“Interested parties”: their significance for quality management system

In early years, Quality management system (QMS) stipulated that companies must monitor customer need satisfaction as a mandatory requirement. However, in the 2008 version, ISO 9001 standard emphasized customer focus as well as the supplier relationship simultaneously. The standard focussed on supplier collaboration for knowledge sharing, expertise development and creating value for mutual benefit. Systems approach to integrating and aligning the processes, further provided opportunity for value creation for customers as well as suppliers. The Concept of treating the next process as customer, improved the collaboration, alignment and integration of processes, thus enabling a systems thinking approach.

The new version of Quality management system: integrated approach

2015 version of ISO 9001 combines the customers, suppliers as well as others as interested parties. Companies must identify and understand the needs and expectations of relevant interested parties. List of interested parties should include:

• direct customers,
• regulators and government agencies,
• distributors,  contractors,
• wholesalers and retailers,  stockists,
• shareholders and lenders,
• suppliers, transporters and partners in supply chain,
• end users,
• Employees.

Relevance of needs and expectations of interested parties must be understood and process integration should be built in such a way as to benefit them as well as the company.  

Section 4.2 of ISO 9001:2015 standard speaks about understanding the needs and expectations of interested parties.

Section 4.1 talks about organizations ability to attain intended outcomes and internal/external issues affecting the capacity of the company, as a result of needs of interested parties.

Section 6.1 mentions the issues and risks and opportunities arising out of needs of interested parties to be addressed in QMS, through plans and processes for prevention of undesirable effects on the intended output of goods and services.

Section 4.3: The scope of your QMS should enable you to address the relevant needs of the interested parties.

Other clauses and areas due to which QMS must address the needs of interested parties:

Section 5.2.2 your Quality Policy

Section 9.3 management review

Section 8.3 design inputs for development of new goods and services

In determining as well as fulfilling  the relevant expectations of   interested parties their relationship with the company must be analysed, as discussed below.

End users and Customers

End users are not buying the goods and services directly, but are affected by the way the processes are carried out and controlled. In many cases end users may be more important than the direct customers, because, they may  not be easily identified and their needs and expectations could be difficult to determine. Monitoring changes in their needs and expectations may be a difficult task and QMS should address these issues. Their requirements may affect the firm’s ability to fulfil them. Their needs and expectations should be utilized in new product development and customer service design and improving the processes.

Customers are the people who buy the company’s goods and services directly. They are more vocal in voicing their expectations.  The company must monitor and   understand the changes in their expectations and needs. They are directly impacted by the quality of goods and services offered as well as the pricing.

Regulators and Governmental agencies

Expectations of regulators and govt. agencies are based on the legal requirements and regulatory controls, such as industry specific environmental regulations, safety regulations and occupational health requirements. Expectations may relate to processes as well as goods and services. These requirements must be addressed in the QMS and any changes in regulatory requirements too need to be identified and addressed promptly.

Supply chain partners and stake holders

Partners in the supply chain such as suppliers, contractors, transporters, stockists, wholesalers and retailers have an important role to play in ensuring effectiveness of your QMS. Their expectations must be addressed by integrating them in the critical processes of the QMS. Similarly employees, shareholders and lenders are also affected by the effectiveness of QMS and their concerns and expectations need to be identified and addressed.

Conclusion

The purpose of your business is to satisfy the needs of the customers and other interested parties. ISO 9001 requires that you understand the needs and the expectations of customers and end users, regulators as well as other interested parties, and address those needs through  integrated processes, which maximize the benefit to the interested parties while also attaining the goals of the company.

 When your QMS ensures integration of the processes in order to fulfil the expectations of the interested parties you are closer to the planned compliance and certification to the requirements of ISO 9001:2015.

ISO 9001 certification

Organisation are looking to achieve ISO 9001 Certification for several reasons eg: getting pre qualified for tenders, Customer request, etc,. To develop and Implement systems quickly and have a systems that adds value to your organisation you may need the services of specialist ISO 9001Consultants who can guide you through the requirements of the ISO 9001 Quality management system including the identification of relevenat interested parties to the organisation.

