ISO 17025 accreditation explained

ISO 17025 accreditation explained

Are you a laboratory? Do you perform any sampling, calibrations, or testing? Then, the International Organization for Standardization (ISO) asks you, Are you technically competent? Here we explain ISO/IEC 17025 accreditation of the general requirements for the competence of testing and calibration laboratories.

ISO 17025 provides detailed parameters for:

    • Proficiency testing
    • Metrological traceability, including the use of reference materials
    • Uncertainty measurement
    • In-house calibrations
    • Management systems operations
Calibration

Proficiency testing

An essential part of proper proficiency testing is using and maintaining a documented plan for three years of sampling activities. This document needs to include a yearly proficiency test (PT) or inter-laboratory comparison (ILC) covering the appropriate parameters, ranges, measurements, test technologies, inspections, methods, and uncertainty of measurements. You may use a PT/ILC provider if they are accredited to ISO/IEC 17043. However, if you choose to develop your own ILC, you need further approval from ANAB. Furthermore, a successful PT/ILC must be completed within 12 months of applying for ISO 17025 accreditation.

For more information and examples within a specific field and industry testing, see the ANAB administrative process rule (PR). Major fields with related parameters for testing scopes can be found in PR 2350, Preparing a Draft Scope of Accreditation for Testing Laboratories.

Metrological traceability

All testing and calibration results must be traceable whenever possible through NIST or another National Metrology Institute (NMI) to the International System of Units (SI units). This means that your metrological traceability, in order of preference, is through an NMI directly, an ISO/EIC 17025 accredited laboratory, using intrinsic standards, or from a weights and measures lab. Applicant and accredited laboratories should use ISO/IEC 17025 accredited calibration laboratory services whenever available. Acceptable ISO/IEC 17025 accredited calibration laboratories are those accredited by ANAB or another accreditation body that is a signatory of the International Laboratory Accreditation Cooperation (ILAC) MRA with the appropriate calibration services listed in the scope of accreditation. If your organization seeks to submit reference standards and equipment to a calibration provider not covered by the traceability hierarchy above, the laboratory shall use the ANAB FM 2808 and apply for the approval of that non-accredited calibration provider. To trace your metrology, use form FM 2807, the traceability and in-house calibration tracking document.

Metrological traceability using reference materials

Reference materials need to fall under:

    • Certified Reference Materials (CRMs) from a reference material producer (RMP) accredited to ISO 17034
    • Standard Reference Materials® (SRM) from NIST (called under trademark).
    • CRM from another National Metrological Institute (NMI). Use of any CIPM-active NMI may be acceptable.
    • The certified values assigned to CRMs are covered by entries in the Joint Committee for Traceability in Laboratory Medicine (JCTLM) database.

If you cannot obtain reference materials from those sources, other authoritative sources or reference methods, or materials from internal validation may be used—document validation of the materials and methods and equipment. For information on Uncertainty Measurement, see the ANAB guidance documents.

In-house calibrations

If you are already ISO 17025 accredited, ANAB allows you to calibrate your own equipment according to your document plan. In accordance, you will:

    • Have the appropriate environment for carrying out the calibration.
    • Appropriately trained personnel to both carry out and check the calibrations.
    • Demonstration of competency to perform the undertaken calibrations.
    • Reference standards, certified reference materials, or reference measuring instruments are traceable with appropriate measurement uncertainties.
    • Documented procedure for each type of calibration.
    • Appropriate means of recording and reporting the data and results of any calculations according to the requirements of ISO/IEC 17025.
    • Estimate, evaluate, and maintain records of uncertainties for traceability realized internally that support tests associated with the scope of accreditation.
    • Complete Form 2807, the traceability and in-house calibration tracking document.

Management systems options

As with quality assurance, your calibration and testing need to be documented, controlled, and tracked thoroughly. One option (A) is to independently meet all the specifications put forth in ISO 17025. The other option (B) is to use a management system that conforms to ISO 9001.

Industry specifics

There are different accreditation requirements set forth by the ANSI National Accreditation Board (ANAB) for:

    • Testing laboratories
    • Calibration laboratories
    • Stand-alone sampling organizations
    • Dimensional Measurement laboratories

To apply for ANAB accreditation for ISO 17025, you will need to detail the items of concern and their measurements. There are different reporting requirements for the varying fields. They are as follows:

Testing laboratories concerning:

    • Acoustics
    • Vibration
    • Biological
    • Microbiological
    • Chemical
    • Construction Material
    • Electrical, Mechanical
    • Non-Destructive
    • Optical
    • Photometric
    • Radiometric
    • Product Safety
    • Thermal
    • Subsurface Munition
    • Information Technology

Need to itemize measurements with the following information:

    • Major field
    • Specific Tests and/or properties measured
    • Specification, standard, method, or test technique
    • Items, materials, or products tested
    • Key equipment or technology

Electromagnetic Compatibility (EMC) or Radio need to itemize the test method (date/revision), test specification(s), range, and any additional comments.

