English is common for most who work in a GxP-regulated industry.
Though most would consider themselves firm English speakers, the truth of the matter is: most will never go beyond some standard vocabulary, and most have only little understanding of English grammar and writing style.
After the Brexit, in Europe very few are English native speakers.
One could likely make a case for that even English EU GxP Guidance and Drug Regulation documents suffer from this issue.
No, English is in fact not easy–good English is just not!
In company GxP documents and reports the English text often suffers from features of other languages which are unknowingly imposed on it because authors and reviewers are not native speakers.
Clarity and quality suffer, content is misrepresented, reports are harder to read later on, procedures are misinterpreted due to undetected ambiguity, even wrong conclusions can be the consequence of using substandard “EUnglish” instead of actual English.
And when a native English speaking authority comes in for inspection (USFDA, TGA, MHRA) all of a sudden QA wonders why the authorities have such trouble seeing through the local QMS and GxP-system and find what they read rather irksome (if You need to look up “irksome” then I totally got You!).
“And here we thought all is fine…”.
Experts Institut offers a customized and Taylor-made applicational training on “Technical Editing of GxP Documents: The Relevance of Quality and Style”.
This training is relevant for really all levels of GMP-/GxP-regulated organizations.
The training provides theoretical elements of English language features and how they can interfere with other languages in GxP documents and reports.
Important elements in English writing style are presented as well.
Application of the theoretical part is then trained in inductive workshop sections to gain immediate hands-on understanding of how all this plays out in real GxP life.
Basic quality systems can make good use of this, just as well established ones can.
It is a great contribution to the foundation of Pharmaceutical Quality Management Maturity.
This training is one of many reasons why Experts Institut is so unique in its work portfolio: We go beyond GMP/GxP-only – We see the big picture – We see the whole.
For your benefit.
Feel free to contact us and make an appointment to talk about how we can customize this expertise to Your need.
Today the world, with its regulated industry, is strongly globalized. The cultural diversity of a company’s staff can be huge. This is one reason why many would assume that the entire world can be talked to, related to and understood quite readily. It is part of everyday work for many after all-or so we think.
In the area of audits and inspections, crossing cultures happens all the time. Where supply chains are globalized, trans-national and trans-continental audits and inspections are mandatory and pretty much normal in many company and regulatory settings.
True Multiculturalism
This poses a problem though: we learn to communicate, read, and perceive in our birth culture. And even if a society is highly diverse, we are still product of a cultural framework that is discrete-in other words, that has boundaries. It is simply impossible for one person to really become multicultural-ourlifespan is just not large enough. You may be the child of a double or third culture set of parents, but true multiculturalism in a single individual is virtually impossible.
So as we are controlled by our birth culture, we do not learn how to properly navigate in foreign cultural contexts (and globalization does not do away with this at all). We may think we know what is going on around us when we engage people from other host cultures, but we really do not. Even in a seasoned friendship with someone from another country, there will still be a vast degree of ignorance in understanding the other person. We believe we know and understand. But we miss most of it in reality. We continue to filter everything we experience, see, hear and judge through what we believe is normal, and our frame of reference is our birth culture. And we cannot stop doing it because we are not even aware of it.
And now it gets interesting: This problem includes audit and inspection situations!
Good auditing is more than knowing compliance requirements, audit methodology, and a work experience of 100+ or even 1000+ audits.
Culture is so powerful that it controls everything we think, say and do. And what we expect of others. In an audit situation (also in GMP inspections), this routinely produces misunderstandings. And many of them are never corrected, simply because neither the auditor nor the auditee is aware of them.
From document reviews, an auditor may conclude that a company is falsifying records, when the truth is though that what the auditor saw has nothing to do with cheating at all.
An auditor may think the auditee is trying to avoid saying the truth about a given audit question or subject, but there is no intent of this in the conversation at all. But the auditor is blind to this.
As a result of examples like these, auditors will put their impressions into the report, in a coded form of course, but it will color all parts of the report and the perception of GMP deficiencies-even the judgment on severeness.
If an auditor is not aware of what is missed and where the personal perception of things is going astray, then such an auditor must improve. The objectiveness of the report will suffer, and the picture that is brought home is greatly inaccurate. We do a disservice to the auditee and to our own sending unit. And frankly, to ourselves…
This plays out even more drastically in audits of suppliers or service providers where no GMP or GxP quality system is available. Such cultural ignorance can make or break the business relationship altogether.
How can you improve?
