Layered Process Audit is a quality tool designed specifically for manufacturing management. It is meant for auditing organizational processes, working conditions, and manufacturing programs.
Layered process audits (LPAs) assure compliance with international industry standards such as the ISO 9001(a standard for quality management systems), the IATF 16949 (a technical standard for the automotive industry), the ISO 14001 (an international environmental management system), and the ISO 45001 ( a standard for safety management). It is also used to vigorously assess whether a company’s production facilities are ready to manufacture the product at hand.
LPAs enable organizations to take corrective actions and optimize processes to minimize costs, boost productivity, and ensure smooth manufacturing operations.
This blog post aims to introduce What is a Layered Process Audit and provide valuable insights to support the implementation of Layered Process Audits in your manufacturing and supply chain programs.
The History and Evolution of Layered Process Audits
Layered Process Audits (LPA) are a pivotal tool in quality management. Its development accelerated with the advent of Statistical Process Control (SPC) techniques, which emerged from early quality control systems that focused on inspection.
Total Quality Management (TQM), which puts a strong emphasis on customer satisfaction and continuous improvement, enabled the concept to further evolve. Notably, the development of LPA was greatly influenced by the automobile sector, as manufacturers like Ford and General Motors implemented it into their supply chain management to guarantee constant quality.
LPA was further developed using Lean and Six Sigma approaches, improving its efficiency in identifying and fixing flaws. With the beginning of the digital age, LPA switched from paper-based audits to digital platforms, which enabled the gathering and analyzing of data in real-time. LPA is now used globally for regulatory compliance, quality management, and manufacturing management as it establishes a culture of continuous improvement and error prevention.
Key Stages of Layered Process Audits
The layered process audit system has four distinct stages:
- Data analysis
Each layer has its own set of objectives.
focuses on setting workplace safety regulations and also standards and guidelines for the manufacturing process.
involves thorough documentation of each step in the layered process audit, such as checklists and logs for data tracking
involves collection and analysis of data to identify potential areas for process enhancement or error avoidance.
recommendations for improvement are made by the layered process audit team in response to their findings.
What are the Key Components of a Layered Process Audit?
Crucial elements to ensure efficient Layered Process Audits for a simplified quality management procedure are:
In audit planning, you define the scope, goals, and criteria of the audit. It involves setting up an audit schedule and choosing the procedures, regions, or departments that will be audited.
Data Collection and Analysis
Data is collected using a number of techniques, including interviews, observations, and document checks. Then, it is examined to determine whether procedures adhere to established standards and to spot any potential problems.
Identifying Gaps and Deviations
This step involves the comparison of collected data against predefined standards or benchmarks. Gaps and deviations from standard procedures are identified and documented.
Recommendations and Action Plans
Recommendations for remedial measures are developed based on the identified gaps and deviations. Action plans are created to deal with the problems and restore process compliance.
The execution of action plans does not mark the conclusion of the auditing process. In order to guarantee that corrective activities are successful and long-lasting, continuous monitoring is essential. In monitoring progress to make further modifications, routine follow-up audits are often conducted.
How to Conduct a Layered Process Audit?
LPAs involve numerous stakeholders and can result in a waste of time if done improperly. As this audit method attempts to minimize substantial hazards throughout the production process, it is essential to adhere to a set of steps that would allow users to adopt it without any problems.
Assemble the LPA team
The first step is to organize an LPA team, which should have a variety of workers from various departments within the company, including sales, administration, quality control, and order fulfillment. The key objective is to have a dynamic team that gives a variety of opinions on the project and not only the experts.
Prepare the audit questions
Make a list of the audit questions you want to be covered. Refer to previously reported manufacturing process problems or issues discovered using a Failure Mode and Effects Analysis (FMEA) as a guide, but make sure they are impartial, precise, and succinct. For quick and simple LPA implementation, you can also use pre-made templates.
Establish the audit plan
This consists of the several layers of audit that must be applied. Name the team or individuals involved, and if you can, state how regularly each level should be audited.