Environmental laboratories need to itemize the technology, specification/standard method/test technique, and analyte.

Calibration and Dimensional Measurement laboratories need to itemize:

    • Parameter/equipment
    • Range
    • Expanded uncertainty of measurement (+/-)
    • Reference standard, method, and/or equipment

Sampling organizations need to itemize:

    • Items, materials, or products sampled
    • Component, parameter, or characteristic sampled
    • Specification, standard, method, or test technique

Follow-up

ANAB has additional, industry-specific requirements for ISO 17025 accreditation for laboratories involved in:

    • Forensics
    • Environmental
    • Food and feed testing
    • Telecom and electronics
    • Calibration
    • Aerospace
    • Cannabis testing
    • Other, non-categorized programs

How we can help

PSC Biotech® has more than 25 years of experience in calibration programs, metrology, criticality analysis, risk assessment, process validation and can provide you with calibrated, validated equipment for your metrology needs. Contact us for more information on how our metrology services can help you in ISO 17025 accreditation.

We are seeking to understand more about the metrology needs of people who visit our website. Please consider filling out our survey so that we may increase our capacities in areas of interest: Metrology Survey.

See Also

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The Complete CQV: Where to Start

CQV engineer

Commissioning, Qualification and Validation (CQV) in the life science pharmaceutical and medical device industries define a detailed and science-based process for the specification, design, and verification of new equipment or systems into a production pipeline. In this article, we’re focusing on an over-all CQV instance, involving the launch of a new or significantly modified product is involved rather than focusing on a discrete instance of equipment qualification (IQ/OQ/PQ). In both cases, though, modern CQV practices are informed by a number of industry/regulatory guidelines including:  

    • ISPE Baseline Guide 5 “Commissioning and Qualification (Second Edition)”
    • U.S. FDA “Process Validation: General Principles and Practices”
    • ICH Q9 “Quality Risk Management”
    • ASTM E 2500 “Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment”

Phase I

The first phase of a comprehensive CQV effort is to finalize the required User Requirement Specifications (URS), and Risk Assessments (RA). Quality Risk Assessments by Subject-Matter-Experts (SMEs) in the process at hand provide risk control strategies and the necessary engineering controls. Once a control strategy has been defined, the Validation Master Plan (VMP) can be developed. The VMP is a high-level document that identifies the amount and sequence of commissioning, verification, and validation activities associated with the Project.  This document captures the CQV strategy and is a living document that is revised throughout the project’s lifecycle to maintain the correct strategic approach for achieving regulatory compliance. 

Additionally, Factory Acceptance Test (FAT) and Site Acceptance Test (SAT) documents are leveraged to accelerate the completion of the project, and they are based on the outcome of the risk assessment (RA). Thus, the Validation Master Plan will incorporate: 

    • Determine the extent of leveraging permissible based on risk assessment per system.
    • Alignment of construction-management inspection test plans and forms.
    • Review of completed inspection test plans.
    • Review of vendor FAT protocols.

CQV with risk in mind

A science-and-risk-based approach to CQV is a current Good Manufacturing Process (cGMP) requirement. Understanding risk assessments and associated control plans helps define your quality risk management process, which is essential for maintaining quality assurance and adhering to regulatory mandates. Risk Assessments will be critical in determining what aspects of the commissioning and verification effort represent the highest risk. Therefore, your engineers will focus the verification efforts to determine the appropriate level of commissioning and qualification testing and documentation performed for each system and equipment. 

CQV engineers review all the project specifications and documentation, focusing on floor plan layouts, equipment and utility piping and instrumentation diagrams, User Requirement Specifications (URS’s), and other documents that specify requirements to be tested/or documented during commissioning.  Based on these specifications, the CQV engineers develop a conservative, risk-based approach for commissioning and qualification using the already developed System Impact Assessment (SIA) as a starting point.  

Next

Check out other blog articles in our CQV series where we will tell you more about the Validation Master Plan. Then watch for future CQV articles on Phase two of a CQV project – the execution phase performed onsite and remotely. On-site, engineers document and test equipment, facilities, utilities, computer systems, processes, and cleaning. Preparing onsite components is the core component of CQV projects, and we look forward to elucidating this process.  