Stop thinking that cultural differences are easy to figure out. You cannot guess them. You need extra training for this.
Understand that cultural differences have little to do with differing food preferences or how a business card must be presented.
Respect that standards-even GMP-can be lived effectively in different ways.
Open to the truth that you do not know everything best.
CS are becoming increasingly important, especially in the pharmaceutical industry, in order to meet the increasing demands on production. At the same time, their use must not compromise patient safety.
This brings with it increasing challenges in the scope of validation and qualification of the system: Proof that CS function properly and do not pose an increased risk to patients can only be provided by taking a holistic view of the system. A master plan is therefore a useful document for defining the scope of the project.
Complexity of the scope of validation
The initial classification of the CS into a software category according to GAMP 5 provides guidance on the complexity of the scope of validation:
Operating systems
N/A
Non-configurable software (standard software)
Configurable software
Individual customer software
A risk assessment is now used to check the criticality of the CS with regard to GxP relevance, i.e. the extent to which there is an impact on patient safety. A detailed identification and analysis of risks and the definition of suitable control measures to minimize or completely exclude these risks is essential. A continuous review is also essential for a complete audit.
In addition to determining areas of application, exact specifications and their influence on patient safety, individually planned tests with suitable acceptance criteria are also included in the CS review.
The validation of the process then goes hand in hand with the qualification of the process environment, divided into the phases of design, installation, function and performance testing. This allows individual specifications to be checked and verified step by step.
Only once qualification and validation have been successfully completed and proof of suitability for the intended process has been provided can the CS be used without any increased risk to patient safety.
Blog post: Field report by an EI consultant from a supplier qualification project for pharmaceutical manufacturers
In the period from 2019 to 2022, I was involved in a project for the supplier qualification of drug manufacturers and active ingredient manufacturers at a pharmaceutical company and generics manufacturer. The project team, consisting of up to four colleagues, was entrusted with various tasks and focal points to ensure smooth implementation.
Before I took over the management of this project, my colleagues had already developed a checklist for the review of audit and inspection reports. As project coordinator, my main responsibility was to manage, coordinate and plan the activities. My tasks included direct customer contact and the exchange of information as well as requesting and evaluating audit reports for supplier qualification. I was also responsible for the creation and versioning of technical agreements, supplier monitoring and internal coordination with the specialist departments.
One of my main tasks was to check and evaluate the inspection reports (audit reports) for content, accuracy and completeness in accordance with the applicable GMP guidelines for the products and to document this using internal guidelines (SOPs) and checklists (audit report review).
The challenges in this project were manifold. A tight schedule due to upcoming production & product releases required the tasks to be completed on time. In addition, global customer contact required effective communication and coordination across European borders. Another challenge was to work through the previous year’s backlog while maintaining ongoing business, particularly due to staff shortages and changes in the team. After completion of the project at the customer’s site, it was important to transfer the newly acquired knowledge and processes to the resident and newly hired staff and to ensure that the quality assurance processes & measures are continuously implemented and adhered to.
Despite the challenges, the long-term collaboration within the team was very successful and our structured approach enabled us to fully meet the client’s requirements. Our work contributed significantly to the quality assurance of the company’s medicines and ensured that suppliers met the required quality standards.
Are you also looking for support in supplier qualification or quality management? Our experienced team is ready to make your project a success. Contact us for a customized solution that is precisely tailored to your needs.
It is almost 8.00 am, we are standing on front of a building which houses an officially GMP-accredited contract laboratory service. Our task for today: carry out a full blown GMP-audit on the contract lab.
On the inside I am a bit excited, because I know that in each audit I do not only evaluate others, but I will also gain and learn! And each auditee – be it a laboratory, a GMP-manufacturer or a material supplier (API, excipients, packaging materials) is different, and each uses different ways and systems to implement GMP. So far so good.
Later that day the audit is over and my co-auditor and I we feel overall happy with the audit. Still – we also feel disillusioned: we had expected a more modern way of raw data, data and document management. What did we find? An almost 100% paper-based GMP- and data management system, with all its nicks and dents when it comes to the GMP such a system can provide – it is alright, but it no doubt has limits.
Fully paper-based – that something like this still exists? And that in a GMP-bound establishment? It sure does still exist.
In the GMP-Universe the Digitization Truck has departed, but by far not delivered to all yet!
