by Naomi B. Whitehead
I really enjoy all the preparation, planning, researching, and verifying that’s involved with comprehensive process audits. Although they can be very rewarding in driving continual improvement and increasing efficiency, process audits can be time consuming so you need to adjust your schedule accordingly.
Process audits: Preparation and planning
First of all, where are you going? Will you be conducting your audit in an office environment, a laboratory, or a warehouse? Will you be in an enclosed area or will you be exposed to the elements occasionally? Does the process use machines, computer software, or both?
Consider what type of dress code is required over the course of the entire audit period, as process audits can last several weeks. Be prepared and make sure you have the required safety shoes, lab coat, raincoat, or whatever else you might need on-site.
Also, consider if you might need to have any measuring devices or tools to verify process controls. What are the hours of operation? If more than one shift, will you plan to cover all shifts over an extended period of time or overlap them?
Process audits: Audit scope and objective
What is the audit’s scope and objective? What are you trying to achieve? Are you focusing on process conformance or are you also seeking process improvement? This is a critical decision, as one will be a comparison to what is written against the actual operation and the other will be what could be changed to enhance performance and/or increase yield.
Process audits: Department objectives
What drives the associates in the department? Start by asking the department manager if the associates have measureable objectives and then work your way down the line to see how well the objectives have been communicated. This information will tie into the audit through observations and interviews.
Process audits: Documentation
To see a complete picture of the process, request or obtain several types of documentation. Flowcharts are essential for inputs, activity, and outputs. A copy of the master document and forms list or a control plan will identify what work instructions, process control forms, and maintenance forms, etc., the department is using. A copy of the training matrix will show you who is trained on what operation. This will give you an idea of how well the department has cross-trained its employees.
Process audits: Previous audit reports
Review previous audit reports concerning the department or audit reports interacting with the process that you’re auditing. Have there been any issues of concern, corrective actions, etc.? Verify the correction of these items through your observations and interviews. Include this information in your audit report.
Process audits: Current issues
Are there any current issues you need to be cognizant of prior to the audit? Review department meeting minutes and manager’s minutes for areas of concern. Are there any concerns with other departments receiving the work?
Familiarize yourself with and review history of the associated records for process controls such as inspection records, measurement values, and calibration histories for relevant equipment, maintenance records, etc. Are these records in good order, consistent, legible with no gaps in dates, and/or contain no unauthorized changes?
Process audits: Schedule the audit
Communicate your proposed audit dates to the department manager and other relevant personnel. Give an estimated time frame of how long you expect to be in the department or on the premises. If appropriate, schedule an opening meeting to explain the purpose for the audit.
Process audits: Opening meeting
This can be a very brief meeting to clarify the intent of the audit, specify the type of samples you will examine, processes you plan to observe, and answer any questions department personnel may have. Are there areas where you should pay particular attention?
Process audits: Process observation
Whether you start from the beginning or work your way back, you need to see how the process flows. Create your own flow diagram to capture the process as it is revealed to you. This activity helps define exactly how product is currently being handled. By drawing your own flow diagram, you can begin to see if there is redundancy, hold ups, staging issues, excessive handling, etc.
During your observations, you will notice how defective product is identified, handled, where it is placed, reworked, etc., and then mark this information in the flow diagram. Consider how the process may flow on the second or third shift if these shifts don’t have the same manpower. What, if any, activities are held for day shift?
Verify the documentation associated with each activity. Is there a work instruction for each step in the process? Are there support forms available and in use? Place this information on your flow diagram, and identify the operators that perform the specific activities on your flow diagram.
Given enough time and depending on the complexity of the process, you will have observed the process as it is currently driven by the operators. Now you can compare your flow diagram to the approved flowchart.
Seek traceability throughout the process. Are you able to identify what stage in the process you are just by looking at the product documentation (route sheet, travel ticket, etc.)? If there is a tracking system, is the product where the system says it is?
Process audits: Activity observation
Observe and note current activity using the work instructions or similar documents. Is the activity performed as written? Have steps been added or dropped? Is there variation between operators? Is there variation in the same operator? Are there regulatory requirements (safety glasses, gloves, lab coats), specific testing requirements, and/or industry requirements that need to be conducted throughout the process? Are these requirements being met?
Process audits: Objective evidence and samples
Collect objective evidence throughout the shift(s) that you observe. Identify evidence by date, time, and if it’s conforming or nonconforming. Objective evidence can be a snapshot of the product or a copy of the documentation for the required activity output. For example, take pictures of the product as it moves from each step in the process to the next or make copies of the travel tickets or paperwork to verify authorization or sign off from one step to another if these are requirements.