Management Review as required by ISO 9001

Management review is a very important part of an organization’s quality management system based on ISO 9001:2015. It is the most important source for continuous improvements. It can be used to bring together all the elements of your quality program and bring cohesiveness to it. It allows the organization to focus on trends, objective evidences as well as data based decisions. It is used to assess the performance of the quality management system and find out opportunities for its improvement. It is held at-least once a year and is a platform for reviewing the quality policy and setting new quality objectives. It is important that the top management be involved in the management review.

The management review requires that a periodic review of the QMS shall be held so as to ensure it is suitable, adequate and effective. It is also required that the alignment of the Quality Management System with the organization’s strategic direction be checked. You should ask your ISO consultant to guide you one how to hold an effective management review.

Management review inputs

The management review process should ensure that all the necessary information is collected ahead of the time so as to allow management to complete this evaluation. Information review should includeand take into consideration

1. The status of actions decided in the previous management review.

2. Changes in the context or the external and internal issues that are relevant to the quality management system.

3. Information gathered on the performance and effectiveness of the quality management system and including the trends in

a. Customer satisfaction

b. Feedback from interested parties

c. The extent to which quality objectives have been met

d. Process performance

e. Conformity of products and services

f.  Nonconformities and corrective actions arising due to them

g. Monitoring and measurement results of processes, products and services

h. Audit results, both internal and external audits

i.  The performance of external providers or suppliers and outsourced processed

4. The adequacy of resources provided for the quality management system

5. The effectiveness of actions taken to address risks and opportunities

6. Opportunities for improvement

7. Suitability of possible changes in the QMS

8. New/proposed regulations or legislations

9. Advances in technology and science

10.Change in preference of buyers

11. New/modified products and services

For the management review to be effective, the attendees should come to the meeting prepared with data, and must have already drawn conclusions from the data.

Management review outputs

After analyzing the inputs given above, the management shall develop some outputs from it that should be in the form of decisions and actions that are related to

1. Opportunities for improvement which can be related to process improvement, quality management system improvement or product improvement

2. Any need for changes to the quality management system

3. Resource needs such as human, infrastructure, equipment or technology etc.

Records

The organization shall keep records of the management review such as minutes of the management review meeting. Observations as well as conclusions and also recommendations for further action from the management review must be recorded. If any corrective action is to be taken, then management must follow up on so as to ensure that the action has been implemented effectively.

The final objective of the management review should be continual improvement of the quality management system. As the QMS is made more effective and efficient, your organizational performance shall likewise improve.

Role Of Consultant In The ISO 9001 Certification Process

Often, organizations deploy consultants to take them through the ISO 9001 certification process. Apart from ensuring that the organization’s certification journey is successful, the consultant optimally deploys the standard in the organization’s context, for its best benefits. I.e. He ensures that the requirements of the standard and the needs /context of the organization are best aligned.

The role of the ISO 9001 consultant is spread across the entire certification process starting from introductory training up to the final certification. The consultant introduces the organization and its top management to the ISO 9001 standard, its requirements & benefits and the certification process. He plays a key role in obtaining the top management buy-in towards the certification.  The consultant conducts detailed training to the key members of the organization on the requirements of the standard. Members from the quality function and other senior members from line function are typically trained at this stage.

Then, the consultant in discussion with the quality team members and other stakeholders understands the organization, i.e. the business , key stakeholders, products and services, operations, structure of the organization, its size &  location of operations. Such an understanding is vital for him to deliver the best in the forthcoming stages of certification. Then, the consultant acquaints himself with the Quality Management System (QMS) of the organization, if any. It remains the pre-requisite for performing a fool proof gap analysis of the QMS against the requirements of ISO 9001. After discussing the gaps with the Quality team, the consultant facilitates the closure of these gaps, i.e. up gradation of the QMS.

