Record is defined as a “Document stating results achieved or providing evidence of activities performed”. It means any document which having some kind of information on it which was generate during perform any activity in process is in storage or kept for recall the evidences while required. Basically the term record is co related to document. Because initially document is created to retrieve the information with respect to any activity. As we know while any activity is carried out in any process there is some kind of inputs and output are required to perform those activities. It is necessary to capture those information related to that particular process so that we can make decision that our process is running Ok or not. So the documents are created which are used to capture those information related to particular processes. While the information is captured and update in document it is called as records because it is an evidences based on which we can say under what condition the process was carried out. The term retention means to retain something, it means retaining the records. As we understand about records are the evidences of information collected during an activity. After creation of record it is necessary to retain those records s that the records can be used in future while it is required to cross verification of any issue related to process. The term retention is focuses on retain the records for future references so that it can be easily made available and play help to analyse the situation. The term Period (Time) means the time period which is identified for keeping something. Time period is the duration of time, we can say that in current context if we talk about retention period of records that generated during an activity it will tell about how long we have to store the records generated during process. Retention Period is define as the period of time frame for which an organization have to keep the records generated during performing its activities. Each records having its defined standard record retention period based on its importance, generally the record retention period is varies from minimum one year to 15 to 20 year .As per international standard the retention period is minimum one year and any customer specific time as per mentioned in the customer specific requirement. So the organization need to follow the retention period requirement to fulfil the standard requirements.

Clause 7.5.3.2.1 Record retention

The organization is required to establish, document, and put into action a policy for retaining records that meets the demands of statutory, regulatory, organizational, and customer requirements. Records such as production part approvals, tooling maintenance and ownership records, product and process design records, purchase orders if relevant, or contracts and their amendments should be kept for the duration that the product is in active production and service, plus an additional calendar year, unless the customer or regulatory agency specifies otherwise. Production part approval records may consist of approved products, relevant test equipment records, or approved test data.

Organization need to define, document, and implement a record retention policy for managing the records in organization system. The process of control which his defied for record shall satisfy all related statutory, regulatory, organizational, and customer requirements which ever applicable. As per IATF 16949:2016 some key document which are listed below need to retain for identified specific retention period:

• PPAP (Production part approvals), tooling records, product and process design related records, purchase orders as per applicability, or contracts and amendments if any shall be retained for the N+1 calendar year.
• N is related to the life of product under production or service. 1 is additional one calendar year after the product service periods
• After consideration of above mentioned inputs one more important thing which is need to consider by organization is customer specific requirement.Organization need to focus on Customer specific requirement for retention period of records.

A record retention policy is an essential component of a Quality Management System (QMS) in compliance with the IATF 16949 standard. While the specific details may vary depending on the organization’s requirements and applicable legal/regulatory obligations, here’s an example of a record retention policy for IATF 16949:

Example of Record Retention policy

1. Purpose: The purpose of this record retention policy is to define the guidelines and requirements for the retention and disposal of records within the organization, in accordance with the IATF 16949 standard and applicable legal/regulatory requirements.
2. Scope: This policy applies to all records generated or received by the organization as part of its Quality Management System, including but not limited to quality planning, design and development, production, monitoring, measurement, and analysis activities.
3. Responsibilities: The following responsibilities are established regarding record retention:
   • Quality Manager: Responsible for overseeing the implementation and maintenance of the record retention policy.
   • Process Owners: Responsible for ensuring that records related to their respective processes are appropriately retained and made available for audit or inspection as required.
   • Record Custodians: Responsible for the proper storage, maintenance, and disposal of records within their designated areas.
4. Record Retention Periods: The organization shall retain records for a specified period based on legal/regulatory requirements, customer-specific requirements, and the organization’s needs for evidence of conformity to IATF 16949. The following are examples of retention periods (Please note that these periods are examples only and should be adjusted based on the organization’s specific requirements):
   • Management Review Records: 3 years.
   • Internal Audit Records: 3 years.
   • Corrective Action Records: 5 years.
   • Design and Development Records: 10 years.
   • Product and Process Validation Records: 10 years.
   • Customer-Specific Requirements: Comply with the specified customer requirements.
5. Record Storage and Accessibility:
   • Records shall be stored in a secure, controlled environment to prevent damage, loss, or unauthorized access.
   • Records shall be organized, labeled, and indexed to facilitate easy retrieval when needed.
   • Access to records shall be provided to authorized personnel, auditors, and regulatory authorities as required.
   • Electronic records shall be protected against unauthorized access, alteration, or deletion through appropriate security measures such as access controls, data backups, and regular system maintenance.
6. Record Disposal:
   • Records shall be disposed of in a manner that ensures confidentiality and prevents unauthorized retrieval.
   • Disposal methods may include shredding, secure electronic erasure, or other approved means.
   • Disposal shall be documented to provide evidence of proper record destruction.
7. Training and Awareness:
   • Employees shall be trained on the record retention policy and their responsibilities regarding record management and retention.
   • Awareness programs shall be conducted periodically to reinforce the importance of proper record retention and disposal.
8. Review and Revision:
   • This record retention policy shall be periodically reviewed and updated to ensure its ongoing suitability, effectiveness, and compliance with applicable requirements.
   • Revisions to the policy shall be communicated to relevant personnel and stakeholders.

Note: It is important to consult with legal counsel and consider specific legal and regulatory requirements applicable to your organization while developing or adopting a record retention policy.

Record retention for Production part approvals

1. PPAP Records:
   • The organization shall retain all PPAP documentation, including the submission package and associated records, as evidence of initial product approval.
   • PPAP records shall be retained for a period of at least the production life of the part or as specified by the customer requirements, whichever is longer.
2. Retention Period:
   • The organization shall retain the PPAP records for a minimum of the production life of the part, which typically corresponds to the duration that the part is actively produced and supplied to customers.
   • In some cases, the customer may specify a longer retention period for PPAP records. In such instances, the organization should comply with the customer requirements.
3. Storage and Accessibility:
   • PPAP records shall be stored in a secure and controlled environment to ensure their integrity, confidentiality, and protection against damage or unauthorized access.
   • The records should be organized, labeled, and indexed for easy retrieval when needed.
   • Access to PPAP records shall be provided to authorized personnel, auditors, and regulatory authorities as required.
4. Disposal:
   • At the end of the required retention period, PPAP records may be disposed of in a manner that ensures confidentiality and prevents unauthorized retrieval.
   • Disposal methods may include shredding, secure electronic erasure, or other approved means.
   • Disposal shall be documented to provide evidence of proper record destruction.
5. Review and Revision:
   • The organization should periodically review and update its record retention policy, including the retention period for PPAP records, to ensure ongoing suitability, effectiveness, and compliance with applicable requirements.
   • Any revisions to the policy should be communicated to relevant personnel and stakeholders.

It’s important to note that the specific retention periods for PPAP records may vary depending on customer requirements, contractual agreements, and any applicable legal or regulatory obligations. Therefore, it is essential to consult with your organization’s legal counsel, customer requirements, and any other relevant stakeholders to determine the exact record retention period for PPAP documentation in your specific context.

According to 7.5.1.1, “Quality management system documentation,” IATF states that the organization’s quality management system must not only be documented but also include a quality manual. The format and structure can be defined by the organization and depends on the organizations size, culture and complexity. An organization’s quality management system will include a quality manual. Within the quality manual, a document such as a table, a list, or a matrix, will be available which indicates where within the organization’s quality management system their customer-specific requirements are addressed. Like IATF 16949 and ISO 9001 requirements, customer specific requirements are mandatory for an organization.Within their processes and/or other documentation, organizations must describe how they will implement the requirements. Documented information is required to include documents and records that are required by the standard and are essential for effective operations of your organizations. Documented information is key to your QMS because it is used as evidence of conformance, allows your organization to be consistent, and prevents loss of knowledge and information. The more complex your process is, the more important it is that it is greatly detailed.

Clause 7.5.1.1 Quality management system documentation

In addition to the requirement given in ISO 9001:2015 Clause 7.5 Documented information, Section 7.5.1.1 mandates that the organization’s quality management system be documented, with inclusion of a Quality manual, available either in hard copy or electronically. The format and structure of this manual are determined by the organization and depend on factors such as its size, culture, and complexity. It may be a single document or a series of documents. If multiple documents are used, a list of these documents must be maintained. The quality manual must outline the scope of the quality management system, including any exclusions, with justification provided. It should also document established processes for the quality management system or refer to them. Additionally, it should detail the organization’s processes, their sequence, interactions (inputs and outputs), and the level of control over any outsourced processes. The manual should include a matrix indicating where customer-specific requirements are addressed within the organization’s quality management system. Similarly, a matrix may be used to show how the requirements of the Automotive QMS standard are addressed by the organization’s processes, aiding in the linkage between these processes and the Automotive QMS.

Please click here for ISO 9001:2015 Clause 7.5 Documented information

The standard requires suppliers to establish and document a quality system as a means of ensuring that product conforms to specified requirements.To establish means to set up on a permanent basis, and the requirement therefore emphasizes that the quality system should form part of the infrastructure of the organization. One of the first decisions to take should be to define the purpose of the quality system, what you want it to do, why you want to create it. Your reasons for creating a documented quality system may be to:

• Ensure products and services satisfy customer requirements
• Maintain the standards which you have been successful in achieving
• Improve standards in those areas where performance is lacking
• Harmonize policies and practices across all departments
• Improve efficiency
• Create stability and minimize variance
• Eliminate complexity and reduce processing time
• Benchmark current performance
• Focus attention on quality
• Ensure products and services are delivered on time
• Reduce operating costs

These are only some of the reasons for creating a quality system. Whatever your reasons are, define and document them and review them frequently. When you evaluate the system these reasons will help determine whether your system is effective.

The standard outlines several types of documents and records that should be included. Here are the key documentation requirements for IATF 16949:

1. Quality Manual: As mentioned earlier, the quality manual is a documented statement of the organization’s QMS policies and procedures. It provides an overview of the QMS and its scope.
2. Procedures: IATF 16949 requires organizations to establish documented procedures to support the effective operation of their QMS. These procedures should cover various processes, such as control of documents, control of records, internal auditing, corrective actions, preventive actions, management review, etc. The procedures should be documented in a clear and understandable manner.
3. Work Instructions: Organizations may need to develop work instructions that provide detailed instructions on how to carry out specific tasks or activities within the QMS. Work instructions are typically used for processes that require a high level of consistency and precision.
4. Process Descriptions: The standard requires organizations to document the key processes within their QMS. These process descriptions should include information such as process inputs, outputs, activities, resources, responsibilities, controls, and measures. Process descriptions help ensure a common understanding of how processes are carried out and how they interact.
5. Forms and Templates: Organizations should establish and maintain appropriate forms and templates to support the collection and recording of data within the QMS. These forms may include customer complaint forms, non-conformity reports, audit checklists, training records, etc.
6. Quality Policy and Objectives: The organization’s quality policy and quality objectives should be documented and communicated within the organization. The quality policy should be a clear statement of the organization’s commitment to quality, and the objectives should be measurable and consistent with the policy.
7. Records: IATF 16949 requires organizations to maintain records to provide evidence of conformity to requirements and the effective operation of the QMS. Records may include audit reports, corrective action reports, management review records, product inspection and test records, training records, customer satisfaction records, etc. These records should be controlled and retained for a defined period.

It’s important to note that while IATF 16949 provides general guidelines for the required documentation, the specific documentation needs may vary depending on the organization’s size, complexity, and industry requirements. Organizations should carefully review the standard and consult with their certification body or quality experts to ensure they meet the necessary documentation requirements.

Mandatory documents and records required by IATF 16949:2016

4.3- Determining the scope of the QMS
4.4.1.2- Product Safety
5.2- Policy
5.3.1 Organizations roles, authorities and responsibilities
6.1.2.1 Analyzing Risk
6.1.2.2 Preventive action
6.1.2.3 Contingency plans
6.2 Quality objectives and plans to achieve them
7.1.5.1.1 Measurement system analysis
7.1.5.2.1 Maintenance and calibration of records
7.2.1 Document competence of workers
7.2.2 Document competence of on the ground training
7.2.3 Document Competence of internal auditors
7.2.4 Document Competence of second party auditor
7.3.1 Document awareness of employees
7.3.2 Document employee empowerment and motivation
7.5.1.1 Document quality management system
7.5.3.2.1 Must control and document record retention
7.5.3.2.2 Document engineering specifications
8.2 Document products and services in regard to customer communication
8.2.3.2 Document product and service changes
8.3.1.1 Document the procedure for design and development or products
8.3.2 Document output reviews on design and development
8.3.2.3 Document information on software development
8.3.3.1 Document product design input
8.3.3.2 Document manufacturing process design input
8.3.3.3 Document process to identify special characteristics
8.3.4 Document design and development
8.3.4.4. Documented the product approval process
8.3.5 Document design and development outputs
8.3.5.2 Document the manufacturing process for design output
8.3.6 Document changes for design
8.3.6.1- Supplemental documentation for design and development changes
8.4.1.2 Document supplier selection process
8.4.2.2 Document requirements for externally provided processes, products and services that are considered statutory and regulatory
8.4.2.4 document process and criteria for supplier evaluation
8.4.2.4.1 Document records of second-party audit reports
8.5.1. Characteristics of product to be produced and service to be provided
8.5.1.5 Document the total productive maintenance system
8.5.2.1 Document identification and traceability
8.5.3 Keep documentation of all property belonging to external providers or customers
8.5.6 Document the process of control of changes
8.5.6.1 Document control of changes- supplemental
8.5.6.1.1 Document temporary change of process control
8.6 Document releases of products and services
8.7.1.1 Document expiration date or quantity authorized under concession
8.7.1.4 Document control of reworked product
8.7.1.5 Document the control of repaired products
8.7.1.6 Document customer notification about the nonconformity
8.7.1.7 Document the process for disposition of nonconforming
8.7.2 Document nonconforming outputs
9.1.1 Document monitoring and measurement results
9.2 Document internal audit
9.2.2.1 Document internal audit programs
9.3 Document results of management reviews
9.3.3.1 Document an action plan when customer performance targets are not met
10.1 Document results of corrective actions
10.2.3 Document a process for problem solving
10.2.4 Document a process for error-proofing
10.3.1 Document a process and plan for continual improvements

Quality Manual

The standard requires the supplier to prepare a quality manual covering the requirements of the standard and also requires the quality manual to include or make reference to the quality system procedures and outline the structure of the documentation used in the system. For a quality manual to be a “manual” it should contain the procedures and instructions, so whether one volume of the manual contains or refers to other documents does not prevent the collection of documents being referred to as the quality manual. Manuals tend to include operating instructions, hence the word manual. The quality manual should therefore contain all the policies and practices but not necessarily in one volume.

The quality manual will typically include following sections:

The scope of the QMS: This is in place to define the boundaries of your QMS, and the scope will be stated in your new IATF 16949 certificate. Basically, the scope explains in short what your company does, for example: “wire and harness production” or “seat belt production.” Besides the type of business you are in, you need to define locations and processes that are included in the scope, as well as the exclusions and justifications for those exclusions. Remember that in IATF 16949, the only permitted exclusion is from clause 8.3 product design and development.

The documented procedures established for the QMS (or references): IATF has requirements for documented procedures, and it is safe to assume that the company will create some additional ones that are not required by the standard, but are necessary for an effective QMS. Simply put, if you need to have a written procedure to make sure that mistakes are not made, you need to have a written procedure. If these procedures are simply in flowchart form they could be incorporated into a short Quality Manual, but more than likely they will include some additional information, and most companies will have some additional procedures as well, so references in the Quality Manual are the simplest thing to do. This also gives you a quick place to look when trying to find a procedure.

A description of the interactions between processes: This is most simply done with a flowchart that identifies all the processes in the organization, with arrows showing how they connect. While an in-depth flowchart may help you to better understand the interactions between processes in your organization, a simple top-level flowchart is all that is needed for most people to understand the basics. This is what is needed in the Quality Manual. IATF 16949 requires the Quality Manual to include a document (i.e., matrix) indicating where within the organization’s QMS the customer-specific requirements are addressed.

Customer-specific requirements: Depending on the approach you take to develop the manual, you will have different options to meet this requirement. The standard itself mentions the matrix as one way of documenting this requirement, so you can just develop a separate document where you will connect the customer-specific requirements with elements of your QMS that are related to those requirements. If you decide to incorporate the correlations of the customer-specific requirements and your QMS into the manual, you can do it the same way as the manual refers to the requirements of the standard.

