controls applied were able to reduce the risk probability or impact. This should be done on a fixed frequency or on events like changes in process, staff, or equipment.

Conclusion

Each business operation of an organization involves risks and opportunities. The key to the success of any organization is to handle these risks and opportunities well in advance. This ensures that there are lesser surprises, better planning and quick decision making.

This, in turn, leads to higher performance and improved customer satisfaction.

Effective Risk Management is vital for the success of any organization and should be done by all levels of management and for all operations.

– Avital Koren is the Director of ISO Global

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AS9100 & The Importance of OASIS - ISOUpdate.com

As competition grows, the need for quality management is becoming more and more critical for every industry. Many industries have taken the backbone to all quality management system standards, ISO 9001, and added elements to ensure it works perfectly for them. The Aviation, Space and Defence industry was one of the first to do this when they released their own unique management systems standard in 1999. If you have been working in the aerospace industry, you understand the importance and criticality that the AS9100 standard now plays.

Defining AS9100

AS9100, which can also be written as EN 9100, was released in October of 1999, by the Society of Automotive Engineers and the European Association of Aerospace Industries. The intent was to create an aerospace standard that would ensure the safety of the consumer and provide the best quality to the customer. Almost all major aerospace companies have adopted these standards in their operations as well as throughout their supply chains.

AS9100 has also been endorsed by the major regulators in the industry: The Federal Aviation Administration (FAA), The U.S. Department of Defense (DoD) and National Aeronautics and Space Administration (NASA).

The AS9100 series of quality standards adds over 100 requirements to the ISO 9001 standard that apply specifically to the aerospace industry, including the following:

  • Additional configuration management
  • Special risk management
  • Industry-critical items
  • Increased focus on timely delivery
  • Focus on product management
  • Approval process and scope for suppliers
  • Prevention of counterfeit parts

Did you know? The AS9100 document was originally introduced by the American Society of Automotive Engineers and the European Association of Aerospace Industries. The document was subsequently picked up by the IAQG as a method of maintaining industry quality levels on a global scale. – Source

What are the Benefits of AS9100 to you as a Business Owner?

AS9100 is an effective way to promote that your organization is consistently capable of providing products and services that meet customer requirements and comply with all relevant and regulatory requirements. AS9100 also demonstrates your organization’s ability to enhance customer satisfaction and improve both processes and practices, and products and/or services.

Engagement in Employees

Understanding the value of engaging employees and having conversations directly about QMS and quality can improve not only the processes they are actively involved in but also the quality of their workmanship. ISO 9001 and AS9100 work to make the most efficient improvements throughout your organization, but engaging employees creates employees who are fully absorbed by and enthusiastic about their work and so take a positive action to further the organization’s reputation and interests. – Source

Engaged employees are more likely to: positively influence other employees; be more productive and profitable; provide better customer service; be more enthusiastic about their work; be comfortable staying in their role; offer positive suggestions for the organization, and offer word of mouth promotion for your organization.

Read a more detailed look into employee engagement.

Customer Satisfaction

Being customer-centric means you are able to extract and fulfil customer requirements and then follow up with feedback and steps that act upon that feedback. Happy customers are repeat customers, and in a study by Bain & Company detailing e-commerce shoppers, the study demonstrated that repeat customers can actually increase their profitability by attracting more clients to your organization through referrals.

Lower Costs

A study undertaken through the American Society for Quality (ASQ) showed that for every $1 spent on your QMS, you could expect to see an additional $6 in revenue, a $16 reduction in costs, and a $3 increase in profits. On average, they saw that quality management systems reduced costs by 4.8%.

Another study undertaken by the Harvard Business School showed that companies that adopted ISO 9001 had the following benefits:

  • Higher rates of survival
  • Increased Sales
  • Growth in employment
  • Increased wages
  • Less waste
  • Improved worker productivity

Read more about the ROI of Quality

The AS9100 Certification Process

AS9100 certification is conducted through an external and impartial audit by an accredited certification body. AS9100D certification is for 3 years, with your first audit being the certification audit, and 2 surveillance audits happening each consecutive year after certification. Every 3 years, if your organization wishes to continue to be certified to AS9100, your certification body will conduct a recertification audit and 2 surveillance audits in this same order.