Implement the LPA program
It’s now time to enforce the program from the planning stages to the execution stage. Follow up proactively and assign corrective actions as needed to ensure efficient and successful LPA implementation.
Verify program effectiveness
Review the data collected, evaluate the program's success, and identify areas where LPAs can be made more successful.
How Does a Layered Process Audit Work?
Layered process audits are designed to satisfy the needs of every stage in the production system. Each layer has its own set of procedures and process checklists. Generally, a layered process audit involves:
- Confirming that procedures are set up and followed correctly.
- If required, take corrective measures.
- Keeping track of all system modifications.
The layered process audit starts with a careful examination of the current work instructions for each layer of the production system. The layered process audit team will then be able to review and assess each layer's effectiveness to make sure everything is operating as it should.
In addition to core principles, the layered process audit also involves
- Interviewing individuals who are involved in the production system.
- Monitoring procedures and activities.
- Examining the credibility of records and papers.
- Reviewing the tracking and inventory control methods.
- Examining adherence to pertinent laws or standards.
- Verifying quality management and material control systems.
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Who does Layered Process Audits?
LPAs are performed by lead auditors and quality engineers. As these are highly technical audits, the auditors need to be familiar with the production processes, components, and materials at hand. For instance, if the LPA is being performed on an electronics contract manufacturer who is making a medical device, the auditor should be familiar with plastic forming processes and electronic components.
Layered Process Audits are usually conducted by teams of auditors who have different manufacturing, engineering, and auditing specialisations. Some organisations choose to add independent external auditors to their LPA auditor teams as this can add extra rigour to the audit. External auditors are also added to fill expertise gaps in the LPA team.
External auditors can be hired as freelancers or through manufacturing consulting and supplier management services companies like AMREP.
What are the benefits of layered process audits?
Good LPA systems deliver benefits in many ways, which include:
Increased Process Efficiency:
LPAs assist in the identification of process bottlenecks, inefficiencies, and deviations. Organizations can improve overall process efficiency, streamline operations, and decrease waste by taking swift action to address these problems.
Enhanced Quality Control:
LPAs put their primary attention on preventing errors and non-conformities at the point of origin, assuring that products constantly satisfy quality requirements. With this proactive strategy, less expensive maintenance is required, and product quality is increased.
Cost Reduction and Savings:
LPAs result in cost savings since they stop errors and process deviations. Less money is spent on warranty claims, scrap, and rework by organizations, which helps them be more profitable. In accordance with a study in 2016 by Applied Logistics, 75% of manufacturing defects result from nonconformance with processes, which is why LPA programs are so effective at reducing quality costs.
LPAs aid in the early detection and rectification of process-related problems. Through this, organizations can reduce the risk of product defects, safety issues, and operational disruptions.
Compliance and Regulatory Adherence:
LPAs are essential in ensuring that procedures adhere to industry standards and regulations. This lessens the possibility of legal problems and fines for non-compliance.
Higher customer satisfaction is a result of consistent product quality brought about by LPAs. The long-term success of an organization depends on its consumers, who are more willing to be loyal and recommend its goods and services to others.
LPA is an effective quality process that enables organizations to avoid selling defective products to clients. It lowers the cost of producing a product by directing the manufacturing process so that it is carried out accurately the first time. Operations execute more effectively as LPA lowers process variance.
We hope you found our blog post about layered process audits to be informative and helpful. For companies with advanced quality management requirements, AMREP can help you with developing your Layered Process Audits (LPA) plan and with identifying suitable auditors.
- Layered Process Audit Programs: A Fast-Track Strategy for Reducing Cost of Quality - https://search.proquest.com/openview/b1e4294fa8a8d672d598a975902872ec/1?pq-origsite=gscholar&cbl=35812
- SO 9001 and related standards Quality management - https://www.iso.org/iso-9001-quality-management.htm
- What is Statistical Process Control? https://asq.org/quality-resources/statistical-process-control
- ISO 45001:2018 - https://www.iso.org/standard/63787.html
- ISO 14001:2015 - https://www.iso.org/standard/60857.html
- IATF 16949:2016 - https://www.aiag.org/quality/iatf-16949-2016