Here are some key elements typically found in the Quality Manual for IATF 16949 compliance:

1. Quality policy: A statement of the organization’s commitment to quality and customer satisfaction, aligned with the requirements of the standard.
2. Scope of the QMS: A description of the boundaries and applicability of the QMS, including any exclusions.
3. Organizational structure: An overview of the organization’s structure, including responsibilities, authorities, and relationships of personnel who manage, perform, or verify work affecting quality.
4. Process descriptions: Detailed descriptions of the processes within the QMS, including inputs, outputs, activities, and interactions. These may cover areas such as design and development, purchasing, production, control of nonconforming products, corrective actions, etc.
5. Quality objectives: The organization’s measurable objectives related to product and process quality, along with targets and plans for achieving them.
6. Documented procedures: A list or reference to the documented procedures required by the standard or the organization’s QMS. These may include procedures for control of documents, control of records, internal audits, management review, etc.
7. Monitoring and measurement: A description of the methods used for monitoring, measuring, analyzing, and improving processes, products, and the QMS as a whole.
8. Risk management: A section on risk assessment and mitigation activities, including preventive actions and contingency plans to address potential risks and opportunities.
9. Customer-specific requirements: Identification and incorporation of any specific customer requirements that go beyond the standard’s provisions.
10. Control of external providers: Processes and criteria for the selection, evaluation, and monitoring of suppliers and subcontractors.
11. Control of nonconforming products: Procedures for identifying, documenting, evaluating, and controlling nonconforming products or services.
12. Management review: A description of the management review process, including the frequency, attendees, inputs, and outputs of the reviews.

The manual is a document that connects all parts of your Quality Management System, and by reading the manual, one can learn a lot about the company’s QMS – not only whether the requirements of the standard are met, but also how they are met. It is very common for many companies to ask for a Quality Manual when they are first assessing a potential supplier, and this is why making your manual an easy-to-read, informative brochure can be helpful. If the person assessing your manual can easily see that you have everything in place for a successful QMS, then they are more likely to look further into your capabilities and capacity to fulfill their business needs. So, when creating your manual, think to yourself, “What do I want customers to see?” Is it a lot of words that will take some time to wade through; or would it be better to give them everything in one easy document so that they can move on to placing an order?

Employee motivation is the way of bringing empowerment in the organisation. This has it’s ways of knowing the people’s behaviour and the productivity towards their work. In terms of the organisational work, Motivation is described as an individual to work. Highly motivated employees are more productive than the normal employees. However motivation and empowerment are some or the other way related to each other. In an organisation it is important to keep employees motivated to get the good job done from them. Motivated employees always look forward to do their work in better ways and also in different ways. There are different ways of motivating employees in every organisation. As per the organisation, the way of motivation differs and also it differs from person to person. Now-a-days people feel that the motivation is a difficult task due the changing workforce environment. Every employee joins the organisation with their different needs and wants. They have their own values, beliefs and the way of behaving, attitude, lifestyle, perception etc. Employee motivation is the level of energy, commitment and creativity that an employee bring in their job. Motivation is vital for any organisation because the employees are the assets of the organisation. It also helps in the growth of the employees along with the organisation. Employees should be motivated by giving the monetary and non monetary benefits and also by rewards and recognition, along with good appraisals, incentives etc. Incentives can be monetary or non monetary. Empowerment basically means to give power or authority to a person. In terms of organisation or work, employee empowerment differs from organisation to organisation as it depends on the work culture and environment. Hence, “Motivation is a key to performance improvement of the employees and which leads to empowerment”.

Clause 7.3.2 Employee motivation and empowerment

The organization needs to have a documented process in place to encourage employees to meet quality objectives, drive ongoing improvements, and foster an environment that encourages innovation. This process should involve promoting awareness of quality and technology across the entire organization.

The personnel must be motivated to achieve the organizations quality objective. The process to motivate employees and promote quality awareness and innovation may include the use of – cross-functional teams; employee surveys; employee recognition awards; improvement suggestions; poster campaigns; quality circles; workshops; etc.

Employee motivation process
The standard requires a process for the motivation of employees to achieve quality objectives and make continuous improvements to be established. Everything achieved in or by an organization ultimately depends upon the activities of its workforce. It is therefore imperative that the organization is staffed by people who are motivated to achieve its goals. Everyone is motivated but not all are motivated to achieve their organization’s goals. Many may be more interested in achieving their personal goals. Motivation is key to performance. The performance of a task is almost always a function of three factors: environment, ability, and motivation. To maximize performance of a task, personnel have not only to have the necessary ability to perform it but need to be in the right surroundings and have the motivation to perform it. Motivation comes from within. Employees therefore cannot be altered at will by a manager, despite what they may well believe to be the case. So what is motivation? It has been defined as an inner mental state that prompts a direction, intensity, and persistence in behavior. It is therefore a driving force within an individual that prompts him/her to achieve some goal. There is a motivation process — not an organizational process but a process Operating inside the individual.

From this diagram it will be Observed that motivation comes from satisfying personal needs and expectations of work. Therefore the motivation to achieve quality objectives must be triggered by the expectation that achievement of objectives will lead to a reward that satisfies a need of some sort. This does not mean that you can motivate personnel solely by extrinsic rewards such as financial incentives. It requires a good understanding of an individual’s pattern of needs. People desire psychological rewards from the work experience or like to feel a part of an organization or team. People can be motivated by having their efforts recognized and appreciated or included in discussions. However, this will only occur if the conditions they experience allow them to feel this way. If a person knows which quality objectives need to be achieved and has the ability to achieve them, and the environment in which the work is to be performed provides the right conditions, the role of the manager in enabling the person to be motivated is that of removing barriers to work motivation. There are two types of barriers that cause the motivation process to break down. The first barrier is job—related; i.e. there is something about the job that prevents the person from being motivated. An example is boring and monotonous work in mass production assembly lines. The second barrier is goal related; that is, attainment Of the goals is thwarted in some way, which results in frustration and a decline in the motivation to continue. Common barriers are:

• Fear of failure, of reprisals, of rejection, of losing, of conflict, of humiliation, of exploitation
• Distrust of management, favoritism, discrimination
• Work is not challenging or interesting
• Little recognition, respect, reward o No authority and responsibility

Empowerment is said to motivate employees as it offers a way of obtaining higher level of performance without the use of strict supervision. However, it is more theory and rhetoric than a reality. To empower employees, managers not only have to delegate authority but put at their disposal resources to use as they see fit and trust their employees to use the resources wisely. If you are going to empower your employees, remember that you must be willing to cede some of your authority but also, as you remain responsible for their performance, you must ensure your employees are able to handle their new authority. Employees not only have to be trained to perform tasks but need a certain degree of experience in order to make the right judgement. Some employees may acknowledge that they are willing to accept responsibility for certain decisions but beware, they may not be ready to be held accountable for the results when they go sour. It is also important that any changes arising from the empowering of employees to improve the process be undertaken under controlled conditions. However, empowerment does not mean that you should give these individuals the right to change policies or practices that affect others without due process. Managers therefore need to understand and analyze human behavior rather than establish a process for motivating employees.

Quality and Technology awareness

The standard requires the employee motivation process to include promotion of quality and Technology awareness on all levels. As indicated above, the motivation process is not an organizational process; the intention is that personnel be made aware of quality and all aspects of its management. It would be better to call the process the communication process since that is all it can achieve. You can take a horse to water but you can’t make it drink, so the saying goes.
It is the same with people! Making them aware of the quality and Technology and how important
they are to the business and consequently to themselves may not motivate certain individuals. The intention is to build an understanding of the collective advantages of adopting a certain style of behavior. It is therefore more important to modify behavior than promote awareness.

Measuring employee satisfaction and understanding

Many companies carry out employee surveys in an attempt to establish their needs and expectations and whether they are being satisfied. It is a fact that unsatisfied employees may not perform at the optimum level and hence product quality may deteriorate. Like customer satisfaction surveys, employee satisfaction surveys are prone to bias. If the survey hits the employee’s desk following a reprimand from a manager, the result is likely to be negatively biased. The results of employee satisfaction surveys are also often disbelieved by management. Management believe their decisions are always in their employees’ best interests, whereas the employees may not believe what management says when management’s track record has not been all that great. Employee satisfaction has less to do with product quality and more to do with relationships. However employee relationships can begin to adversely affect product quality if no action is taken. By all means install a process for measuring employee satisfaction but design the survey with great care and treat the results with caution as they cannot be calibrated. A common method for measuring satisfaction is to ask questions that require respondents to check the appropriate box on a scale from “strongly agree” to “strongly disagree”. Measuring employee understanding of appropriate quality objectives is again a subjective process. Through the data analysis you will have produced metrics that indicate whether your quality objectives are being achieved. If they are being achieved you could either assume your employees understand the quality objectives or you could conclude that it doesn’t matter. However, it does matter as the standard requires a measurement. Results alone are insufficient evidence. The results may have been achieved by pure chance and in six months’ time your performance may have declined significantly.The only way to test understanding is to check the decisions people make. This can be done with a questionnaire but is more effective if one checks decisions made in the workplace. Is their judgement in line with your objectives or do you have to repeatedly adjust their behavior? For each quality objective you should have a plan that defines the processes involved in its achievement. Assess these processes and determine where critical decisions are made and who is assigned to make them. Audit the decisions and ascertain whether they were contrary to the objectives. A simple example is where you have an objective of decreasing dependence upon inspection. By examining corrective actions taken to prevent recurrence of non conformities you can detect whether a person decided to increase the level of inspection in order to catch the non conformities or considered alternatives. Any person found making such a decision has clearly not understood the quality objective.

Clause 7.3.1 of the IATF (International Automotive Task Force) refers to the “Awareness” requirement in the IATF 16949 standard, which is specific to the automotive industry and focuses on quality management systems for automotive production. This clause emphasizes the need for organizations to ensure that employees are aware of their contribution to product or service conformity, as well as their impact on quality.Here’s a breakdown of the key elements of clause 7.3.1 “Awareness” in the IATF:

1. General Awareness: The organization should establish a process to ensure that all employees are aware of their individual roles and responsibilities in achieving quality objectives. This includes understanding the importance of meeting customer requirements, adhering to the quality management system, and contributing to the overall product or service conformity.
2. Quality Policy and Objectives: Employees should be familiar with the organization’s quality policy and objectives. They should understand how their work aligns with these objectives and how their actions can impact the quality of products or services delivered to customers.
3. Training and Competence: The organization should provide appropriate training and development opportunities to enhance employees’ skills, knowledge, and awareness of quality management principles. Training should be aligned with employees’ roles and responsibilities and should cover relevant quality standards and requirements.
4. Communication: Effective communication channels should be established to disseminate information related to product or service conformity, quality objectives, and customer requirements. This ensures that employees receive timely and accurate information that enables them to make informed decisions and contribute to quality improvement efforts.
5. Employee Engagement: The organization should promote employee engagement and involvement in quality-related activities. This includes encouraging suggestions for process improvements, providing opportunities for participation in quality initiatives, and recognizing and rewarding employees’ contributions to quality excellence.
6. Management Review: Top management should review the effectiveness of the awareness process to ensure that it is adequately implemented and maintained. Management should also provide resources and support to foster employee awareness and engagement in quality management activities.

Compliance with clause 7.3.1 of the IATF standard helps organizations create a culture of quality awareness and continuous improvement. By ensuring that employees understand their roles, responsibilities, and impact on product or service conformity, organizations can enhance product quality, customer satisfaction, and overall business performance in the automotive industry.

In addition to the requirement given in ISO 9001:2015 Clause 7.3 Awareness. In clause 7.3.1 Awareness — supplemental The organization keeps records showing that all employees understand how their actions affect product quality and the significance of their roles in achieving, maintaining, and enhancing quality. This includes understanding customer requirements and the risks associated with non-conforming products for customers.

Please click here for ISO 9001:2015 Clause 7.3 Awareness.

Understanding and acknowledging their impact on product quality is essential for employees in any organization. When employees are aware of how their work directly or indirectly affects the quality of the products or services they deliver, it can lead to several positive outcomes:

1. Accountability: Employees who understand their impact on product quality tend to take greater responsibility for their tasks. They become more invested in delivering high-quality work and are less likely to engage in practices that compromise quality.
2. Motivation: Recognizing the connection between their efforts and the final product quality can motivate employees to strive for excellence. They are more likely to take pride in their work, seek opportunities for improvement, and go the extra mile to deliver superior outcomes.
3. Continuous Improvement: Awareness of their impact on product quality encourages employees to seek ways to enhance their skills and knowledge. They may actively participate in training programs, seek feedback, and collaborate with colleagues to find innovative solutions. This focus on continuous improvement can lead to higher-quality products over time.
4. Collaboration: When employees understand their role in product quality, they are more likely to collaborate effectively with colleagues. They recognize that their work is interconnected with others, and by working together, they can collectively achieve better results. Collaboration facilitates knowledge sharing, problem-solving, and a shared commitment to delivering high-quality products.
5. Customer Satisfaction: Employees who grasp the impact of their work on product quality are more likely to align their efforts with customer expectations. They understand that meeting or exceeding customer requirements leads to higher satisfaction and positive brand reputation. This customer-centric mindset can drive employees to deliver products that consistently meet or surpass quality standards.

To foster this awareness among employees, organizations can implement transparent communication channels, provide regular feedback and performance evaluations, offer training opportunities, and establish a culture that values quality and continuous improvement. By doing so, employees become more conscious of their impact on product quality and contribute to the overall success of the organization.

Risks involved for the customer with non-conforming product.

Providing customers with non-conforming products can have several risks and negative consequences for a business. Some of the key risks include:

1. Dissatisfied Customers: Non-conforming products do not meet customer expectations or specifications. This can result in customer dissatisfaction, leading to complaints, negative reviews, and a damaged reputation. Dissatisfied customers may also choose to switch to competitors, resulting in lost business opportunities.
2. Loss of Trust and Reputation: Consistently delivering non-conforming products erodes customer trust and damages the reputation of the business. Negative word-of-mouth spreads quickly, making it challenging to attract new customers and retain existing ones. Rebuilding trust and reputation can be a time-consuming and costly process.
3. Legal and Compliance Issues: Non-conforming products may violate regulatory standards, industry regulations, or legal requirements. This can expose the business to legal liabilities, fines, lawsuits, and potential recalls. Violations can also lead to reputational damage, impacting relationships with stakeholders such as suppliers, partners, and investors.
4. Increased Costs: Providing non-conforming products often results in increased costs for the business. This includes costs associated with rework, repairs, or replacements, as well as potential warranty claims or refunds to customers. The business may also incur additional expenses for investigations, corrective actions, and implementing quality control measures to prevent future non-conformities.
5. Internal Disruptions: Non-conforming products can disrupt internal operations and strain resources. Employees may need to allocate extra time and effort to rectify the issues, leading to productivity losses and decreased efficiency. This can impact overall business performance and profitability.
6. Damaged Supplier Relationships: If non-conforming products are a result of faulty inputs or components from suppliers, it can strain relationships with those suppliers. This can lead to disruptions in the supply chain, delays in product delivery, and difficulties in sourcing quality materials in the future.

To mitigate these risks, businesses should prioritize quality control, establish robust inspection processes, implement effective corrective actions, and invest in continuous improvement efforts. It is crucial to ensure that products meet or exceed customer expectations, adhere to relevant standards and regulations, and maintain a strong focus on customer satisfaction. Additionally, fostering open communication channels with customers and promptly addressing any quality issues can help mitigate risks and maintain a positive brand image.

