There are two accrediting bodies in the United States that accredit forensic service providers to ISO/IEC 17020 and ISO/IEC 17025. These are A2LA and ANAB. Accreditation of a forensic science service provider is sometimes confused with CALEA accreditation. CALEA is an accrediting body that accredits law enforcement agencies to a different set of standards.

There are hundreds of accredited laboratories in the United States. While based on the same standards, quality manuals and policies and procedures can vary greatly among laboratories. Below are a sample of quality manuals for reference and inspiration.

Boise Police Department Crime Lab

Houston Forensic Science Center

Las Vegas Metropolitan Police Department Crime Lab

Phoenix Police Department Laboratory Services Bureau

San Diego Police Department Crime Lab

Tucson Police Department Crime Laboratory

This list of terms and definitions is meant to help the user understand terms used in quality management in crime laboratories and forensic units. This list is not exhaustive.

Laboratory accreditation represents the formal recognition to competent laboratories indicating technical competence to perform in accordance with industry standards. It also provides a means for customers to identify and select reliable testing, measurement and calibration services able to meet their needs.

When achieving accreditation, departments will realize an immediate return on investment in cost, time, and resources. An essential outcome of accreditation is to minimize the risk of reporting inaccurate results to the customer through continued conformance to requirements and a commitment to ensuring:

• Repeatable and validated processes
• Intentional stakeholder engagement
• Employee competency and proficiency
• Dependable customer service
• Continuous improvement
• Risk analysis and mitigation
• Validated systems and practices
• A quality management system

Achieving accreditation represents the ongoing commitment to continue to strive to meet and exceed customer expectations by understanding their objectives, developing and delivering innovative solutions, and becoming an invaluable resource to the customer.

Here are some benefits of accreditation.

1. Accreditation improves outcomes and mitigates risks.
2. Accreditation identifies strengths and gaps in programs and processes. Accreditation reveals what is missing from a lab’s programs and processes and focuses attention on the areas greatest needed.
3. Accreditation promotes communication and employee empowerment across organizations. It gives each person a better understanding of how they contribute to the organization’s mission. By working toward the same standard, labs begin speaking a common language and can learn from each other’s experiences.
4. Accreditation fosters a culture of quality and safety. When employees see the positive outcomes of a well-run system, they want to continue making improvements together.
5. Accreditation can decrease risks and liability costs and adverse events. Other financial benefits that have been cited are improved operational efficiency and reduced liability. Accreditation tells the customers that you have made a commitment to best practices and regulatory requirements.
6. Accreditation promotes confidence in the laboratory output with all customers, including law enforcement agencies, the criminal justice system and the general public.
7. ISO accreditation is recognized by all in the forensic science community as the highest achievement indicating scientific and technical competence in accordance with the international standard.

Laboratories that have achieved accreditation offer assurance to customers that they are doing business with technically competent personnel that keeps risk mitigation in mind. To meet the ISO standards, the lab is required to have a good quality management system in place designed to minimize the chance of errors from occurring and the ability to take immediate action when nonconformities do occur. The ISO 17020 and 17025 standards also require labs to implement and track measures like risk-based thinking and continuous process improvement as an iterative process.

The cost of accreditation will vary. To receive a cost estimate, the laboratory should contact the accrediting body for a quote for accreditation and the accreditation cycle.

Please note that annual maintenance for lab equipment, competency and proficiency testing of lab personnel must be considered in the reoccurring costs to maintain accreditation.

On average, it can take 18 – 24 months. However, there are many variables that can impact the speed and progression of reaching your accreditation goal.

Once the laboratory has selected an accrediting body, the laboratory and the accrediting body work together on preparing for accreditation. Prior to submitting an application to the accrediting body, the FSSP should understand the requirements for the accreditation program and the complexities involved in their scope of accreditation.

Prior to purchasing the ISO standard, contact the accrediting body to review their accreditation programs and which program is best suited for your lab.

https://www.iso.org/standards.html

Document control refers to a set of procedures intended to oversee the creation, review, approval, release, revisions, distribution, access, storage, security, and disposal of documents. It is the basis upon which compliance, accuracy, integrity, efficiency, and accountability are built. Remember – when you create a document you need to make sure the correct version is available to all that need access to the document.