In our line of work at Experts Institut we are time and again surprised as to how many companies in the drug manufacturing, medical device and cosmetic GMP area operate with a very low degree of digitalization of processes and data management. It grounds everyone I believe and alerts us to the reality that digitization is by far not as advanced in the regulated industry as we might want to make ourselved believe or think – as much as it is a socio-economic and political desire among regulators and industry. In fact though, it is not(!) a given, it is not a self-propagating realization all over the place. And this does not only concern small companies who seem to just not be able to finance the digital transformation. It also concerns for example medium-size GxP-entities. If You think that the size of a company is an indicator for its degree of digitalization then You need to think again. There is no such connection. You’d be surprised what we encounter in our daily work.
Even politics, cultural Western optimism and the strong drive to achieve and constantly change towards something new is not always the recipe for producing a digital revolution by and large.
Incentives for change must come from the market, it must be attractive, plausible to implement and at reasonable cost. And in a highly regulated area like the white industry(Pharmaceutical GMP, Medical Device Quality Assurance, Cosmetic-Industry) New means not only Opportunity, but also Risk. And in white industry products the risk is considerable. An excellent example is the timidity of the GxP-industry to enter continuous manufacturing transformation – for a lack of experience with the regulators in this area. A similar reason may be at the root of the spotty coverage of digitalization.
Concerns and Opportunities of Digitalization for GxP Establishments
Some companies shy away from larger transformations due to finances thin-stretched, and due to a blurred understanding where then the actual benefit of digital data- and process-management really hit home positively.
Others simply do not see any need to change and keep up with modernization because for a period of time resisting change can go without noticing any consequences in the business numbers and balances. Even in terms of basic GMP-systems quite a few companies are chronically underfinanced.
Again others are apprehensive about the risk that may come to their data and company information due to migrating everything into electronic formats, networks and clouds – and that is a very understandable risk. There are solutions to protect data from even the most sphisticated attacks, but they will cost.
Looking at the opportunities: once digitalization has reached a company’s operational processes – where product is actually made (not just where warehousing and document management are electronic) – a company has arrived on a temporary plateau of readiness for tomorrow.
And here is the thing: that readiness will likely make or break any business eventually – but most certainly a GMP-business!
You will need digitalized company processes (manufacturing, analytics, logistics, quality management, compliance, engineering and technical systems) and data management to be ready for:
a globalized approach in making business wich data, knowledge and information sharing at the top (regulatory submission, block chain approaches for decentralized data management),
adapting to constantly advancing regulatory standards for GMP-data management and managing modern technologies in development and even in routine production (see for examples EU GMP Guide Annex 1),
advancing cost efficiency concerning staff Your system would otherwise require to cater to the massive burden of GMP-/GxP-requirements.
Where to start? And how to get on the truck?
Digitalization in a GMP-/ GxP-liable company typically follows some sort of evolutionary model.
Basic for any company is to have at least material management systems, warehousing and logistics managed by electronic systems. At least for article data and inventory as well as location and status management such systems are standard. This is nothing new of course. But I tell You: there are in fact some companies that don’t even have that.
The second layer is often electronic Document Management (eDMS).
Then comes electronic batch record – at least partially, more often electronic deviation and change management or other QM subsystems – mostly non-integrated but separate applications.
and then – typically – a full electronic Quality Management System, some commpanies using the opportunitydigitizing their business and administrative processes if they haven’t so yet.
Global companies need to deal with additional issues with data sharing and data security across the corporation, leading to for example decentralized data storage solutions for example controlled via block chain technology.
And by the latest at that point comes the phase of trying to integrate all of this.
Basic Evolutionary Degress of Digitalization in GMP and GxP-liable Companies (pharmaceutical manufacturing and on-coming suppliers, medical devices industry, cosmetics).
As You can see: if Your company is currently a low-digitized business – do not be dismayed – You may have just about missed out all those years where all the others have hustled and bustled to add one little digital island system after the other. And You now have the advantage to look back on this and make a decision to roll out digitalization compreheneively and for the first time!
Digitalization in a GMP-Environment
There are challenges of course. Digitalization cannot be rushed or it will result in a gigantic failure with data loss, loss of company spirit and – worst case – of good people who will quit over the frustration of the failed digitalization effort. Leadership will lose credibility and trust – which is worse than anything from a company perspective.
