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.

Measurement Systems Analysis (MSA) is an important component of the International Automotive Task Force (IATF) 16949 standard, which is the quality management system (QMS) standard for the automotive industry. MSA aims to ensure that measurement systems used in automotive manufacturing processes are reliable, consistent, and capable of providing accurate data for decision-making.In IATF 16949, specifically in Clause 7.1.5.1.1, MSA is addressed as part of the requirements for determining the suitability and effectiveness of measurement systems. This clause emphasizes the need for organizations to assess and validate their measurement systems to ensure their reliability and accuracy.Here are some key points related to Measurement Systems Analysis in IATF 16949:

1. Evaluation of Measurement Systems: Organizations are required to evaluate their measurement systems to determine their suitability for the intended application. This evaluation includes assessing the capability of the measurement systems to provide accurate and consistent data.
2. Measurement System Studies: Organizations should conduct measurement system studies to assess the variation and stability of the measurement systems. These studies involve statistical analysis techniques, such as Gauge R&R (Repeatability and Reproducibility) studies, to determine the sources of measurement error and quantify their impact on the measurement results.
3. Criteria for Acceptance: The standard sets specific criteria for the acceptance of measurement systems. These criteria may include acceptable levels of repeatability and reproducibility, as well as other relevant performance indicators.
4. Corrective Actions: If measurement system studies reveal deficiencies or unacceptable performance, organizations are required to take corrective actions to improve the measurement systems. This may involve calibration, maintenance, training, or replacement of equipment, as necessary.
5. Documentation: The results of measurement system studies, including the evaluation and any corrective actions, should be properly documented. This documentation serves as evidence of compliance with the MSA requirements of IATF 16949.

By incorporating Measurement Systems Analysis into their quality management systems, automotive organizations can ensure that their measurement systems provide accurate and reliable data, leading to improved product quality, customer satisfaction, and overall process efficiency.

As identified in the control plan, for each type of inspection , measurement and test equipment system statistical study must be conducted to analyse the variation. The analytical method and acceptance criteria must conform to those in reference manual either in

• AIAG – measurement system analysis (MSA)
• ANFIA – AQ 024 MSA Measurement system analysis
• VDA – Volume 5 “Capability of Measuring System”
• Any other if approved by customer.

Records of customer approval for alternative methods must be kept, along with the findings from analyzing alternative measurement systems. The prioritization of measurement system analysis studies should concentrate on critical or special product or process characteristics.

[ This article only covers MSA as given in IATF 16949:2016 For detail study in MSA click here]

The standard requires appropriate statistical studies to be conducted to analyze the variation present in the results of each type of measuring and test equipment system. Your control plan must define the measurement and monitoring required and the type of Monitoring and Measuring Device needed for it, including the frequency of measurement and acceptance criteria. Use customer reference manuals, such as the Measurement Systems Analysis (MSA) manual, to conduct statistical studies on Monitoring and Measuring Device’s referenced in your control plans. Ensure that personnel performing such statistical studies are trained and competent to do so. The quality of measurement data is subject to variability related to the measuring device, the measuring process, the operator using the measuring device, the product being measured, the environment the measurements are made in, etc. The study and control of the statistical characteristics (bias, repeatability, reproducibility, stability and linearity) that measure these variables is called Measurement System Analysis (MSA). The IATF 16949 standard requires that the MMD or category (verniers, calipers, etc.) of Monitoring and Measuring Device referenced in product Control Plans be subject to statistical analysis. The analysis methods and acceptance criteria for the statistical characteristics referred to above must conform to automotive OEM – MSA reference manuals. Other methods and acceptance criteria may be used if approved by the customer. A measurement system consists of the operations (i.e. the measurement tasks and the environment in which they are carried out), procedures (i.e. how the tasks are performed), devices (i.e. gages, instruments, software, etc. used to make the measurements), and the personnel used to assign a quantity to the characteristics being measured. Measurement systems must be in statistical control so that all variation is due to common cause and not special cause. IATF 16949 therefore requires that you devise a measurement system for all measurements specified in the control plan in which all variation is in statistical control. It is often assumed that the measurements taken with a calibrated device are accurate, and indeed they are if we take account of the variation that is present in every measuring system and bring the system under statistical control. Variation in measurement systems arises due to bias, repeatability, reproducibility, stability, and linearity.

• Bias is the difference between the observed average of the measurements and the
• reference value.
• Repeatability is the variation in measurements obtained by one appraiser using one measuring device to measure an identical characteristic on the same part.
• Reproducibility is the variation in the average of the measurements made by differ-
• ent appraisers using the same measuring instrument when measuring an identical
• characteristic on the same part.
• Stability is the total variation in the measurements obtained with a measurement system on the same part when measuring a single characteristic over a period of time.
• Linearity is the difference in the bias values through the expected operating range of the measuring device.

It is only possible to supply parts with identical characteristics if the measurement system as well as the production processes are under statistical control. In an environment in which daily production quantities are in the range of 1,000 to 10,000 units, inaccuracies in the measurement system that go undetected can have a disastrous impact on customer satisfaction and hence profits. Gage and test equipment requirements are required to be formulated during product design and development and this forms the input data to the process design and development phase. During this phase a measurement system analysis plan is required to accomplish the required analysis. During the product and process validation phase, measurement system evaluation is required to be carried out during or prior to the production trial run and during full production continuous improvement is required to reduce measurement system variation.

MSA Techniques

When performing Measurement Systems Analysis (MSA) for IATF 16949 compliance, several statistical methods and tools can be used to assess the reliability and capability of measurement systems. Here are some commonly employed techniques:

1. Gauge R&R (Repeatability and Reproducibility) Study: This is a fundamental statistical method for MSA. It evaluates the amount of variation in measurements attributable to repeatability (variation within the same operator and equipment) and reproducibility (variation between different operators and equipment). Gauge R&R studies can be performed using statistical techniques such as ANOVA (Analysis of Variance) to quantify the sources of variation.
2. Control Charts: Control charts are used to monitor and control measurement system performance over time. These charts can be employed to track measurement data and detect any variations or out-of-control conditions in the system. Common control charts used in MSA include the X-bar and R charts for continuous data and the p-chart for attribute data.
3. Capability Analysis: Capability analysis is used to assess whether a measurement system is capable of meeting specified requirements. Statistical indices like Cp, Cpk, and %GR&R (Percent Gauge R&R) are calculated to determine if the measurement system is capable of consistently providing accurate and precise measurements within specified tolerances.
4. Correlation Analysis: Correlation analysis examines the relationship between different measurement systems or between a measurement system and a reference standard. Statistical measures like correlation coefficients (e.g., Pearson’s correlation coefficient) can be used to quantify the strength and direction of the relationship.
5. Analysis of Bias: Bias analysis is performed to determine if there is a systematic difference between the measurement system and a known reference value. Statistical techniques, such as a t-test or bias plot, can be used to assess the magnitude and significance of any bias.
6. Linearity Analysis: Linearity analysis evaluates how well a measurement system maintains a linear relationship between measurements and the true values across the measurement range. Statistical methods like regression analysis can be used to assess linearity and identify any deviations from linearity.
7. Stability Analysis: Stability analysis examines the long-term performance and consistency of a measurement system over time. Control charts or other statistical techniques can be used to monitor trends, shifts, or drifts in the measurement data to ensure the stability of the system.
8. Sample Size Determination: Statistical methods can be employed to determine the appropriate sample size for conducting MSA studies. Techniques such as power analysis can help determine the minimum sample size needed to achieve a desired level of statistical confidence.