Those that perform a quality management system audits, gap assessments and internal audits, a common question that people ask is: “Do I need to control this document?” Here are some considerations to be aware of shown below:

Documents can be in any media: “Any media” means that documents can be written in paper, electronic, video, audio or similar formats. The documents can be written, pictorials, flow charts, or a combination of these formats.

Documents Need to be Identified: A simple identifier is the title of the document appearing on the footer or header of each page.

Documents Need to be Approved: Designate a person or group of people with the authority to determine whether documents need to be controlled and approved. Ideally, the person, such as a document control officer, should be someone that is aligned with the strategic direction of the laboratory and understands the implications and impact of the document.

Documents Need to be Controlled Version Control: Documents must have an identifiable version number visible throughout the document to determine if the correct version is being used. The version can be alphanumeric or by date.

Distribution Control: Documents must be made available to individuals that have a need to know and must be easily accessible.

Keeping Document Control Effective
Here are some examples of keeping document control simple:

Document Stamps: Stamps showing the document status such as: “Reference Only,” “Uncontrolled,” “Not a Controlled Document,” “Master Copy,” etc.

Footer Controls: “Not valid if printed,” “Check system for latest version,” “Not valid after 24 Hours,” etc.

Watermark Controls: Using watermark to notate “Draft”, “Controlled”, “Uncontrolled”, etc.

All these are methods of control but can be misunderstood by those using them. Remember, these are controls; however, assessors will always check for effectiveness. Assessors will consider whether or not the laboratory knows where to find the current version of the document.

What is the Most Common Document Control Issue When Employees are Asked: “What Document do you use?”

Employees may point to a document on their laptop or desktop, or pull the document out from their toolbox or desk drawer, and in most cases, these copies are out of date.

Summary of Document Control

Document Control is used to help the laboratory document processes and procedures that are critical to operate. These documents should align with the strategy and help the laboratory meet requirements in a consistent manner.

Organizing documents on your server? View this Document Tree.

A laboratory’s documentation of compliance with the quality manual is measured through an accreditation/audit process. Such accreditation inspections or audits are performed by forensic scientists, either internal or external to the laboratory, and are intended to evaluate and document and operational compliance with established standards.

An internal audit should begin with the team clearly understanding why the audit is being conducted.

The following questions should be answered before the audit begins:

• Why is audit being conducted?
• How will the audit support the organization in achieving its goals and objectives?
• What enterprise risk(s) does the audit address?
• Was an audit conducted in the past, and if so, what were the results of the previous audit(s)?
• Have there been significant changes in the process recently or since the previous audit?

Request and obtain documentation on how the process works is the next step in preparing for an audit.

Locate the following information for the audit:

• All policies, procedure documents, and organization charts
• Key reports used to manage the effectiveness, efficiency, and process success
• Access to systems and applications used in daily work
• Description and listing of master data for the processes being audited, including all data fields and attributes

Before meeting with stakeholders, the internal audit team should hold a meeting to confirm a high-level understanding of the objectives of the audit. Audit planning and the audit plan are important to ensure participant roles and expectations are clear and audit objectives are met.

Nonconforming work is simply work that does not comply with a requirement.  The requirement includes accreditation standards, safety standards, a laboratory’s own policies and procedures or any other requirement that a laboratory has agreed to follow. Nonconforming work can range from minor situations with negligible impact on the quality of work to major situations that have a significant impact on the quality of work. In any complex organization such as a crime laboratory, nonconforming work will occur.

The laboratory should have a policy of handling nonconforming work.  Some of the questions the laboratory should answer in the policy are:

1. Who manages the nonconforming work including the stoppage/resumption of work, if necessary?
2. Is there an evaluation made regarding the significance of the nonconforming work and its impact on previous results?
3. Is there a decision made on the acceptability of the nonconforming work?
4. When is the customer notified? By whom?
5. When is work recalled?
6. What records are retained that document the handling of the nonconforming work? When the conformance has a significant impact on the quality of work or the nonconforming work could recur thus increasing its impact, the laboratory’s corrective action policy should be implemented.

Finally, the laboratory should communicate the philosophy and practice of handling nonconforming work to its employees and external customers.  Although nonconforming work are often cast in a negative light, they do allow the laboratory’s Quality Assurance program an opportunity to evaluate and, if necessary, improve the laboratory’s work processes and work product.