It is important to note that before the certification audit can take place, your organization will need to internally assess that all AS9100 requirements are met. Consider this in layman’s, the period your organization needs to prepare for and study for a test.

You should also note that because of the complementary nature of ISO 9001 and AS9100, any organization seeking AS9100:2016 certification must first comply with ISO 9001:2015.

More on the Relationship Between ISO 9001 and AS9100

Some of the most important alterations between the 2008 and 2015 iterations of ISO 9001 that directly relate to AS9100 include:

  • A 10 clause structure based on the Annex SL formatting model
  • An increased focus on external processes, products and services
  • An expanded focus on stakeholder satisfaction and company performance
  • An improved approach to risk-based thinking and risk mitigation

Source

The AS9100 Certification Process starts with your organization understanding the guidelines that have been set out by AS9100 and ensuring the requirements are being met. Your organization might want to consider looking for a Consultant to help implement processes. To remain impartial, your AS9100 auditor and your Certification Body cannot offer suggestions to help you pass requirements, you will need to work with a third party to ensure success for your certification.

Find a Consultant here.

After you’re satisfied that your efforts will meet AS9100 requirements, your organization will then appoint an internal auditor that periodically checks whether those standards are being conformed to or not. In the case that an internal employee with the capability or experience does not exist, outsourcing to an auditor should be considered.

After your organization is satisfied with your capacity to achieve certification, you will want to start finding quotes from AS9100 Certification Bodies. Consider your choice of Certification Body carefully as you will be working with them consistently through the certification process, and at least once per year during recertification and surveillance audit periods.

It is important to note that if you are dissatisfied with your current CB, you can transfer your certificate to a different Certification Body at any time during the process. There is a transfer fee involved in moving your certificate, and to transfer your data in OASIS. However, you might find it is worth the investment.

You can find a Registrar here.  

What is OASIS

OASIS or Online Aerospace Supplier Information System, is an online directory of members of the IAQG that houses information on certified suppliers and their audits, accredited certification bodies, AQMS auditors, accreditation bodies, and participating National Aerospace Industry Associations (NAIA). – Source

The IAQG website defines themselves as “a cooperative organization within the aerospace & defence industry comprised of 3 sectors (Americas – AAQG, Asia/Pacific – APAQG and Europe – EAQG)” … and their purpose is defined to “establish and maintain a dynamic cooperation based on trust between aerospace & defence companies on initiatives to make significant improvements in quality performance and reductions in cost throughout the value stream”. – Source

The Importance of OASIS

Online Aerospace Supplier Information System (OASIS) is a database used to assist in the management and transparency of AS9100. OASIS is free to join and provides organizations with access to a list of CB’s, training providers, and accreditation bodies. OASIS can also be used to find other certified organizations or auditors who can perform AS audits.

Did you know? Through OASIS, you can check other organizations’ certification status and additional information regarding their certification such as approval status and the date of their last audit. The results of an organization’s audit can also be requested through OASIS.

While OASIS is a free database, it is mandatory. If any aerospace certified supplier refuses to be a part of OASIS or refuses to set up an OASIS administrator, Certification Bodies are required by the IAQG to revoke their certificate of registration. Your CB will be responsible for collecting and uploading information, including certificates, pertaining to individual aerospace companies into OASIS.

Why is AS9100 and its regulation so important? Consider the relationship you have and want to portray to your customers, suppliers, clients, and major interested parties. Certification to AS9100 is a way to demonstrate to these bodies that you are taking an active interest in promoting quality and efficiency in your industry. AS9100 is a cost-effective ROI, a confidence builder, and employee engaging solution to your inefficiency problems.