To ensure that employees are aware of the impact on product quality and the importance of their activities in achieving, maintaining, and improving quality, as well as the risks involved for the customer with non-conforming products, you can follow these steps:

1. Communication and Training:
   • Clearly communicate the organization’s quality policy, objectives, and customer requirements to all employees.
   • Conduct regular training sessions to educate employees about quality standards, processes, and their individual roles and responsibilities in maintaining product quality.
   • Provide training on identifying and mitigating risks associated with non-conforming products, emphasizing the potential consequences for customers and the organization.
2. Visual Aids and Documentation:
   • Use visual aids, such as posters or displays, to highlight the importance of product quality and the impact of employees’ activities on achieving it.
   • Develop easy-to-understand documentation, including work instructions, process maps, and standard operating procedures, that clearly outline quality requirements and the risks associated with non-conformities.
3. Employee Engagement:
   • Foster a culture of quality by encouraging employee involvement and active participation in quality improvement initiatives.
   • Establish channels for employees to provide feedback, suggestions, and ideas for enhancing product quality and reducing non-conformities.
   • Recognize and reward employees who consistently demonstrate a commitment to maintaining and improving product quality.
4. Performance Feedback:
   • Regularly provide feedback to employees on their performance, specifically highlighting their impact on product quality.
   • Conduct performance evaluations that assess employees’ understanding of quality requirements and their adherence to processes that ensure product conformity.
   • Address any gaps or areas for improvement through coaching, mentoring, or additional training.
5. Continuous Improvement:
   • Encourage employees to identify and report quality issues or potential risks associated with non-conforming products.
   • Establish a system for employees to submit suggestions for process improvements and empower them to implement changes when appropriate.
   • Conduct regular reviews and audits to identify areas where employee awareness and understanding of quality impact can be further enhanced.
6. Cross-Functional Collaboration:
   • Encourage collaboration among different departments or teams to foster a holistic understanding of how each employee’s activities contribute to product quality.
   • Conduct cross-functional training sessions or knowledge-sharing activities to promote a broader awareness of quality requirements and customer risks.
7. Management Support:
   • Ensure that top management actively supports and reinforces the importance of employees’ impact on product quality and the risks associated with non-conforming products.
   • Provide necessary resources, such as time, training, and tools, to support employee awareness and engagement in quality-related activities.
   • Include quality performance and awareness as key considerations in management reviews and decision-making processes.

By following these steps, organizations can foster a culture of quality awareness and empower employees to understand the impact of their activities on product quality, customer requirements, and the risks associated with non-conforming products. This collective understanding and engagement can contribute to the organization’s ability to deliver high-quality products, meet customer expectations, and minimize risks for the customer.

Second-party auditors play a vital role in assessing and ensuring the quality and compliance of suppliers within a supply chain. To be effective, second-party auditors should possess certain competencies. Here are some key competencies for second-party auditors:

1. Technical Knowledge: Second-party auditors should have a strong understanding of the specific industry or sector they are auditing. This includes knowledge of relevant quality standards, regulations, industry practices, and supplier requirements. They should be able to interpret and apply these standards effectively during the audit process.
2. Audit Methodologies: Competent second-party auditors are familiar with various auditing methodologies, techniques, and tools. They should be able to plan and execute audits, gather objective evidence, analyze findings, and make accurate assessments of supplier performance.
3. Communication Skills: Effective communication is essential for second-party auditors. They should be able to clearly and accurately convey audit objectives, requirements, and findings to both suppliers and internal stakeholders. They should also be skilled in active listening, asking probing questions, and facilitating constructive dialogue during the audit process.
4. Analytical and Problem-Solving Skills: Second-party auditors must possess strong analytical skills to evaluate complex supplier systems, processes, and data. They should be able to identify non-conformities, root causes, and areas for improvement. Additionally, they should be adept at problem-solving and recommending appropriate corrective actions.
5. Ethical Conduct: Second-party auditors need to uphold the highest standards of integrity and professionalism. They should demonstrate ethical behavior, maintain confidentiality, avoid conflicts of interest, and act impartially during audits. Ethical conduct helps ensure fairness, credibility, and trust in the auditing process.
6. Interpersonal Skills: Second-party auditors frequently interact with suppliers and internal stakeholders. Therefore, they should have strong interpersonal skills, including the ability to build rapport, negotiate effectively, and manage conflicts professionally. Collaboration and relationship-building are important for establishing trust and cooperation with suppliers.
7. Report Writing and Documentation: Accurate and comprehensive reporting is critical for second-party auditors. They should possess excellent writing skills to document audit findings, observations, and recommendations in a clear, concise, and objective manner. Well-written reports enable suppliers to understand the audit outcomes and take appropriate actions for improvement.
8. Continuous Learning: Competent second-party auditors embrace a mindset of continuous learning and professional development. They stay updated on industry trends, changes in regulations, and emerging best practices. They actively seek opportunities to enhance their knowledge, skills, and competencies through training, certifications, and networking.

It’s important to note that the specific competencies required for second-party auditors may vary depending on the industry, sector, and specific audit requirements. Organizations should define the desired competencies and establish training programs or qualification criteria to ensure the competency development and ongoing improvement of their second-party audit team.

Clause 7.2.4 Second-party auditor competency

The organization needs to prove that the auditors conducting second-party audits are capable. In addition to meeting customer-specific requirements for auditor qualification, second-party auditors should be skilled in the automotive process approach to auditing, which includes risk-based thinking. They must understand the relevant customer and organizational requirements, as well as the applicable ISO 9001 and IATF 16949 requirements within the audit’s scope. Additionally, they should be proficient in the relevant manufacturing processes to be audited, including PFMEA, control plan, and the relevant core tool requirements within the audit’s scope. They should know how to plan, conduct, prepare audit reports, and close out audit findings.

The organization shall demonstrate the competence of the auditors undertaking the second-party audits. Competency requirements are a match to internal auditors.This clause refers to second-party auditors and its purpose is to ensure they are competent and meet CSRs for auditor qualification and demonstrate the minimum core competencies and understanding of:

• the automotive process approach to auditing, including risk-based thinking
• applicable CSR and company requirements
• the ISO 9001 and IATF 16949® requirements
• manufacturing processes audited, including PFMEA and control plan
• core tool requirements 
• how to plan, conduct, prepare audit reports and closeout audit findings

Training a supplier quality audit team requires a structured approach to ensure that team members acquire the necessary skills and knowledge. Here is a step-by-step guide to training your supplier quality audit team:

1. Identify Training Needs: Conduct a thorough assessment of your team’s current knowledge and skills. Determine the areas where improvement is needed, such as auditing techniques, quality standards, regulations, communication skills, and industry-specific requirements.
2. Develop a Training Plan: Based on the identified training needs, create a comprehensive training plan. Consider the following elements:
   • Training objectives: Clearly define the goals and outcomes you want to achieve through the training program.
   • Training methods: Select appropriate training methods such as classroom training, workshops, online courses, simulations, role-playing exercises, and practical hands-on experience.
   • Training materials: Prepare or gather relevant training materials, including industry standards, auditing guidelines, case studies, and sample audit reports.
   • Training schedule: Determine the duration and frequency of training sessions, allowing sufficient time for practice and reinforcement.
   • Resource allocation: Identify trainers or subject matter experts who can deliver the training effectively.
3. Conduct Training Sessions:
   • Classroom training: Organize interactive training sessions where trainers can present concepts, methodologies, and techniques. Encourage active participation and address questions or concerns.
   • Practical exercises: Provide opportunities for trainees to practice audit scenarios and conduct mock audits. This hands-on experience helps them apply their knowledge and develop practical skills.
   • Role-playing: Use role-playing exercises to simulate real-world audit situations, allowing trainees to practice communication, negotiation, and conflict resolution skills.
   • Case studies: Analyze and discuss real-life examples of supplier quality audit findings, non-conformities, and corrective actions. This helps trainees understand the complexities of supplier audits and learn from past experiences.
   • Online courses or e-learning: Supplement the training with online courses or e-learning modules that cover specific topics or standards. This can provide flexibility and self-paced learning opportunities for team members.
4. Reinforce Learning:
   • Follow-up sessions: Conduct regular follow-up sessions to reinforce key concepts, address any challenges, and provide additional guidance.
   • Continuous improvement: Encourage ongoing learning and development within the team. Provide access to relevant resources, articles, webinars, and industry updates.
   • Feedback and evaluation: Gather feedback from trainees to assess the effectiveness of the training program. Use this feedback to make improvements and tailor future training sessions accordingly.
5. Certification and Recognition:
   • Establish criteria for certification or recognition of team members who demonstrate proficiency in supplier quality audits.
   • Recognize and reward achievements to motivate and encourage continuous improvement.
6. Stay Updated:
   • Supplier quality audit requirements, industry standards, and regulations may evolve over time. Ensure your team stays updated by attending conferences, seminars, and training sessions conducted by industry experts or professional organizations.

Remember, training is an ongoing process, and it’s crucial to regularly assess the effectiveness of your training program and make necessary adjustments to meet the evolving needs of your supplier quality audit team.

he internal audit is one of the key functions for maintaining excellence within a QMS (Quality Management System), If you have a QMS that is IATF 16949 certified, then you will understand the importance of the internal audit function in both getting the QMS ready for audit, and maintaining the standards of performance after the audit itself. As one of the key functions within the QMS, the internal audit can identify gaps in performance or processes. It can also identify non-compliance with legislation and the standard itself. Given this, the effectiveness of the internal audit often depends on the expertise, knowledge, and eye for detail of the person appointed to conduct the audit. Besides a documented process for verifying the competency of internal auditors and referring to ISO 19011, internal auditors, as well as process and product auditors, should be able to demonstrate competence in Understanding of the automotive process approach for auditing, including risk-based thinking, Understanding of customer-specific requirements, Understanding of applicable ISO 9001 and IATF 16949 requirements related to the scope of the audit, Understanding of the applicable core tools related to the scope of the audit, Understanding how to plan, perform, report and close out the audit findings.

Clause 7.2.3 Internal auditor competency

The organization must establish a documented process to ensure that internal auditors are competent, considering both organization-defined requirements and any specific requirements from customers. For further guidance on auditor competencies, ISO 19011 can be referenced. The organization must keep a record of qualified internal auditors. Internal auditors for quality management systems, manufacturing processes, and products need to understand the automotive process approach for auditing, including risk-based thinking. They should also comprehend applicable customer-specific requirements, ISO 9001, and IATF 16949 requirements related to the audit scope, as well as the relevant core tool requirements. Auditors must be skilled in planning, conducting, reporting, and closing out audit findings. Manufacturing process auditors should, at a minimum, demonstrate technical knowledge of the relevant manufacturing processes being audited, including process risk analysis such as PFMEA and control plan. Similarly, product auditors should, at a minimum, show competence in understanding product requirements and using relevant measuring and testing equipment to confirm product conformity. If the organization’s personnel provide the training to achieve competency, documented evidence must be kept to show the trainer’s competence with the aforementioned requirements. Internal auditor competence must be maintained and improved by conducting a minimum number of audits per year, as determined by the organization, and staying informed about relevant requirements based on internal changes such as process or product technology and external changes such as updates to ISO 9001, IATF 16949, core tools, and customer-specific requirements.

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In this clause, it is important to note that if the organization’s personnel provide the training to achieve internal auditor competency, records shall exist to show the instructor’s competency with the internal auditor requirements. In addition, a documented process will verify internal auditors are competent with regard to any of the organization’s and/or customer-specific requirements. (ISO 19011 is a good reference and provides detailed guidance for auditing management systems.) Automotive quality management system auditors shall also have the following minimum competencies and understanding of these key elements: the automotive process auditing approach and risk-based thinking, applicable ISO 9001 and IATF 16949® requirements, applicable customer-specific requirements (CSRs), core tool requirements, planning, conducting, reporting, and closing out audit findings. At a minimum, manufacturing process auditors need to have a technical understanding of the relevant manufacturing process(es) to be audited (including process risk analysis (such as PFMEA) and control plan), and product auditors must demonstrate competence in understanding product requirements, measurement, and conformity. Maintenance of and improvement of auditor competence are demonstrated through:

• executing a minimum number of audits per year, as defined by the company
• maintaining knowledge of relevant requirements
• internal changes: process technology, product technology
• external changes: ISO 9001, IATF 16949®, AIAG® Core Tools, and CSRs

Internal auditors play a crucial role in ensuring compliance with the requirements of the IATF 16949:2016 standard, which is specifically focused on quality management systems for automotive production and relevant service parts organizations. To effectively perform internal audits in this context, auditors should possess the following competencies:

1. Knowledge of IATF 16949:2016: Internal auditors must have a thorough understanding of the requirements and key concepts of the IATF 16949:2016 standard. This includes knowledge of the core quality management principles, the structure of the standard, and the specific automotive industry requirements.
2. Quality Management System (QMS) expertise: Auditors should have a solid understanding of quality management systems, including the ISO 9001 standard upon which IATF 16949 is based. They should be familiar with the various components of a QMS, such as document control, record keeping, internal audit processes, corrective actions, and continual improvement.
3. Automotive industry knowledge: It is important for internal auditors to be familiar with the automotive industry, its specific terminology, processes, and best practices. This knowledge helps auditors better understand the context in which the QMS operates and allows them to assess conformity effectively.
4. Audit planning and execution: Competent auditors should have the ability to plan and conduct effective audits. This includes developing an audit plan, defining audit objectives and scope, preparing checklists, and conducting interviews and document reviews to gather evidence. Auditors should also possess good communication and interpersonal skills to effectively engage with auditees.
5. Process approach and risk-based thinking: IATF 16949:2016 emphasizes the process approach and risk-based thinking in quality management. Auditors need to understand how these concepts apply to the organization being audited and evaluate the effectiveness of process controls and risk management practices.
6. Data analysis and problem-solving: Internal auditors should be capable of analyzing data and identifying trends or patterns that may indicate potential non-conformities or areas for improvement. They should also be skilled in problem-solving techniques to assist auditees in addressing any identified issues.
7. Ethical conduct and confidentiality: Auditors must uphold high ethical standards, maintaining objectivity, impartiality, and confidentiality throughout the audit process. They should avoid conflicts of interest and ensure that audit findings are reported accurately and without bias.
8. Continuous learning and development: As the IATF 16949 standard evolves and new industry practices emerge, auditors need to stay updated with the latest requirements and developments. This may involve attending training courses, participating in professional development activities, and engaging in networking opportunities within the field.

It is important to note that organizations may have specific competency requirements for their internal auditors beyond these general guidelines. Therefore, it is advisable to consult the specific organization’s policies, procedures, and any additional training or certification programs they may have in place for their auditors.

The qualification/training requirements may vary for the different types of audits required by this standard. You must define the minimum qualification/training requirements for internal auditors for each type of audit :

• Personnel performing QMS audits or manufacturing process audits must have adequate training on – the requirements of the IATF 16949 standard; training on the automotive process to auditing; audit practices and audit experience as defined by ISO 19011 and IATF guidance; QMS processes and their interaction; customer requirements and applicable regulatory requirements. Also review specific internal auditor training requirements at OEM customer or IATF websites.
• Personnel performing product audits must have training on – production and delivery processes; audit practices and techniques; product specific customer requirements and applicable regulatory requirements. Product specific auditors do not necessarily need training on the requirements of the IATF 16949 Standard.

Customers are likely to require internal auditors to at least have taken an Internal Auditor Training Course that meets the requirements of ISO 19011 but are unlikely to require Lead Auditor Registration. Process audits requires the auditor to have at least two years’ practical experience in process management in the automotive industry and to have performed at least three process audits with the support of a technical expert from the process area. For product audits several technical and human characteristics of the auditor are:

• Knowledge of the purpose of the product audit
• Product and quality specific knowledge
• Use of inspection, measuring, and test specifications
• Mastery of inspection, measuring, and test techniques
• Knowledge of handling of nonconformities
• Evaluating products
• Reporting skills
• Physical suitability (eye sight test etc.)
• Good intelligence
• Good intuition
• Personnel reliability
• Practical experience in manufacturing
• Knowledge of production processes and of their application
• Knowledge of and access to information about customer expectations

On-the-job training is a form of training provided at the workplace. During the course of this process a trainee is given a hands-on experience of tools, techniques, machinery, software, materials, or equipment. This training is provided by the co-worker, training manager, or professional trainers. The motive of on-the-job training is to train the workers on a certain skill set, which they will use in day-to-day tasks. On-the-job training (OJT) is a type of job instruction that takes place directly at the worksite. The learner, who may be inexperienced, performs job tasks or observes them being performed by a more experienced worker in the same work area. This provides an opportunity for the learner to use real machines, equipment, tools, processes, and procedures while developing the knowledge, skills, and competencies required to perform their job role. It is important to note that OJT is not the same as job training that takes place in a classroom, via a webinar, e Learning courses, or in an academic setting. However, OJT can be included as part of a well-constructed, well-structured job training program that includes other types of job training.