CQV Engineers and Project Managers

PSC Biotech® Commissioning, Qualification, and Validation Engineers and Project Managers are available to:

    • Develop the Validation Master Plan.
    • Complete Gap and Risk Assessments.
    • Perform Pre-Startup Safety Reviews.
    • Generate, perform, and document the Factory Acceptance Test (FAT) and Site Acceptance Test (SAT).
    • Execute a System Impact Assessment (SIA).
    • Provide Installation and operational qualifications (IQ/OQ) for Building Management System (BMS) Systems and Environmental Monitoring Systems Development and assessments for maintenance programs.
    • Detailed Operational Qualifications Process Validation (PV).
    • SOP development and preventative maintenance implementation.
    • Turnover documentation package preparation.
    • Compile the CQV Issues Log.
    • Finalize the project with a CQV Summary Report (CQVSR).

Furthermore, unless otherwise requested, PSC Biotech assigns a Project Manager to each CQV project. The Project Manager utilizes our exclusively developed Project Tracker (PT) software to maintain an accurate and up-to-date deliverable document status. With years of expertise and regulatory awareness, our engineers execute CQV projects in a highly efficient manner to get your product started as soon as possible. See our project success pages for examples. Contact us for a bespoke assessment and cost estimate.

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ISO 17025 accreditation explained

Metrology 101

Why you need a calibration program

Metrology is the scientific study of measurement.

If you make things, you need to calibrate the buildings, equipment, and processes that you use to make things.

If it moves or measures and doesn’t breathe, it might need calibration. Your calibration program identifies the critical items that need calibration, the items that are for information only, etc.

If you can’t measure it, you can’t calibrate it.

Calibration

Once you decide what needs calibration, you need to determine what measurements you need to make. Your calibration program establishes the tolerances, the calibration interval, and the measurement data that you or your calibration service providers must generate for “it,” whether “it” is your buildings, your equipment, or your process(es).

Whether you do it yourself or have calibration service providers do it for you, your Quality Assurance group is ultimately responsible for your calibrations. If you use a service provider, use one that has current Good Manufacturing Practice (cGMP) experience.

You Might Need Verifications

Once you calibrate, you can perform verifications. Verifications are your in-process checks performed on the floor during the calibration interval to ensure that “it” is still in calibration. Not everything needs verification.

How Do I Decide if I Need Verifications?

Do a criticality assessment of your system to identify which things need verification and which do not. Your criticality assessment should take into account measurement systems that affect Quality Control data or customer requirements. How critical is the parameter, e.g., the temperature, mass/volume, pressure, etc., being measured? Suppose you have determined that the parameter in a step is critical to the quality attributes, perhaps even a Critical Control Point (CCP), of your product or process. In that case, you may want to design a verification for that step.

Calibration versus Verification

Calibration uses a reference standard at least four times, and usually ten times or more, accurate than the tolerance you set for whatever you are calibrating. This ratio of the accuracy of the standard to the working device is the total accuracy ratio or TAR. For example, if your process requires a ± 4 RPM for a mixer or centrifuge, then the reference standard needs to perform at a stated accuracy within ± 1 RPM.  Calibrations are done by members of your Metrology staff or your service provider who are adequately trained via the appropriate procedures.

Verification uses a working standard that is suitably accurate to show that the item you are verifying is within the tolerance that you set for it. You want the verification standard to be accurate, robust, easy to use, and give you a “go-no go” result in a short time so that you can get back to processing. Verifications are done by your production personnel on the floor in the plant and recorded on batch records or similar documentation.

 Calibration

    • Performed at regular intervals as defined in your Quality System
    • Performed for troubleshooting when a measurement is outside of expected operating readings
    • Calibration label on the device states the date of performance and the due date
    • Displays a legible calibration sticker traceable to documentation

Verification

    • Designed into the process and performed during manufacturing or periodically
    • Done before use to identify equipment operating outside of expected performance
    • Recorded in pre-operation or batch records
    • Part of the equipment logs, batch record, etc., for the equipment, process, etc.

Summary

You need a comprehensive program for calibration and verification of your facility, equipment, and process(es). When deciding how to incorporate equipment into your calibration program, criticality and risk assessments are best practices, especially surrounding attributes critical to quality.

