Layered Process Audit (LPA)

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A process based approach to internal audits created by Karl Door

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  • ASR Logo smallLayered Process Audit (LPA)

    A process based approach to internal audits

  • slide 2/38


    • audit-flow-chartWhat are Layered Process Audits?

    • Who Performs the Audits?

    • Benefits of the LPA Approach

    • Phases of LPA Implementation

    • LPA and the QMS Standards

    • Summary

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    What are Layered Process Audits?

    • online-formLayered Process Audit (LPA) is a program for performance of internal audits.

    • Audits are performed by multiple levels of the organizations personnel instead of being performed by a small team of auditors.

    • LPA includes all levels of the organization from Top Management to the operational functions.

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    What are Layered Process Audits?

    • Once fully implemented, LPA will allow for the auditing of Key Characteristics of products and processes at a higher frequency than traditional audits.

    • Process conformance is verified closer to “real time” than with traditional audits.

    • Correction or improvement efforts will be applied much closer to the triggering event.
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    What are Layered Process Audits?

    • flow-chartLPA includes Quality Management System, Manufacturing Process and Product audits in one format.

    • The need for repeated audits to address all of these areas is eliminated.

    • The goal of LPA is to ensure continuous conformance of the QMS, processes and products

    • This will, in turn, improve process stability and first-time through capability.
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    What are Layered Process Audits?

    In most implementations, two types of audit formats are utilized for LPA

    • Process Control Audits

    • Inspection, Error and Mistake Proofing Verification Audits

    Process Control Audits will address conformance to the procedures and instructions that make up the management and process control aspects of the QMS.

    Verification Audits will ensure that the product conformity checks in place are working as planned.

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    Who Performs the Audits?

    • Actually, anyone in an organization can be an LPA Auditor.

    • Top Management owns the process and may play a role in the performance of the audits.

    • Top Management will take responsibility for:
      • the allocation of resources,

      • confirmation of audit results,

      • ensuring action is taken when indicated and

      • the overall effectiveness of the LPA process

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    Who Performs the Audits?

    • In most implementations Manufacturing Management performs the management level of the LPA

    • The process control level is normally performed by Supervisors, Lead Workers and Quality Auditors

    • The process control level is normally performed by Supervisors, Lead Workers and Quality Auditors

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    Who Performs the Audits?

    • who-auditsIt is a recommended practice to have all managers participate in LPA.

    • This indicates “buy in” to the organization and enhances the perception of value for the LPA process.

    • This practice also ensures that feed back to Top Management is not “filtered” through manufacturing or quality, but comes from a cross section of the organizations management.

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    Who Performs the Audits?

    • The leadership role of management in the LPA process cannot be over emphasized.

    • Leadership will find LPA a useful tool in their efforts to:

      • Fix system problems

      • Instill discipline in the organization

      • Encourage improvement of effectiveness

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    Who Performs the Audits?

    • LPA represents a commitment of time and of effort for the organization, however, that effort has been shown to pay real dividends.

    • Early phase audits will find problems and offer the opportunity for correction on the system.

    • In later phases audits will find improvement and opportunities to fix issues before they become problems.

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    Benefits of the LPA Approach

    • The initial benefits the organization will realize from the implementation of LPA include:

      • Identification of variation in their processes

      • Identification of high risk in the performance of manufacturing processes

      • Identification of potential or actual process steps where operator errors can easily occur

    As these become evident from the findings of the LPA process management of the affected areas and process owners will become aware of the problems and effective corrective actions can be applied.
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    Benefits of the LPA Approach

    • lab-testingAs the LPA process continues and matures the organization will begin to see benefits such as:

      • Reduction of variation in processes

      • Prevention of errors and mistakes in operations

      • Reduced rework and scrap

    As these benefits are realized the organization will find that wastes that were inherent in the processes will begin to yield to correction and improvement efforts. The organization will begin to experience measureable reduction in costs.
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    Benefits of the LPA Approach

    • In a fully mature LPA process the organization will be experiencing benefits like:

      • Improved communication

      • Improved discipline

      • Continuous improvement activities

      • Standardization

    The overall efficiency of the processes and effectiveness of the QMS is a proven result from a well organized and maintained LPA process. One classic example found a 95% increase in first-time through capability and a 60% reduction in scrap and rework costs.
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    Phases of LPA Implementation

    • pass-failA properly implemented LPA process will begin to show improvement and cost benefits very quickly.