Refer to the Sample Form Repository for examples of how nonconforming work can be documented.

A corrective action is a measure (i.e. policy or procedure) that is put in place in order to eliminate, or attempt to eliminate, the cause of nonconforming work or departure from the laboratory’s current protocols.

Corrective actions differ from corrections because they aim to prevent future occurrences, whereas corrections fix the result of nonconforming work, but do not necessarily address the cause of it. Corrective actions differ from preventive actions because they are a response to nonconforming work that has already occurred, and directly address the apparent cause of that nonconforming work.

To determine if nonconforming work requires a corrective action, the lab must analyze what occurred, evaluate possible causes, assess impact and risk, and estimate the probability of recurrence if no measure is taken to prevent the cause.

Examples of things to consider when reviewing and evaluating nonconforming work are:

• Actual and potential impact on the integrity of laboratory operations and the management system
• Whether re-work and/or amended reports are required
• Number of cases or samples affected

The laboratory’s response to the nonconforming work and the implemented corrective action should be proportional to what occurred. Corrective actions may be documented in a form, memo, or report.

Once a corrective action is implemented, it must be monitored to assess its effectiveness. The length of time for monitoring is determined by the lab and should be appropriate for the specific action. Laboratories might have a policy to monitor effectiveness in an internal audit or management review or might include a specific monitoring plan in the corrective action report. After a reasonable monitoring period, the lab many determine that the a) the corrective action appears to be effective, b) there is not enough evidence to determine if the corrective action is effective and the monitoring period must be extended, or c) the corrective action is ineffective and additional cause analysis is warranted.

Refer to the Sample Form Repository for examples of how corrective action can be documented.

As part of the continuous improvement process, laboratories must seek positive and negative feedback from its customers. This can be through surveys, testimony feedback forms, records of communication with customers, etc. Laboratories will often include a link to a survey in the signatures of staff email.

Information obtained from customer feedback should be used to identify areas for improvement. Common areas that can be improved based on customer feedback include the submission process, clarity of reports, turnaround times, pre-trial conferences, and testimony.

Complaints can be received as negative feedback from customer surveys, through a dedicated complaint system that is communicated to the customer, or general communications.

Refer to the Sample Form Repository for examples of complaint forms and surveys.

Laboratories must monitor their performance by comparison of results to other labs through interlaboratory comparisons or proficiency tests. An interlaboratory comparison involves two or more laboratories conducting testing on the same or similar items in accordance with predetermined conditions. A proficiency test is a type of interlaboratory comparison where participant performance is evaluated against pre-established criteria.

Intralaboratory comparison involves tests on the same or similar items within the same laboratory. This may be accomplished by a lab preparing a test for its staff to participate in. Some laboratories might refer to these as ‘internal proficiency tests’, though technically, a proficiency test refers to a test procured externally.  If multiple staff participate in a proficiency test or other type of interlaboratory comparison, the laboratory can compare the tests of the staff to one another to monitor performance as an intralaboratory comparison.

Performance monitoring programs must be documented and planned considering all of the methods that the laboratory performs. Performance monitoring should include all personnel that perform laboratory activities in the accredited discipline. Accrediting bodies may have specific requirements for a performance monitoring program.

If a testing activity cannot be monitored via proficiency test or other interlaboratory comparison, the lab may substitute a more appropriate method of monitoring, such as direct observation, if allowed by the accrediting body.

Typically, if a team approach is used to testing, the same approach may be used for proficiency test and/or other interlaboratory comparisons. Additional types of activities that may be used to monitor laboratory and/or personnel performance include sample retesting and ‘blind proficiency tests’ where the analyst is unaware that the items they are testing are associated with a test rather than evidence items.

The outcome of the proficiency tests must be reviewed and documented. Refer to the Sample Form Repository for examples of how proficiency testing can be documented.

The Annual ASCLD Symposium is held each Spring and includes workshops and plenary sessions which may include topics in quality management.

AFQAM hosts and annual training seminar each Fall. The meeting is comprised of workshops and a plenary session.

Laboratory accreditation represents the formal recognition to competent laboratories indicating technical competence to perform in accordance with industry standards. It also provides a means for customers to identify and select reliable testing, measurement and calibration services able to meet their needs.

