Validation Resources Blog

Engineers of all disciplines will be aware of the strong shift towards continuous, data driven approaches to manufacturing in recent years. While many might be familiar with Process Capability and Process Performance, many Engineers have been unable to gain experience in these areas due to the resistance of some sectors embracing this approach.

And there are the fundamental challenges of CpK and Ppk. Some old manufacturing processes simply do not adapt well to this approach. So here is a basic overview of what Cp, Cpk, Pp and Ppk are all about.

Process Capability and Process Performance

A measure of Process Capability, CpK or Process Performance, Ppk is often used as acceptance criteria for Critical-to-Quality Attributes where variable data is collected. Variable data is also known as continuous data. (In simple terms, data that is in number format, for example a component dimension, when measured with a Vernier calipers gives a value that is “variable” 2.22mm, 2.21mm, 2.31mm etc.) Collection of variable data allows trending which is beneficial in identifying potential issues before they impact the quality of the product. For example, a shift in data may indicate that a machine tool is wearing and is nearing its end of life.

Process Capability and Process Performance refers to the ability of a process to meet specific dimensional or physical requirements and how well they fall within specification limits -how consistently do measurements fall within the upper and lower specification limits.

Pp (Process Performance) and Cp (Process Capability): quantify the stability of a process, i.e., the amount of variation in the output.

Ppk and Cpk represent both the degree of variability AND the degree that the output is centred between the lower and upper specification limits.

Pp and Ppk are calculated using the standard deviation of the entire population and represent a long term performance. Pp and Ppk values are used to describe the Process expected over the long term

Cp and Cpk are calculated using a sample standard deviation and represent the potential that could be achieved if sources of variation are identified and eliminated.

Cp and Cpk are more commonly used for short term assessment.

Check out our simple and concise Cheatsheet for Process Capability and Process Performance here

INTRODUCING KNOWLEDGE BOX?

Knowledge Box is for professionals working in the medical device and pharmaceutical industries, who require a flexible and tailored approach to training and upskilling. Next time you or your employee's wish to train - get Knowledge Box certified. 

HOW IS THE TRAINING ROLLED OUT?

Courses are delivered through email with each candidate completing the content through self-learning.
Each training program is made of the following elements:

• Between 4 and 6 self-learning sessions completed on a weekly basis.
• Technical tasks to be completed by the participant for each session.
• Upon completion of the program, an open book exam consisting of 30 multiple-choice questions.
• On successful completion of the course and exam, each candidate receives a Certificate of completion.

Interested or want to take a course? Find out more? Email  info@validationresources.ie  

EVENT: Process Validation: applications in Engineering, Medical Device and Pharmaceutical industries

Join us in March 2016 for a full days training, demonstrating the application of Process Validation in Engineering and the Life-science sector.  

Venue: The Forge, Teesside University, Darlington Campus

Date: Thursday 24th March 2016

Book now here  

Cost: £290.00 per delegate 

Learning Objectives

¨Define the business benefits and regulatory requirements of Process Validation

¨Recognise the key elements of Process Validation

¨Formulate a methodology to design and execute Validation Studies

¨Apply Process Capability and Process Performance criteria to Validation 

Click here to book now. 

ISO 9001 is a Quality management standard that drives businesses to implement and maintain a process approach to all activities within the company. A process is essential a sequence of steps that can be replicated time after time. At the heart of ISO 9001 is customer satisfaction and continuous improvement. These are well recognized elements in growing and maintaining a strong business.

The latest edition of ISO 9001, has recently been published.This brings together over three years of revision work by experts from almost 100 participating countries.

ISO Secretary, General Kevin McKinley explains: “ISO 9001 allows organizations to adapt to a changing world. It enhances an organization’s ability to satisfy its customers and provides a coherent foundation for growth and sustained success.”

With well over 1.1 million certificates issued worldwide, ISO 9001 works to help organizations provide products and services of consistently good quality.

Having a process approach also helps to optimize processes and identify where the issue lie

The earlier versions of ISO 9001 were very prescriptive, with many requirements for documented and controlled procedures and records. The 2008 edition, the establishment of processes and managing processes became the mantra.

The 2015 edition puts greater focus on performance, risk based thinking and the Plan-Do-Check-Act methodology.

If you interested in Medical Devices,you will find ISO 13485, the Quality Management System for Medical Devices a useful reference also.

Visit amazon.com here  

Engineers are increasingly seeking employment within  regulated industries such as Life Sciences. Medical Device Manufacturing and Pharmaceutical Manufacturing provide competitive salaries and generally stable employment. For those who aim to cross over from more traditional forms of engineering, the requirements of cGxP may be unfamiliar and daunting at first.

 However, meeting the regulatory requirements is fundamental in allowing the sale and export of products to different markets throughout the globe. Therefore, it is not long before an understanding and competency in cGxP and Validation is required by Engineers, Scientists or Managers.

Now, ValidationResources.org have published  a handbook introducing the concepts of cGxP and Validation. The book is entitled "An Introduction to cGxP and Validation for Engineers"

"An Introduction to cGxP and Validation for Engineers" was written to assist Engineers and Professionals in acquiring the fundamental skills and knowledge needed in Medical Device and Pharmaceutical Companies. 

The book brings together the Key Principles of Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), Equipment Validation and Process Validation. Case studies based on industry experience are also included, helping the reader to appreciate the practical application of  cGxP and Validation.

Click Here  to see the hardcopy available.