These are just a few examples of statistical methods and tools that can be utilized for MSA in accordance with IATF 16949. The specific techniques employed will depend on the characteristics of the measurement system and the requirements of the organization. It is essential to have a good understanding of statistical analysis and to use appropriate software or statistical packages to perform the necessary calculations and graphical representations.Regenerate response

Steps to Conduct MSA

When conducting a statistical study for Measurement Systems Analysis (MSA), there are several key steps involved. Here is an overview of the typical process:

1. Define the Objective: Clearly define the objective of the MSA study, such as evaluating the capability of a measurement system or identifying sources of measurement variation.
2. Select Measurement Systems: Identify the measurement systems that will be included in the study. This may involve selecting specific instruments, gauges, or devices used for measurement.
3. Define Measurement Characteristics: Determine the specific characteristics or features that will be measured by the selected measurement systems. For example, if measuring the length of a part, the characteristic could be the distance in millimeters.
4. Plan the Study: Develop a study plan that outlines the methodology, sample size, measurement procedure, and other relevant details. The plan should be designed to ensure statistical validity and reliability of the study.
5. Data Collection: Collect data by performing measurements using the selected measurement systems. Follow the defined measurement procedure consistently for each sample or part.
6. Repetition and Reproducibility: Analysis: Conduct a Gauge R&R study to evaluate the repeatability and reproducibility of the measurement systems. This involves comparing the variation within each system (repeatability) and the variation between different systems or operators (reproducibility).
7. Statistical Analysis: Use statistical techniques to analyze the collected data. This may include calculating various statistics such as range, standard deviation, analysis of variance (ANOVA), and calculation of gauge R&R components (e.g., repeatability, reproducibility, and interaction).
8. Interpret Results: Interpret the results of the statistical analysis to assess the performance of the measurement systems. Determine if the systems meet the required criteria for accuracy, reliability, and capability. Identify any sources of measurement error or variation that need to be addressed.
9. Take Corrective Actions: If the study reveals deficiencies or unacceptable performance, take appropriate corrective actions to improve the measurement systems. This may involve recalibration, adjustment, repair, or replacement of equipment, as well as training for operators.
10. Documentation: Document all the study details, including the study plan, data collection procedures, analysis results, interpretations, and any corrective actions taken. This documentation serves as a record of compliance with MSA requirements and facilitates future reference.

Remember, conducting an MSA study requires knowledge of statistical methods and tools. It is recommended to involve individuals with expertise in statistical analysis or quality engineering to ensure accurate and reliable results.

Prioritization of critical or special products

When it comes to conducting Measurement System Analysis (MSA) studies, prioritization should indeed focus on critical or special product or process characteristics. Here’s why:

1. Significance: Critical or special product or process characteristics are those that have a significant impact on the quality, performance, or compliance of the product or process. These characteristics are directly related to customer requirements, regulatory standards, or key performance indicators. By prioritizing them, you ensure that the most important aspects are thoroughly assessed and validated.
2. Risk mitigation: MSA studies help evaluate the reliability and accuracy of measurement systems. By focusing on critical characteristics, you reduce the risk of erroneous measurements and the potential for defective products or non-compliance. Prioritizing these characteristics allows you to identify and address measurement errors that could have a substantial impact on the final product or process.
3. Resource optimization: MSA studies can be time-consuming and resource-intensive. Prioritizing critical or special characteristics helps allocate resources effectively. By focusing efforts on the most significant aspects, you can maximize the efficiency of the study and ensure that resources are not wasted on less critical measurements.
4. Continuous improvement: MSA studies are often part of a broader quality management system aimed at continuous improvement. By prioritizing critical or special characteristics, you can identify areas for improvement and take corrective actions accordingly. This targeted approach allows you to make meaningful enhancements to the measurement process and ultimately improve overall product or process quality.

However, it’s important to note that while prioritizing critical or special characteristics is essential, it doesn’t mean that other characteristics should be ignored completely. Depending on the context, it may be necessary to address other characteristics as well, especially if they contribute to the overall performance or customer satisfaction. A balanced approach should be taken to ensure comprehensive and effective measurement system analysis.

AIAG – measurement system analysis (MSA)

The Measurement Systems Analysis (MSA) reference manual published by the Automotive Industry Action Group (AIAG) is a widely recognized and authoritative resource for MSA in various industries, including automotive. The manual provides detailed guidance on conducting MSA studies and interpreting the results. The current version of the AIAG MSA reference manual is the fourth edition, published in 2010. It is commonly referred to as AIAG MSA 4th edition.The AIAG MSA reference manual covers a range of topics related to MSA, including:

1. Introduction to MSA: Provides an overview of MSA and its importance in quality management.
2. MSA Fundamentals: Explains the basic concepts and terminology used in MSA.
3. Measurement Systems Analysis Techniques: Describes different MSA techniques, including Gage R&R studies (crossed and nested designs), attribute agreement analysis, linearity and bias studies, stability analysis, and capability analysis.
4. MSA Study Design and Planning: Provides guidance on planning and designing MSA studies, including sample size determination, selection of measurement systems, and selecting appropriate measurement techniques.
5. Data Analysis and Interpretation: Covers statistical analysis techniques for MSA data, including analysis of variance (ANOVA), calculation of variance components, calculation of percent study variation, and assessment of measurement system capability.
6. MSA for Continuous Data and Attribute Data: Explores the specific considerations and techniques for MSA when dealing with continuous (variables) data and attribute (categorical) data.
7. MSA for Nondestructive Testing: Discusses MSA considerations for nondestructive testing methods, such as radiographic inspection, ultrasonic testing, and magnetic particle testing.

The AIAG MSA reference manual provides practical examples, templates, and case studies to aid in understanding and implementing MSA. It is a valuable resource for professionals involved in quality management, process improvement, and data analysis.It’s important to note that the AIAG MSA reference manual is a separate publication from the IATF 16949 standard. However, it aligns with the requirements of the IATF 16949 standard and is commonly used in conjunction with it, especially in the automotive industry.