Clause 7.2.2 Competence — On the Job training

Any individual who assumes new or modified responsibilities that impact compliance with quality, internal, regulatory, or legislative requirements must receive on-the-job training, including training on customer requirements. Contract or agency personnel with comparable responsibilities should also undergo on-the-job training. The extent of detail in the on-the-job training should match the individual’s level of education and the complexity of the tasks they are expected to carry out in their daily duties. Individuals whose work could influence quality must be made aware of the repercussions of not meeting customer requirements.

You must determine the scope and duration for effective on the job training for product related work. This training must be provided to all full-time as well as contract and agency personnel performing such work. They must also be informed of what nonconformities may arise and the consequence to the (internal and external) customer. Appropriate records must be kept of such training as well as training effectiveness. On-the-job training applies to all employees, with all levels of skill, in all fields, regardless of education. A good OJT program gives new workers hands-on experience to learn how the workplace functions and how their role and responsibilities fit in. It’s an essential process employees must go through to be able to successfully perform their job duties. There are two common types of on-the-job training: structured and unstructured. Unstructured OJT programs lack specific goals, plans, and objectives, and they’re often inefficient and ineffective. Structured OJT programs, on the other hand, have defined goals and outcomes, a list of necessary information and skills, and specific roles for the mentee, mentor, and OJT supervisor. Structured programs tend to be more effective but require more time, effort, and expense to set up. Other types of on-the-job training include apprenticeships, coaching, mentoring, and job rotation. Changes require on-the-job training, whether it’s a change in employees, promotions, or how you do business. Some of the most common changes that need some sort of on-the-job training include:

• Change in technology.
• Change in business practice. 
• Change in company policies. 
• Lots of new employee hires. 
• Noticeable slow-down in productivity. 
• Business is growing.
• Current training was the bare minimum.

On the Job Training Methods

Coaching : In this method, the training is given by the senior employee or internal trainer to the new recruit. The trainee can solve their queries and do hands-on through the demonstration and instruction given by their seniors.
Mentoring : On-the-job training is given by manager or internal trainer, who are well known in their day-to-day tasks. The training is based on a one-to-one training method where the manager or the trainer is considered as a mentor who guides trainees in the situations of difficulty.
Structured Training : In this training method, the trainer designs the step by step training procedure for the trainee, that includes the job overview, instruction and demonstration for the skill needed in the job role. The trainee can ask doubts and clarify with their trainer and also the trainee can provide their feedback on how effective the program is from them.
Job Rotation : In this training method, the new recruits are shifted to other connected job roles, to make them well-versed in different job backgrounds. It helps them to learn new tools and technologies and can perform multiple tasks if needed. They can also make good networks with other people in the organization.
Understudy : In this method, the senior employee trains an assistant or subordinate to perform their tasks and duties in case the former vacates their position due to transfer, promotion, death, or retirement.

On-the-job training	Off-the-job training
Training given at job location by the supervisor or professional trainers having good working experience in their field	Training is given outside the real job location, this training is basically given by an outsourced vendor
Based on practical implementation with tools and technologies as per the company requirements	Mostly based on theoretical implementation based on simulations, tests, and videos.
Takes less time and is inexpensive, as company supervisors, internal trainers, or co-workers personally train new employees	More time taking and expensive as compared to on-the-job training, as companies need to hire external trainers

Benefits of OJT training
On-the-job training seems like it would mainly benefit employers. After all, well-trained and skilled employees mean increased productivity and growth. But there’s much more to it.

1. On-the-job training is planned to fit the business: Each business is unique and has specific requirements—training employees on-the-job may help get business needs met more quickly.
2. Happier, more loyal employees: When on-the-job training is continually updated and relevant, employees are likely to be more committed to growing their careers at your business. They are also likely to be happier and more excited about their work.
3. Builds a pool of “promotable” employees: By providing on-the-job training to employees, you are creating a highly-skilled workforce in your business, as well as creating a mindset of “always learning.” This pays off big when you need to promote managers in the future. You have a loyal and skilled pool of employees to choose from who already know your business.
4. On-the job-training attracts employees during hiring: If your company exists in a tight job market or in an industry where it is difficult to attract (and retain) good employees, on-the-job training can help. It’s an attractive benefit for employees who want to better themselves, and it indicates the possibility of promotion.

How to create an on-the-job training programs in 5 steps

Creating a training program is not difficult as long as you break it down into logical steps. The ADDIE method is particularly useful when starting a training program from scratch:

• Analysis: Assess what your employees need to know in order to successfully do their jobs.
• Design: Determine what your on-the-job training program will look like.
• Development: Establish methods, resources, and materials that will be in your training program.
• Implementation: Decide who, when, and how you will implement your training program.
• Evaluation: Get feedback so you can know if your training met everyone’s needs.

The ADDIE method is flexible, essentially asking that you consider what you need and want for your specific business, and then design and measure accordingly.

1. Assess your employees and the skills needed for the job

Analysis is a particularly important part of successfully creating a training program. You will be answering questions such as:

• What do your employees need to know?
• What do your employees already know?
• How do your employees learn best?
• What do you need from your employees?
• What do your employees expect?
• What kind of training meets all of these needs?
• Do you have qualified people to do the training?

Know what you want over the long term: First, what are your broad and strategic goals? Is it productivity? Profits? Loyal employees? Community reputation? Continued growth, both financially and as a team? Write down the long-term goals you want to see. Keep these in mind as you follow through with the rest of the assessment process.

Know what each specific job requires: Assessment includes determining the specific needs of specific employees and jobs.Start by listing the qualifications, knowledge, and hard and soft skills a specific job requires. You are trying to create a definition of what an ideal employee in that specific job is able to do.Next, list what skills most employees have when they arrive.Finally, consider times you’ve had to repeat yourself or ask employees to redo work. Recall the communication or hiccups that slow things down.It’s best practice to do this for each position or team in your company. Now you have a better picture that compares what an employee needs and what they generally have. That gap is where your training is going to fill in.

Identify necessary tools and systems: Look at the list you made where you identified gaps in employee performance. Was it solely based on a lack of the employee’s skills and education, or can blame be placed on the tools and systems they had to work with?Before you can create a training program, you need to be sure those tools and systems are in order. All the training in the world won’t improve employee productivity and output if what they have to work with is broken.

Common areas of breakdown are:

• Communication systems. Do you have a complex or vague communication system? Communication breakdown is fixed most often by simplifying the system, but also by enforcing adherence to it. It’s important to have a good communication app, like When I Work, to keep your team connected.
• Technology. Being trained to use new technology is exciting and can instill a sense of loyalty. Make sure to update your technology before investing in training for outdated tech.
• Job boundaries. If one employee expects a job description to be honored and others are busy doing everything, you’ll have lots of conflict. Are employee work boundaries (or the lack thereof) made clear?

Be sure you aren’t asking your employees to use broken tools and systems. Get things streamlined and up-to-date so that any training feels like forward motion instead of a waste of time.

2. Design the training program

Decide which formats and materials will fit best with your objectives and your workplace: classroom-style training, mentorship, and structured programs are all options.Structured on-the-job training programs are the most basic, task-oriented, and useful for employees who are performing repetitive tasks, such as an industrial job.Using a company-standardized checklist of necessary tasks, the trainer (usually a coworker who regularly performs these same tasks) works with the new employee. Once the new employee has demonstrated the necessary skill, they are signed off to begin.However, if the job at hand is more fluid than repetitive, you will need a trainer who is a skilled teacher. Not everyone learns the same way, and a good trainer has to determine how an employee learns in order to apply the training to them effectively. Some people learn by:

• Doing: Practice doing actual tasks or through simulations.
• Feeling: Participate in role playing, group activities, or talk about personal experiences that relate.
• Thinking: Prefer independent activities, reading, or taking tests.
• Observing: Attend lectures and seminars, solve specific problems, or discussions.

While you may not be able to tailor an entire training course to each learning style, this at least allows you to create a set of possible options.For example, you may allow a new employee to choose whether to take a written test, have a conversation, or do role playing to illustrate their new knowledge.

3. Develop your training with the right materials

Once you know how your training will look, you can find materials to flesh out your training objectives outline in a variety of places:

• Your company handbook
• Current employee knowledge base
• Industry and online resources
• Universities with related programs
• Department of Labor
• Government extension or outreach programs

Decide how often the training will occur: On-the-job training is rarely a one-time event, and periodic training throughout an employee’s career is common. For example, on-the-job training might include circumstances such as:

• Learning about company policies
• How to work the factory line
• How to respond to customers
• Using the new inventory system
• How to fill out business expenses and financial reports for reimbursement
• Updates on changes to communications systems
• How new laws affect employees and their jobs
• Refresher course on last year’s teamwork training

Clearly, training ought to be an ongoing matter since most employees, depending on their job, will need to stay informed as the business changes.

Use an outline: Design the on-the-job training program much as you would an outline, with each main section being the objective you want the employee to achieve before moving onto the next section.At the end of each section, determine how you will measure employee success. Do they need to demonstrate a skill to you? Pass a test? Role play scenarios dealing with an irate customer? Each objective should have a defined success goal that must be met before the employee moves on to the next step.

4. Implement with the right trainers

Implementing a training program isn’t easy. Before you dive in, be sure you know the best people to conduct the training, whether it be a manager, coworker, mentor, or a designated training coordinator.  You also may choose to outsource your training and use an in-house coordinator to work with the company handling the training. This can be helpful if you do not have the resources or knowledge to conduct successful training, or in cases of highly-specialized systems or equipment.

5. Evaluate with employee feedback

Determine how successful your on-the-job training program is with a simple approach:

Use a survey: Use a carefully planned survey that allows for anonymity, and consider giving the survey during, immediately following, and several months after the training. 

Look for improvement in employee work: Improved employee performance will almost always positively impact profit and growth.You can measure employee improvement by comparing productivity markers from before training to after (e.g. higher commissions from sales or more items assembled).

Monitor employee retention: Take note: are your trained employees staying on longer than what you’d experienced before training?Some things are more difficult to measure, like customer service and attitudes. Observation and conversations with managers will help you be more aware of what’s going on across departments.Overall, you should trust your gut. If you notice an improvement in workplace culture that coincides with hitting company performance goals, that’s what you’re looking for.On-the-job training helps you build the future of your business with your employees as the foundation.

Competence is defined as the set of skill & personnel characteristics which can demonstrate easily in presence of someone and based on demonstration we can improve these skill & personnel characteristics so the efficiency or performance of function or system can be increase.
Competence shows that you have the ability to do something in well manner. It also tell that you are capable to performing a task or job effectively that is assign to you. It include the knowledge and skills needed which is required to a problem or task which his assign to someone. It is the ability of someone to apply knowledge and skills to achieve intended results. The standard is focus that everyone, not only the top management, become familiar with the QMS requirement such that guideline, policies, goals, targets, objectives and the way to achieve them. Standard want that everyone who is part of organization and giving their contribution towards QMS must aware about the things and also know about the impact if they are not performing their task holistically.

In the context of IATF standards (specifically the IATF 16949:2016 standard), competency refers to the ability of individuals or organizations to perform their assigned tasks effectively and consistently. The standard emphasizes the importance of having competent personnel who possess the necessary skills, knowledge, and experience to carry out their roles and responsibilities. IATF 16949:2016 includes specific requirements related to competency, such as:

1. Identifying the necessary competencies: Organizations must determine the competencies required for each role and function within their quality management system. This involves identifying the knowledge, skills, and experience necessary to perform the tasks effectively.
2. Providing appropriate training: Organizations are required to provide training or take other measures to ensure that personnel possess the necessary competencies. This includes initial training for new employees, as well as ongoing training to maintain and enhance competencies.
3. Evaluating competency: Organizations must assess the effectiveness of their training programs and evaluate the competency of personnel through various methods, such as performance evaluations, examinations, or practical assessments.
4. Documenting competency: Competency requirements and evidence of competency must be documented, including records of training, qualifications, and evaluations.

Overall, competency, as defined by the IATF, relates to having the right skills, knowledge, and experience to carry out tasks effectively within the automotive industry, particularly in the context of quality management systems.

Clause 7.2.1 Competence

In addition to the requirements given in ISO 9001:2015 clause 7.2 Competence. Clause 7.2 also has the following additional requirements. The organization must create and uphold a documented process for identifying training needs, which includes raising awareness and conducting activities to ensure the competency of all individuals involved in activities that can impact product and process requirements. Additionally, there should be a process for qualifying personnel who carry out specific tasks to achieve customer satisfaction.

Please click here for ISO 9001:2015 clause 7.2 Competence

Planning for HR process controls requires having a documented procedure that defines or references – competency criteria; skills evaluation; identification of training needs; types of training; provision of training; how training effectiveness is evaluated; methods to communicate awareness of the importance of quality requirements and meeting quality objectives, to all employees. Criteria for competency must be developed based on appropriate education, skills, training and experience for activities, tasks, functions and processes. The level and detail of such qualifications will depend upon the complexity of product, process, technology and customer and regulatory requirements. It is up to your organization to determine the necessary criteria for the various functions and activities affecting product and QMS. A “Skills Matrix” is a useful tool used by organizations to determine and manage the competency levels required by different activities and functions. The competency criteria for personnel with responsibility for design and development must be defined as well as the specific tools and techniques they need to use. These may include – computer-aided design (CAD); design for manufacturing (DFM); design for assembly (DFA); design of experiments (DOE); etc. For a full list of these tools, refer to the IATF TS 16949:2002 guidance document.

Identifying training needs

The standard requires the supplier to establish and maintain documented process for identifying training needs. Training should not be carried out just because a training course is available. Training is expensive and should be directed at meeting specific needs. Training needs can be identified in two ways: as requirements for training and as a plan for providing the required training. Requirements for training arise in several ways as a result of:

• Job specifications
• Process specifications, maintenance specifications, operating instructions, etc.
• Development plans for introducing new technologies
• Project plans for introducing new equipment, services, operations, etc.
• Marketing plans for launching into new markets, new countries, new products and services
• Contracts where the customer will only permit trained personnel to operate customer owned equipment
• Corporate plans covering new legislation, sales, marketing, quality management, etc.
• An analysis of nonconformities, customer complaints, and other problems
• Developing design skills , problem solving skills , statistical skills.
• Introducing a quality system, thus requiring awareness of IATF 16949, the quality policies and objectives, and training in the implementation of quality system procedures, standards, guides, etc.
• The procedures that govern these activities should include provisions for training. As a minimum they should specify the skills and knowledge required of a person carrying out the activities and where necessary the examination criteria for judging that the person has acquired an adequate level of proficiency.

The requirement for identifying training needs has two dimensions: new training needs and retraining needs. Retraining should be identified by assessing the effectiveness of previous training, the recency of its application, and then scheduling the appropriate courses. Once the training requirements have been specified, managers should plan the training needed for their staff. This requires a training plan. Although the standard does not specifically require a training plan, without one you may have difficulty demonstrating that you have identified the training needs. All plans must serve an objective. You train people for a purpose: to give them skills that you want them to have. The skills required must be specified in the first place. You could have several training plans, each covering a different subject. Technical training could be separate from managerial training and professional training separate from manual skill training. Each manager should plan for the training of his/her own staff so there may be department training plans, divisional training plans, company training plans, etc. The training plans should identify the person responsible for coordinating the training, the type of training, the organization that will deliver the training, the course material to be provided, examination and certification arrangements, the venue, the dates of the courses, and the attendees. It is interesting to note that the only procedures required are for identifying training needs and not for designing training courses, conducting training, or maintaining records.

Qualification of personnel

The standard requires personnel performing specific assigned tasks be qualified on the basis of appropriate education, training, and/or experience, as required. This requirement is somewhat vague as it does not define what a specific assigned task is. Any task assigned to an individual could be a specific assigned task: e.g. window cleaning, typing, fitting, managing, designing, etc. Within organizations some staff are appointed to particular positions that are unique in the organization and others perform jobs that are common within a particular group. So the window cleaning, typing, and fitting jobs are not assigned to a specific individual whereas the manager, and sometimes the designer, is assigned a specific task unique to themselves. Such personnel make judgement upon which the determination of quality depends and so they should be qualified to make such judgement. To be qualified, a person should be able and competent to perform the required tasks at the time they are required to perform them. It follows therefore that a footballer with a broken leg would not be qualified to play football; similarly, a person who takes a training course but has not acquired the skills is also not qualified. A person who once had the skills but has not applied them for some time may also be considered not qualified for the task. This suggests that a person’s current ability needs to be evaluated in order to qualify personnel for specific assigned tasks. You will need to maintain documentary evidence that these personnel have the necessary education, training, and experience to carry out the tasks assigned to them. This is where job specifications can help. For each of these positions — not the individuals but the position they occupy — you should produce a job specification that specifies the requirements an individual must meet to occupy this position. It should include academic qualifications, training, and experience requirements, as well as personal characteristics, so that in recruiting for the position you have a specification with which to compare candidates.