Get a Quote for AS9100D Certification

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Food Safety & HACCP - ISOUpdate.com

On average, 35-45% of interviewed consumers reported being extremely concerned with food safety and the hazards posed by unsafe food supply. Studies conducted by the World Health Organization show that 1 in every 10 people in the world falls ill eating contaminated consumables resulting in 420,000 losing their lives. These numbers reflect a trend and an increase in people at risk of consuming contaminated food are suggestive of a frightening reality: a rise in the problems with food safety.

Causes for Rising Food Concerns

There are several factors that have collectively caused the rise in food safety problems. Consider current methods of distribution, our increased reliance on imports, and the quality and regulations involved in food handling during production and at the consumer level.

Imports & Food Safety

The volume of imported food, particularly meat, vegetables, and fruit, is on the rise globally. “Some 95% of the seafood consumed in the US is imported; 50% of the fresh fruit and about 25% of the vegetables are imported”, Matthew Wise, deputy branch chief for outbreak response at the CDC.

The wider the geographic area is, the more challenging it becomes to effectively check, monitor, and screen the diverse imports. This high volume is enabling hazardous food content to enter our nation and be distributed for consumption.

Food & Animal Production

The quality of the methods used in the production and distribution of food is also to blame for the rise in food safety issues. A constant need from suppliers and wholesalers for an increase in profits and a decrease in expenses has led farmers to integrate risky practices into production.

Farms that raise poultry and animals for meat might opt for poor quality feed that could be either pre-contaminated or contaminated by poor handling practices to increase their profit margins.
Moreover, it isn’t easy to spot sick animals as some illnesses do not present outward symptoms. For example, Listeria, a rare but very serious foodborne illness with a high mortality rate of 20-30%, presents in ruminants (such as cattle, goats, and sheep) most commonly as neurologic signs. This can be a loss of balance, circling, fever, decreased activity and unusual body spasms. – Source

Another example of difficult disease prevention, if a hen’s reproductive organs are infected, the yolk of an egg can be contaminated in the hen before it is even laid.

Produce & Potential Harm

Poor practices related to increased production aren’t only limited to meat, but also affect fruits and vegetables. An increase in awareness in food safety has moved some to opt for fresh produce, unfortunately, fresh produce doesn’t undergo processes to remove contamination and kill germs. Furthermore, if contaminated water or ice is used to wash, pack, or chill fruits or vegetables, the contamination can spread to those items. – Source

Restaurant & Food Preparation Industries

The production of food isn’t the only industry plagued by poor quality. Restaurant and food preparation industries have their own vices.

Economically Motivated Adulteration

The U.S. Food and Drug Administration (FDA) has defined economically motivated adulteration (EMA) as the “fraudulent, intentional substitution or addition of a substance in a product for the purpose of increasing the apparent value of the product or reducing the cost of its production, i.e., for economic gain.”

To maximize profits, food can be subjected to questionable practices to either make it last longer, taste better, or increase its volume.

Cases of EMA

  • Melamine in Food
    • Added to infant formula & dairy apparently to enhance the perceived quality
    • Added to flour intended for pet food apparently to enhance protein content
  • Diethylene Glycol
    • Drugs and foods contaminated from substitution with toxic syrup. At least eight mass poisonings around the world in the past two decades.

Food Handling & Safety

Lifestyles pressured by time have increased “leftovers” and buying ready to eat dishes, and people often use the same utensils working on different substances causing cross-contamination. Risks are highest during the summer when food is much more prone to contamination if it isn’t refrigerated properly. Germs grow quickly at room temperature, multiply in as little as a few hours, and reheating or boiling food after it has been left at room temperature won’t always make it safe. – Source

HACCP’S Solution

HACCP provides a solution to many of food safety concerns. HACCP is an acronym for Hazard Analysis and Critical Control Points. The system is preventative in nature rather than reactive. This allows problems to be dealt with at the root rather than by reacting to outbreaks or problems after they occur.