Software tools to conduct MSA

There are several software tools available that can be used to conduct Measurement System Analysis (MSA). Here are some commonly used tools:

1. Minitab: Minitab is a statistical software package that offers a range of tools for data analysis, including MSA. It provides a user-friendly interface and a dedicated MSA module that guides users through the steps of conducting various MSA studies.
2. JMP: JMP is a data analysis and visualization tool developed by SAS. It provides robust capabilities for conducting MSA, including Gage R&R studies, attribute agreement analysis, and capability analysis. JMP offers a visual and interactive interface for MSA analysis.
3. Quality Companion: Quality Companion is a software tool from Minitab that offers comprehensive support for quality improvement projects. It includes MSA analysis capabilities along with other quality tools such as process mapping, control charts, and project management features.
4. QI Macros: QI Macros is an Excel add-in designed specifically for Lean Six Sigma and process improvement. It provides a set of templates and tools, including MSA analysis. QI Macros offers a simplified approach to conducting MSA directly within Excel.
5. R and Python: R and Python are powerful programming languages commonly used in data analysis and statistical modeling. They have various packages and libraries that provide MSA functionality. Examples include the “qcc” package in R and the “statsmodels” library in Python.
6. Excel: While Excel is not specifically designed for MSA, it can still be used for basic MSA calculations and analysis. Excel offers built-in functions and tools such as control charts, ANOVA, and regression analysis that can be utilized for conducting MSA studies.

When choosing a software tool for MSA, consider factors such as ease of use, available features, compatibility with your data format, and the specific requirements of your analysis. Additionally, ensure that the chosen tool supports the type of MSA study you want to conduct, whether it’s Gage R&R, attribute agreement analysis, linearity analysis, or others.

Environment for the operation of processes include controls for ergonomics; personnel safety and facility conditions that are conducive to achieving product quality. Some of the factors to consider in determining and managing ergonomics include – (worker movement; fatigue; manual effort and loads, etc); workplace location; social interaction; heat; light; humidity; airflow; noise; vibration; etc). The applicability and degree to which applicable of these factors will vary from facility to facility. The focus should be employee safety, welfare and product conformity. Personnel safety – factors to consider may include – defined responsibility for safety; error-proofing in DFMEA and PFMEA; knowledge and application of regulations; lessons learned from internal/external audits and corrective actions; records of accidents; workplace risk analysis; safety procedures; and use of safety equipment. Facility conditions include cleanliness of premises. Factors to consider may include defined responsibilities for order and cleanliness; appropriate disposal conditions; appropriate space and storage conditions; clean intact transport and operating equipment; organized, clean and well lit workplaces and inspection stations; hygiene standards; availability of facilities for lockers; lunchroom; cafeteria; washrooms; etc. Performance indicators to measure the effectiveness of processes that determine and control the effective use of infrastructure may include equipment maintenance – uptime/downtime; productivity equipment and workforce; accident and safety incidents; non-value added use of floor space; excessive handling and storage; number of instances specific resources were not available or delayed; etc.

Clause 7.1.4.1 Environment for the operation of processes

In addition the the requirements given in ISO 9001:2015 Clause 7.1.4 Environment for the operation of processes, in Clause 7.1.4.1 states that the organization needs to keep its facilities clean, tidy, and well-maintained in a way that matches the requirements of the product and manufacturing processes.

please click here for ISO 9001:2015 Clause 7.1.4 Environment for the operation of processes

The environment for the operation of processes is an important aspect within the IATF 16949 standard, which is a quality management system requirement for automotive suppliers. The standard recognizes the significance of providing a suitable work environment for the effective operation of processes and the well-being of employees. Here are some key considerations related to the work environment within the context of IATF 16949:

1. Health and Safety: The organization is required to establish and maintain a safe and healthy work environment. This includes identifying and addressing potential hazards, providing appropriate safety equipment, implementing safety procedures, and ensuring compliance with applicable health and safety regulations.
2. Ergonomics: The standard emphasizes the importance of ergonomics to minimize the risk of work-related injuries and promote employee well-being. Organizations should consider ergonomic principles when designing workstations, tools, and equipment to optimize efficiency and reduce physical strain on employees.
3. Cleanliness and Order: The work environment should be clean, organized, and well-maintained. This helps to prevent contamination, ensure efficient operations, and create a positive atmosphere for employees. Adequate measures should be taken to manage waste, cleanliness, and sanitation as required by the processes and regulatory requirements.
4. Noise and Vibration Control: If the processes involve high levels of noise or vibration, the organization should implement appropriate control measures to mitigate their impact. This may include using noise-damping materials, providing hearing protection, or implementing vibration isolation techniques to protect the health and comfort of employees.
5. Temperature and Humidity: Depending on the nature of the processes, maintaining suitable temperature and humidity levels may be necessary. Extreme variations in temperature or humidity can affect both product quality and employee comfort, so organizations should ensure that the work environment is appropriately controlled.
6. Employee Well-being: The organization should promote employee well-being by addressing factors such as employee comfort, adequate lighting, ventilation, and access to amenities such as restrooms and break areas. This can contribute to employee satisfaction, productivity, and overall morale.

To maintain premises in a state of order, cleanliness, and repair consistent with the product and manufacturing process needs, consider the following practices:

1. Regular Cleaning and Housekeeping: Implement a regular cleaning schedule to ensure that all areas of the premises are cleaned and maintained. This includes floors, walls, ceilings, equipment, storage areas, and common spaces. Assign responsibilities to specific individuals or teams to ensure accountability for cleanliness.
2. Establish Cleaning Procedures: Develop and document clear cleaning procedures that outline the methods, frequency, and responsibilities for cleaning different areas and equipment. Ensure that employees are trained on these procedures and understand their roles in maintaining cleanliness.
3. Implement 5S Methodology: Adopt the principles of 5S (Sort, Set in Order, Shine, Standardize, Sustain) to organize and maintain the work environment effectively. This methodology promotes a systematic approach to workplace organization, cleanliness, and visual management.
4. Preventive Maintenance: Establish a preventive maintenance program to proactively address repair and maintenance needs. Regularly inspect equipment, machinery, utilities, and infrastructure to identify potential issues and address them promptly. This helps to prevent breakdowns, minimize downtime, and ensure a safe working environment.
5. Equipment Calibration and Verification: Regularly calibrate and verify equipment to ensure accurate and reliable operation. This includes measuring devices, testing equipment, and any machinery that affects product quality or process control. Keep records of calibration activities to demonstrate compliance and traceability.
6. Risk Assessment and Mitigation: Conduct periodic risk assessments to identify potential hazards or risks that may impact the premises or manufacturing processes. Implement appropriate measures to mitigate these risks, such as installing safety systems, using protective equipment, or implementing process controls.
7. Training and Employee Engagement: Provide training to employees on the importance of maintaining a clean and organized work environment. Foster a culture of cleanliness and orderliness by encouraging employee involvement and ownership in maintaining the premises. Regularly communicate expectations and provide feedback to reinforce good practices.
8. Continuous Improvement: Establish a culture of continuous improvement where employees are encouraged to identify opportunities for enhancing cleanliness, organization, and repair. Implement suggestions and monitor the effectiveness of any improvements made.