Increasing sensitivity to customer requirements

The personnel whose work affects quality to be informed of the consequences to the customer of nonconformities with quality standards. This is tougher than you might think but you can make it easier. You have produced the Design FMEA and the Process FMEA and in these two documents you have the basic information you need to inform your staff. The FMEA should have identified the sources and causes of failure. Make your staff aware of these documents but also provide other information that enables them to see the effect a part failure has at system level or on the complete vehicle. Staff may have no idea of the function the part they are producing performs, where it fits, how important it is. This education is vital to increasing sensitivity. In many organizations this sensitivity is low. The manager’s task is to heighten sensitivity so that everyone is in no doubt what effect a nonconformity has on the customer.

Evaluation of training effectiveness

The standard requires training effectiveness to be periodically reviewed with special attention given to customer-specific requirements. If the education, training, and/or experience has not been effective, the person concerned could be considered to be unqualified. Therefore in order to ensure that staff are suitably qualified, the effectiveness of the education, training, and/or experience received should be evaluated.
There are three parts to the evaluation:

• An evaluation of the training course or training activity immediately on completion
• An evaluation of the training received weeks after the training
• An evaluation of the skills developed months after the training

Training course evaluation (the initial stage) Course evaluation by the students themselves can only indicate how much they felt motivated by the training courses. It is not effective in evaluating what has been learnt. This is more likely to be revealed by examination at the end of the course or periodically throughout the course. However, the type of examination is important in measuring the effectiveness of the training; e.g. a written examination for a practical course may test the theories behind the skills but not the practical mastery of the skills themselves. A person may fail an exam by not having read the question, so examination by itself cannot be a valid measure of training effectiveness. You want information to be conveyed to your staff, a lecture with accompanying slide show may suffice. Slide shows are good for creating awareness but not for skill training. For the latter, practical opportunities are needed.

Training effectiveness — short term (the intermediate stage) On returning to work after the course, it is important that the skills and knowledge learnt are put to good effect as soon as possible. A lapse of weeks or months before the skills are used will certainly reduce the effectiveness. Little or no knowledge or skill may have been retained. Training is not about doing something once and once only. It is about doing something several times and at frequent intervals. One never forgets how to ride a bicycle or drive a car regardless of the time lapse between each attempt, because the skill was embedded by frequency of opportunities to put the skill into practice in the early stages. Therefore to ensure effectiveness of training you ideally need to provide opportunities to put into practice the newly acquired skills as soon as possible. The person’s supervisor should then examine the trainee’s performance through sampling work pieces, reading documents he/she produces, and observing the person doing the job. If you have experts in the particular skills then in addition to appraisals by the supervisor, the expert should also be involved in appraising the trainee’s performance. Pay particular attention to the trainee’s understanding of customer requirements. Get this wrong and you could end up in trouble with your customer!

Training effectiveness — long term (the final stage)
After several months of doing a job and applying the new skills, the trainee will acquire techniques and habits. The techniques shown may not only demonstrate the skills learnt but also those being developed through self-training. The habits may indicate that some essential aspects of the training had not been understood and that some re-orientation is necessary. It is also likely that the person may have regressed to the old way of doing things and this may be due to matters outside his/her control. The environment in which people work and the attitudes of the people they work with can have both a motivating and demotivating effect on an individual. Again the supervisor should observe the trainee’s performance and engage the expert to calibrate his/her judgement. Pay particular attention to customer requirements and whether the trainee really understands them. If there are significant signs of regression you will need to examine the cause and take corrective action.

Periodic evaluation
Once the skills have been acquired through evidence of a person’s performance, the supervisor can revert to the annual appraisal of performance and identify retraining needs through that process.

Maintaining training records
The standard requires the supplier to maintain appropriate records of training. Whenever any training is carried out you should record on the individual’s personal file, details of the course taken, the dates, duration, and exam results. Copies of the certificate should be retained on file as evidence of training. You may find it useful to issue each individual with a personal training log, but do not rely on this being maintained or retained by the person. Often training records are held at some distance away from an individual’s place of work and in certain cases, especially for certificated personnel performing special processes, individuals should carry some identification of their proficiency so as to avoid conflict if challenged. Records of training should include records of formal training, where the individual attends a training course and on-the—job training, where the individual is given instruction while performing the job. The records should indicate whether the prescribed level of competence has been attained. In order to record competence, formal training needs to be followed by on-the-job examination. The records should also indicate who has conducted the training and there should be evidence that this person or organization has been assessed as competent to deliver and evaluate the training. Training records should contain evidence that the effectiveness of training given has been evaluated and this may be accomplished by a signature and date from the super visor against the three stages of evaluation — initial, intermediate, final. Periodic reviews of training records should be undertaken to clearly identify retraining needs. You will need two types of training records: those records relating to a particular individual and those relating to particular activities. The former is used to identify an individual’s competence and the latter to select by skill the competent people for specific assignments.

All kinds of Laboratory mechanical, chemical, dimensional, performance, metallurgical, etc. is a center that provides measurement, testing, and calibration services. We must consider two types of laboratories, internal and external laboratories.  The internal laboratory is the laboratory inside the building that belongs to the organization, that is, your company.   The external laboratory is the laboratory where you receive support and service from outside. Laboratories play a crucial role in the automotive industry, supporting various aspects of product development, quality control, and regulatory compliance. Here are some key roles of laboratories in the automotive industry:

1. Product Development and Testing: Laboratories are involved in the testing and evaluation of automotive components, systems, and materials during the product development stage. They conduct performance testing, durability testing, safety testing, and other specialized tests to ensure compliance with industry standards and specifications.
2. Quality Control and Inspection: Laboratories perform quality control inspections to verify the conformity of automotive parts, materials, and finished products. They conduct measurements, inspections, and tests to ensure that products meet the specified requirements and comply with relevant regulations.
3. Calibration and Metrology: Laboratories provide calibration services for measuring equipment and instruments used in automotive manufacturing and testing processes. They ensure that measurement equipment is accurate and reliable, maintaining traceability to national or international standards.
4. Emission Testing and Compliance: Laboratories play a vital role in emission testing to verify compliance with environmental regulations, such as emission standards for vehicles. They perform emission measurements and analysis, including exhaust gas analysis and particulate matter testing.
5. Material Analysis and Validation: Laboratories conduct material analysis and validation to ensure the quality and performance of automotive materials. They perform tests for mechanical properties, chemical composition, thermal properties, and other material characteristics to ensure they meet required specifications.
6. Failure Analysis and Investigations: In case of product failures or issues, laboratories conduct failure analysis and investigations to identify root causes and provide solutions. They use advanced techniques such as microscopy, spectroscopy, and mechanical testing to analyze failed components and identify design or manufacturing issues.
7. Research and Development: Laboratories engage in research and development activities to drive innovation in the automotive industry. They explore new materials, technologies, and testing methodologies to enhance product performance, safety, and efficiency.
8. Regulatory Compliance: Laboratories assist automotive manufacturers in meeting regulatory compliance requirements. They provide testing and certification services to ensure adherence to safety standards, emission regulations, and other applicable industry regulations.
9. Advanced Testing and Simulation: With the growing complexity of automotive systems, laboratories employ advanced testing and simulation techniques. This includes virtual testing, computer-aided engineering, and simulation tools to assess vehicle performance, crashworthiness, aerodynamics, and other critical factors.
10. Training and Education: Laboratories often offer training programs and educational resources to support skill development and knowledge enhancement in the automotive industry. They provide training on testing methodologies, equipment operation, standards compliance, and best practices.

Overall, laboratories play a vital role in ensuring the quality, safety, and performance of automotive products. They contribute to product development, quality control, regulatory compliance, and continuous improvement efforts in the automotive industry.

Clause 7.1.5.3.1 Internal laboratory

An organization’s internal laboratory facility should have a clear scope outlining its ability to conduct the necessary inspection, testing, or calibration services. This scope needs to be documented as part of the quality management system. The laboratory must establish and follow requirements to ensure the technical procedures are adequate and that laboratory personnel are competent. It should also outline the testing of products and the capability to perform these services accurately, with traceability to the relevant process standard. If no national or international standards are available, a methodology must be defined to verify the capability of the measurement system. Any customer requirements must be taken into account. This process should include a review of related records. Third-party accreditation to ISO/IEC 17025 or equivalent may be utilized to demonstrate that the organization’s in-house laboratory complies with the requirement of IATF 16949.

In many organizations, the internal laboratory may conduct more technical and comprehensive inspection, testing and calibration using more complex and sensitive equipment, methods and standards. You must have document the internal laboratory scope; You must also specify technical requirements for – adequacy of procedures; personnel training and competency; testing methods; traceability to relevant process standards; control of test specimens; records needed, etc. Your internal laboratory scope must specify the tests, evaluations and calibrations it is qualified to perform; provide a list of the equipment used to perform these activities; and a list of the methods, standards, etc., used. The procedures used in the laboratory could be established practices; MONITORING AND MEASURING DEVICE manufacturer’s reference or user manuals; industry standards, methods and practices; customer specified methods; and regulatory methods and practices. These procedures typically address testing methods and standards; identification and traceability; etc. The need to have a documented laboratory procedure or manual would depend on the scope and complexity of product testing and inspection. OEM customers may have specific competency and training requirements for laboratory personnel.

Scope of Internal Laboratory Facility

An organization’s internal laboratory facility should have a defined scope that outlines its capabilities to perform the required inspection, test, or calibration services. This scope defines the range of activities and services that the laboratory is competent to undertake.The defined scope typically includes the following elements:

1. Testing or Inspection Methods: Specify the specific testing or inspection methods that the laboratory is capable of performing. This may include mechanical testing, chemical analysis, dimensional measurements, electrical testing, environmental testing, and more. The scope should clearly identify the methods that the laboratory is competent in.
2. Equipment and Instrumentation: List the equipment and instrumentation that the laboratory possesses and is qualified to use for the testing, inspection, or calibration services. This includes specifying the range and accuracy of the equipment, as well as any applicable certifications or accreditations.
3. Standards and Specifications: Identify the relevant standards, regulations, or specifications that the laboratory adheres to when conducting testing, inspection, or calibration activities. This ensures that the laboratory is operating in compliance with the necessary requirements.
4. Range of Testing: Define the range of materials, products, or components that the laboratory is qualified to test, inspect, or calibrate. This includes specifying any limitations or exclusions within the laboratory’s scope of services.
5. Accreditation and Certifications: If applicable, mention any accreditations or certifications that the laboratory has obtained. This may include ISO 17025 accreditation or specific industry certifications that validate the laboratory’s competence and adherence to recognized standards.

By having a well-defined scope, an internal laboratory facility can clearly communicate its capabilities, areas of expertise, and limitations to internal stakeholders, customers, and regulatory bodies. This ensures that the laboratory operates within its defined competencies, maintains the necessary resources, and provides accurate and reliable testing, inspection, or calibration services to support organizational quality objectives.

Adequacy of the laboratory technical procedures

The adequacy of laboratory technical procedures is crucial to ensure the accuracy, reliability, and consistency of testing, inspection, or calibration activities. Here are some key aspects to consider in assessing the adequacy of laboratory technical procedures:

1. Documentation and Availability: Technical procedures should be properly documented, easily accessible, and up-to-date. They should provide clear and detailed instructions on how to perform specific tests, inspections, or calibrations. The procedures should be readily available to laboratory personnel and maintained in a controlled manner.
2. Compliance with Standards and Regulations: Laboratory technical procedures should align with applicable standards, regulations, and customer requirements. They should incorporate relevant methods, guidelines, and specifications to ensure compliance with established criteria. Regular review and updates of procedures should be conducted to reflect any changes in standards or requirements.
3. Clarity and Consistency: Technical procedures should be written in a clear and concise manner, using language that is easily understandable by laboratory personnel. They should provide step-by-step instructions, including necessary calculations, equipment setup, sample preparation, and data recording. Consistency in terminology, units of measurement, and data reporting should be maintained throughout the procedures.
4. Method Validation and Verification: Technical procedures should undergo validation and verification to ensure their effectiveness and suitability for the intended purpose. This involves conducting experiments, comparing results with reference methods, and assessing the precision, accuracy, and reliability of the procedures. Method validation and verification should be documented to demonstrate the adequacy of the procedures.
5. Risk Assessment and Mitigation: Technical procedures should include considerations for identifying and managing potential risks associated with the testing, inspection, or calibration activities. Risk assessment should address factors such as equipment limitations, sample handling, potential hazards, and sources of measurement uncertainty. Mitigation measures should be incorporated into the procedures to minimize risks and ensure reliable results.
6. Training and Competence Requirements: Technical procedures should outline the necessary training and competence requirements for laboratory personnel involved in conducting the activities. This includes specifying the qualifications, skills, and knowledge needed to perform the procedures accurately and effectively. Training records and competency assessments should be maintained to demonstrate compliance with these requirements.
7. Continual Improvement: Technical procedures should be subject to continual improvement based on feedback, data analysis, and emerging best practices. Regular review and updates should be conducted to incorporate lessons learned, address identified issues, and enhance the efficiency and effectiveness of the procedures.
8. Document Control and Change Management: Technical procedures should be subject to proper document control and change management processes. This ensures that changes to the procedures are controlled, documented, communicated, and implemented in a systematic and controlled manner.

By evaluating and ensuring the adequacy of laboratory technical procedures, organizations can enhance the consistency, accuracy, and reliability of their testing, inspection, or calibration activities. This contributes to maintaining high-quality standards, meeting customer requirements, and supporting overall organizational objectives.

Competency of the laboratory personnel

The competency of laboratory personnel is critical to ensuring accurate and reliable testing, inspection, or calibration results. Here are some key aspects to consider in assessing the competency of laboratory personnel:

1. Education and Training: Evaluate the educational background and qualifications of laboratory personnel. Look for relevant degrees, certifications, or diplomas in fields related to the laboratory’s activities. Consider the level of formal education and training received by the personnel.
2. Experience and Expertise: Assess the level of experience and expertise of laboratory personnel in conducting the specific testing, inspection, or calibration activities. Consider the number of years of experience and the range of projects or tests they have been involved in. Experience in relevant industries or specific techniques adds value to their competency.
3. Technical Knowledge: Evaluate the depth and breadth of technical knowledge possessed by laboratory personnel. They should have a solid understanding of the principles, theories, and methods related to the laboratory’s activities. Assess their knowledge of relevant standards, regulations, and industry best practices.
4. Skill Proficiency: Assess the practical skills and proficiency of laboratory personnel in performing the required tasks and techniques. Consider their ability to operate laboratory equipment, conduct measurements, perform analyses, interpret results, and troubleshoot issues. Proficiency in using relevant software or data analysis tools is also important.
5. Continuing Professional Development: Evaluate the commitment of laboratory personnel to continuous professional development. Look for evidence of participation in relevant training programs, conferences, seminars, or workshops. Consider their involvement in professional organizations or societies related to their field of expertise.
6. Quality Management Systems Knowledge: Assess the understanding and application of quality management system principles by laboratory personnel. They should be familiar with the requirements of relevant standards (e.g., ISO 17025) and follow established quality procedures and processes. Competency in document control, data integrity, and adherence to standard operating procedures is essential.
7. Communication and Collaboration Skills: Consider the communication and collaboration skills of laboratory personnel. They should be able to effectively communicate with team members, clients, and stakeholders. Strong interpersonal skills, the ability to work in teams, and effective documentation practices contribute to overall competency.
8. External Proficiency Assessments: Evaluate the participation of laboratory personnel in external proficiency testing or inter-laboratory comparison programs. These programs assess the competence of laboratories and provide an external benchmark for performance.
9. Supervision and Oversight: Assess the level of supervision and oversight provided to laboratory personnel. Effective management, mentoring, and quality control practices play a role in maintaining and improving competency levels.
10. Competency Assessment and Records: Establish processes for assessing and documenting the competency of laboratory personnel. This may involve regular performance evaluations, skills assessments, training records, and competency matrices. These records demonstrate that personnel have the necessary skills and knowledge to perform their assigned tasks competently.