 If the organization does not have any QMS in place, then the consultant develops the QMS from scratch. This includes framing the Quality policy, developing Quality Manual, procedures, guidelines, formats and checklists. At this stage, the consultant works closely with the quality team and line function members of the organization so that the QMS developed is practical and implementable. Such an interaction helps get the buy-in of the line function in deploying the procedures, guidelines and systems. The role of consultants remains in translating the requirements of the standard to the context of the organization. A successful consultant is one who right sizes the definition and deployment of the standard i.e. neither more nor less of processes.

Also, he prepares an ISO 9001/QMS awareness program capsule for training of the employees. He along with quality team members delivers training to the employees across the organization.

The consultant’s role is vital even in the deployment phase, where the organization faces various issues in deploying the new procedures / systems.  Many organizations use the consultant’s service in developing a pool of internal auditors i.e. the consultants deliver internal auditor training to a set of employees, to qualify them as trained internal auditors. Also, the consultants ensure that the organization conduct the internal audits, as per the requirements of the standard. The quality department takes consultant’s help in conducting the management review. Here again, the consultant’s ensure that the management review is conducted in line with the inputs and outputs mentioned in the standard. 

Production and Service Provision as per ISO 9001

This is the main clause of ISO 9001 Quality management system which relates to the actual production process of a product or service.

Control of Production and Service

The standard requires the organization to undertake production and service under controlled conditions including delivery and post-delivery activities. These controlled conditions shall include:

• Documented information should be made available that define the characteristics of products and services.
• Documented information should be made available that define the activities that are to be performed and results that are to be achieved.
• Undertake monitoring and measuring activities for process and product and ensure acceptance criteria have been met.
• Suitable infrastructure and process environment is used.
• Ensure that suitable monitoring and measuring equipment are available and used.
• Competent and qualified personnel.
• Validation and re-validation of processes where the output that is resulting cannot be verified by subsequent measurement and monitoring.
• Implementation of actions to prevent any human error.
• Implementation of release, delivery and post-delivery activities for products and services.

Identification and Traceability

The organization shall use suitable means to identify process outputs, where necessary so as to ensure conformity of products and services.

It shall identify the current status of process outputs regarding monitoring and measurement requirements throughout the production process.

It shall control the unique identification of process outputs where traceability is required. Keep documented information or records required to maintain traceability.

Process outputs means the results of any activities which are ready for delivery to internal or external customer. They can include products, services, components or intermediate parts.

External Provider Property

External provider property can be equipment, tool, material or drawing etc. The organization shall take care of the external provider property while it is in its care so that there is no damage or deterioration.

The organization shall identify, verify, safeguard and protect external provider property given for incorporation or use in the products or services.

When the external provider property is lost, damaged or found unsuitable for use it shall be reported to the external provider and documented information is retained on what has happened.

Preservation

The organization shall ensure the preservation of process outputs during the production and service provision up to that extent required to maintain conformity of products and services.

Preservation includes identification, handling, packaging, storage, transmission or transportation and protection.

Post-Delivery Activities

The organization shall meet the requirements for post-delivery activities required for products and services. The organization shall consider the extent of post-delivery activities required for

• Risks or potential undesired consequences associated with the products or services.
• The nature, the use and the intended lifetime of products and services.
• Customer requirements.
• The customer feedback.
• The legal requirements.

Post-delivery activities can include the following

Actions to be taken under warranty.The contractual obligations e.g. maintenance.The supplementary services e.g. recycling or the final disposal.

Control of Changes

The organization shall review and control changes that are unplanned that are essential for production and service to the level required to ensure conformity with the specified requirements.

The organization shall retain information that describes

• The result of review of changes.
• The person who is authorizing the changes.
• Any necessary action resulting from review.