Plant, facility, and equipment planning involves the strategic assessment, design, and implementation of physical assets to support operational activities within an organization. It entails analyzing requirements, selecting suitable locations, determining facility layout, acquiring and deploying equipment, and considering long-term maintenance and sustainability. Planning for the types of infrastructure resources needed for your business may include – facility; production equipment; IT equipment and software; laboratory; packaging; dies; molds; tooling; jigs; fixtures; storage; transportation; communication; office; materials; labor; utilities and supplies, etc. The key strategic business factors to be considered for infrastructure planning include: future needs; current availability and capacity; cushion for growth; contingency planning; linkage to current and future product programs. This planning may be done through business planning; quality management planning and planning for QMS processes . The actual deployment of such resources may be determined by each process owner. You must have a facilities plan for developing your infrastructure. This plan must address – plant layout; optimization of material travel and value-added use of floor space; synchronous material flow; waste reduction and lean manufacturing; facility and equipment maintenance; equipment capability and consistency; control of the work environment; employee and product safety; facility day to day housekeeping; and contingency planning. . The productivity and effectiveness of existing operations must be evaluated through consideration of – ergonomic and human factors; operator and line balance; storage and buffer inventory levels; use of automation; value added content and use of a work plan. You are required to maintain your infrastructure. Your planned preventive maintenance program should include controls for – schedule and timing; availability and training of personnel; types and scope of maintenance; maintenance and competency/training records; tracking to maintenance objectives; use, storage and control of spare parts; control of any maintenance outsourcing; etc.

Here are the key steps involved in plant, facility, and equipment planning:

Assess Requirements: Understand the organization’s operational needs, production capacity, growth projections, and regulatory compliance requirements. Identify the specific requirements for the plant, facility, and equipment, such as space, utilities, specialized infrastructure, and safety considerations.

Location Selection: Evaluate potential locations based on factors such as proximity to suppliers and customers, transportation access, availability of utilities, labor market, zoning regulations, and cost considerations. Choose a location that aligns with the organization’s strategic objectives and provides optimal operational efficiency.

Facility Layout Design: Develop a facility layout plan that optimizes workflow, minimizes material handling, and maximizes space utilization. Consider factors such as production flow, departmental interdependencies, safety requirements, ergonomics, and future expansion needs. Utilize tools like process flow diagrams, value stream mapping, and 3D modeling to aid in the design process.

Equipment Selection: Determine the specific equipment needed to support production processes and operational requirements. Consider factors such as capacity, capability, reliability, maintenance requirements, technological advancements, and compliance with industry standards. Evaluate different suppliers, obtain quotes, and select equipment that best meets the organization’s needs and budget.

Procurement and Installation: Once the equipment is selected, initiate the procurement process, including negotiations, purchase orders, and delivery schedules. Plan for the installation and integration of equipment into the facility, considering factors such as space requirements, utility connections, safety measures, and compliance with relevant regulations. Develop a detailed implementation timeline to ensure a smooth transition.

Maintenance Planning: Establish a comprehensive maintenance plan for the plant and equipment to ensure their optimal performance, longevity, and minimal downtime. This includes preventive maintenance schedules, calibration procedures, spare parts inventory management, and training programs for maintenance personnel.

Safety and Environmental Considerations: Incorporate safety protocols and regulations into the facility design and equipment selection, ensuring compliance with local, national, and industry standards. Implement safety training programs for employees and establish procedures for emergency response and incident management. Consider environmental sustainability by implementing energy-efficient practices, waste management systems, and environmentally friendly technologies.

Future Expansion and Flexibility: Anticipate future growth and changes in operational requirements. Design the plant and facility layout to accommodate potential expansion and modifications. Consider factors such as scalable infrastructure, adaptable floor plans, and flexible equipment arrangements to support future needs without significant disruptions.

Continuous Improvement: Regularly evaluate the performance of the plant, facility, and equipment using key performance indicators (KPIs). Monitor efficiency, productivity, maintenance effectiveness, safety records, and customer satisfaction. Identify areas for improvement, implement corrective actions, and continuously optimize the plant, facility, and equipment planning processes. By following these steps, organizations can develop effective plant, facility, and equipment plans that align with their operational needs, support growth, ensure safety, and drive operational excellence.

Clause 7.1.3.1 Plant, facility, and equipment planning

Using a multidisciplinary approach that considers risk identification and mitigation methods, the organization must develop and enhance plans for the plant, facility, and equipment. When creating plant layouts, the organization must optimize the flow of materials, material handling, and efficient use of floor space, which includes managing nonconforming products and ensuring synchronized material flow when necessary. Methods need to be established and put into practice for evaluating whether new products or operations are feasible for manufacturing. These evaluations should also include capacity planning. These methods should also be used to assess proposed changes to current operations. It is essential to maintain process effectiveness, periodically reassessing it in relation to risks and integrating any changes made during process approval, control plan implementation, maintenance, and job set-up verification. Evaluations of manufacturing feasibility and capacity planning should be considered during management reviews. These requirements should also incorporate the principles of lean manufacturing and apply to supplier activities on-site, where applicable.

Multi discipline Approach

When developing a Plant, Facility, and Equipment Plan within the context of IATF 16949, here are some key considerations:

1. Facility Layout: Design an efficient and well-organized facility layout that supports the production processes. Consider factors such as material flow, workstations, storage areas, and traffic patterns to optimize workflow and minimize waste.
2. Equipment Selection: Choose appropriate equipment based on the requirements of the manufacturing processes and product specifications. Ensure that the selected equipment is capable of meeting quality and production targets.
3. Maintenance Planning: Develop a comprehensive maintenance plan for all critical equipment to ensure their reliability and minimize downtime. Establish preventive maintenance schedules, calibration procedures, and spare parts inventory management systems.
4. Tooling and Gauging: Define requirements for tooling and gauging equipment to ensure accurate and consistent product measurements and adherence to customer specifications. Establish procedures for tooling maintenance, calibration, and replacement.
5. Capacity Planning: Assess production volume requirements and plan the capacity of the plant and equipment accordingly. Consider factors such as lead times, demand fluctuations, and planned growth to ensure adequate production capabilities.
6. Risk Assessment: Conduct a risk assessment to identify potential hazards and risks associated with the plant, facility, and equipment. Implement appropriate measures to mitigate or eliminate these risks, such as safety protocols, emergency response plans, and equipment safeguards.
7. Environmental Considerations: Incorporate environmental considerations into the plan, including waste management, energy efficiency, and compliance with environmental regulations. Implement measures to minimize the environmental impact of operations and promote sustainability.
8. Continual Improvement: Establish processes for monitoring and measuring the performance of the plant, facility, and equipment. Use key performance indicators (KPIs) to track productivity, quality, maintenance effectiveness, and other relevant metrics. Implement corrective actions and drive continual improvement initiatives based on the collected data.