By evaluating and ensuring the competency of laboratory personnel, organizations can maintain the quality and reliability of their testing, inspection, or calibration services. It helps instill confidence in the accuracy and reliability of the results, supports compliance with standards, and contributes to overall customer satisfaction.

Testing of the product

Testing of the product in an internal laboratory provides organizations with the advantage of having direct control over the testing process and ensuring that products meet specific quality standards. Here is an overview of the testing process in an internal laboratory:

1. Test Planning: Develop a comprehensive test plan that outlines the objectives, scope, and requirements for product testing. Identify the specific tests to be performed, testing methods, acceptance criteria, and any applicable industry standards or regulations.
2. Test Equipment and Facilities: Ensure that the laboratory is equipped with the necessary testing equipment and facilities to perform the required tests. Calibrate and maintain the equipment according to established procedures and schedules to ensure accuracy and reliability.
3. Test Method Development: Develop or adopt appropriate test methods for the specific product being tested. This may involve using industry-standard test methods or developing custom methods tailored to the product’s requirements.
4. Test Execution: Conduct the tests according to the defined test plan and procedures. Follow the established protocols, safety guidelines, and quality control measures during test execution. Record all relevant data and observations during the testing process.
5. Data Analysis and Interpretation: Analyze the test results using appropriate statistical or analytical methods. Compare the results against predefined acceptance criteria or performance specifications. Interpret the data to determine if the product meets the required standards or if further actions are needed.
6. Defect Identification and Reporting: Identify any defects, deviations, or non-conformities discovered during testing. Document and report the findings, including detailed descriptions of the issues, their impact on the product, and recommendations for corrective actions.
7. Test Reporting: Prepare test reports summarizing the testing process, methodology, results, and conclusions. Clearly communicate the product’s performance against specified criteria, highlighting any areas of concern or improvement. Include any relevant graphs, charts, or supporting data to enhance the report’s clarity and accuracy.
8. Test Record keeping: Maintain accurate and organized records of all testing activities, including test plans, protocols, results, and reports. This ensures traceability, facilitates future analysis or audits, and supports ongoing quality control and improvement efforts.
9. Continuous Improvement: Regularly review and evaluate the testing process to identify opportunities for improvement. Incorporate feedback from test results, customer feedback, or changes in industry standards to enhance testing methodologies and practices.
10. Collaboration and Communication: Foster collaboration and effective communication between the laboratory personnel, other departments, and stakeholders involved in the product development and quality control processes. This ensures a shared understanding of testing requirements, facilitates problem-solving, and promotes a culture of quality.

Testing products in an internal laboratory allows organizations to closely monitor and control the quality of their products. It enables timely identification and resolution of any product issues, leading to improved customer satisfaction, compliance with standards, and overall product excellence.

Capability to perform these services correctly traceable to the relevant process standard

The laboratory shall specify and implement capability to perform these services correctly, traceable to the relevant process standard when no national or international standard(s) is available, the organization shall define and implement a methodology to verify measurement system capability. The laboratory, as part of its quality management system, should specify and implement the capability to perform testing, inspection, or calibration services correctly. This capability should be traceable to relevant process standards or, in the absence of national or international standards, the organization should define and implement a methodology to verify the measurement system capability. Here are the key considerations:

1. Specification of Service Capability: The laboratory should define and document its service capabilities, including the specific tests, inspections, or calibrations it can perform accurately and reliably. This may involve specifying the range of parameters, materials, or components that the laboratory is competent to handle.
2. Traceability to Process Standards: When relevant national or international standards exist for the testing, inspection, or calibration services, the laboratory should ensure that its procedures and methods are traceable to these standards. This involves establishing a clear chain of traceability from the laboratory’s measurements to the specified standards.
3. Methodology Development: In cases where no national or international standards are available, the organization should develop and implement a methodology to verify the measurement system capability. This methodology should include procedures, techniques, and acceptance criteria to ensure accurate and reliable measurements.
4. Measurement System Analysis: The laboratory should conduct measurement system analysis to assess the capability and performance of its measurement systems. This analysis helps identify sources of measurement error, variability, and bias within the laboratory’s processes and equipment.
5. Calibration and Equipment Verification: The laboratory should calibrate and verify its measurement equipment to ensure accurate and reliable results. Calibration activities should be performed using traceable reference standards and documented in calibration certificates or records.
6. Measurement Uncertainty: The laboratory should estimate and document the measurement uncertainty associated with its test, inspection, or calibration services. This provides an indication of the range of potential measurement errors and helps ensure the reliability and accuracy of the reported results.
7. Proficiency Testing and Inter laboratory Comparisons: The laboratory should participate in proficiency testing or inter laboratory comparisons to assess its measurement system capability against other laboratories. These external assessments provide a valuable benchmark for evaluating the laboratory’s performance and identifying areas for improvement.
8. Quality Control and Assurance: The laboratory should establish robust quality control and assurance processes to monitor and control the accuracy and reliability of its testing, inspection, or calibration services. This includes implementing regular checks, audits, and reviews of procedures, methods, and equipment to ensure compliance with established standards and requirements.
9. Continuous Improvement: The laboratory should continuously strive for improvement in its measurement system capability. This involves analyzing measurement data, identifying trends or patterns, and implementing corrective and preventive actions to enhance the accuracy and reliability of measurements.
10. Documentation and Records: The laboratory should maintain comprehensive documentation and records of its measurement system capability verification activities. This includes records of equipment calibration, measurement system analysis results, proficiency testing reports, and any corrective actions taken.

By specifying and implementing the capability to perform services correctly and establishing a methodology to verify measurement system capability, laboratories can ensure the accuracy, reliability, and traceability of their testing, inspection, or calibration services. This contributes to overall quality assurance, customer satisfaction, and compliance with relevant standards and requirements.

Customer Requirement

As part of the laboratory’s quality management system, it is essential to specify and implement customer requirements effectively. This includes understanding, documenting, and reviewing customer requirements, as well as maintaining records related to these requirements. Here are the key considerations:

1. Understanding Customer Requirements: The laboratory should have a process in place to clearly understand and document customer requirements. This involves actively engaging with customers to gather information about their specific needs, expectations, and any relevant standards or specifications.
2. Documentation of Customer Requirements: The laboratory should document customer requirements in a clear and organized manner. This can be done through the use of contracts, purchase orders, specifications, or other appropriate forms of documentation. The documented customer requirements should include relevant details such as test parameters, acceptance criteria, deadlines, and any special instructions or considerations.
3. Implementation of Customer Requirements: The laboratory should ensure that customer requirements are effectively implemented in its testing, inspection, or calibration processes. This involves communicating the requirements to relevant personnel, providing necessary instructions, and allocating resources to meet customer expectations.
4. Review of Customer Requirements: Regularly review and verify customer requirements to ensure their completeness, accuracy, and alignment with the laboratory’s capabilities. This includes reviewing contracts, purchase orders, or any other relevant documents to confirm that the laboratory can fulfill the specified requirements.
5. Risk Assessment and Mitigation: Consider conducting a risk assessment of customer requirements to identify any potential risks or challenges associated with meeting those requirements. Develop appropriate mitigation measures to address identified risks and ensure successful compliance with customer expectations.
6. Records of Customer Requirements: Maintain records of customer requirements and related communications. This includes keeping copies of contracts, purchase orders, specifications, or any other documents provided by the customer. Record any changes or updates to the requirements and maintain a documented trail of customer interactions.
7. Communication with Customers: Establish effective communication channels with customers to address any queries, clarifications, or changes to requirements. Maintain open lines of communication to ensure that both parties have a clear understanding of expectations and can address any issues or concerns in a timely manner.
8. Customer Feedback and Satisfaction: Seek customer feedback on the laboratory’s performance in meeting their requirements. This feedback can be gathered through surveys, feedback forms, or other appropriate means. Act upon customer feedback to continuously improve the laboratory’s processes and enhance customer satisfaction.
9. Continuous Improvement: Continuously strive to improve the laboratory’s understanding and implementation of customer requirements. This can be achieved through regular internal reviews, lessons learned from customer interactions, and ongoing process improvement initiatives.
10. Compliance with Confidentiality: Ensure that customer requirements and related information are handled with confidentiality and in accordance with applicable privacy and data protection regulations.

By specifying and implementing customer requirements effectively and maintaining records related to these requirements, laboratories can ensure that customer expectations are met, improve customer satisfaction, and strengthen their relationships with clients. This contributes to the overall success and reputation of the laboratory.

7.1.5.3.2 External laboratory

External, commercial, or independent laboratory facilities utilized by the organization for inspection, testing, or calibration services must have a defined laboratory scope that encompasses the ability to conduct the necessary inspections, tests, or calibrations. This can be demonstrated either by accreditation to ISO 17025 or a national equivalent standard, or by evidence showing that the external laboratory is approved by the customer. Such evidence might include customer assessments or customer-approved second-party assessments confirming that the laboratory meets the requirements of ISO 17025 or its national equivalent. The second-party assessment could be carried out by the organization assessing the laboratory using a method approved by the customer. In cases where a qualified laboratory is not available for a specific piece of equipment, calibration services may be conducted by the equipment manufacturer, provided they meet the requirements outlined for internal laboratories. However, if necessary the use of calibration services from sources other than qualified or customer-accepted laboratories may be subject to confirmation by government regulatory bodies.

If you use an external laboratory, you must have evidence that it is ISO/IEC 17025 (or national equivalent) accredited or acceptable to the customer. Ensure that the external laboratory’s ISO/IEC 17025 accreditation is not out of date and its scope includes the activities you have contracted it to perform.When an organization utilizes external, commercial, or independent laboratory facilities for inspection, testing, or calibration services, it is crucial that these facilities have a defined laboratory scope. This scope should include the capability to perform the required services accurately and effectively. Here are key considerations:

1. Defined Laboratory Scope: The external laboratory should clearly define its laboratory scope, specifying the types of inspection, testing, or calibration services it can provide. This includes identifying the specific tests, measurements, or evaluations the laboratory is qualified to perform.
2. Applicable Standards and Specifications: The laboratory scope should align with applicable standards, regulations, and specifications relevant to the organization’s industry or specific requirements. It should demonstrate the laboratory’s competence and compliance with these standards.
3. Accreditation and Certifications: Evaluate the laboratory’s accreditation and certifications, such as ISO/IEC 17025, which demonstrate the laboratory’s adherence to recognized quality management system requirements. These accreditations indicate that the laboratory has undergone rigorous assessment and is competent to provide reliable services.
4. Equipment and Facilities: Ensure that the external laboratory has the necessary equipment, instruments, and facilities to support the required inspection, testing, or calibration services. The laboratory should maintain its equipment in proper working condition and calibrate it regularly.
5. Personnel Competence: Assess the competence and qualifications of the laboratory personnel who will be performing the services. The laboratory should have qualified and experienced staff who are trained in the relevant methods and techniques and possess the necessary skills to carry out the required tasks accurately.
6. Quality Management System: Evaluate the laboratory’s quality management system to ensure that it has appropriate processes and procedures in place for ensuring the quality, traceability, and reliability of the inspection, testing, or calibration services. This includes document control, records management, corrective actions, and proficiency testing.
7. Traceability and Metrological Traceability: The laboratory should have a robust system to ensure traceability of measurements and results to national or international standards. This demonstrates that the laboratory’s measurements are reliable, accurate, and comparable.
8. Reporting and Deliverables: Confirm that the external laboratory provides clear and comprehensive reports or deliverables that meet the organization’s requirements. The reports should include all relevant information, such as test results, measurements, observations, and any applicable uncertainties.
9. Audit and Monitoring: Regularly assess and monitor the performance of the external laboratory to ensure ongoing compliance with the defined laboratory scope. This may involve conducting audits, evaluating performance metrics, or reviewing customer feedback.
10. Confidentiality and Data Security: Ensure that the external laboratory has appropriate measures in place to protect the confidentiality and security of sensitive information, test results, and proprietary data shared by the organization.

By ensuring that external, commercial, or independent laboratory facilities have a defined laboratory scope that aligns with the organization’s requirements, the organization can have confidence in the capabilities and reliability of the services provided by these facilities.

Accredation to ISO/IEC 17025 or national equivalent

According to ISO/IEC 17025, the external laboratory used for inspection, testing, or calibration services by an organization should be accredited to ISO/IEC 17025 or the national equivalent standard. The accreditation should specifically include the relevant inspection, test, or calibration service in the laboratory’s scope of accreditation. Here are the key points to consider:

1. Accreditation to ISO/IEC 17025: The external laboratory should have achieved accreditation to ISO/IEC 17025, which is the international standard for the competence of testing and calibration laboratories. This accreditation demonstrates that the laboratory has been assessed and deemed competent to perform specific inspection, testing, or calibration services.
2. Inclusion of Services in Scope: The laboratory’s accreditation should specifically include the relevant inspection, test, or calibration service within its scope. The scope of accreditation defines the types of services for which the laboratory is accredited and verifies its competence in performing those services.
3. Certificate of Accreditation: The external laboratory should possess a valid certificate of accreditation issued by an accreditation body. The certificate should clearly state the scope of accreditation, including the specific inspection, test, or calibration service covered by the accreditation.
4. Mark of National Accreditation Body: The certificate of calibration or test report provided by the accredited external laboratory should include the mark or logo of the national accreditation body that has issued the accreditation. This mark serves as a symbol of the laboratory’s recognized competence and compliance with the required standards.
5. Compliance with Accreditation Requirements: The external laboratory should demonstrate ongoing compliance with the requirements of its accreditation. This involves adhering to the technical criteria, quality management system requirements, proficiency testing, and any other obligations specified by the accreditation body.
6. Traceability and Metrological Traceability: The accredited laboratory should ensure traceability of measurements to national or international standards as part of its accreditation. This verifies that the laboratory’s measurements are reliable, accurate, and traceable to recognized reference standards.
7. Review of Accreditation Status: It is essential to periodically review the accreditation status of the external laboratory to ensure it remains valid and up to date. This includes confirming that the accreditation is still active, verifying the scope of accreditation, and checking for any limitations or conditions imposed by the accreditation body.

By utilizing an accredited external laboratory, organizations can have confidence in the laboratory’s competence, reliability, and adherence to recognized standards. The inclusion of the mark of a national accreditation body on the certificate of calibration or test report further supports the credibility and traceability of the laboratory’s services.

Evidence that the external laboratory is acceptable to the customer

Such evidence may be demonstrated by customer assessment, for example, or by customer-approved second-party assessment that the laboratory meets the intent of ISO/IEC 17025 or national equivalent. The second-party assessment may be performed by the organization assessing the laboratory using a customer-approved method of assessment. This assessment provides an independent evaluation of the laboratory’s compliance with ISO/IEC 17025 or the national equivalent standard. Here’s how it can be accomplished:

1. Selection of the Second Party: The customer selects a qualified and independent second party to assess the external laboratory. This second party could be the customer’s internal quality team, a third-party auditing organization, or an industry expert familiar with laboratory accreditation and compliance.
2. Assessment Scope and Objectives: Define the scope and objectives of the second-party assessment in collaboration with the customer and the laboratory. This includes identifying the specific areas to be evaluated, such as management systems, technical competence, equipment calibration, documentation, and adherence to relevant standards.
3. Assessment Plan: Develop an assessment plan that outlines the assessment process, timeline, criteria for evaluation, and required documentation. This plan should be agreed upon by all parties involved, including the customer, the laboratory, and the second party conducting the assessment.
4. On-Site Assessment: Conduct an on-site assessment of the external laboratory. The second party assesses the laboratory’s compliance with ISO/IEC 17025 or the national equivalent standard by reviewing relevant documentation, interviewing personnel, observing processes, and verifying adherence to quality management procedures.
5. Compliance Evaluation: Evaluate the laboratory’s compliance with the standard’s requirements, focusing on key aspects such as technical competence, personnel qualifications, equipment calibration, quality control, documentation control, and traceability of measurements.
6. Findings and Recommendations: Document the findings of the assessment, including any areas of non-compliance or opportunities for improvement. Provide recommendations to address identified gaps or deficiencies, along with suggestions for enhancing the laboratory’s compliance with the standard.
7. Customer Approval: The customer reviews the assessment findings and recommendations. Once satisfied with the assessment results, the customer provides formal approval, acknowledging that the laboratory meets the intent of ISO/IEC 17025 or the national equivalent standard.
8. Ongoing Monitoring: Periodically monitor the laboratory’s compliance with the standard to ensure continued conformance and quality performance. This can include periodic assessments, audits, or surveillance visits to verify that the laboratory maintains its compliance.
9. Communication and Reporting: Communicate the results of the second-party assessment to all relevant stakeholders. This includes sharing the assessment report, findings, recommendations, and the customer’s approval of the laboratory’s compliance with the standard.
10. Continuous Improvement: Encourage the laboratory to take corrective actions and implement the recommended improvements identified during the assessment. Foster a culture of continuous improvement to enhance the laboratory’s performance and maintain customer confidence.

