Environment / Food Safety / Quality / Safety
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To ensure companies uphold standards (internal or external) and continuously improve performance, audits are critical. In short, there are three primary purposes of auditing:
- Verify conformance with the standard/requirement – Are we doing what the standard/requirement says we must do?
- Verify implementation of stated procedures – Are we following the steps in our documented procedures?
- Evaluate effectiveness – Are we accomplishing our goals and objectives?
For an audit to be effective, appropriate mechanics must be in place when it comes to planning, execution, and reporting.
As with most things, your execution will only be as good as your plan. All good audits must begin with planning. This involves everything from planning for your team, to planning out the scope of the audit, to planning all the associated logistics.
Auditors: Who Is on the Team?
Depending on the size and complexity of the audits, audit teams need to be selected. These individuals must be independent of the area being audited and trained in the basic elements of the facility’s management system and/or programs. Team members will be led by a trained auditor. The auditor’s responsibilities include the following:
- Comply with and communicate audit requirements
- Prepare working documents under the direction of the Lead Auditor
- Plan and carry out the assigned responsibilities within the scope of the audit
- Collect and analyze evidence to draw conclusions
- Document audit observations and findings
- Report audit results to Lead Auditor
- Retain and safeguard audit documents
- Cooperate with and support the Lead Auditor
- Assist in writing the report
As indicated above, one person on the team is typically designated the Lead Auditor. This individual will coordinate audit assignments and address any questions/concerns that may arise. Specifically, the Lead Auditor has the following responsibilities:
- Assigns team members specific management system/program elements, functions, or activities to audit
- Provides instructions on the audit procedure to follow
- Makes changes to work assignments, as necessary, to ensure the achievement of audit objectives
Audit Objectives, Scope, and Plans: What Are We Auditing?
The audit is all about:
- Conformance – auditing sections of the standard/requirements to determine if the system conforms
- Implementation – auditing work instructions to see if they are being followed
In determining the audit scope, it is importation to define what is to be audited (e.g., policy, planning, implementation, checking/corrective action, management review). If the organization has more than one physical location, the scope may outline what physical locations and/or organizational activities are to be audited (e.g., production lines or departments). These factors will ultimately also help determine the length of the audit.
Logistics: How Are We Going to Do This?
There are many things to factor into the audit from a logistical standpoint for it to go smoothly. Safety should always be of utmost concern. What precautions do auditors need to take? Is there any PPE that might be necessary? Do auditors need any special safety training introduction or training before conducting the audit? Consider the facility. Auditors need to understand the operation/activity being audited. In line with this, the auditor must also have an understanding of whether there is any equipment or special resources needed, ranging from technical support (e.g., tablets, smartphones) to lunch. Finally, it is important to make sure there are no conflicts of interest when it comes to the auditor and the facility that is being audited.
Once planned appropriately, audits should be conducted according to the program elements. Interviews and objectives evidence will both provide the support needed to conduct a valid audit.
The auditor must know in advance which elements are being covered in an audit so he/she can:
- Control the pace of the audit.
- Guide the course of the audit.
That being said, additional audit activities should not be restricted if other issues arise.
Auditing should only be done against current controlled work instructions or procedures related to the program elements. Procedures that are being used in the field must be verified. Historical and/or uncontrolled procedures should not be used.
Auditors must remember that they are creating a record. Notes should include statements, document numbers, identifiers (e.g., department, area), positions. Common pitfalls to be avoided in taking notes include abbreviations, no location identifier for observations, no document references, illegible, pejorative, cryptic. These things all impact the credibility of the audit.
The goal of an interview in the audit is to obtain valid information. However, how questions are asked will impact the answer. Auditors must prepare and know what questions need to be asked and how to ask them in advance of the audit. Creating an atmosphere of trust and open communication is key to getting open and honest responses. Remember, the goal is to audit the system, not the interviewee.
The following are good rules of thumb for conducting effective audit interviews:
- Direct questions to the person who does the job, not to the supervisor.
- Never talk down to anyone.
- Speak the person’s language.
- Speak clearly and carefully.
- Use who, what, where, when and why in your questioning vs. can or does.
Objective evidence provides verifiable information, records, or statements of fact. This is vital in any audit report. Objective evidence can be based on any of the following:
- Examination of documents
- Observation of activities and conditions
- Results of measurements
- Other means within the scope of the audit
Evidence should be firsthand evidence based on witnessed fact, not supposition, presumption, hearsay, rumor, or conjecture. It can be qualitative or quantitative, but it should be repeatable.
Findings form the basis of the report. Findings can be classified in one of two ways:
- Nonconformance is the observed absence of or lapse in a required procedure or the total breakdown of a procedure that can cause a negative impact on the organization’s environmental performance. These can fall into a few categories:
- Does not meet the requirements of the standard. This may include issues identified with records, procedures, work instructions, and use of controlled documents.
- Is not fully implemented. Most commonly, these implementation nonconformances may relate to training, communication, and documentation.
- Is improperly implemented. This is often demonstrated by worker lack of understanding, improper implementation of written work instruction, or missing stated required deadlines.
- Opportunity for improvement is just that—an opportunity to improve management to either reduce impacts, minimize legal requirements, prevent future nonconformances, or improve business performance.
The following examples and tips can serve as guidelines for writing useful and more concrete findings that will the company to identify opportunities for improvement:
- Do not overstate conclusions.
- Poor: The procedure for handling spent light bulbs is being ignored.
- Better: Three spent fluorescent bulbs were found in the general trash.
- State the problem clearly and exactly.
- Poor: Instruments are not being calibrated.
- Better: The sampling and analytical instruments in the wastewater treatment plant are not calibrated.
- Avoid generalities.
- Poor: The area’s empty drum management process is inadequate.
- Better: The hi-lo driver in the area handling empty drums was not trained on hazardous material handling.
- Communicate the extent of the problem fully.
- Poor: All cardboard in the catalytic converter area is being sent to the compactor.
- Better: None of the cardboard in the catalytic converter area was being stored and/or evaluated for reuse as dunnage.
- Do not focus on criticisms of individuals.
- Poor: Jim Jones had no understanding of the safety policy.
- Better: Discussions with several employees indicated that the safety policy was not fully understood.
- Give specific references.
- Poor: Hazardous waste area inspections have not been conducted.
- Better: Weekly hazardous waste storage area inspections (VMEWP-008) have not been conducted since June 2002.
- Avoid indirect expressions.
- Poor: There were occasions when the reports were not filed on time. It appears the air monitoring equipment is not calibrated.
- Better: Reports were filed late on ten occasions in 2002. There were no records of air monitoring equipment calibrations for 2001 or 2002.
Audits are a skilled activity. They provide the basis for assessment of conformance and, correspondingly, company actions to improve performance. For audits to be valuable, however, the audit process must be consistent and controlled. Clearly and correctly documented nonconformances lead to appropriate corrective actions—the mechanism for translating audits into improvements.