Designing Plant layout

Here are some key aspects to consider when designing a plant layout in line with IATF principles:

1. Process Flow: Analyze the production processes and create a layout that ensures a smooth and logical flow of materials and components through the plant. Minimize unnecessary movement, backtracking, and congestion. Consider factors such as process sequence, material handling methods, and production rate requirements.
2. Workstation Design: Design workstations to optimize ergonomics, efficiency, and operator safety. Consider factors such as task requirements, workstation dimensions, equipment placement, lighting, and noise control. Ensure that workstations comply with relevant safety regulations and standards.
3. Material Handling: Determine the most efficient and safe methods for moving materials within the plant. Consider equipment such as conveyors, forklifts, automated guided vehicles (AGVs), or other suitable handling systems. Design the layout to minimize material transportation distances and eliminate bottlenecks.
4. Equipment Placement: Strategically place equipment, machinery, and tools within the plant layout. Consider factors such as workflow, space utilization, access for maintenance, and safety requirements. Ensure that equipment is properly spaced to allow for safe operation, maintenance, and operator movement.
5. Safety Considerations: Prioritize safety in the plant layout design. Incorporate safety measures such as clear signage, emergency exits, fire suppression systems, and safety barriers. Ensure that the layout adheres to local safety regulations and international standards such as ISO 45001 (Occupational Health and Safety Management Systems).
6. Material Storage: Determine the appropriate storage areas for raw materials, work-in-progress (WIP), and finished goods. Consider factors such as inventory management systems, accessibility, material flow, and rotation methods (e.g., FIFO). Implement storage systems that maximize space utilization and facilitate efficient material handling.
7. Traffic Flow: Plan the layout to ensure smooth and safe movement of vehicles and personnel within the plant. Separate pedestrian and vehicle traffic where necessary, designate clear traffic lanes, and provide adequate signage and markings. Ensure compliance with local traffic regulations and internal safety policies.
8. Expansion and Flexibility: Anticipate future growth and changes in production requirements when designing the plant layout. Plan for scalability and flexibility to accommodate modifications or expansion without significant disruptions. Consider modular designs and flexible space allocation to adapt to changing needs.
9. Lean Manufacturing Principles: Incorporate lean manufacturing principles into the plant layout design, such as the 5S methodology (Sort, Set in order, Shine, Standardize, Sustain) and waste reduction strategies. Optimize the layout to minimize waste, streamline processes, and create a visual workplace.
10. Continuous Improvement: Regularly review and analyze the plant layout to identify areas for improvement. Engage employees in the continuous improvement process and encourage their input and feedback. Implement changes based on data analysis, productivity metrics, and customer feedback to drive ongoing optimization.

Manufacturing feasibility assessments

A manufacturing feasibility assessment is a critical process for evaluating the viability and potential success of introducing a new product or establishing new manufacturing operations. It helps identify potential challenges, risks, and opportunities associated with the manufacturing process. Here are some key considerations for conducting a manufacturing feasibility assessment:

1. Product Design and Development: Evaluate the product design to ensure its compatibility with manufacturing processes. Assess factors such as complexity, required materials, manufacturing technologies, and assembly methods. Identify any design features that may pose challenges or require specialized manufacturing capabilities.
2. Manufacturing Processes: Analyze the required manufacturing processes and determine their feasibility. Consider factors such as equipment availability, technical expertise, production capacity, lead times, and costs. Assess whether the existing manufacturing facilities and capabilities are sufficient or if additional investments or partnerships are needed.
3. Supply Chain Assessment: Evaluate the availability and reliability of the necessary raw materials, components, and resources required for manufacturing. Assess the supplier base, potential risks in the supply chain, and any potential bottlenecks or dependencies. Consider alternative suppliers and develop contingency plans to mitigate supply chain disruptions.
4. Cost Analysis: Conduct a comprehensive cost analysis to determine the financial feasibility of manufacturing the new product or establishing new operations. Consider direct costs (materials, labor, equipment), indirect costs (overhead, maintenance, utilities), and any additional investments required (facilities, tooling, training). Compare the projected costs with anticipated revenues and market demand to assess profitability.
5. Production Capacity and Scaling: Assess the production capacity of the manufacturing operations and their ability to meet the anticipated demand for the new product. Evaluate the scalability of the manufacturing process to accommodate future growth. Consider factors such as equipment capacity, labor availability, floor space, and potential constraints in scaling up production.
6. Quality and Compliance: Evaluate the quality requirements of the new product and the ability of the manufacturing processes to meet those requirements consistently. Consider quality control measures, inspection protocols, and adherence to regulatory standards and industry certifications. Identify any potential quality risks and develop strategies to mitigate them.
7. Operational Efficiency: Analyze the efficiency of the manufacturing processes and identify opportunities for improvement. Consider lean manufacturing principles, automation possibilities, waste reduction strategies, and process optimization techniques. Assess the potential for increasing productivity, reducing cycle times, and improving overall operational performance.
8. Human Resources and Training: Evaluate the availability and skills of the workforce required for the manufacturing operations. Assess the need for specialized training or hiring new employees with specific expertise. Consider labor costs, employee retention strategies, and the ability to attract and retain skilled workers.
9. Risk Assessment and Mitigation: Identify potential risks and challenges associated with the manufacturing process. Evaluate factors such as market demand volatility, competition, technological disruptions, regulatory changes, and geopolitical factors. Develop risk mitigation strategies and contingency plans to address these challenges.
10. Timeline and Project Management: Develop a timeline and project plan for implementing the manufacturing operations or launching the new product. Consider factors such as lead times for equipment procurement, facility setup, employee training, and regulatory approvals. Ensure that the project plan accounts for dependencies, milestones, and resource allocation.

By conducting a thorough manufacturing feasibility assessment, you can identify potential barriers and risks early on, make informed decisions, and develop strategies to address challenges. This assessment lays the foundation for a successful and efficient manufacturing process for the new product or new operations.

When conducting a manufacturing feasibility assessment, capacity planning should indeed be an integral part of the assessment process. Here’s how capacity planning can be incorporated into a manufacturing feasibility assessment:

1. Define Production Requirements: Determine the production requirements for the new product or operations. This includes estimating the expected demand, production volume, and production rate needed to meet market demand.
2. Assess Existing Capacity: Evaluate the current manufacturing capacity in terms of available resources, such as floor space, equipment, and labor. Identify any limitations or bottlenecks that may impact the ability to meet the production requirements.
3. Gap Analysis: Compare the production requirements with the existing capacity to identify any gaps. Assess whether the current capacity can handle the projected production volume or if additional resources and capacity enhancements are necessary.
4. Scalability and Flexibility: Evaluate the scalability and flexibility of the manufacturing operations. Consider the ability to scale up or down production volume in response to changing market demands. Assess the feasibility of adding shifts, expanding facilities, or acquiring additional equipment to accommodate fluctuations in production requirements.
5. Resource Planning: Plan the allocation of resources needed to meet the projected production volume. This includes determining the number of skilled workers required, evaluating the availability of equipment, and assessing the availability of raw materials and components from suppliers.
6. Production Efficiency: Consider factors that impact production efficiency, such as production cycle times, equipment uptime, and production yields. Analyze the potential for process improvements, automation, and lean manufacturing practices to enhance production efficiency and increase capacity utilization.
7. Financial Considerations: Assess the financial implications of capacity planning. Evaluate the cost of acquiring additional capacity or making capacity enhancements compared to the potential revenue and profitability of the new product or operations.
8. Risk Analysis: Identify potential risks and uncertainties that may impact capacity planning, such as supply chain disruptions, equipment breakdowns, or labor shortages. Develop contingency plans and risk mitigation strategies to address these risks and ensure uninterrupted production.

By incorporating capacity planning into the manufacturing feasibility assessment, organizations can ensure that they have the necessary resources and capabilities to meet production requirements and capitalize on market opportunities. It helps identify any constraints or limitations early on and allows for appropriate planning and decision-making to optimize production capacity.