By conducting a customer-approved second-party assessment, the external laboratory can provide additional assurance to the customer that it meets the intent of ISO/IEC 17025 or the national equivalent standard. This assessment serves as an independent validation of the laboratory’s compliance and strengthens the customer’s confidence in the laboratory’s capabilities and reliability.

Calibration service Performed by Equipment Manufacturer

In situations where a qualified laboratory is not available for a particular piece of equipment, calibration services may be performed by the equipment manufacturer. This can be a viable option to ensure that the equipment remains calibrated and accurate. Here are some key points to consider:

1. Manufacturer’s Expertise: The equipment manufacturer is typically the entity with in-depth knowledge of the equipment’s design, specifications, and calibration requirements. They understand the intricacies of the equipment and have access to the necessary technical documentation and resources.
2. Calibration Procedures: The manufacturer will have established calibration procedures specific to their equipment. These procedures are designed to ensure accurate and reliable calibration based on the equipment’s intended use and performance specifications.
3. OEM Calibration Standards: The manufacturer is likely to have access to original equipment manufacturer (OEM) calibration standards, which are specifically developed for their equipment. These standards provide traceability to recognized measurement standards and help maintain the accuracy and reliability of the equipment’s measurements.
4. Equipment-Specific Considerations: Certain equipment may have unique calibration requirements or specialized calibration methods that are best addressed by the manufacturer. This can be due to proprietary technologies, complex functionality, or specific calibration techniques that require specialized knowledge and expertise.
5. Equipment Warranty: In some cases, the manufacturer’s calibration services may be part of the equipment’s warranty or support agreement. Availing calibration services from the manufacturer can ensure compliance with warranty terms and conditions.
6. Equipment Updates and Recalibration: The manufacturer can also provide updates or modifications to the equipment’s firmware, software, or hardware components during the calibration process. This helps maintain the equipment’s performance and accuracy in line with the latest advancements and specifications.
7. Technical Support: Engaging with the manufacturer for calibration services can provide access to technical support and expertise in case any issues or questions arise during the calibration process. This can be particularly valuable when dealing with complex equipment or intricate calibration requirements.
8. Equipment-Specific Certifications: Some equipment may require specific certifications or approvals that can only be provided by the manufacturer. Availing calibration services from the manufacturer ensures compliance with these equipment-specific certifications, ensuring regulatory or industry compliance.
9. Documentation and Records: The manufacturer’s calibration services typically provide comprehensive documentation and calibration certificates specific to the equipment. These records serve as evidence of calibration and can be important for quality control, regulatory compliance, and audits.
10. Availability and Cost: It is important to consider the availability and cost of calibration services provided by the manufacturer. In some cases, the manufacturer may have limitations on their calibration services due to capacity or geographic constraints. Additionally, the cost of calibration services provided by the manufacturer should be evaluated in comparison to other available options.

While availing calibration services from the equipment manufacturer can be a practical solution in the absence of a qualified laboratory, it is important to ensure that the manufacturer has the necessary expertise, resources, and calibration capabilities to perform the required services accurately and reliably.

Calibration and verification are important processes in the context of the International Automotive Task Force (IATF) standard, specifically in relation to clause 7.1.5.2.1. This clause pertains to the calibration and verification of monitoring and measuring equipment used in the automotive industry.Calibration refers to the process of comparing the measurements of a given instrument or equipment with a known standard to ensure its accuracy. It involves adjusting or aligning the equipment to meet specific requirements or standards. Calibration is typically performed by using traceable standards or certified reference materials.Verification, on the other hand, is the confirmation through the provision of objective evidence that specified requirements have been met. In the context of IATF, verification involves checking whether the monitoring and measuring equipment used in automotive manufacturing or testing is capable of providing accurate and reliable results.Clause 7.1.5.2.1 of the IATF standard emphasizes the importance of calibration and verification in maintaining the quality and reliability of measurement systems within the automotive industry. It requires organizations to establish and maintain processes for the calibration and verification of all relevant equipment used for monitoring and measuring product conformity.To comply with this clause, organizations must implement the following steps:

1. Identify relevant monitoring and measuring equipment: Determine which equipment is critical for ensuring product conformity and quality within the organization’s processes.
2. Establish calibration requirements: Define the specific calibration requirements for each identified equipment, including the frequency of calibration and the reference standards to be used.
3. Perform calibration: Carry out the calibration activities according to the established requirements. This may involve adjusting or aligning the equipment to match the reference standards and ensuring its accuracy.
4. Maintain calibration records: Document the details of each calibration performed, including the date, the personnel involved, the reference standards used, and the results obtained. These records serve as evidence of compliance with the calibration requirements.
5. Conduct verification: Regularly verify the performance of the monitoring and measuring equipment to ensure its ongoing accuracy and reliability. This may involve periodic checks, inter-laboratory comparisons, or other appropriate methods.
6. Document verification activities: Keep records of the verification activities conducted, including the methods used, the results obtained, and any actions taken to address identified discrepancies.

By adhering to these steps, organizations can demonstrate their commitment to maintaining accurate and reliable measurement systems as required by the IATF standard. Effective calibration and verification processes help ensure that the automotive products manufactured or tested meet the necessary quality and safety standards.

The standard requires the supplier to calibrate inspection, measuring, and test equipment used to demonstrate the conformance of product to the specified requirements. Calibration is concerned with determining the values of the errors of a measuring instrument and often involves its adjustment or scale graduation to the required accuracy. You should not assume that just because a device was once accurate it will remain so forever. Some devices, if well treated and retained in a controlled environment, will retain their accuracy for very long periods. Others, if poorly treated and subjected to environmental extremes, will lose their accuracy very quickly. Ideally you should calibrate measuring devices before use in order to prevent an inaccurate device being used in the first place and afterwards to confirm that no changes have occurred during use. However, this is often not practical and so intervals of calibration are established which are set at such periods as will detect any adverse deterioration. These intervals should be varied with the nature of the device, the conditions of use, and the seriousness of the consequences should it produce incorrect results. It is not necessary to calibrate all test and measuring equipment. Some equipment may be used solely as an indicator, such as a thermometer, a clock, or a tachometer; other equipment may be used for diagnostic purposes, to indicate if a fault exists. If such devices are not used for determining the acceptability of products and services or process parameters, their calibration is not essential. However, you should identify such devices as for “Indication Purposes Only” if their use for measurement is possible. You don’t need to identify all clocks and thermometers fixed to walls unless they are used for measurement. Having observed that you record the time when observations were made, a zealous assessor may suggest that the clock be calibrated. If the time is not critical to product or process acceptability, calibration is unnecessary. There are two systems used for maintaining the accuracy and integrity of measuring devices: a calibration system and a verification system. The calibration system determines the accuracy of measurement and the verification system determines the integrity of the device. If accuracy is important then the device should be included in the calibration system. If accuracy is not an issue but the device’s form, properties, or function is important then it should be included in the verification system. You need to decide the system in which your devices are to be placed under control and identify them accordingly. There are two types of devices subject to calibration: those that are adjustable and those that are not. An adjustable device is one where the scale or the mechanism is capable of adjustment (e.g. micrometer, voltmeter, load cell). For non-adjustable devices a record of the errors observed against a known standard can be produced which can be taken into account when using the device (e.g. slip gage, plug gage, surface table, thermometer). Comparative references are not subject to calibration. They are, however, subject to verification. Such devices are those which have form or function where the criteria is either pass or fail (i.e. there is no room for error) or where the magnitude of the errors does not need to be taken into account during usage. Such devices include software, steel rules/tapes, templates, forming and molding tools. Devices in this category need carry no indication of calibration due date. The devices should carry a reference number and verification records should be maintained showing when the device was last checked. Verification of such devices include checks for damage, loss of components, function. Some electronic equipment has self-calibration routines built in to the start-up sequence. This should be taken as an indication of serviceability and not of absolute calibration. The device should still be subject to independent calibration at a defined frequency.

Clause 7.1.5.2.1 Calibration/verification records

In addition to the requirement given in ISO 9001:2015 7.1.5 Monitoring and measuring resources , addition requirement in clause 7.1.5.2.1 are as follows.

A documented process is necessary to oversee calibration/verification records. Records of calibration/verification activities for all gauges and measuring and testing equipment including employee-owned equipment relevant for measuring, customer-owned equipment, or on-site supplier-owned equipment that are essential for demonstrating compliance with internal, legal, and customer requirements must be maintained. These activities and records should include the following details: adjustments due to engineering changes; instances of readings being out-of-calibration; evaluation of the risk posed by the out-of-calibration state; documentation of past measurement results obtained with the specific test equipment, the most recent calibration date, and the next due dates; notification to the customer if suspected products or materials have been shipped; statements confirming conformity to specifications after calibration/verification; confirmation that the software version used for product and process control matches the specified version; records of calibration and maintenance activities for all measuring instruments; verification of production-related software used for product and process control.

Please click here for ISO 9001:2015 7.1.5 Monitoring and measuring resources

Requirements for what needs to be measured and the acceptance criteria may come from the customer, regulatory, industry and your own organization. Clause 8.1 Operational planning and control must determine the following – what specific product and process characteristics needs to be monitored and measured; the criteria for product acceptance; the type of monitoring and measurement device needed; frequency – at what stages of realization to do it; sample size; etc. You must then determine what MONITORING AND MEASURING DEVICE is appropriate for each measuring or monitoring requirement. Consideration must be given to the measurement capability (precision) of the MONITORING AND MEASURING DEVICE which may have to be several times greater than the tolerance criteria for product measurement. This would depend on the industry you are in and the criticality of end use for the product (e.g. the precision requirements for an engine block or for ball bearings may be much greater than say for cutting leather to cover a car seat). Personnel using MONITORING AND MEASURING DEVICE’s must have competence and training in the use of MONITORING AND MEASURING DEVICE’s in terms of their function, range and precision of measurement, reliability, use and maintenance. MONITORING AND MEASURING DEVICE’s may include measurement and testing tools; equipment; hardware and software. They may be owned by your organization; your employees or the customer. MONITORING AND MEASURING DEVICE’s may be used to verify product as well as to measure process conformity (e.g. a temperature controller on an oven). Besides MONITORING AND MEASURING DEVICE’s used for product conformity, you may need to calibrate and control certain MONITORING AND MEASURING DEVICE’s used in related and peripheral processes such as production equipment; tooling; maintenance; etc. To ensure valid measurement and monitoring results, MONITORING AND MEASURING DEVICE’s must be controlled. A process is required, to control the selection; purchase; identification; status; calibration; use; verification or adjustment; use; handling; maintenance and storage; training; nonconforming MONITORING AND MEASURING DEVICE’s; calibration records; etc. Appropriate records need to be kept of the use of these controls. All MONITORING AND MEASURING DEVICE’s used for product verification must be capable of being calibrated, verified or both. Calibration is setting or correcting an MONITORING AND MEASURING DEVICE, usually by adjusting it to match or conform to a dependably known and traceable standard (e.g. adjusting a micrometer or caliper to conform to master blocks traceable to national standards). Verification is confirming that the MONITORING AND MEASURING DEVICE is meeting or performing to acceptable national measurement standards and does not involve any correction or adjustment (e.g. verifying a ruler or tape measure against a calibrated ruler that has been calibrated to a national standard). A ruler or tape measure is generally not capable of being calibrated and when it gets out of calibration its use must be discontinued. There are MONITORING AND MEASURING DEVICE’s that are capable of being both calibrated and verified (e.g. a CMM- coordinate measuring machine) and may require both to be done in specific situations based on frequency of use and criticality of measurement. This requirement also applies to the use of computer software whose calibration status must be established prior to initial use and reconfirmed (verified) at defined intervals. You must define the frequency and method of calibration for each type and level (shop floor; laboratory or standard) of MONITORING AND MEASURING DEVICE. Your calibration records must identify what standard you used for calibration and show traceability of the standards you use at your facility to national or international standards. In rare circumstances, national or international standards may not exist for calibrating a specific MONITORING AND MEASURING DEVICE. In such situations consider using industry, manufacturer or even your own organizational standard to validate the accuracy and reliability of your MONITORING AND MEASURING DEVICE. Consult with your customer if the contractual circumstances require it.

A multitude of software tools are available to manage and control MONITORING AND MEASURING DEVICE’s including all the record keeping details required . There are many acceptable methods to identify MONITORING AND MEASURING DEVICE’s and their calibration status. The methods you select must consider the manufacturers recommendations; frequency of use; environment the MONITORING AND MEASURING DEVICE is used in; etc. Where an MONITORING AND MEASURING DEVICE is found to be out of calibration, you must take appropriate correction action to contain and re-verify the product affected, to the extent practical. This is in addition to containing, repair and recalibration of the defective MONITORING AND MEASURING DEVICE. Customer or internal engineering changes may result in a change in product measurement, requirements and/or the MONITORING AND MEASURING DEVICE to be used.  These changes would normally be reflected in your control plan. Ensure that your calibration process shows clear linkage to your process for change control and control plan .

1) Calibration/verification activities due to revisions due to engineering changes

When engineering changes occur in a product or process, it may be necessary to perform calibration and verification activities to ensure that the monitoring and measuring equipment used is still accurate and reliable. Here are the steps typically involved in calibration/verification activities due to revisions caused by engineering changes:

1. Identify the impact: Assess the engineering changes and determine which monitoring and measuring equipment are affected. Understand the nature of the changes and how they may influence the equipment’s calibration status.
2. Review calibration requirements: Evaluate the existing calibration requirements for the affected equipment. Determine if any adjustments or additions need to be made to accommodate the engineering changes. Consider factors such as measurement ranges, accuracy tolerances, and new reference standards, if applicable.
3. Update calibration procedures: Revise the calibration procedures to reflect the changes brought about by the engineering revisions. Document any new steps, adjustments, or additional measurements required to ensure accurate calibration.
4. Perform calibration: Follow the updated calibration procedures to recalibrate the affected equipment. Make any necessary adjustments or alignments to ensure the equipment meets the new requirements. Use appropriate traceable standards or reference materials during the calibration process.
5. Verify equipment performance: After calibration, conduct verification activities to confirm that the equipment is performing as intended. This may involve performing test measurements, comparing results against known standards, or conducting inter-laboratory comparisons to validate accuracy and reliability.
6. Update calibration records: Record the details of the calibration and verification activities performed as part of the engineering change process. Include information such as the date of calibration, personnel involved, reference standards used, and verification results. Ensure that all records are updated to reflect the revised calibration status.
7. Communicate changes: Inform relevant personnel and stakeholders about the engineering changes and the corresponding updates to the calibration and verification procedures. Ensure that everyone involved understands the revised requirements and follows the updated processes.
8. Ongoing monitoring: Regularly monitor the performance of the recalibrated equipment to ensure its continued accuracy. Consider implementing a schedule for periodic re-verification to maintain confidence in the equipment’s reliability, especially when significant engineering changes occur.