HACCP has 7 basic principles:

STEP 1: HAZARD ANALYSIS

A team analyzes the sequence of steps or procedures and identifies all the points where a hazard is likely to occur.

STEP 2: DETERMINE CCP’S (CRITICAL CONTROL POINTS)

Keeping the earlier hazards in mind, the team identifies critical control points where a hazard may be completely eliminated or reduced.

STEP 3: ESTABLISH LIMITS FOR CCP’S

A critical limit is then established using scientific data to a maximum/minimum value for something to be at such that it eliminates or reduces risk of hazards to an acceptable level.

STEP 4: ESTABLISH PROCEDURES FOR MONITORING

A complete procedure of how, when and by whom measurements or readings are taken to compare them with the previously established limits for CCP’s.

STEP 5: ESTABLISH CORRECTIVE ACTION

A plan of action that needs to be followed after a deviation in the critical limit for something has occurred. This is required in the case of, for example, identifying contamination that exceeds the maximum limit and following a sequence of steps to clean that contamination, discard all product on the line and restart.

STEP 6: VERIFICATION

The verification process is the act of making sure that the process controls are adequate in controlling the hazards, and the HACCP plan is being followed properly.

STEP 7: VALIDATION

A sequence to validate the HACCP plan as a whole. Scientific evidence needs to be obtained and then evaluated that the plan to eliminate hazards from the food production process as a whole is, in fact, capable of doing so.

While there are factors like distribution, production, preparation, and EMC’s that have collectively resulted in a rise in food safety problems, there is a movement towards a solution. Quality Standards and regulations using Critical Control Points and HACCP’s 7 Principles allows problems to be dealt with at the root rather than by reaching to outbreaks and devastation of inaction.

Is your organization working in the food production, handling or preparation industry? Looking to implement HACCP within your organization? Find a Consultant and Registrar to help you implement your system and get certified, right here on ISOUpdate.com!

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Does ISO 45001 Differ from OHSAS 18001 - ISOUpdate.com

OHSAS 18001 was the management system standard designed to minimize work-related injuries and casualties to make the workplace safer. ISO 45001 replaced OHSAS 18001 in March 2018 and should be implemented in all organizations regardless of their size or operational risk levels. The new system is the culmination of the effort of 70 countries. But why is OHSAS 18001 being changed to ISO 45001? And does ISO 45001 replace OHSAS 18001?

Why is OHSAS 18001 being changed to ISO 45001?

OHSAS 18001 attempts to cover all the potential risks involved in a workplace, however, despite that, 2.78 million deaths due to occupational accidents or work-related diseases are reported annually.

Non-fatal work-related injuries and illnesses are reported at a staggering 374 million each year.
The burden of poor occupational safety practices is estimated at 3.94% of the global GDP each year.

ISO 45001 aims to assist organizations to take the appropriate steps to make the workplace safer and further minimize the potential health hazards encountered by employees of all organizations. – Source

What are the differences between OHSAS 18001 and ISO 45001?

The concepts behind the two standards are similar, however, certain improvements have been made in ISO 45001 from OHSAS 18001.

For example, response protocols for hazardous situations and risks remain largely the same, but measures have been taken to implement a proactive approach towards preventing risks and the indicators of the new system’s performance have also been enhanced.

Main improvements made in ISO 45001 include:

  1. ISO 45001 is based on the Annex SL, which was designed by ISO to make it easier for organizations that comply with more than one management system standard.
  2. With ISO 45001, maintaining an organization’s safety is the responsibility of the organization’s top management. Instead of delegating this important task, the onus of competition and effectiveness is on management.
  3. ISO 45001 calls for increased involvement of employees with management to make the workplace safer. From mandatory training and awareness programs to share the results of internal audits and assessments, ISO 45001 ensures that everyone takes on the responsibility of ensuring workplace safety.
  4. In addition to the preventive tactics and hazard response mechanisms that are a part of OHSAS 18001, ISO 45001 will mandate periodical audits and safety analysis and risk evaluation of the organization to prevent health and safety hazards.
  5. ISO 45001 changes the criterion behind documenting information. Rather than mandatory documentation of all procedures, future documentation will only be required for risk control capacity to allow organizations to monitor and audit their current safety protocols and how to improve them.
  6. ISO 45001 requires organizations to conduct necessary checks to ensure that contractors and suppliers are also taking the appropriate steps to minimize risks.