Quality objectives are specific, measurable goals that an organization sets to improve its quality management system and meet customer requirements. These objectives are typically derived from the organization’s quality policy and are aligned with its overall business objectives. Quality objectives provide a clear direction and focus for the organization’s quality efforts and serve as a basis for monitoring and measuring performance. When implementing IATF 16949, organizations typically set quality objectives to drive continuous improvement and meet customer requirements. Here are some common quality objectives in IATF 16949:

1. Defect reduction: This objective focuses on minimizing defects and improving product quality. It may involve implementing robust quality control measures, conducting thorough inspections, and reducing the number of nonconformities.
2. Customer satisfaction: Ensuring customer satisfaction is a crucial objective in IATF 16949. It involves meeting customer requirements, addressing customer feedback and complaints, and maintaining high levels of customer satisfaction throughout the product lifecycle.
3. On-time delivery: Timely delivery of products is essential in the automotive industry. Organizations may set objectives related to meeting delivery deadlines, reducing lead times, and improving overall delivery performance to customers.
4. Cost reduction: Cost management is important in automotive manufacturing. Objectives may include reducing production costs, optimizing processes to eliminate waste and inefficiencies, and improving cost-effectiveness throughout the supply chain.
5. Process efficiency: Improving process efficiency helps organizations streamline operations and enhance productivity. Objectives may involve reducing cycle times, improving process flow, implementing lean manufacturing principles, and optimizing resource utilization.
6. Supplier performance: Managing supplier relationships and ensuring their performance is critical for automotive manufacturers. Quality objectives may include improving supplier quality, reducing defects from incoming materials, and enhancing collaboration with suppliers to meet quality standards.
7. Continuous improvement: IATF 16949 emphasizes a culture of continuous improvement. Objectives may involve implementing methodologies such as Six Sigma or Lean to drive ongoing enhancements in quality, productivity, and customer satisfaction.

It’s important to note that quality objectives should be specific, measurable, achievable, relevant, and time-bound (SMART) to effectively guide the organization’s efforts and monitor progress towards quality goals. These objectives should be regularly reviewed, updated, and communicated to all relevant stakeholders to ensure alignment and commitment throughout the organization.

IATF 16949:2016 Clause 6.2.2.1 Quality objectives and planning to achieve them

In addition to the requirements given in ISO 9001:2015 Clause 6.2 Quality objectives and planning to achieve them, in clause 6.2.2.1,

Top management must make sure that quality objectives are set, implemented, and kept up for the appropriate functions, processes, and levels across the organization to meet customer requirements. The findings from the organization’s review of its interested parties and their relevant needs should be taken into account when the targets.

Please click here for ISO 9001:2015 Clause 6.2 Quality objectives and planning to achieve them

Top Management

Top management has a crucial role in defining, establishing, and maintaining quality objectives that align with customer requirements. Here are some key points related to this responsibility:

1. Leadership and commitment: Top management must demonstrate leadership and a strong commitment to quality objectives. They should communicate the importance of meeting customer requirements and drive the organization’s focus on achieving them.
2. Establishing quality objectives: Top management is responsible for establishing quality objectives at relevant functions, processes, and levels within the organization. These objectives should be aligned with the organization’s quality policy and be consistent with customer expectations.
3. Ensuring relevance and effectiveness: Top management needs to ensure that the quality objectives are relevant to the organization’s context, customer needs, and industry requirements. The objectives should be measurable, achievable, and time-bound to provide a clear direction for improvement efforts.
4. Cascading objectives: Top management should ensure that quality objectives are cascaded down to different levels and functions within the organization. This involves communicating the objectives, providing necessary resources and support, and fostering a culture of accountability for their achievement.
5. Monitoring and reviewing: Top management is responsible for monitoring the progress towards quality objectives and reviewing their effectiveness. This includes regular performance reviews, data analysis, and management reviews to assess if the objectives are being met and if any adjustments or corrective actions are needed.
6. Continuous improvement: Top management should promote a culture of continuous improvement by encouraging employees to contribute ideas, providing training and resources for improvement initiatives, and recognizing and rewarding achievements related to quality objectives.

By actively fulfilling these responsibilities, top management plays a crucial role in ensuring that quality objectives are defined, established, and maintained throughout the organization to meet customer requirements effectively.

Quality objective to meet customer requirements

Quality objectives to meet customer requirements should be designed to enhance customer satisfaction, deliver products or services that meet or exceed customer expectations, and ensure a high level of product or service quality. Here are some examples of quality objectives that can help meet customer requirements:

1. Improve product/service quality: Set objectives to reduce defects, improve product/service reliability, and enhance overall quality to meet or exceed customer expectations.
2. Enhance on-time delivery: Establish objectives to improve delivery performance, reduce lead times, and ensure timely delivery of products or services to meet customer deadlines.
3. Increase customer satisfaction: Set objectives to measure and improve customer satisfaction levels, based on feedback, surveys, or other metrics, aiming to meet or exceed customer expectations.
4. Minimize customer complaints: Define objectives to reduce the number and severity of customer complaints, focusing on identifying root causes, implementing corrective actions, and preventing recurring issues.
5. Enhance product/service customization: Establish objectives to enhance the organization’s capability to tailor products or services to individual customer requirements, offering customization options and flexibility.
6. Strengthen communication with customers: Set objectives to improve communication channels with customers, such as response times to inquiries or feedback, providing accurate and timely information, and proactive engagement to understand customer needs better.
7. Continuously improve customer feedback mechanisms: Establish objectives to improve the collection, analysis, and utilization of customer feedback to identify opportunities for improvement and address customer concerns effectively.
8. Develop strong relationships with customers: Define objectives to foster long-term customer relationships, focusing on building trust, understanding customer preferences, and providing personalized support.
9. Ensure compliance with customer-specific requirements: Set objectives to meet any specific requirements outlined by individual customers, such as technical specifications, delivery protocols, or industry-specific standards.
10. Enhance after-sales support: Establish objectives to improve post-purchase customer support, including warranty services, technical assistance, and prompt resolution of customer issues or concerns.

Review of interested parties and their relevant requirements

Considering the results of the organization’s review regarding interested parties and their relevant requirements is an important factor when establishing quality objectives. The review of interested parties refers to the process of identifying and understanding the individuals, groups, or organizations that have an interest or impact on the organization’s ability to achieve its objectives and satisfy customer requirements.Here’s how the results of the interested parties review can inform the establishment of quality objectives:

1. Identify customer requirements: The review helps identify the specific requirements, needs, and expectations of customers. This information can be used to define quality objectives that directly address customer satisfaction and meet their specific needs.
2. Determine regulatory and legal requirements: The review helps identify relevant regulations, laws, and standards that the organization needs to comply with. Quality objectives can be established to ensure adherence to these requirements and demonstrate regulatory compliance.
3. Address stakeholder expectations: The review also identifies other stakeholders, such as suppliers, employees, shareholders, and the community, who have expectations or requirements related to the organization’s quality performance. Quality objectives can be designed to address and meet these expectations.
4. Prioritize objectives based on importance: The review of interested parties can help prioritize quality objectives based on their significance to different stakeholders. By understanding the needs and expectations of various parties, the organization can allocate resources and focus on objectives that have the greatest impact on customer satisfaction and stakeholder relationships.
5. Foster continuous improvement: The results of the interested parties review provide valuable insights for identifying areas of improvement. Quality objectives can be established to address these areas and drive continuous improvement efforts, ensuring that the organization remains responsive to the evolving needs of its interested parties.