If available, take samples throughout and/or submit test samples to the test laboratory to objectively verify the process from start to finish. Do samples conform to written requirements during the various process stages?
Process audits: Process controls
The monitoring and measurement methods performed by the operators or other personnel prior to, during, or after the shift(s) should be observed and verified using your own gage or other relevant devices. Are there critical parameters that may affect the quality of the product during the processing phase, such as room or equipment temperature and humidity, pressure, concentration of consumables, cycle time, etc.? Are these process controls monitored and recorded? Are they actual measurement values or indicators like check marks? Do the records reveal who took the measurements?
Process audits: Preventive maintenance
If there is a preventive maintenance program related to the process under audit, review records to indicate if the maintenance activities are performed as scheduled.
Process audits: Variation
Document any and all variation noted during your process observation or when reviewing the records. Variation is the greatest cause for error and may be a direct link to increased breakage, rework, poor yields, etc.
Process audits: Interviews and feedback
During any audit, you’ll want to clarify process details and talk to operators. Try using open-ended questions, such as, “Why do you do what you do the way that you do it?” The operator may give you a funny look, but you’ll get some interesting answers. Keep in mind that, “I don’t know. My boss told me to do it this way.” is an answer!
The dialogue you are trying to establish is if the operator is aware of his or her quality objectives, that there is a defined set of instructions, possibly critical parameters, and regular monitoring, measuring, etc., involved in the operator’s day-to-day activities. Is he or she committed and involved with the process as a whole? Does he or she understand the required product or system input and his or her activity’s desired output, or is he or she merely an island with no interaction with other operators?
Unless a facility is totally robotic, its operators are likely the most important part of its processes. The attitude, motivation, and recognition of process operators should be included in all comprehensive process audits.
Finally, how well the department meets its goals and quality objectives is a reflection of leadership.
Process audits: Training records
Verify training records for the operators you observed performing process activities. Who you choose and whether you verify randomly or 100 percent can be based on how similar the operations were in comparison to the work instructions. Those operators showing the greatest variation to the written instruction or poor record compliance may go to the top of the list for training verification. This exercise may prove a fertile field for verifying the lack of training documentation for that operator or possibly to offer a recommendation for a refresher.
Process audits: Assessment
After an audit, it’s time for you to gather your thoughts, review your notes, and evaluate the collected objective evidence. What is your overall picture of the organization?
Begin by using a big white board as a visual aide. Describe categories like process flow, work instructions, process controls, preventive maintenance, training, regulatory requirements, etc., on the top. Then, in color (green for compliant, red for noncompliant) start to list the objective evidence collected. You may want to start this visual aide at the beginning of a complex process audit rather then summarizing at the end.
Categorize nonconformances as chronic or isolated based on the amount of red in each category. This visual also helps keep perspective. Finally, writing a brief summary that recognizes what the department is doing right and where it has the greatest opportunities for improvement helps it avoid focusing on the small stuff.
Process audits: Closing meeting
Schedule a short closing meeting with relevant personnel. Thank them all for their time and cooperation while you were in their department. If you have nonconformances to discuss, remind everyone that these are process audits seeking improvements, not fault-finding missions. Let the group know that a formal report will be submitted shortly.
Process audits: Audit report
An audit report is the fruit of your labor. Address the findings based on your summary and objective evidence. Don’t be afraid to recognize the extra efforts of the operators and managers who attempted to fulfill the company and department goals and objectives to motivate others and help build morale.
Nonconformances should be linked directly to the standard or written requirement, so be sure to state them specifically. Stating opportunities for improvement is where you can really shine as an auditor. Here you can offer recommendations that will help streamline the process to reduce excessive processing, omit redundancy, fill gaps, formally train or re-train operators, enhance process controls, or perhaps change the process sequence for better overall output.
Include monetary savings if this is a known value. For example, by eliminating the redundancy of several process steps you save money in labor and consumables, or machines would have less down time costing money due to emergency maintenance if the department included more meaningful, measurable process controls during the shift and/or developed a preventive maintenance program.
Process audits: Summary
In summary, process audits can be of great value to the company in terms of improvement and lean initiatives. They’re also wonderful learning experiences for auditors.
About the author
Naomi B. Whitehead is a regional quality manager for Carl Zeiss Vision.
Tags: process audits.