    • To implement an effective LPA process it has been shown that a structured approach if the best approach.

    • The structure presented here is based on a Four Phase Implementation Plan.

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    Phases of LPA Implementation

    Phase I

    • Implementation of LPA should begin with those processes or manufacturing areas where the most potential for improvement exists.

    • A “shot gun” approach to LPA in which all of the processes of the organization are scheduled right at the start usually does not work as well as a step by step approach.

    • The step by step also gives personnel the opportunity to develop and improve auditing techniques and skills.

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    Phases of LPA Implementation

    Phase I

    • The areas of highest risk should be the first ones exposed to LPA.

    • Determining which areas these are will involve review of data regarding:

      • Customer complaints

      • First-time through capability

      • High RPN values on FMEA

      • Large number or complex inspections / error proofing

      • Operator, Supervisor, Maintenance and Quality input

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    Phases of LPA Implementation

    Phase I

    • Some organizations may not have sufficient data for a good decision making process in all of the areas noted.

    • The areas where sufficient data is available should be used to make the determination of which processes to apply LPA to first.

    • The organization will want to look at implementation of measurement to collect data for all of the items listed at some point in time.

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    Phases of LPA Implementation

    Phase I

    • To complete the implementation of LPA an Audit Plan will need to be developed.

    • As noted, the LPA process will first apply to those processes or areas with the highest risk.

    • Eventually all processes and areas will be included, in most implementations this is within 6 months of the starting point.

    • It is important to keep an ongoing record of “Lessons Learned” from each expansion of the LPA process so that improvements are not lost.

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    Phases of LPA Implementation

    1-blue-boxForm a LPA team with responsibility for implementation of the process

    2-blue-box Develop a procedure for the LPA process

    3-blue-box Based on the key process elements to be audited, develop an audit checklist or other suitable tool

    4-blue-box Determine assignments for audits

    5-blue-box Determine frequency of audits

    6-blue-box Develop measurements of the LPA process and begin monitoring the process and collecting the data

    7-blue-box Report to Top Management at agreed upon frequency
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    Phases of LPA Implementation

    Phase I

    • The LPA team should be made up of representation from all of the disciplines in the organization. This is called a “Cross-Functional Team”.

    • The LPA team should be made up of representation from all of the disciplines in the organization. This is called a “Cross-Functional Team”.

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    Phases of LPA Implementation

    Phase I

    • Audit checklists or tools should make sense to the organization with respect to:

      • The size of the organization

      • The scope of the processes to be audited

      • The complexity of the processes and products

      • The level of competency of the auditors

    In some instances a formal checklist structure will be the best tool. Other tools might include process flow charts, Process Turtles and/or Control Plans.

    An example of a simple audit schedule in on the next slide.
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    Phases of LPA Implementation


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    Phases of LPA Implementation

    Phase II

    • Once the plan has been developed and the LPA team is satisfied with the results of the planning phase, the plan will need to be approved.

    • Approval is normally supported by a formal presentation to Top Management at which the LPA team presents the outputs from Phase I.

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    Phases of LPA Implementation

    • Top Management will be requested to approve the plan in order to kick off implementation.

    • This approval should take into consideration:
      • Resources required to accomplish implementation
      • Time commitment to accomplish the audit plan
      • Acceptance of the checklists or tools that will be used
      • Commitment to repeat the process once the first LPA cycle has been completed

    Top Management is site dependant, but always represents those individuals with the responsibility and authority to direct the efforts of the organization. Examples might include a Plant Manager, a Vice-President, COO, CEO and/or the Owner.
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    Phases of LPA Implementation

    Phase II

    • Remember, the LPA process and the Audit Plan only apply to the completion of LPA for those processes identified as high risk in Phase I.

    • As this cycle of audits is completed the entire process will revert back to Phase I and the selection of new processes will take place.

    • The former processes will remain on the LPA and will be scheduled along with the new ones.

    • This is how the LPA process expands to encompass the entire organization.

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    Phases of LPA Implementation

    Phase III

    • business-meetingAfter approval has been achieved there needs to be a formal “roll out” of the LPA process to the organization.

    • In most implementations this is done at all employee meetings.