By considering the requirements and expectations of interested parties during the establishment of quality objectives, the organization can align its quality management system with the needs of its stakeholders, enhance customer satisfaction, and improve overall performance.

Monitoring of quality objectives

Monitoring quality objectives is a crucial step in ensuring their effectiveness and driving continuous improvement within an organization. Here are key steps involved in monitoring quality objectives:

1. Establish measurable indicators: Quality objectives should be accompanied by specific measurable indicators or key performance indicators (KPIs). These indicators provide quantitative or qualitative data that can be tracked to measure progress towards the objectives.
2. Collect and analyze data: Regularly collect data related to the identified indicators. This data can come from various sources such as inspections, audits, customer feedback, production records, or process measurements. Analyze the data to assess the organization’s performance against the defined quality objectives.
3. Review performance: Conduct periodic reviews of the collected data to evaluate performance against the quality objectives. Compare the actual performance with the target or desired levels set for each objective. Identify trends, patterns, or areas of improvement that require attention.
4. Take corrective actions: If the analysis reveals any gaps or deviations from the desired levels of performance, take appropriate corrective actions. These actions can include process adjustments, training and development initiatives, resource allocation, or improvement projects aimed at addressing the identified issues.
5. Communicate results and feedback: Share the results of the monitoring process with relevant stakeholders. This can involve providing feedback to employees, management, and other involved parties about the progress made towards the quality objectives. Transparency and effective communication are essential to foster a culture of continuous improvement and accountability.
6. Adjust objectives as needed: Based on the monitoring results and the organization’s evolving needs, consider making adjustments to the quality objectives. This can involve revising the objectives themselves, modifying the associated indicators, or updating the target levels to better align with current expectations and business priorities.
7. Continuously improve: Use the monitoring process as an opportunity to identify opportunities for improvement in the quality management system. Look for ways to enhance processes, address recurring issues, or implement best practices to drive ongoing improvements in quality performance.

By implementing a robust monitoring process, organizations can track their progress, identify areas of concern, and make informed decisions to ensure the effective achievement of quality objectives. Regular reviews and adjustments enable organizations to stay responsive to changing customer requirements, industry trends, and internal capabilities.

Contingency planning in the automotive industry refers to the process of preparing for and managing potential disruptions, risks, or unexpected events that could impact the operations, production, supply chain, or overall business continuity of automotive companies. It involves developing strategies, procedures, and responses to mitigate and recover from such events, ensuring minimal disruption to the business and maintaining the ability to deliver products and services to customers.Here are some key aspects of contingency planning in the automotive industry:

1. Risk Assessment: Automotive companies assess potential risks and vulnerabilities that could affect their operations, such as natural disasters, supply chain disruptions, economic downturns, regulatory changes, or quality issues. By identifying these risks, companies can better plan and allocate resources to address them.
2. Business Continuity Planning: Companies develop strategies and procedures to ensure the continuity of critical business functions during disruptions. This includes identifying alternative production sites, establishing backup supply chains, securing critical resources, and implementing redundant systems to minimize downtime.
3. Supply Chain Management: Automotive manufacturers rely on complex supply chains that involve numerous suppliers and logistics networks. Contingency planning involves diversifying suppliers, establishing clear communication channels, and maintaining good relationships to mitigate potential disruptions. This may include having backup suppliers, safety stock of critical components, or alternative transportation routes.
4. Crisis Management: Contingency planning includes developing crisis management protocols and communication strategies to effectively respond to unexpected events. This involves establishing an incident response team, defining roles and responsibilities, and implementing communication channels to ensure timely and accurate information dissemination to employees, customers, suppliers, and other stakeholders.
5. Testing and Training: Contingency plans are regularly tested through simulated scenarios or drills to identify gaps and areas for improvement. Training programs are conducted to educate employees on their roles and responsibilities during emergencies and ensure they are familiar with the contingency plans.
6. Regulatory Compliance: Contingency planning also involves keeping abreast of regulatory requirements and incorporating them into the plans. Automotive companies need to comply with various safety, environmental, and quality regulations, and contingency plans should address potential risks associated with compliance.

Contingency planning in the automotive industry is crucial to ensure business resilience, maintain customer satisfaction, and minimize financial losses during unforeseen events. It allows companies to be proactive and prepared rather than reactive when disruptions occur, ultimately safeguarding their operations and reputation.

Clause 6.1.2.3 Contingency plans

To develop a Contingency plan, the organization must identify and assess both internal and external risks to all manufacturing processes and infrastructure equipment necessary to maintain production levels and meet customer requirements. The contingency plans need to be based on the level of risk and how it could affect the customer. The contingency plan needs to be ready to ensure a steady supply and should think about potential situations like important equipment breaking down, interruptions in supplies from outside, regular natural disasters, fires, loss of utilities, cyber-attacks on computer systems, lack of workers, or problems with infrastructure. It should also outline how customers and other concerned parties will be informed about the extent and duration of any situation that affects customer operations. The contingency plan should regularly undergo testing to ensure its effectiveness. Simulations like drills, are one way to carry out these periodic tests. The contingency plan must undergo a review by a multidisciplinary team, including top management, at least once a year. It may be updated based on the findings of this review. The contingency plans must be documented, and records detailing any revisions, along with the persons authorizing them, must be kept. The contingency plans need to have measures in place to confirm that the produced item still meets customer requirements after production resumes following an emergency where production was halted and regular shutdown procedures were not followed.

Contingency plans in relation to internal and external risk assessment The first step in emergency planning in accordance with the IATF standard is a thorough assessment of internal and external risks for all manufacturing processes and essential equipment. Organizations must identify risk factors such as:equipment or tools damage, interruptions in deliveries,natural disasters, fires,disruptions in media supplies,labor shortage,disruptions in infrastructure. It concerns the development and implementation of adequate training and awareness of employees. As you can see, all scenarios come down to focusing on the most critical areas and developing appropriate contingency plans. The above activity can be developed during the definition of the risk and opportunity analysis, which is described in a separate article. Contingency Plans in relation to IATF requirements. The next step is to define contingency plans appropriate to the identified risks and potential impact on the client. The IATF standard requires that they contain the following strategies for action in the event of emergencies: – procedures – defined responsibilities – supply continuity plans Notification and Communication. An important aspect of contingency plans is the appropriate notification of customers and other stakeholders when emergencies occur. Remember to take into account their scale and expected duration in communication. Organizations should have notification procedures in place that allow for prompt and effective communication with customers. Transparency in communication allows customers to prepare properly and minimizes uncertainty. In addition, it is worth analyzing the Customer Specific Requirements in this area. Another important element is regular testing of the contingency plans effectiveness. We are talking about their simulations, which are carried out to ensure that they are effective and adapted to changing conditions. One of the more practical solutions is to implement a form that will contain the following sections: What (Emergency description)? Where? When? Who is responsible for the area/activities? Description of the reaction and conduct of the individuals involved. Results/decision to escalate to stakeholders.the IATF standard requires contingency plans to be reviewed at least annually with the participation of an interdisciplinary team, including top management. The vast majority of organizations will carry out this activity during a management review.