By following these steps, organizations can effectively manage calibration and verification activities resulting from engineering changes. This helps maintain the accuracy and reliability of the monitoring and measuring equipment, ensuring the quality and conformity of the products or processes throughout the revised engineering implementation.Regenerate response

2) Incidents of out-of-calibration readings

When incidents of out-of-calibration readings occur in monitoring and measuring equipment, it is crucial to conduct calibration and verification activities to address the issue. Here are the steps typically involved in calibration/verification activities due to incidents of out-of-calibration readings:

1. Identify the incident: Recognize and document any instances where the monitoring and measuring equipment has provided readings that are outside the acceptable calibration range or deviate from expected values. Identify the affected equipment and gather relevant data regarding the incident.
2. Isolate the equipment: If possible, remove the equipment from service and isolate it to prevent its further use until calibration or verification is completed. This ensures that no inaccurate measurements are taken with the out-of-calibration equipment.
3. Investigate the cause: Determine the cause of the out-of-calibration readings. This may involve analyzing factors such as environmental conditions, equipment handling, maintenance practices, or potential damage to the equipment. Identify any contributing factors to prevent future incidents.
4. Assess the impact: Evaluate the impact of the out-of-calibration readings on product quality, safety, or compliance. Determine if any non-conforming products were produced as a result and take appropriate corrective actions if necessary.
5. Perform calibration/verification: Depending on the nature of the incident and the equipment involved, perform calibration or verification activities. Calibration involves adjusting the equipment to meet specified accuracy requirements, while verification confirms the equipment’s performance against reference standards without making adjustments.
6. Update calibration records: Document all calibration or verification activities performed in response to the incident. Include details such as the date, personnel involved, procedures followed, reference standards used, and the results obtained. This documentation helps maintain a traceable record of the equipment’s calibration status.
7. Implement corrective actions: If the out-of-calibration incident was caused by specific issues, implement corrective actions to prevent recurrence. This may involve equipment maintenance, improved handling procedures, environmental controls, or staff training.
8. Communicate and train: Inform relevant personnel about the incident, the corrective actions taken, and any revised procedures or requirements. Provide training if necessary to ensure proper equipment handling and usage to prevent future out-of-calibration incidents.
9. Ongoing monitoring: Regularly monitor the performance of the recalibrated or verified equipment to ensure its continued accuracy. Implement a schedule for periodic re-calibration or re-verification to maintain confidence in the equipment’s reliability.

By following these steps, organizations can effectively address incidents of out-of-calibration readings and ensure the accuracy and reliability of their monitoring and measuring equipment. This helps maintain product quality, compliance with standards, and customer satisfaction.

3) Assessment of the risk caused by the out-of-calibration condition

Assessing the risk caused by an out-of-calibration condition is important to understand the potential impact on product quality, safety, and compliance. Here are some key steps in assessing the risk associated with an out-of-calibration condition:

1. Identify potential risks: Consider the potential consequences of using equipment that is out of calibration. This could include inaccurate measurements, faulty product evaluation, non-compliance with regulations or standards, compromised safety, increased scrap or rework, customer dissatisfaction, or potential product recalls.
2. Determine severity: Evaluate the severity of the potential risks identified. Assess the impact of inaccurate measurements or non-compliance on product performance, safety, or customer satisfaction. Classify the severity level based on the potential consequences, such as minor impact, moderate impact, or severe impact.
3. Assess likelihood: Determine the likelihood of the identified risks occurring due to the out-of-calibration condition. Consider factors such as the frequency of equipment use, the criticality of measurements in the process, the level of control over the equipment, and the historical performance of the equipment. Classify the likelihood as low, medium, or high.
4. Evaluate risk levels: Combine the severity and likelihood classifications to determine the overall risk level associated with the out-of-calibration condition. Use a risk matrix or similar tool to assess the risk level as low, medium, or high. This helps prioritize actions and resources for mitigating the identified risks.
5. Mitigate risks: Develop and implement appropriate measures to mitigate the identified risks. This may involve actions such as recalibrating the equipment, replacing faulty components, implementing additional quality checks, adjusting process parameters, conducting additional inspections, or using alternative equipment. The specific mitigation measures will depend on the assessed risk level and the potential consequences.
6. Monitor and review: Continuously monitor the effectiveness of the mitigation measures and regularly review the risk assessment. If necessary, adjust the mitigation actions or reassess the risk levels based on new information or changes in the operating conditions.
7. Document and communicate: Document the risk assessment process, including the identified risks, their severity and likelihood classifications, and the implemented mitigation measures. Communicate the findings and actions to relevant stakeholders, including management, quality assurance personnel, and operators, to ensure awareness and compliance with the mitigation measures.

By conducting a thorough risk assessment, organizations can better understand the potential impact of an out-of-calibration condition and take appropriate measures to mitigate the associated risks. This helps maintain product quality, safety, and compliance while minimizing potential adverse effects on customer satisfaction and business operations.

4) Records previous measurement results obtained with this piece of test equipment, last calibration date and the next due dates;

When a piece of inspection, measurement, and test equipment is found to be out of calibration or defective, it is essential to retain documented information on the validity of previous measurement results obtained with that equipment. This documentation helps ensure traceability and provides information for decision-making regarding the impacted measurements. Here are the key details that should be retained:

1. Equipment identification: Clearly identify the specific piece of equipment that was found to be out of calibration or defective. Include details such as the equipment’s unique identifier, model number, and any other relevant information for proper identification.
2. Previous measurement results: Document the previous measurement results obtained using the equipment. Include information such as the date of the measurement, the specific measurement performed, and the recorded value. This information helps establish a record of the historical data obtained with the equipment.
3. Calibration status: Note the calibration status of the equipment at the time of the previous measurements. Document the last calibration date and the associated calibration certificate or report. This provides information on the calibration state of the equipment during the previous measurement activities.
4. Next due date: Record the next due date for calibration on the calibration report or certificate. This information helps schedule and plan future calibration activities for the equipment.

By retaining this documented information, organizations can:

• Assess the impact: Determine the impact of the out-of-calibration or defective condition on the validity of the previous measurement results. This helps understand the potential inaccuracies or uncertainties associated with the affected measurements.
• Take corrective actions: Use the documented information to decide on appropriate corrective actions. This may involve recalibration, repair, replacement, or any other necessary steps to address the out-of-calibration or defective condition.
• Plan future calibration activities: By noting the next due date for calibration, organizations can schedule and plan the timely calibration of the equipment to ensure its continued accuracy and reliability.
• Maintain traceability: The retained documentation enables traceability and provides an audit trail for the equipment’s calibration history and measurement results. This supports compliance with quality standards and regulatory requirements.

It is important to establish clear procedures for documenting and retaining this information, ensuring its accessibility and confidentiality as needed.

5) Notification to the customer if suspect product or material has been shipped

If a suspect product or material has been shipped to a customer, it is crucial to promptly notify the customer about the situation. Open and transparent communication helps maintain trust and enables the customer to take appropriate actions. Here’s a general guideline on how to handle the notification process:

1. Gather information: Gather all relevant details about the suspect product or material, including its identification, batch or lot number, production or shipment dates, and any specific concerns or issues associated with it. This information will help provide a clear and accurate description of the situation to the customer.
2. Assess the risk: Evaluate the potential risk or impact of the suspect product or material on the customer. Consider factors such as safety concerns, compliance with specifications or regulations, and any potential effects on the customer’s operations or end products. This assessment will guide the content and urgency of the notification.
3. Prepare the notification: Craft a clear, concise, and factual notification message. Include the essential information such as the reason for the notification, a description of the suspect product or material, any known risks or concerns, and the actions being taken to address the issue. Provide contact information for further inquiries or assistance.
4. Determine the communication method: Decide on the most appropriate method of communication based on the urgency and significance of the situation. Depending on the customer relationship, consider options such as phone calls, email notifications, written letters, or a combination of these channels. Choose a method that ensures timely and effective communication.
5. Notify the customer: Contact the customer or send the notification message using the chosen communication method. Be proactive and ensure that the message reaches the appropriate person or department within the customer’s organization. Provide the necessary information to facilitate their understanding of the situation and enable them to take appropriate actions on their end.
6. Offer support and solutions: Express a willingness to assist the customer in managing the situation. Offer support, provide guidance on potential next steps, and outline any corrective measures or remedial actions being implemented. Demonstrate a commitment to addressing the issue and minimizing any negative impact on the customer.
7. Document the notification: Maintain a record of the notification sent, including the date, recipient, method of communication, and the content of the message. This documentation ensures that the communication process is properly documented for future reference or audits.
8. Follow-up and resolution: Stay in regular communication with the customer to provide updates on the progress of investigations, corrective actions, or any further information that may arise. Work closely with the customer to resolve the issue to their satisfaction and ensure the necessary steps are taken to prevent similar incidents in the future.

Remember, it is important to adhere to any applicable legal or contractual requirements regarding customer notifications, such as specific time frames or obligations outlined in agreements or regulations.

6) Statements of conformity to specification after calibration/verification

fter calibration or verification of monitoring and measuring equipment, statements of conformity to specification can be issued to indicate that the equipment meets the specified requirements. These statements provide assurance that the equipment is accurate and reliable for use in measuring or monitoring processes. Here are some key points to include in statements of conformity:

1. Equipment identification: Clearly identify the specific equipment for which the statement of conformity is being issued. Include details such as the equipment’s unique identifier, model number, and any other relevant information for proper identification.
2. Calibration/verification information: State that the equipment has undergone calibration or verification activities, specifying the methods and standards used. Include the date of calibration or verification and reference the corresponding calibration certificate or verification report.
3. Specification reference: Refer to the applicable specification, standard, or requirements against which the equipment was calibrated or verified. This may include industry standards, customer-specific requirements, or regulatory standards.
4. Conformity statement: Declare that the equipment, after calibration or verification, conforms to the specified requirements. This statement signifies that the equipment is accurate, reliable, and capable of providing measurements within the specified tolerances.
5. Measurement range: Specify the measurement range within which the equipment has been calibrated or verified. This ensures that users understand the valid range of measurements for which the equipment’s accuracy has been confirmed.
6. Validity period: Indicate the period of validity for the statement of conformity. This refers to the duration for which the calibration or verification is considered valid. It is typically based on the recommended calibration interval or the specific requirements of the application.
7. Authorized signature and contact information: Include the name, position, and signature of the authorized person issuing the statement of conformity. Provide contact information for further inquiries or requests related to the equipment’s calibration or verification.
8. Additional details (optional): Include any additional relevant information, such as any limitations or restrictions on the use of the equipment, special handling requirements, or any specific conditions under which the statement of conformity is applicable.

It is important to ensure that the statements of conformity are accurate, complete, and in compliance with any applicable regulations, standards, or customer requirements. Proper documentation and record-keeping of these statements support traceability and demonstrate compliance with quality assurance practices.

7) Verification that the software version used for product and process control is as specified

To verify that the software version used for product and process control is as specified, organizations can follow these steps:

1. Document software specifications: Clearly define and document the required software version(s) for product and process control. This includes identifying the specific software version number, any associated modules or components, and any other relevant details.
2. Configuration management: Implement a robust configuration management process to track and control software versions used in the organization. This process should include procedures for identifying, acquiring, installing, and validating software versions.
3. Software version tracking: Maintain a comprehensive record of the software versions used for product and process control. This can be done through a configuration management system or a designated document that lists the approved software versions and their corresponding specifications.
4. Regular audits: Conduct periodic audits to verify that the software versions in use align with the specified requirements. Compare the software versions being used against the documented specifications to ensure compliance.
5. Documentation review: Review relevant documentation, such as configuration records, system logs, or installation records, to confirm that the documented software versions are being consistently used in product and process control.
6. Testing and validation: Perform testing and validation activities to verify that the specified software versions are functioning correctly and meet the intended purpose. This can involve conducting functional testing, performance testing, or other appropriate methods to ensure the software is working as expected.
7. Change management process: Implement a robust change management process for software updates. Any changes to the software version used for product and process control should go through a controlled process, including evaluation, testing, and approval, to ensure the changes align with the specified requirements.
8. Documentation and records: Maintain proper documentation and records of the software versions used for product and process control. This includes maintaining records of software installations, updates, validations, and any associated validation or verification results.

By following these steps, organizations can effectively verify that the software version used for product and process control aligns with the specified requirements. This helps ensure consistency, accuracy, and compliance in software usage, contributing to overall product quality and process efficiency.

8) Records of the calibration and maintenance activities for all gauging

Maintaining records of calibration and maintenance activities for all gauging equipment, including employee-owned equipment, customer-owned equipment, and on-site supplier-owned equipment, is crucial for ensuring traceability, compliance, and effective equipment management. Here are the key aspects to consider when documenting these activities:

1. Equipment identification: Clearly identify each piece of gauging equipment involved, including its unique identifier, model number, and any other relevant information for accurate identification.
2. Calibration and maintenance schedule: Establish a calibration and maintenance schedule for each piece of gauging equipment based on regulatory requirements, industry standards, and internal policies. This schedule should outline the frequency of calibration and maintenance activities.
3. Calibration certificates and reports: Retain copies of calibration certificates and reports for all gauging equipment. These documents should include details such as the date of calibration, equipment condition before and after calibration, calibration standards used, calibration results, and any adjustments made during calibration.
4. Maintenance records: Document all maintenance activities performed on the gauging equipment. This includes preventive maintenance, corrective maintenance, repairs, and adjustments made to ensure the equipment’s optimal performance. Record the date, nature of maintenance performed, parts replaced, and personnel involved.
5. Calibration and maintenance logs: Maintain a centralized log or database to record all calibration and maintenance activities. This log should include information such as equipment identification, date of calibration/maintenance, the purpose of the activity, personnel responsible, and any relevant notes or observations.
6. Employee-owned equipment: If employees use their own gauging equipment, establish procedures for documenting calibration and maintenance activities. Ensure that employees provide calibration certificates or maintenance records for their equipment, and retain these records as part of the overall equipment documentation.
7. Customer-owned equipment: If the organization is responsible for calibrating or maintaining customer-owned gauging equipment, maintain separate records for each customer’s equipment. Document calibration and maintenance activities performed on customer-owned equipment, including any communication or approvals obtained from the customer.
8. Supplier-owned equipment: If suppliers provide gauging equipment for on-site use, establish procedures for documenting calibration and maintenance activities for this equipment. Obtain and retain calibration certificates or maintenance records provided by the supplier.
9. Record retention: Ensure that all calibration and maintenance records are securely stored and retained for the required period. This duration may be determined by regulatory requirements, industry standards, or organizational policies.
10. Compliance audits: Regularly conduct internal audits to review the calibration and maintenance records for all gauging equipment. This helps ensure compliance with established procedures and provides an opportunity to identify any deviations or non-conformists.

By diligently documenting calibration and maintenance activities for all gauging equipment, organizations can ensure proper equipment management, compliance with standards, and traceability of measurement results.

9) Production-related software verification used for product and process control

Production-related software verification plays a critical role in ensuring the effectiveness and reliability of software used for product and process control. Here are the key considerations for verifying production-related software:

1. Requirements verification: Verify that the production-related software meets the specified requirements. This involves ensuring that the software functionalities, features, and performance characteristics align with the intended use and organizational needs. Conduct a thorough review and analysis of the software requirements documentation to ensure completeness and accuracy.
2. Functional testing: Perform functional testing to verify that the software functions as intended. This involves executing test cases or scenarios that validate the software’s functionalities and ensure it behaves correctly under different conditions. The testing should cover all critical aspects of the software’s operation and use.
3. Performance testing: Conduct performance testing to assess the software’s performance under expected usage scenarios. This includes measuring response times, throughput, system scalability, and resource utilization to ensure the software can handle the expected workload efficiently.
4. Integration testing: Verify the software’s compatibility and proper integration with other systems, modules, or components that it interacts with. This testing ensures smooth data exchange, functionality, and communication between different software components or systems.
5. Data integrity and security: Verify the software’s ability to maintain data integrity and security. This includes validating data input and output, encryption mechanisms, access controls, and compliance with data protection regulations. Perform vulnerability assessments and penetration testing to identify and address potential security risks.
6. User acceptance testing: Involve end-users and stakeholders in user acceptance testing to verify that the software meets their requirements and expectations. Gather feedback and insights from users to identify any usability issues, user interface concerns, or functional gaps that need to be addressed.
7. Version control and change management: Implement robust version control and change management practices to ensure proper identification, tracking, and documentation of software versions and changes. This includes establishing procedures for software updates, maintaining a change log, and validating the impact of changes on product and process control.
8. Documentation and records: Document all verification activities, including test plans, test results, issues identified, and any corrective actions taken. Maintain proper records to demonstrate compliance with verification processes and provide an audit trail for future reference.
9. Compliance with standards and regulations: Ensure that the production-related software adheres to relevant industry standards, regulations, and quality management system requirements. This includes validating compliance with applicable standards such as ISO 9001, IATF 16949, or specific industry-specific standards.
10. Ongoing monitoring and validation: Continuously monitor the performance of the production-related software and conduct periodic reviews and validations to ensure it remains effective, reliable, and aligned with changing requirements.

By following these steps, organizations can effectively verify production-related software used for product and process control, ensuring its reliability, functionality, and compliance with requirements.