What are the benefits of switching to ISO 45001 from OHSAS 18001?

ISO 45001 can help improve the level of occupational health and safety, thereby improving working conditions and optimizing productivity. ISO 45001 is based on the Annex SL framework, which allows organizations to easily integrate it with the other standards of ISO.

ISO 45001 actively informs and educates all levels of employees about the risks involved in workplaces and uses a progressive approach to OH&S performance with frequent improvements.

Implementing ISO 45001 will allow organizations to speed up response to any compliance issues, lower costs incurred due to accidents and thereby reduce the costs of insurance as risk levels reduce. ISO 45001 may also improve productivity due to streamlined operations and save your organization on manpower due to lowered employee turnover rates and improved employee attendance.

Want to implement the new standard in your organization? Contact a Registrar to get a quote today.

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How Can Total Quality Management Improve Organizational Effectiveness? - ISOUpdate.com

Today’s organizational environment is filled with constant and rapid change; technology changes with the blink of an eye, competition is increasing, and customers are demanding greater quality and lower costs. To adapt to these changes and still meet their goals, organizations need to be efficient. Efficiency requires an overall approach and cannot be reached by focusing on a particular process, or on a specific area within an organization. But, how can total quality management improve an organization’s effectiveness?

What is Total Quality Management?

Total Quality Management: a business philosophy which focuses on customer satisfaction and relies on an understanding that a strong focus on employees is necessary to achieve efficiency within an organization.

Total Quality Management is oriented to create quality awareness across an organization, and it considers both the organization’s processes and the employees as integral aspect in an organization quality improvement capacity.



Total Quality Management promotes commitment, participation, cooperation and continuous improvement within organizations. Because every employee and every process is important in achieving organizational effectiveness, Total Quality Management can assist in this matter by empowering all employees and making everyone responsible for meeting internal and external customers expectation.

Every employee, regardless of their role within the organization, can improve quality within their processes.

Total Quality Management can also help organizations achieve effectiveness is by encouraging a dynamic approach to quality improvement. Variations can occur within processes that can negatively alter the desired results.

These variations need to be detected, communicated and addressed promptly to prevent deviations from proposed goals. Therefore Total Quality Management, by encouraging teamwork and empowering employees to make decisions, can facilitate good communication and an effective response within and across different functional units within an organization.

Organizational effectiveness is reached by achieving common goals. Since internal and external customers expectations drive organization’s processes, by meeting and exceeding these expectations, organizations can reach their goals and also obtain a competitive advantage.

Many organizations can utilize Total Quality Management to increase their efficiency. Total Quality Management has been implemented in manufacturing, education, government administration and services. Any type of organization can benefit from Total Quality Management and use it to adapt to constant changes, improve their effectiveness and thus increase competitiveness.



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What are NADCAP Special Processes for Aerospace? - ISOUpdate.com

The term ‘special processes’ was first mentioned by ISO (International Organization for Standardization), which publishes a series of international quality assurance and management standards that help organisations document, monitor and improve their quality systems. Standardized quality assurance aims to improve customer satisfaction and overall organisational performance. One of the requirements to meet these standards is a series of special processes that need validation for service and product provision. But, what are NADCAP special processes for Aerospace?

Special Processes & Aerospace

The aerospace industry has implemented its own quality standards based on ISO 9001 which contain additional requirements specific to the industry. AS9100, AS9110 and AS9120 are the International Standards for Aerospace Quality Management Systems.