PSC Biotech has years of experience in calibration programs, metrology, criticality analysis, risk assessment, process validation and can provide you with calibrated, validated equipment for your metrology needs. Contact us now! PSC Biotech®

If you found this material relevant, please take a moment to share how you manage calibration at your site(s): Metrology Survey

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What happens when something goes wrong? CAPAs for Equipment

What happens when something goes wrong? CAPAs for Equipment

What is a CAPA? It is the acronym given to Corrective and Preventative Action, as defined by the FDA. A CAPA is triggered when a product, process, or documentation has a non-compliance issue. CAPAs can be triggered from small or large issues. A small issue might be repeated product loss from intermittent equipment error. Whereas a more significant CAPA trigger results from errors in product packaging that trigger a Form 483 from the FDA.

If you are in the pharmaceutical, biotechnology, or healthcare industries, you need proper CAPA support to bring your systems back to an acceptably maintained, calibrated, and validated condition. Solutions can range from small procedural changes to system redesign/revalidation. CAPAs are put in place for regulatory compliance but also reliable and profitable operations.

Who is the right team to investigate, document, solve, and resolve the issue?

 

Equipment CAPA for Manufacturing malfunction

CAPA investigation:  Who? What? Where? When? and Why?

The parameters of a CAPA problem need to be correctly defined. Each CAPA investigation can be unique since there can be a single or several different root causes.  Often a team is required with different areas of expertise to bring up all possible scenarios.

Areas of investigation can include:

    • Equipment evaluation: For example, verifying vendor utilities as specified versus what was installed.
    • Software evaluation: Code check if the proper alarms were programmed and work properly.
    • Equipment comparison. For example, do similar pieces of equipment have the same problem? If not, what is the difference? These differences could be in process parameters, design, etc.
    • Test runs: Physically test potential change controls before implementing (e.g., ramp rates, alarm settings, and proposed software changes) and return to the currently validated state.
    • Operations evaluation: For example, does the event occur on a specific shift/operator time, times of the year, during other operation events, or only for certain product sizes?
    • Interviews: Personnel such as Operators, Mechanics, and Supervisors may have knowledge that the area engineers don’t have. Use them; they appreciate the acknowledgment of their operations knowledge.
    • Prior CAPA investigations: Sometimes, similar CAPAs for systems and equipment have occurred in the past outside of the effectiveness monitoring period.  Information from these CAPAs will help to avoid the same mistakes, or even provide a forgotten solution.

CAPA Mitigation:  How to minimize risk while work is progressing?

CAPAs take time to solve.  A good risk assessment will help mitigate risks while the CAPA work proceeds.

Examples of mitigations can include:

    • Operations Changes: For example, a reverse osmosis (RO) water system trips from low flow on Monday mornings.  The short-term mitigation would be staggering cleaning systems’ use of RO until the situation was remediated.  Another example is switching problematic processes to another line that doesn’t have that problem.
    • Awareness Training: For the RO system example, operators and supervisors would be made aware of the situation so they could check usage before starting their work.
    • Documentation: Document all events after CAPA has started to help see if additional causes exist and if mitigations are helping.

CAPA Activities & Documentation:

CAPA investigations generate a probable list of root causes.  Each root cause will have its own activities and documentation.

Types of CAPA activities and the documentation required:

    • Correction: Example – Replace a failed sensor or equipment component.  Documentation includes the basic maintenance work order.
    • Corrective Action: Example – Change calibration or maintenance schedules due to reliability. Documentation includes SOP changes.
    • Preventative Action: For example, repair PLC control code to mitigate missing alarms or proper pump priming.  This example would be a weekend software validation change control.
Get CAPA help from PSC Consultants

CAPA Effectiveness Monitoring / Closure:

After CAPA activities are completed, there will be a period of Effectiveness Monitoring before CAPA closure.  If effectiveness monitoring fails, the CAPA will revert to the investigation phase. Successfully closing a CAPA will result in greater equipment uptime and remediate regulatory compliance issues.

PSC Biotech has experienced and efficient CAPA investigation and support services.

If you need CAPA Investigation and technical support service, contact PSC Biotech®. Our professional services group has the right technical expertise to ask the right questions and help solve your CAPA problem in a timely manner.

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What is Method Transfer, and Why is it Important?

What is Method Transfer, and Why is it Important?

Written By: Mattew Greer, Technical Writer, PSC Biotech®

When bringing new products from one facility to another or from a product development to production environment , understanding the requirements for the transfer of validated analytical methods used for testing of said products is essential. It is important to compare the initial and transfer laboratories and confirm that the latter has the capability to perform the validated method correctly and consistently. The transfer needs to check that the methods adhere to the United States Pharmacopeia (USP) and any other applicable standards as well. The goal in a successful method transfer should be to reduce the number of variables in your lab which could affect the quality of the final product. These methods need to be taken from the primary lab and transcribed into approved documents for testing at the final lab. This paper will list some of the various types of method transfer possible and how PSC Biotech® can provide assistance.