    • It is important that:
      • Top Management is involved in the roll out
      • The timing, plan and methods that will be used in the LPA process are clearly presented
      • The reasons and benefits for adopting the LPA process are discussed
      • The fact that all processes will eventually be included is made clear

    It is always a good idea to have a Q & A session as part of the roll out to let everyone have their questions and concerns heard. There will always be some resistance to any change and this is a good point in the implementation to address that as well.
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    Phases of LPA Implementation

    Phase III

    • When starting the audit cycle the LPA auditors and team should review the results of the audits and the checklists / tools frequently.

    • These reviews should include questioning:

      • The adequacy of the auditing approach

      • The usefulness of the checklists / tools

      • The issues that auditors are encountering that are becoming barriers to effective audits

      • Lessons Learned from the process

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    Phases of LPA Implementation

    Phase III

    • woman-man-in-meetingAs issues and problems are identified it is crucial that the following steps are taken:

      • Notify the management and supervision of the area or process

      • Ensure that a corrective action process is in place, supported by a form and a detailed procedure, that is followed in addressing the problem

      • Have the auditor(s) review the results of the corrective action with those who developed it:
        • Confirm that correction of the immediate problem has occurred
        • Confirm that a good root cause evaluation has been accomplished
        • Confirm that the corrective action plan addresses the root cause and establishes a systemic correction

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    Phases of LPA Implementation

    Phase IV

    • As the first cycle of LPA is completed the LPA team will review the results looking for improvements to the process.

    • The LPA team will look for:

      • How well the LPA has preformed in identification of opportunities for improvement

      • How valid the findings have been

      • Lessons Learned from the audits

      • Effectiveness of corrective actions

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    Phases of LPA Implementation

    Phase IV

    • The team should also seek feedback from the personnel involved in the processes being audited and the auditors.

    • The LPA team will make any adjustments that the review would indicate are needed.

    • Once the changes are agreed upon and in place the LPA process will be cascaded into the rest of the organization following the same phased approach until all processes have been included.

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    • group-of-business-peopleLPA is an audit of the processes in an organization.

    • The LPA checklist or other tools should be “living documents” that are reviewed and changed as the need arises.

    • Top Management must remain involved and must continue to show support for the LPA process.

    • Involvement of the customer in the LPA process is always a good idea.

    • Expansion of the LPA process to non-manufacturing areas is recommended.

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    • In the Appendix sections there are more detailed examples of:

      • Appendix A    LPA Implementation Scheduling

      • Appendix B    LPA Checklist

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    Appendix A

    The following example for the initial and subsequent LPA schedule is based on the following points:
    • The organization has determined that LPA will be implemented on both of the operating shifts 1st (7:00 AM – 3:30 PM) and 3rd (7:00 PM – 3:30 AM).

    • The LPA auditors will be the Team Lead for each work unit, the Floor Supervisors and the Manufacturing Manager. There are four (4) Floor Supervisors: Receiving, Shipping & Warehouse; Cutting & Forming; Welding & Assembly; Paint.

    • The organization has identified nine (9) key processes for product realization.

    • The evaluation of the data from the product realization processes determined that there were three (3) processes that would be the first ones implemented for LPA based on customer and internal issues: Work Order, Weld / Weld Dress, Assemble.

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    Notes on example schedule:
    • The layers are arranged so that the selected audits will each get audited in each layered pass to complete the cycle.

    • The Supervisors have been assigned so that they are not auditing the area that they have primary assignment for.

    • All shifts are covered.

    • The LPA that is not on this example is the inspection and error proofing. As noted in the first slide, the Quality Floor Auditors would do this audit and the standard approach is to do any inspection stations and error proofing for a process once per shift.

    • As the organization completes the first cycle, processes will be added to this schedule following the same arrangement and trying to avoid the Supervisors doing an audit of a process they have primary responsibility for.

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    Appendix B

    The following is an example of a checklist that can be used in LPA. The following should be noted regarding checklists:
    • Care needs to be taken to ensure that the checklist design does not distract the auditor from performing a process based audit.

    • Checklists should be reviewed after each audit cycle to determine how well they are working and if there are modifications that are required.

    • There is no standard for the tool(s) to use to document LPA, a checklist is just one tool that might be useful. The LPA Team needs to decide what tool(s) to use based on their understanding of the organization and the processes.

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