The more integrated You advance Your digitalization the more keeping in with the validated state is a true GMP-challenge. And a huge caveat I must place here is: Be very thorough when working with validation-packages from software suppliers! They come from a non-GMP quality system environment – often no QMS around the software development at all – and so You need to take charge of what is done concerning validation (initial, updates, integration and post-integration management) – even and especially when it is an ISPE GAMP®5 category 3 or category 4 system. And do not mistake brand names for assurance of GMP-compliance. Our audit practice shows that even systems which are heavily advertized for can lack basic regulatory compliance requirements or are not fully compatible with local national GxP-requirements (an issue that even electronic deviation workflows or eBR systems can have).
For some newer technologies (Blockchain Technology, Decentralized Data Management, AI / Machine Learning / Neuronal Networks) You must understand: regulatory agencies are yet to say and to judge what they require from the GxP-viewpoint, depending on each situation of digital integrated process landscaping and data generation and management. Of course You can apply the current GxP-regulations’ point to now – but it may not in all cases be what You need.
And take a good look where You will market Your products: some regulatory agencies are on high alert concerning data and processes in digitalized environments and close to publishing guidance, others are – yet – fast asleep but won’t be forever.
What We (EI) do when We support a company in digitalization or digital transformation?
We Support Your planning – Organization and Required Efforts:
Feasibility study, digitalization concept, regularoy GMP-/GxP- and cGMP compliance assessment, also of existing levels of digitalization.
We prepare Your body of documents:
With You we estalish and review the required GxP-relevant document You will need for individual systems and for global structure concept papers and policies keeping in with Your data integrity and data security requirements.
We work with those from Your company who will live and operate the / in the system:
Coordinating a digitalization project can be challenging and requires a sober and coordinative mind and management skills. Often companies new in the arena of digitalization do not have personnel to carry such a project and coordinate all the stakeholders – on top of their daily workload. But we (EI) have people who can take such a mandate and help Your own people advance in knowledge and with the project alike.
We keep alliance with partners who can drive the actual digitalization of data, especially if You find no suitable business counterpart for example doing power BI for data pooling structures and more.
What will it take Your company (with or without external help)?
If You do digitalization – especially if You take a larger step (no matter in what area in Your GMP-, GDP, or GxP-company), You might as well do it wholeheartedly.
It will take extra effort on the part of everyone involved, and this is a real extra – not just an imaginary thought. Prepare Your staff wisely! Communicate with credibility where this is going.
It will take a darn good project manager and project management structure that can react to the unforeseen.
It will take nerve – lots of nerve – to face how many things that used to be non-digitalized actually never really worked! This will cause delay.
It will take plausible timelines that are only to a limited degree tied to immediate business goals – for then if it (digitalization) delays or fails – then all fails!
And – most importantly – it will take a change agent to generate acceptance of the things that are coming.
All things considered: be courageous and give it a go. In the long run there will likely be no way around a rather comprehensive digitalization for GxP-companies. Now is a good time.
The GMP Management Review: A highly underestimated instrument of quality assurance
The GMP Management Review: A highly underestimated instrument of quality assurance
The management review is not a new instrument in the GMP quality system; it is also a topic within the latest EU GDP Guidance. Nevertheless: in reality, many GMP companies still do not really know how to deal with this topic – the implementation of the management review is completely lacking in some places. Where does that come from…?
Quality system ICHQ10
It is often not clear to the management and senior management of a GMP company how this requirement for a management review fits into the existing quality system, let alone what the background and purpose of the requirement is. The answer is described in the Guidance on the Pharmaceutical Quality System ICHQ10 – as part of the EU GMP Guidance (Part III Q10), every company should be familiar with this document for its own benefit.
The lack of establishment of the management review
However, the lack of establishment of the management review is not just another item on the list of inspection deficiencies – unfortunately, it is much more serious: for many companies, the management review is part of an actual reorganization of the quality system – in accordance with ICHQ10.
GMP guidelines
Gone are the days when anyone could set up a quality system as they saw fit based on the chapters of the GMP guidelines – a collection of SOPs and processes from the guidelines that were linked together as best they could to form a quality system. Anyone who has not yet realized that ICHQ10 must be the leading principle – the big bracket around the pharmaceutical quality system of a GMP company – has some catching up to do.
ICHQ10
Does this mean having to completely rebuild a quality system? In most cases, adaptation to ICHQ10 should be feasible with manageable effort. However, anyone who has not taken ‘quality management’ in the GMP guidelines seriously for many years – i.e. has seen it more as a formality than an effective management tool – will now have to invest in order not to completely miss the boat when it comes to the GMP compliance required today. And that’s right: this applies not only to the developers of new drugs and their legacy products, but also to manufacturers of generics.