ISO 9001 certification

Organisation are looking to achieve ISO 9001 Certification for several reasons eg: getting pre qualified for tenders, Customer request, etc,. To develop and Implement systems quickly and have systems that add value to your organisation you may need the services of specialist ISO 9001 Consultants who can guide you through the requirements of the ISO 9001 Quality management system in relation to production and service provision.

Tips To Energize Your Internal Auditing Program

Preparation is the key to an effective, thorough and a value-added internal audits program. Internal auditors cannot be content by preparing for the audit not by giving sufficient time to achieve their objectives. They will be required to have enough time on their hands to prepare for the job ahead. They should be aware about the fact that if the audit is expected to last for a couple of hours, the preparation for the job will take at least 2 1/2 times the amount of time. Therefore, they will be required to allot sufficient time for the preparation without which they are likely to run out of questions before the completion of the audit.

It is quite easy to comment about the time needed for the audit but in reality, is quite difficult, especially for the auditors. The time restrictions placed on them are the major obstacles they face when they decide to allocate enough time and prepare for the job they are required to complete. It is quite possible for them to have other responsibilities than internal auditing competing for the time available with them. In such conditions auditors will do well to follow the example by many trained internal auditors and learn how to spread their workload. This will lead to better preparation and completion of the audit as required by the laws.

Effective planning for internal auditing requires auditors to follow some steps, which are simple and will allow them to perform their duties effectively. Auditors must be prepared to understand how they can allocate the time needed to manage such tasks in the best manner. They cannot be under the impression that they will be able to handle such issues within a short time. They will be required to allocate some time even for the learning of the simple steps that have been mentioned below:

• They will have to learn the process.
• They have to identify with the interfaces within the standard.
• They need to understand proper compliance to the standard and also to identify with process interfaces and potential process failure modes.
• Reviewing old audits, developing audit questions and the audit plan will also be a requirement, which they will not be able to ignore.

They are required to become familiar with the process before they begin to audit the same. They need to know the working of the process, what the objectives are, what are the outputs, inputs, activities, resources and controls. The amount of knowledge they need to collect is vast and can make an ordinary individual feel he or she may not be suitable to the task. However, these are requirements, which will have to be overcome by people who have decided to get into the business of internal auditing.

Understanding a process alone will not be of any help unless the auditor is willing to consider his or her role within the process of auditing. It is absolutely necessary for them to be fully prepared to conduct the audit in an impartial manner by looking for any information provided with an open mind. It is a foregone conclusion that they will not be able to complete their job effectively if they are not fully aware of their responsibilities and the way they are required to conduct themselves.

Auditors will be required not to forget their role as the guardians of the process they are required to audit. They should be making every attempt to energize their internal auditing program by getting all the information they need and performing their roles to the best of their knowledge. 

Showcasing Your Business To The World With HACCP

If you have an intention of showcasing your business to the world you do not have to be concerned about this matter. Unlike in the past when you could only achieve this objective by getting involved in advertising, you now have different methods that will allow you to tell the world about your business and even to get plenty of benefits because you made an attempt to do so. Rather than spend money on publicizing your business in any way you just have to make an application to get certified for HACCP. This is a system designed specifically for businesses involved in the sector of food.

Matters of food safety have been addressed through the HACCP management system with a series of analysis and control points to ensure safety from biological, chemical and physical hazards of food production starting from the procurement and the handling of raw material right down to the manufacture, distribution and consumption of the finished products. The management system makes it clear in order to ensure successful implementation of the HACCP system the overall management of your company must be fully committed to the concept. Being compliant with the system gives your business an opportunity to show the world you are committed to all aspects of the food industry and are making every effort continually to implement and improve the systems as specified by the governing body.

Before you consider making an application to become certified you must try to understand the benefits the concept can offer to your business. This is a management system by which the safety of food is addressed through the analysis and control of a number of hazards, including biological, chemical, physical and the procurement of raw material. It also considers matters related to the production, distribution and even consumption of the finished product. This concept has been designed for use in all segments of the food industry beginning from the growing and harvesting of raw material to the final preparation of the food for consumption. It will be essential for you to understand what the current good manufacturing practices are for the development and successful implementation of HACCP.