In the AS9100 series of standards, special processes refer to a set of linked procedures that lead to the creation of products and services whose end results would not otherwise be measured, monitored or verified before being released to the customer. Hence, these products and services require special attention during production to ensure that they are free of defects.

NADCAP

Nadcap-Flag-ISOUpdate.comIn the aerospace industry, the National Aerospace and Defence Contractors Accreditation Programme (NADCAP) plays a major, and mandatory, role acting as an approval body of the process used and ensuring the product is correct.

The accreditation process involves specific audits based on NADCAP requirements. For a NADCAP audit to take place, a company must first be AS9100 certified.

NADCAP Special Processes & Aerospace

Since special processes include procedures that alter or change the mechanical, chemical or physical parts of products within the operation or process, they require rigorous, standard-specific practices as well as qualified personnel or employees.

Organisations must have a well-defined procedure for review and approval for both equipment and qualifications of its employees.

Aerospace companies must provide evidence that proves their ability to achieve planned or expected results. This can be done by showing and keeping records of the processes involved in creating the product. This will allow the auditor to compare the processes to the existing standard requirements or procedures.

Examples

For instance, if a certain product was produced at a temperature of 100 degrees Fahrenheit, then the same temperature should be used in observation during the audit and still produce the same product. This serves to improve and display trust in the validity of the product and the set of processes the industry follows.

Revalidation is an important aspect of special processes, especially when changes are made to a product.

Using the previous example, when a product that was initially manufactured at a temperature of 100 degrees Fahrenheit is now being manufactured at 98 degrees Fahrenheit, the company must ensure the product’s validity and functionality remains the same.

Documenting Change

A key aspect to process change is documenting the change.

When changes are made to the process of making a product, the company, with the help of an auditor must ensure the process is revalidated to ensure that the product still meets the same specifications as it did before the changes were made.

The process of revalidation also emphasises the importance of industry standards such as ISO 9001 and AS9100 especially in a highly engineered industry such as aerospace.

In conclusion, special audited processes are very important in the aerospace industry because they determine the validity of a product by ensuring companies adhere to international standards, improving and increasing the production of quality products, and customer satisfaction.

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What is ISO 8601 Proper Notation of Dates and Times - ISOUpdate.com

As we welcome in the new year, if you are like us, you might struggle to remember the new date, let alone the order it should appear in when you denote it. The transition from 2018 to 2019 can be a headache, but did you know that ISO has a standard for that. Yes, even the date has a proper format, and it’s laid out in ISO 8601, the Date and Time Format Standard. ISO 8601 presents dates and times in a standardized format thereby removing confusion in international communication.

What is ISO 8601?

ISO 8601 is the international standard for recording and denoting dates and times using numbers to avoid confusion from different interpretation.

What is the ISO 8601 Date Format?

The internationally agreed way to represent the date is YYYY-MM-DD.

The internationally agreed way to represent time is hh:mm:ss.ffffff

When denoting time alongside the date, the Standard format is YYYY-MM-DDThh:mm:ss.ffffff +|-hh:mm

YYYY = four-digit year
MM = two-digit month
DD = two-digit day of the month
T = a set character indicating the start of the time element
hh = two digits of an hour (00 through 23)
mm = two digits of a minute
ss = two digits of a second
mmm = three digits of a millisecond (000 through 999)
+|- = time zone designator (Z or +hh:mm or -hh:mm), the + or – values indicate how far ahead or behind a time zone is from the UTC (Coordinated Universal Time) zone.

US time zone values are as follows:

EDT = -4:00
EST/CDT = -5:00
CST/MDT = -6:00
MST/PDT = -7:00
PST = -8:00

The History of ISO 8601

The first edition of the ISO 8601 standard was published as ISO 8601:1988 in 1988. It unified and replaced several older ISO standards on various aspects of date and time notation: ISO 2014, ISO 2015, ISO 2711, ISO 3307, and ISO 4031. It has been superseded by a second edition ISO 8601:2000 in 2000 and by the current third edition ISO 8601:2004 published on 2004-12-01. ISO 8601 was prepared by, and is under the direct responsibility of, ISO Technical Committee TC 154.