Conclusion
The ray of hope: The management review according to ICHQ10 is not just a manageable hurdle. In particular, the mandatory involvement of senior management means that this is the best opportunity to date to overcome the long-standing and well-known shortcomings of the in-house quality system.
One of the new chapters in Annex 1 deals with media systems. In addition to requirements for the design and operation of water systems, vacuum and cooling systems are also listed for the first time. Among other things, the new Annex 1 covers the requirement:
“6.23 There should be periodic cleaning/disinfection for both vacuum and cooling systems.”
Condensation phenomena
My comment: This requirement can be misunderstood. This does not mean, for example, that the piping system of the coolant should be cleaned / disinfected (as the first requests for comments have already been received by gmp-experts), which will be difficult as a purely technical system. Rather, this refers to the areas of installations where condensation can lead to localized and permanent moisture formation and thus the risk of germ formation and even biofilm formation.
Regular checks
What should you do? Regular monitoring means integrating these points into routine hygiene monitoring and regularly cleaning and disinfecting the affected areas, e.g. in the refrigerator, but also in the cooling register of a ventilation system. For the latter, the application of VDI 6022 Sheet 3, for example, would be highly recommended. A very good basis for a suitable hygiene plan is provided here in the form of a directly implementable checklist.
Cleaning / disinfection of vacuum systems
The cleaning / disinfection of vacuum systems primarily refers to all systems that are used to remove loads (heat, vapors, moisture, particles) from the environment of the product / process (generally referred to as source exhaust air systems). These can be classic extraction systems on workbenches, vacuum cleaners or permanently connected central extraction systems on process plants (e.g. vapor extraction systems on washing machines).
Pipes / fittings and filters
In any case, cleaning / disinfection in relation to the corresponding clean room zone in which the system is located includes the removal of all contaminants from pipes / fittings and filters that could return to the process / product in the opposite direction to the suction direction during operation.
Requirement from Annex 1
Conclusion of this new requirement from Annex 1: A corresponding maintenance / cleaning plan and integration into routine monitoring as a GMP routine is the necessary basis for this and should be included in the company’s hygiene system as an important component of the Contamination Control Strategy (CCS).
https://experts-institut.com/wp-content/uploads/2023/02/Medien.webp504784Dipl. Ing. Wolfgang Rudloffhttps://experts-institut.de/wp-content/uploads/2023/02/GEMI_Logo_Slogan_color_RGB.webpDipl. Ing. Wolfgang Rudloff2023-02-18 17:06:092024-03-12 14:50:15Media systems – new chapter in Annex 1
Process stability – process capability – controlled state – Important terms that should not be missing in any current process validation!
Guidelines for process validation
In the current guidelines on process validation (FDA Guidance, Annex 15, Aide memoire 07122901) as well as in more and more inspection reports, there is a requirement for proof of process stability, process capability and the continuation of the controlled state. What is meant by this?
A stable process is a process that predictably delivers products of comparable quality batch after batch. This state can also be referred to as a “controlled process” or a “process under (statistical) control”.
However, process stability does not automatically mean that the process also delivers a product that conforms to specifications. A stable process can also predictably deliver products that are not of the desired quality.
Process stability
Fig. 2: Stable process that violates the specification limits
Therefore, in addition to the term process stability, the guidelines also include the requirement for appropriate process capability. The calculation of the process capability in the form of the process capability index (Ppk or Cpk) sets the scatter of the results and the position of the mean value in relation to the specification limits. High process capability means that the results are so far away from the specification limits that it is very unlikely that OOS results will occur in the batch.
If a process is stable and has good process capability, a product is manufactured that is firstly comparable with the previously produced batches (process stability) and secondly lies safely within the specification limits (process capability).
Process capability
However, the terms process stability and process capability always refer only to a single product characteristic, e.g. the content of the medicinal product, and not, as the terms imply, to the entire process. It is therefore quite possible that a process delivers tablets with reproducible, specification-compliant content, but that these show completely different active ingredient releases from batch to batch.
Product features
Accordingly, it is essential to first identify all critical product features that need to be assessed as part of process validation in a risk-based manner and then, in a second step, to check whether the process is stable and capable with regard to all critical product features.
The EU and FDA guidelines on process validation require that the stability of manufacturing processes must be proven. How can this be achieved?
A simple and effective way to analyze your data with regard to process stability is to display the results to be evaluated in control charts.