When achieving accreditation, departments will realize an immediate return on investment in cost, time, and resources. An essential outcome of accreditation is to minimize the risk of reporting inaccurate results to the customer through continued conformance to requirements and a commitment to ensuring:

• Repeatable and validated processes
• Intentional stakeholder engagement
• Employee competency and proficiency
• Dependable customer service
• Continuous improvement
• Risk analysis and mitigation
• Validated systems and practices
• A quality management system

Achieving accreditation represents the ongoing commitment to continue to strive to meet and exceed customer expectations by understanding their objectives, developing and delivering innovative solutions, and becoming an invaluable resource to the customer.

Here are some benefits of accreditation.

1. Accreditation improves outcomes and mitigates risks.
2. Accreditation identifies strengths and gaps in programs and processes. Accreditation reveals what is missing from a lab’s programs and processes and focuses attention on the areas greatest needed.
3. Accreditation promotes communication and employee empowerment across organizations. It gives each person a better understanding of how they contribute to the organization’s mission. By working toward the same standard, labs begin speaking a common language and can learn from each other’s experiences.
4. Accreditation fosters a culture of quality and safety. When employees see the positive outcomes of a well-run system, they want to continue making improvements together.
5. Accreditation can decrease risks and liability costs and adverse events. Other financial benefits that have been cited are improved operational efficiency and reduced liability. Accreditation tells the customers that you have made a commitment to best practices and regulatory requirements.
6. Accreditation promotes confidence in the laboratory output with all customers, including law enforcement agencies, the criminal justice system and the general public.
7. ISO accreditation is recognized by all in the forensic science community as the highest achievement indicating scientific and technical competence in accordance with the international standard.

Laboratories that have achieved accreditation offer assurance to customers that they are doing business with technically competent personnel that keeps risk mitigation in mind. To meet the ISO standards, the lab is required to have a good quality management system in place designed to minimize the chance of errors from occurring and the ability to take immediate action when nonconformities do occur. The ISO 17020 and 17025 standards also require labs to implement and track measures like risk-based thinking and continuous process improvement as an iterative process.

The cost of accreditation will vary. To receive a cost estimate, the laboratory should contact the accrediting body for a quote for accreditation and the accreditation cycle.

Please note that annual maintenance for lab equipment, competency and proficiency testing of lab personnel must be considered in the reoccurring costs to maintain accreditation.

On average, it can take 18 – 24 months. However, there are many variables that can impact the speed and progression of reaching your accreditation goal.

Once the laboratory has selected an accrediting body, the laboratory and the accrediting body work together on preparing for accreditation. Prior to submitting an application to the accrediting body, the FSSP should understand the requirements for the accreditation program and the complexities involved in their scope of accreditation.

Consider the stakeholder chart below and the impact on those stakeholders when preparing for accreditation. The lab may want to include stakeholders in the planning for accreditation.

The link below will show an example of how documents can be aligned with the ISO 17025:2017 requirements.
Document Tree

• Begin by reviewing the accreditation programs on their website. For example: www.anab.org and www.a2la.org or https://www.pjlabs.com/
• Contact accrediting bodies to discuss their program and costs estimates. Also, discuss which ISO standard may be best suited for your lab based on your operations and the scope of accreditation. (ISO 17025:2017 or ISO 17020:2012)
• Once the lab decides which standard to use and the accrediting body, purchase the standard (www.iso.org)
• Contact that accrediting body to obtain their checklists/requirements required for accreditation. These checklists are in addition to the ISO standard.

One way is to network with other accredited labs. Other examples:

• Review documents from accredited laboratories to understand how the manuals are structured and aligned with the ISO requirements.
• Schedule a visit to observe an assessment or an internal audit of an accredited laboratory.
• Join ASCLD and have access to over 800 members from domestic and international laboratories, industry, and other forensic organizations.
• Attend virtual and in-person training from the accrediting body or other resources such a these free webinars: https://www.pjlabs.com/training/pjla-webinars
• Attend the annual ASCLD symposium to network with other accredited laboratories.
• Consider assistance from the ASCLD Accreditation Initiative https://www.ascld.org/accreditation-initiative/
• Check out the resources on the ASCLD Accreditation Initiative Toolkit
• Dedicate resources to the accreditation process to include a quality manager.