Method Transfer Types

There are typically four different types of method transfers that are based on the availability of the initial testing lab as well as the complexity of the products being tested.

Comparative Testing

Comparative Testing means to test a predetermined number of samples of the same lot by both the sending and receiving facilities and comparing the results. The transfer protocol from the initial lab will determine the acceptance criteria and procedures.

 

Co-validation

If both the initial and transfer site needs to collaborate to complete the validation, the appropriate transfer method is to co-validate. This would mean keeping lines of communication between both sites in order to confirm the reproducibility. This strategy is optimal for dealing with multiple laboratories. Similar to the comparative testing, the protocols will come from the primary site.

Revalidation

This type of testing is necessary if the initial laboratory is not available to receive the proper methods. Revalidation is the most consuming of all the method transfers but needed when the initial lab is not accessible. Usually this work involves repeating all validation testing initially performed.

Transfer Waiver

Depending on the lab’s experience and the complexity of a method, opting for a transfer waiver is a viable option for some transfers. A risk assessment would need to be taken into consideration to confirm this approach is valid.

What Can PSC do for you?

Method transfer can easily become a hassle, and that is where PSC Biotech® can help. We employ a team of professional consultants who are available to transition documents with ease. Our services are offered in the form of a local team who can come onsite to collaborate to make sure your facility is ready for any type of method transfer. We can take the methods provided and generate documents that are compliant with the USP guidelines. Contact us today.

About PSC 

PSC Biotech® offers partnership opportunities for leaders looking to advance themselves throughout the Life Sciences industry through a multitude of resources and solutions. PSC has served the Life Sciences industry for over twenty (20) years with exemplary professionalism, quality solutions, and client-focused services. Our goal is to provide unmatched software and hardware consulting services to Life Science companies so they can perform at their highest potential.   

Procedures, Policies, Protocol, … Oh My

Procedures, Policies, Protocol, … Oh My

Written By: Mattew Greer, Technical Writer, PSC Biotech®

Your cGMP documents must comply with the applicable laws and regulations.  They don’t have to be easy to understand but they should be.  Writing compliant and easy to understand and use documents, that are “good” documents, is hard and time consuming work.

Easy to understand and use documents reduce the possibility of errors and increase understanding.  You want the best facility, equipment, and personnel.  You should want the best documents as well.  Good documents will save you time and money and will help to minimize human errors.

You can write good documents.  It just takes time and resources.  Sometime, lots of time and resources that you could make better use of doing something else.  So why PSC®?  Simply put, PSC® can do it for you and let you concentrate on running your business.

PSC Biotech® employs a team of skillful technical writers with the ability to create any documentation needed to help your operations run effectively and efficiently. If you are looking for documentation for qualification of equipment and systems, our writers can draft “good” documents for your Quality Management System that meet your goals, actual practices, and industry standards. PSC® writes whatever you need, including:

  • Easy to use templates
  • Policies
  • Standard Operation Procedures (SOPs)
  • Qualifications protocols
  • Logbooks
  • Protocols
  • Reports
  • Risk Assessments
  • Gap Analysis Documentation
  • Forms

When PSC® writes your documents, whether it is one, a few, or an entire quality management system, you also have access to PSC’s® network of Subject Matter Experts (SMEs) who know global laws, regulations, and guidance documents.  PSC® writes every document to conform to the way you operate and to ensure regulatory compliance.

PSC® can write your documents on-site or remotely.  PSC® can assign a dedicated writer or assemble a team, depending on your wishes, the volume of documents and the time frame for delivery.  Our team will work with your team to get you the compliant documents you need.

About PSC Biotech®

PSC Biotech® is a leading Life Sciences and Biotechnology consulting firm.  PSC® strives to provide you with solutions to your needs that are cost-effective and meet your quality requirements.  PSC Biotech® can provide our electronic Quality Management System (eQMS) software, ACE®, to process, control, and manage not only your documents but also integrate the training into a single system.  ACE® is flexible, so the workflow is your workflow, not a rigid, inflexible workflow that doesn’t reflect how you operate your business.

If you need technical writing, PSC Biotech® is happy to help. PSC Biotech® can help with almost all of your needs.  If you don’t see what you need, call us!  It is our pleasure to address your business needs with the utmost care and concern. Contact us today.

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