In contrast to the Excel charts usually used in process validations, the control chart does not contain any acceptance criteria, but statistical key figures that allow the current production to be compared with previous productions. For example, the plotted mean value of previous results can be used to identify mean value shifts in current production (see Fig. 1), while the display of warning and intervention limits allows the scattering of results to be evaluated (Fig. 2).
The warning and intervention limits in control charts are calculated from the mean value and the standard deviation of the sample, which should comprise at least 30 data points.
This is based on the assumption that, in the case of a nominal distribution, 95 % of the values lie within the range of mean ± 2σσ and 99.7 % of all values lie within the range of mean ± 3σσ (see Fig. 3).
What does that mean?
If 100 values are entered in the control chart, no values outside the intervention limits may occur with an unchanged stable process and only 5 values may be in the range between the warning limit and the intervention limit.
If 1000 values are entered in the control chart, only 3 values will be outside the intervention limits if the process stability remains unchanged.
What else is important:
Setting intervention limits based on the results of only a few batches, e.g. three process validation batches, carries the risk of underestimating the “normal” inter-batch variability, i.e. the differences between the individual batches, so that the calculated intervention limits may not be sufficient. are too narrow. It therefore makes sense in this case to clearly state that the limits determined are provisional limits that will be adjusted in the further course of batch production as soon as further findings on inter-batch variability have been obtained.
By the way: By using control charts, you are using a statistical tool and thus already fulfilling the requirement for statistical analyses of your data!
If you have fewer than 30 data points from the production of previous batches, it makes more sense to carry out a purely visual evaluation of process stability based on diagrams without intervention limits, but with the reported acceptance criteria.
https://experts-institut.com/wp-content/uploads/2023/02/Prozessstabilitaet-BLOG.webp378575Dipl. Ing. Wolfgang Rudloffhttps://experts-institut.de/wp-content/uploads/2023/02/GEMI_Logo_Slogan_color_RGB.webpDipl. Ing. Wolfgang Rudloff2023-02-18 17:00:402024-03-12 14:50:02Proof of process stability
The calculation of the process capability in the form of the process capability index (Ppk or Cpk) sets the scatter of the individual results and the position of the mean value in relation to the specification limits. The higher the process capability index, the further away the individual results are from the specification limits.
Calculation of the process capability index:
The following parameters are included in the calculation of the process capability index:
Mean value (μ)
Standard deviation of the mean value (σ)
Upper and lower specification limit (OSG and USG)
The first step is to calculate the process capability indices “Cpo” and “Cpu” for the upper and lower specification limits:
Cpu = (μ – USG)/(3σ) USG = lower specification limit
Cpk = min(Cpo, Cpu)
In a second step, the lower value (Cpk = smallest process capability value) of the two values is selected:
The calculation of meaningful Cpk values is only possible from 25 – 30 individual values.
Sample calculation:
Investigated quality characteristic: content of a medicinal product
Specification limits: 95 – 105 mg
Average value: 98 mg
Standard deviation: 0.5 mg
Cpo = (105 mg – 98 mg)/(3×0.5 mg) = 4.7
Cpu = (98 mg – 95 mg)/( 3×0.5 mg) = 2.0
Cpk = min(Cpo, Cpu) = 2.0
But what do the Cpk values obtained mean?
Cpk = 1.00
If 1 million units are checked, 2699 faulty units would be found. The distance of the mean value to the next specification limit corresponds to 3 times the standard deviation (3σ) of the values.
Cpk = 1.33
If 1 million units are checked, 66 faulty units would be found. The distance of the mean value to the next specification limit corresponds to 4 times the standard deviation (4σ) of the values.
Cpk = 1.67
If 1 million units are checked, no faulty units would be found. The distance of the mean value to the next specification limit corresponds to 5 times the standard deviation (5σ) of the values.
Cpk = 2.00
If 1 million units are checked, no faulty units would be found. The distance of the mean value to the next specification limit corresponds to 6 times the standard deviation (6σ) of the values.
The limit values selected for the CpK value should be determined on a risk basis. This means that the more critical a quality characteristic is, the higher the acceptance criterion for the CpK value should be.
Examples of a risk-based definition of suitable acceptance criteria:
https://experts-institut.com/wp-content/uploads/2023/02/Blog-JK-061120-1-980x513-1.webp513980Dipl. Ing. Wolfgang Rudloffhttps://experts-institut.de/wp-content/uploads/2023/02/GEMI_Logo_Slogan_color_RGB.webpDipl. Ing. Wolfgang Rudloff2023-02-18 16:52:152024-03-12 14:50:05Sensible limit values for process capability
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