Click Here  to see the Kindle ebook version available at  www.amazon.com  and   www.amazon.co.uk 

Chapter 1- An Introduction to GDP

Chapter 2- An Introduction to GMP

Chapter 3- An Introduction to Test Method Validation

Chapter 4- An  Introduction to Equipment Qualification

Chapter 5- An Introduction to Process Validation

-Case Studies 

Purchase "An Introduction to cGxP and Validation for Engineers"

A Brief History of Hip Replacements

The main method of manufacturing for Hip and Knee replacements is by Lost Wax Investment casting. However, 3D printing technologies are becoming a viable option with many of the leading Hip and Knee manufacturers developing new products using Additive Manufacturing aka 3D printing.

It is interesting to look at the history of Hip replacements and how far the industry has come.

Below is a brief look at the art of Artificial Hip Joint Replacement and their performance.

1891 – Gluck, Ivory ball and socket joints

1923-1937- Smith-Peterson, Use of celluloid resin for Heads and Co-Cr alloy for stem. Necrosis (tissue death) resulted in the failure of the implants.

1930-1946 Judet Bro, the femoral head was made of methyl methacrylate. Failure was attributed to wear and loosening.

1938-Wiles, first total hip replacement made of stainless steel. Failure attributed to loosening and inadequate fixation.

1950-McKee, Metal on Metal Co-Cr alloy. Failure due to high friction.

1957-Charnley, Stainless steel on PTFE Cup. Failure due to excessive wear.

1959-Charnley, Stainless steel on UHMWPE. Good performance

1963-Ring, Press fit Co-Cr head on Ti Stem

1980’s – saw the introduction of porous coatings and cementless fixations.

It will be an interesting few years to see new technologies such as 3D-pritning in action and what products can be realised.  Watch this space.

Continued Process Verification – in a nutshell!

OK, so you have come through Process Design and Process Qualification. The Commercial train is steaming ahead. However, to take it back to basics, there are 3 stages of Process Validation, the 3^rd been Continued Process Verification. Naturally, as the 3^rd and final element, it is often left aside or not given proper attention.

The aim of continued process verification is to ensure a validated process stays in control, or in a state of compliance.

Information within the scope of Continued Process Verification can include:

Defects and Complaints reporting

Deviations and CAPAs

Trending of outputs against lines/shifts/personnel, preventative maintenance schedules

Reviewing Batch to Batch Variation

A correct approach to Continued Process Verification will help to ensure that a process remains within its validated state during the commercial lifecycle. Furthermore, it should help to identify problematic trends before they start to effect product quality. 

What Med Device companies look for in a Packaging PQ?

Speaking from experience of working with Medical Device companies, there are some key points to note when it comes to Packaging Validations. Any Process validation be it cleaning or packaging examines the repeatability and consistency of the process, taking into account normal variation. This “process stability” can depend on several factors that influence the performance and quality of packaging. To take a Simple Blister packaging machine. The following factors should be challenged in a Packaging Performance Qualification.

Setup – If multiple tooling is available, setup should be challenged by a tool change, at a minimum of 3 distinct setups. Remember, that Standardised setups, appropriately trained people and documented procedures should be in place.

Worker-At a minimum, two workers/operators should be used during the qualification, this takes into account normal variation from operator to operator. For example, there might be subtle differences in how components are placed.

Material- Three distinct lots for each component should be used during the execution of the Packaging PQ. This takes into account potential lot to lot differences of the material eg. Thickness.

Time- The validation should be conducted over a suitable period of time to take into account normal variation. E.g. start, middle and end of shift.

It is important to point out that PQ studies should be executed at nominal settings. Typically, 3 consecutive lots are produced.

And there you have it! By reviewing the influencing/ dominating factors of a process, a validation can be suitably designed to ensure an appropriate level of challenge is achieved.

Looking for more content, check out this pod-cast by the BBC, In-business Program on the subject "Packaging in a Pickle"

Modern living generates ever increasing amounts of packaging to wrap up the things we purchase and that generates widespread criticism of the packaging industry. But packaging companies are trying to innovate to respond to both environmental and marketing needs. Peter Day investigates what is wrapped around the products we all buy.

When a Deviation is encountered during a Validation, it is important that cool heads prevail. Many times I have witnessed frenzied activity which had no value and did not help resolve the Deviations. First of all, the Deviation Procedure should be consulted, take a step back and fully assess the situation. Below are 6 points worth noting when you encounter a Deviation.

No. 1 Provide all the Details

A lack of detail is every Auditors dream! The very first aim of a Deviation is to describe the deviation event. The “Five W's” (who, what, where, when, why) are always a helpful start when writing the description. Remember that providing all the detail will help to ensure traceability if there is a need to re-visit a Deviation in the future.

No. 2 Assess the Impact on Patient and Product

It is best practice to address the impact of the Deviation on both the product (if being manufactured or tested) and the end user or patient. A simple statement such as “there is no impact on the product as the deviation is limited to an ergonomic issue relating to the operator position" can suffice. Likewise a statement such as “there is no impact or risk to the patient as all product will be destroyed per SOP XYZ on completion of this validation”.

No. 3 Avoid Gaps in Supporting Information

It is very hard to close a deviation if test results or supporting data is misplaced. Always ensure data is captured in a timely manner. Attachments should be annotated as per GDP.

No. 4 Approval

Time is money and it is sometimes very tempting to move forward without stopping to think about the correct actions required to resolve a deviation. When the deviation is properly described, investigated and its impact properly understood, agreement on how to move forward and resolve the deviation should be collectively decided and documented. Typically Quality approval is required for the planned resolution in advance of completing the tasks required.

No. 5 Don’t Forget the Basics- GDP

Remember to follow GDP when signing and dating any document or attachment. If you spot an error, point it out to the person responsible.

No. 6 It’s not over till it’s over

Remember that the planned resolution of a deviation should be completed and verified prior to a deviation closure. All testing should be completed and documented accordingly. It is also best practice not to leave final approval linger. If it can be closed, close it. It simply may be forgotten if put on the long finger.