ISO 2014, though superseded, is the standard that originally introduced the all-numeric date notation in most-to-least-significant order [YYYY]-[MM]-[DD]. The ISO week numbering system was introduced in ISO 2015, and the identification of days by ordinal dates was originally defined in ISO 2711.

ISO 8601 is currently in the process of being updated and split into two parts anticipated to be released in March 2019. – Source

Read more about ISO Standards

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Understanding ISO 21041 and Unit Pricing - ISOUpdate.com

With ISO 21041, consumers can now make better and easier buying decisions that allow them to compare the values of related products and decide accordingly which one to spend their valuable dollars on. Following ISO 21041 and its protocol is not only beneficial for the consumers but also for the retailers through unit pricing.

Did you know: ISO 21041 is the result of an international effort that was led by a team of experts from Australia?

What is ISO 21041?

ISO 21041:2018, namely, Guidance on unit pricing, sets down several prerequisites that will allow consumers to compare the prices of similar items to make more informed buying choices.

ISO 21041 guides store owners and retailers on an effective way to display unit pricing on all the products in their stores, regardless of whether they are on shelves or in packages, as well as in the advertisements for these products and demonstrates how important it is to educate and provide clarity to consumers to maintain transparency.

What is Unit Pricing?

Unit Pricing, also known as comparative pricing, is the way of pricing products or services such that the price displayed shows the price of one standard unit of measure. This way, consumers can easily determine which product provides more value.

For example, if one milk company offers milk in a liter pack and another company offers milk in a half liter pack, then unit pricing demands that the prices of both companies be displayed according to one liter. This way, consumers can easily decide which company to opt for instead of having to perform calculations.

Understanding ISO 21041 and Unit Pricing Labels - ISOUpdate.com

Why is Unit Pricing Necessary?

Inconsistent pricing methods can lead to a confusing shopping experience for consumers, which can lead to purchase trade off, where a potential customer determines your product is less than a competitor based on value. Even worse, this confusion can increase their decision avoidance, where a purchase could have been made but was bypassed to avoid emotional costs of making the decision. – Source

This level of confusion leads to distrust among the consumers for the retailer. By opting for an easy to understand and evaluate method of pricing, retailers can demonstrate that they believe in transparency and aiding their consumers. This is because price transparency is one of the most effective ways to gain the trust of consumers as it makes it easier to make purchasing choices.

This relationship between consumer trust and pricing transparency was apparent in a study conducted by Australia’s Queensland University of Technology, where consumers remarked that unit pricing helped them make easier purchasing decisions so that they could shop with a higher confidence.

The research also showed that adopting unit pricing also led to a positive change in the attitudes of the consumers towards retailers.

Unit Pricing and Global Consumerism

Standardized unit pricing will also make it easier for consumers to make more informed buying decisions on a more global level.

By adopting ISO 21041 ambiguity and confusion around the pricing system can be nearly eliminated.

Summary

“ISO 21041 includes guidance on the provision of unit price, their units of measure used to express unit price including weight, length, volume, count, area and other forms of measure. ISO 21041 also highlights guidance on the display of unit price, and the implementation, communication and education of consumers.

ISO 21041 is applicable to any retailer, including supermarkets, hardware stores, pharmacies, convenience stores, automotive parts suppliers and pet product suppliers.

Note: ISO 21041 is applicable to packaged and non-packaged food and consumer products where the price is displayed, including

— at point of sale, including in-store and online, and

— when relevant communications about the product are released (including advertising by electronic and printed formats).

Note: ISO 21041 excludes services and merchandise, such as clothing and electronic goods sold as a single item.”  – Source

In short, adopting ISO 21041 and standardized unit pricing not only helps the consumers make better choices but is also beneficial for the retailers as it promotes positive consumer attitudes and increases customers trust in your brand.

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