ASCLD Accreditation Toolkit

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:

1. Repeatable and validated processes
2. Intentional stakeholder engagement
3. Employee competency and proficiency
4. Dependable customer service
5. Continuous improvement
6. Risk analysis and mitigation
7. Validated systems and practices
8. 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.

Visit www.ascld.org/ascldaccreditationtoolkit to review the roadmap and steps to 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

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 https://www.ascld.org/ascldaccreditationtoolkit/
• Dedicate resources to the accreditation process to include a quality manager.

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.

The management review is designed to examine the Quality System of the laboratory and all sections to determine if it meets the standards set by the Laboratory and the ISO requirements. The review shall also serve as a guide for future determinations regarding the effectiveness and direction of the Quality System due to changes in the organization, facilities, staffing, equipment, activities, budget, and workload and is conducted by key stakeholders at intervals set by the laboratory.

The management review shall consider, but not be limited to, the following:

• Changes in internal and external issues that are relevant to the Laboratory.
• Fulfilment of objectives.
• Suitability of policies and procedures.
• Status of actions from previous management reviews.
• Outcome of recent internal audits.
• Effectiveness of previous actions and implemented improvements.
• Corrective actions and nonconformity records.
• Assessments by external bodies.
• Technical Leader annual report.
• Outcomes of the assurance of the validating of results including results of inter-laboratory comparisons or proficiency tests.
• Changes in the volume and type of the work or in the range of laboratory activities.
• Customer and personnel feedback.
• Complaints.
• Recommendations for improvement.
• Work Authorizations.
• Adequacy of Resources.
• Results of risk identification, including risks to impartiality.
• Other factors, such as quality control activities and staff training.

Proficiency Testing aims to confirm the competency of an individual’s laboratory staff performance of conducting testing and analysis to ensure valid and reliable testing results and the overall proficiency of testing laboratories

Competency testing is an integral part of the forensic training process and is administered as part of a comprehensive assessment of technical skills and knowledge during basic training, and prior to the initiation of casework by a forensic science practitioner on a newly validated technology, technique, or method.

Quality assurance and quality control policy and procedures provide a framework for laboratories to meet its goals, along with a plan and the details on how to meet those goals.

Quality Assurance may encompass a range of activities that enable laboratories to achieve and maintain high levels of accuracy and proficiency despite changes in test methods or the volume of what is being tested. A good QA system does these four things:

• Establishes standard operating procedures (SOPs) for each step of the laboratory testing process, ranging from specimen handling to instrument performance validation;
• Defines administrative requirements, such as mandatory recordkeeping, data evaluation, management reviews, and internal audits to monitor adherence to SOPs;
• Specifies corrective actions, risk analysis and risk management practices, customer feedback and actions to address feedback, documentation, analysis of laboratory operational trends, and the persons responsible for carrying out corrective actions when problems are identified; and
• Sustains high-quality employee performance through proficiency and competency testing, training, evaluations and technical reviews of work products, work authorizations, and executing a clear laboratory communication plan.

Risk management provides a means to objectively assess and mitigate the factors impacting these errors or failures that may otherwise go unnoticed. Risk management is an intentional process and consists of three parts: identifying risk, assessing risk, and controlling risk. These three phases can be accomplished using a variety of different tools and methods to assess the laboratory operations.