The concept is recognized internationally with a number of countries having passed legislation to ensure every business engaged in the food industry needs to be certified for HACCP. This is a clear indicator that if you are successful in your attempt the certificate in your possession will give you the ability to showcase your business to the world. You will have no difficulties in participating in businesses in any part of the globe and get involved in expansions that you believed never existed. However, in order to become recognized must make an effort to have the concept implemented within your business and even make the attempts to improve the system continuously. If you are not committed to this factor, it is unlikely for you to be considered as a suitable business that is fit for the certification.

The size of your business or a number of years you have been involved do not make any difference to the certifying body as long as you are willing to make a commitment that you are prepared to follow the guidelines as described. The certificate will not be issued to you overnight because there are several steps, which you will have to go through before the certifying body confirms your business is credible enough to be certified.

If you do not have proper information about how you can go ahead and apply for the certification you can very well contact and HACCP consulting company that will be willing to assist you in your endeavor. They will provide you with all the information needed and even make it possible for you to become certified within a certain period of time. This is an option you can utilize if you do not have enough information about these matters. However, it is certain that you will be able to showcase your business to the world and even get plenty of opportunities at expansion if you are successful in your objective. 

Is HACCP Consulting The Answer To Food-borne-Illnesses?

An illness because of having contaminated foodstuff is quite common with the United States and all parts of the globe. After giving the matter plenty of thought governments worldwide have concluded they should have a system which will make it mandatory on food producers of all types to follow a set of guidelines and deliver products that can be consumed by all. Presently, all organizations in the business of foodstuffs are required to follow the Hazard Analysis And Critical Control Points, which also has the abbreviation of HACCP. Authorities who have promulgated the ordinance have given several methods to show how it will be easier for organizations to deliver safe and healthy foodstuff to its consumers simply by implementing the guidelines specified under HACCP.

The authorities have also clarified that it will be better for organizations to contact HACCP consulting companies to understand how they can comply with the requirements. Organizations have not been any leeway in these matters because of the vast data that is on hand to show how foodstuff can get contaminated during any stage of the production, packaging, storage and even handling by different people. Information is easily available that contamination of foodstuffs can happen because of contact by humans and even by bacteria and therefore, safeguards have been defined to avoid such incidences.

Whether HACCP consulting is the answer to food-borne illnesses or not is a matter of individual perception. It will not be difficult to find a number of organizations believing that they have all the knowledge they need and are not required to contact a consulting company simply to understand how they should be handling, storing or transporting foodstuff. Perhaps these organizations believe they are the final authority in such matters and not need advice from anyone just because they have been in the business for quite some time. However, the facts on the ground are entirely different because incidences have been recorded where the best organizations delivered products that had been contaminated for various reasons. It is only after such incidences that the authorities concluded that it was better to have the guidelines of HACCP along with HACCP consultant as a solution to the problem.

The United States and Europe both have passed legislation to confirm HACCP as a requirement, which will have to be followed by organizations dealing in foodstuffs. They have even specified penalties for those that do not conform to the standards specified. However, this is not a standard procedure in some parts of the world where the problem still exists. This is not an indicator that governments of these countries are ignorant about the problems or has stayed away from making certain that the guidelines are followed. It is the lax attitude within the countries that is perhaps a reason why the problem has continued to foster with no improvements being seen for quite some time.

Organizations that feel they can easily get the information about HACCP from various sources are free to adopt this method if they consider it better for their requirements. However, it must be specified that they cannot ignore the requirement of HACCP consulting because the individual offering the services will have information that will not be available through other sources. These are people who are trained in these matters and are also in regular touch with the certifying bodies. Therefore, it can be considered highly essential to have HACCP consulting services for organizations involved in the business of foodstuffs.