While the specific steps may vary depending on the industry or organization, here is a general framework that can be followed when developing a contingency plan:

1. Identify Potential Risks: Conduct a thorough risk assessment to identify potential risks or events that could disrupt normal business operations. These could include natural disasters, supply chain disruptions, technological failures, cyberattacks, or regulatory changes. Consider both internal and external factors that could impact the organization.
2. Assess Impact and Probability: Evaluate the potential impact of each identified risk and assess the likelihood or probability of its occurrence. This helps prioritize risks and focus resources on addressing the most significant threats. Consider the potential consequences on operations, finances, reputation, and customer satisfaction.
3. Develop Response Strategies: Based on the identified risks, develop response strategies to address each scenario. This involves determining the actions and measures required to minimize the impact and ensure business continuity. Response strategies may include alternative production plans, backup suppliers, crisis communication protocols, data backup and recovery processes, or employee safety measures.
4. Establish Communication Channels: Define clear communication channels and protocols for internal and external stakeholders during a crisis or disruption. Establish a crisis management team and assign specific roles and responsibilities. Ensure that communication plans include regular updates, clear instructions, and mechanisms to receive feedback and gather information.
5. Allocate Resources: Determine the resources required to implement the response strategies effectively. This includes financial resources, personnel, equipment, technology, and any other necessary assets. Ensure that resources are readily available and accessible when needed.
6. Test and Refine the Plan: Regularly test the contingency plan through simulations or drills to identify any gaps, weaknesses, or areas for improvement. This helps validate the effectiveness of the plan and familiarize employees with their roles and responsibilities. Based on the results of testing, refine the plan and make necessary adjustments to enhance its effectiveness.
7. Document the Plan: Document the contingency plan in a comprehensive and accessible format. Include all relevant information, such as contact details, key procedures, decision-making protocols, and recovery steps. Ensure that the plan is regularly reviewed, updated, and communicated to all relevant stakeholders.
8. Training and Awareness: Provide training and awareness programs to employees to ensure they understand the contingency plan and their respective roles during a crisis. Conduct regular training sessions and keep employees informed about any updates or changes to the plan.
9. Regular Review and Maintenance: Continuously monitor the internal and external environment for changes that may impact the effectiveness of the contingency plan. Review the plan periodically to ensure its relevance and make necessary updates based on lessons learned from real incidents or exercises.

Contingency planning is an ongoing process that requires regular review, refinement, and adaptability. By following these steps, organizations can enhance their readiness to respond to potential disruptions and minimize their impact on operations.

Here are some examples of contingency planning in the automotive industry:

1. Key Equipment Failures: Develop a contingency plan that identifies critical equipment and outlines procedures for maintaining, repairing, or replacing them in the event of failures. This may include having spare parts, backup equipment, or access to external repair services.
2. Interruption from Externally Provided Products, Processes, and Services: Identify critical externally provided products, processes, and services that are essential to your operations. Establish relationships with alternative suppliers or have backup plans in place to mitigate the impact of interruptions from external sources.
3. Recurring Natural Disasters: Conduct a risk assessment to identify recurring natural disasters that could impact your organization. Develop a contingency plan that outlines specific actions to be taken before, during, and after such events. This may include evacuation procedures, backup power systems, and alternative production or storage facilities.
4. Fire: Implement fire prevention measures and establish emergency response protocols to minimize the impact of fires. This includes fire detection systems, evacuation plans, fire suppression equipment, and employee training on fire safety.
5. Utility Interruptions: Develop strategies to address utility interruptions, such as power outages or water supply disruptions. This may involve backup power generators, alternative sources of utilities, or agreements with utility service providers for prioritized service restoration.
6. Cyber-attacks on Information Technology Systems: Implement cybersecurity measures to protect information technology systems from cyber threats. Develop incident response plans to detect, contain, and recover from cyber-attacks. This includes regular backups, network security measures, employee awareness training, and collaboration with cybersecurity experts.
7. Labour Shortages: Develop contingency plans for managing labour shortages, such as cross-training employees, utilizing temporary workers, or engaging with staffing agencies to ensure the continuity of critical operations during labour disruptions.
8. Infrastructure Disruptions: Identify potential infrastructure disruptions, such as transportation disruptions or facility closures, and develop strategies to mitigate their impact. This may involve alternative transportation routes, backup facilities, or collaborations with other organizations for shared resources.

Here are some steps to conduct periodic tests of contingency plans:

1. Define Testing Objectives: Determine the specific objectives of the test. It could be to validate the effectiveness of the contingency plan, identify gaps or weaknesses, train employees on their roles, or evaluate the response and recovery capabilities of the organization.
2. Select Test Scenarios: Choose scenarios that simulate potential disruptions or events that the contingency plan is designed to address. These scenarios could include natural disasters, equipment failures, cyber-attacks, or supply chain disruptions. Consider both internal and external factors that may impact the organization.
3. Establish Test Parameters: Clearly define the scope, timing, and participants of the test. Determine the duration of the test, whether it will be conducted in real-time or simulated, and who will be involved, including key stakeholders, employees, suppliers, and external parties if necessary.
4. Conduct the Test: Execute the test according to the defined parameters. This may involve simulating the occurrence of the chosen scenario and observing how the organization responds. It could include activating backup systems, implementing alternative processes, communicating with stakeholders, and evaluating the effectiveness of the response.
5. Evaluate the Results: Analyze the results of the test to identify strengths, weaknesses, and areas for improvement. Evaluate the effectiveness of the contingency plan in addressing the specific scenario and identify any gaps or issues that arose during the test. Document observations and lessons learned.
6. Update the Contingency Plan: Based on the test results and identified areas for improvement, update the contingency plan accordingly. Revise procedures, communication protocols, resource allocations, or any other necessary elements of the plan to enhance its effectiveness and address the identified gaps.
7. Train and Communicate: Provide feedback to employees and stakeholders involved in the test. Communicate the results, lessons learned, and any changes made to the contingency plan. Conduct additional training or awareness programs to ensure that employees are familiar with the updated plan and their roles during a real event.
8. Schedule Regular Testing: Establish a schedule for future tests to ensure that the contingency plan remains up to date and effective. Regularly review and assess the plan to align it with changing circumstances, new risks, or updated organizational requirements.

Remember that contingency plan testing should be conducted in a controlled and safe manner to avoid unintended disruptions or negative consequences. It is also essential to involve relevant stakeholders and seek their input during the testing process to ensure a comprehensive evaluation of the plan.By conducting periodic tests of contingency plans, organizations can validate their preparedness, identify areas for improvement, and enhance their ability to effectively respond to and recover from disruptions or unexpected events.